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Sysmex is active in a broad spectrum of healthcare areas. In addtion to information for healthcare professionals we also provide applied information for privat individuals seeking assistance in our
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Publications

The articles included in this list provide the latest scientific research with respect to body fluids, platelets, red blood cells.

White Blood Cells

Flagging

Schuff-Werner P et al.(2016): Performance of the XN-2000 WPC channel-flagging to differentiate reactive and neoplastic leucocytosis. Clin Chem Lab Med 54(9):1503
What we see as the essence: The XN-1000 demonstrated an excellent performance for differentiation between neoplastic and reactive leukocytosis.

Jones AS et al. (2015): The value of the white precursor cell channel (WPC) on the Sysmex XN-1000 analyser in a specialist paediatric hospital.J Clin Pathol 68:161
What we see as the essence: "The flagging efficiency of the XE-5000 and XN-Series were compared in paediatric blood samples: sensitivity was improved when only the WDF channel of the XN was used while both sensitivity and specificity were improved when also the WPC channel was used."

Hotton J et al. (2013): Performance and Abnormal Cell Flagging Comparisons of Three Automated Blood Cell Counters -Cell-Dyn Sapphire, DxH-800, and XN-2000. Am J Clin Pathol 140:845–852.
What we see as the essence: "Repeatability, linearity and carryover was good for all tested analysers, and correlation between the analysers was good for HGB, MCV, PLT and WBC.
Quotes: "The XN showed a higher sensitivity than the SAPH and DxH for all flags of interest." "For the first time, we have decreased the slide review for our laboratory from 20% with the SAPH to 9.3% with the XN."

Briggs CJ et al. (2011): Improved Flagging Rates on the Sysmex XE-5000 Compared With the XE-2100 Reduce the Number of Manual Film Reviews and Increase Laboratory Productivity. Am J Clin Pathol 136: 309–316.
What we see as the essence: "The increased specificity of the XE-5000 eMM (efficient multichannel messaging) flagging reduces the number of manual film reviews, particularly for blast and abnormal lymph flags. "

Granulocytes

Hampson P et al. (2016): Neutrophil Dysfunction, Immature Granulocytes, and Cell-free DNA are Early Biomarkers of Sepsis in Burn-injured Patients: A Prospective Observational Cohort Study. Ann Surg.; early online
What we see as the essence: Neutrophil and IG counts correlated with sepsis risk in burn patients. They could be used as predictive markers of sepsis in burn patients together with other markers such as the phagocytic index and cell free DNA.

Stiel L et al. (2016): Neutrophil Fluorescence: A New Indicator of Cell Activation During Septic Shock-Induced Disseminated Intravascular Coagulation. Crit Care Med;44(11):e1132
What we see as the essence: Neutrophil fluorescence (NEUT-RI) above 57.3 FI had a sensitivity of 90.9% and a specificity of 80.6% for diagnosis of disseminated intravascular coagulation in patients with septic shock.

Park SH et al. (2015): Sepsis affects most routine and cell population data (CPD) obtained using the Sysmex XN-2000 blood cell analyzer: neutrophil-related CPD NE-SFL and NE-WY provide useful information for detecting sepsis. Int J Lab Hematol. 37(2):190
What we see as the essence: NE-SFL and NE-WY parameters have a good potential as sepsis markers and have a high specificity and sensitivity to differentiate between sepsis and non-sepsis groups.

Ha SO et al. (2015): Fraction of immature granulocytes reflects severity but not mortality in sepsis. Scand J Clin Lab Invest.; 75(1):36
What we see as the essence: Sepsis patients with an IG count on the XE-2100 of more than 0.5% were more likely to suffer from severe sepsis or septic shock, while WBC, CRP and PCT were not predictive of sepsis severity. None of the tested markers could predict 28-day mortality.

Arneth B et al. (2015): Technology and New Fluorescence Flow Cytometry Parameters in Hematological Analyzers. J Clin Lab Anal: 29(3): 175
What we see as the essence: "This paper gives a good overview of the technology behind the XE-Series and the benefits of flow cytometry and automatic cell counting. It shows that the XE-5000 delivers faster accurate results than older analysers."

Cornet E et al.(2015): Contribution of the new XN-1000 parameters NEUT-RI and NEUT-WY for managing patients with immature granulocytes. Int J of Lab Hematol.: 37(5): e123
What we see as the essence: "Normal values were determined on the XN-Series for the structural neutrophil parameters NEUT-GI , NEUT-RI  and NEUT-WY. In addition, it was shown that NEUT-GI and NEUT-WY can be used to predict IG% values within a 72 h time frame."

Zimmermann M et al.(2015): Detection and quantification of hypo- and hypergranulated neutrophils on the new Sysmex XN hematology analyzer: establishment of an adapted reference interval for the neutrophil-granularity-intensity compared to XE-technology in adult patients.Clin Lab 61: 235–241.
What we see as the essence: "The reference intervals for NEUT-GI (XN-Series) and NEUT-X (XE-Series) were determined using 246 blood-healthy control patients: 140.91 - 160.46 channels and 129.20 - 142.33 channels, respectively. Neutrophil granularity was higher in ICU patients."

Wiland EL et al. (2014): Adult and child automated immature granulocyte norms are inappropriate for evaluating early-onset sepsis in newborns. Acta Paediatr.: 103(5): 494.
What we see as the essence: "A study on the XE-5000 showed that IG counts were increased during the first 2 days after birth. Therefore, the authors conclude that the use of adult and child norms for IG% is not appropriate for newborns when evaluating early-onset sepsis."

Nierhaus A et al. (2013): Revisiting the white blood cell count: immature granulocytes count as a diagnostic marker to discriminate between SIRS and sepsis - a prospective, observational study. BMC Immunology 14:8
What we see as the essence: "Direct quote: Our findings demonstrate that sepsis is associated with an increased immature granulocyte count. The IG count can differentiate between patients with an infection and those who are not infected, particularly within the first critical hours after an initial SIRS alert. Using ROC analysis we found the IG count a superior biomarker for sepsis compared to C-reactive protein, lipopolysaccharide binding protein and interleukin-6."

Cimenti C et al. (2012): The predictive value of immature granulocyte count and immature myeloid information in the diagnosis of neonatal sepsis. Clin Chem Lab Med 50: 1429–1432.
What we see as the essence: "Compared to a manual smear review, automated detection of IG # and IMI # represents a fast, accurate and less labour-intensive method and could improve screening and monitoring for early onset sepsis in neonates."

Roehrl MHA et al. (2011): Age-dependent reference ranges for automated assessment of immature granulocytes and clinical significance in an outpatient setting. Arch Pathol Lab Med 135: 471–477.
Free online.
What we see as the essence: "The use of appropriate reference ranges makes the IG count a powerful haematologic parameter for outpatient care that is associated with differential diagnoses that are distinctly characteristic of that setting."

Zimmermann M et al.(2011): Granularity Index of the SYSMEX XE-5000 hematology analyzer as a replacement for manual microscopy of toxic granulation neutrophils in patients with inflammatory diseases. Clin Chem Lab Med 49: 1193–1198.
What we see as the essence: "The Granularity Index (GI) is suited to quantify the degree of toxic granulation of neutrophils. The GI is a parameter calculated from automated, standardised measurements. The authors suggest that it should replace the time-consuming and subjective microscopic procedure."

Le Roux G et al. (2010): Routine diagnostic procedures of myelodysplastic syndromes: value of a structural blood cell parameter (NEUT-X) determined by the Sysmex XE-2100™. Int J Lab Hematol 32: e237–243
What we see as the essence: "NEUT-X and the calculated granularity index GI help to screen for myelodysplastic syndromes (MDS) with increased sensitivity without increasing unnecessary smears."

Furundarena J et al. (2009): The utility of the Sysmex XE-2100 analyzer's NEUT-X and NEUT-Y parameters for detecting neutrophil dysplasia in myelodysplastic syndromes. Int J Lab Hematol 32: 360–366.
What we see as the essence: "The parameters NEUT-X and NEUT-Y can be used to detect neutrophil dysplasia arising from MDS and chronic myelomonocytic leukaemia (CMML)."

Linssen J et al. (2008): Automation and validation of a rapid method to assess neutrophil and monocyte activation by routine fluorescence flow cytometry in vitro. Cytometry B (Clin Cytometry) 74: 295–309. Free online.
What we see as the essence: "Fluorescence flow cytometry can measure  activation steps of monocytes and polymorphonuclear neutrophils to defined external stimuli. This may potentially be applied as a screening and surveillance method for inflammatory diseases."

Fernandes B and Hamaguchi (2007): Automated enumeration of immature granulocytes. Am J Clin Pathol 128: 454–463.
What we see as the essence: "The use of appropriate reference ranges makes the IG count a powerful haematologic parameter for outpatient care that is associated with differential diagnoses that are distinctly characteristic of that setting."

Ansari-Lari A et al. (2003): Immature granulocyte measurement using the Sysmex XE-2100. Relationship to infection and sepsis. Am J Clin Pathol 120: 795–799.
What we see as the essence: "The automated IG count matches the manual IG count very well. At significantly elevated levels, it is a very specific predictor of sepsis. Multiparameter algorithms might be more successful at lower concentrations."

Briggs C et al. (2000): New quantitative parameters on a recently introduced automated blood cell counter – the XE 2100. Clin Lab Haematol 22: 345–350.
What we see as the essence: "The IG count correlated with visual counts thus potentially improving screening and monitoring of various pathological conditions and reducing turnaround time."

Low WBC mode

SEO JY et al. (2015): Performance evaluation of the new hematology analyzer Sysmex XN-series. Int J Lab Hematol. 37(2): 155
What we see as the essence: "A good correlation was found between the XN- and XE-Series for all parameters. The XN-Series dramatically reduced the smear rate (by 58%). Even at counts below 500/µl the XN provided an accurate WBC count using the Low WBC mode."

Tanaka Y et al. (2014): Elimination of interference by lipids in the Low WBC mode in the automated hematology analyzer XN-2000. Int J Hematol. 36(4): e50
What we see as the essence: "The study shows that potential interferences by the contamination of lipids have been eliminated in the two leukocyte channels of the XN-series, particularly compared to non-fluorescent methods. Furthermore, the new Low WBC mode showed better precision for leukopenic samples than the whole blood (WB) mode."

NRBC

Monteiro Juior JG et al. (2015): Nucleated Red Blood Cells as Predictors of All-Cause Mortality in Cardiac Intensive Care Unit Patients: A Prospective Cohort Study. PLoS One. 29;10(12):e0144259
What we see as the essence: "The presence of NRBC (XE-2100) was associated with a higher ICU mortality (49.4% vs 21.7%, P<0.001) as well as in-hospital mortality (61.4% vs 33.3%, p = 0.001). "

Cremer M et al. (2015): Nucleated red blood cells as marker for an increased risk of unfavorable outcome and mortality in very low birth weight infants. Early Hum Dev.; 91(10):559-563 
What we see as the essence: "This study of 438 low birth weight infants indicates that an NRBC count obtained 24-120 h after birth can serve as a surrogate marker for later severe morbidity and mortality. The optimal cut-off value was 2x10^9/L with 83% sensitivity and 75% specifity. "

Tantanate C et al. (2014): Performance evaluation of the automated nucleated red blood cell enumeration on Sysmex XN analyser. Int J Lab Hematol. 2015;37(3):341. 
What we see as the essence: "NRBC counts from the XN-Series could replace manual counts: the precision of the XN-Series was superior and a small bias (manual counts slightly higher than NRBC counts from the XN-Series) was only observed for NRBC counts above 200/100 WBC "

Hotton J et al. (2013): Performance and Abnormal Cell Flagging Comparisons of Three Automated Blood Cell Counters -Cell-Dyn Sapphire, DxH-800, and XN-2000. Am J Clin Pathol 140:845–852.
What we see as the essence: "Repeatability, linearity and carryover was good for all tested analysers, and correlation between the analysers was good for HGB, MCV, PLT and WBC.
Quotes: "The XN showed a higher sensitivity than the SAPH and DxH for all flags of interest." "For the first time, we have decreased the slide review for our laboratory from 20% with the SAPH to 9.3% with the XN. "

Parco S et al. (2013): Public banking of umbilical cord blood or storage in a private bank: testing social and ethical policy in northeastern Italy. J Blood Med 4: 23–29.
What we see as the essence: "An excellent correlation was found between manual NRBC counts and NRBC counts from the XE-2100 (R2 = 0.94) in umbilical cord blood. This number may be used to correct the WBC count and thereby guarantee an adequate WBC concentration for blood banking of umbilical cord blood. "

Gasparović V et al. (2012): Nucleated red blood cells count as first prognostic marker for adverse neonatal outcome in severe preeclamptic pregnancies.Coll. Antropol 36: 853–857.
What we see as the essence: "An increased count of nucleated red blood cells in preterm newborns born from pregnancies with severe preeclampsia seems to be the first significant marker for detecting adverse neonatal outcome. "

Kuert S et al (2011): Association of nucleated red blood cells in blood and arterial oxygen partial tension. Clin Chem Lab Med 49: 257–263.
What we see as the essence: "The NRBC count is an independent risk indicator of poor prognosis and mortality, NRBC-positive patients required a longer stay in the intensive care unit. "

Danise P et al. (2011): Evaluation of nucleated red blood cells in the peripheral blood of hematological diseases. Clin Chem Lab Med 50: 357–360.
What we see as the essence: "NRBC are found in nearly all onco-haematological diseases at diagnosis and frequently during therapy. They are absent at remission. "

Danise P et al. (2009): Nucleated red blood cells and soluble transferrin receptor in thalassemia syndromes: relationship with global and ineffective erythropoiesis. Clin Chem Lab Med 47: 1539–1542.
What we see as the essence: "The NRBC count helps defining ineffective erythropoiesis in thalassaemia patients and supporting transfusion management "

Stachon A et al. (2007): Nucleated red blood cells in the blood of medical intensive care patients indicate increased mortality risk: a prospective cohort study. Crit Care 11: R62.
What we see as the essence: "The NRBC count is one indicator of mortality ─ persistence (observed in daily screenings) and high concentration are both indicators for poor prognosis."

Stachon A et al. (2006): Poor prognosis indicated by nucleated red blood cells in peripheral blood is not associated with organ failure of the liver or kidney. Clin Chem Lab Med 44: 955–961.
What we see as the essence: "The NRBC count is one indicator of mortality independent of other factors such as kidney or liver failure. "

Stachon A et al. (2006): Daily monitoring of nucleated red blood cells in the blood of surgical intensive care patients. Clin Chim Acta 366: 329–335.
What we see as the essence: "NRBC count is an early indicator of mortality - daily screening is recommended."

Otsubo H et al. (2005): Persistent nucleated red blood cells in peripheral blood is a poor prognostic factor in patients undergoing stem cell transplantation. Clin Lab Haematol 27: 242–246.
What we see as the essence: "Monitoring NRBC in stem cell transplantation patients provides useful clinical information - NRBC can be observed persistently in non-survivors."

Stachon A et al. (2004): High in-hospital mortality of intensive care patients with nucleated red blood cells in blood. Clin Chem Lab Med 42: 933–938.
What we see as the essence: "The NRBC count is of high prognostic power regarding in-hospital mortality"

Wang FS et al. (2003): Development and clinical application of nucleated red blood cell counting and staging on the automated haematology analyser XE-2100. Clin Lab Haematol 25: 17–23.
What we see as the essence: "The NRBC count correlates well with flow cytometry."

Stachon A et al.  (2002): Nucleated red blood cells indicate high risk of in-hospital mortality. J Lab Clin Med 140: 407–412.
What we see as the essence: "NRBC are often an only transient observation, but they indicate a poor prognosis, whether transient or persistent."

Briggs C et al.  (2000): New quantitative parameters on a recently introduced automated blood cell counter - the XE 2100. Clin Lab Haematol 22: 345–350.
What we see as the essence: "The automated NRBC count was highly correlated with the manual reference count (r2=0.97) and thus eliminates the need for manual NRBC counts."

Other Body Fluids

Xu W et al. (2016): Evaluation of Sysmex XN-1000 hematology analyzer for cell count and screening of malignant cells of serous cavity effusion. Medicine (Baltimore);96(27):e7433
What we see as the essence: The study found that the XN-Series body fluid mode has an excellent performance, which makes it a reliable and practical alternative to optical microscopy for synovial fluids in clinical laboratories.

Seghezzi M et al. (2016): Optimization of Cellular analysis of Synovial Fluids by optical microscopy and automated count using the Sysmex XN Body Fluid Mode. Clin Chem Acta 462:41
What we see as the essence: The study found that the XN-Series body fluid mode has an excellent performance, which makes it a reliable and practical alternative to optical microscopy for synovial fluids in clinical laboratories.

Tanaka M et al. (2016): Performance evaluation of the XN-550 Automated Hematology Analyzer body Fluid Mode — Considerations for Operational Conditions for Cell Counting with Cerebrospinal and Synovial Fluids —. Sysmex J Int 26 (1) Free online (after free registration) 
What we see as the essence: Good performance of body fluid mode on XN-L was found compared to manual microscopy and XN-9000 for cerebrospinal and synovial fluid samples.

Buoro S et al. (2016): Cell population data and reflex testing rules of cell analysis in pleural and ascitic fluids using body fluid mode on Sysmex XN-9000. Clin Chem Acta; early online
What we see as the essence: "Results of the study confirm that the XN-BF module on Sysmex XN-9000 is a suitable alternative to optical microscopy for screening body fluid samples. Peritoneal and pleural fluids were analysed in the study. Authors implemented own validation rules that increased the productivity."

Fleming C et al. (2015): Clinical relevance and contemporary methods for counting blood cells in body fluids suspected of inflammatory disease. Clin Chem Lab Med 53(11):1689
What we see as the essence: "Excellent review on body fluid analysis. Several different analysers were compared, including the XE-5000, XN-Series and UF-Series."

Labaere D et al. (2015): Detection of malignant cells in serous body fluids by counting high-fluorescent cells on the Sysmex XN-2000 hematology analyzer.Int J Lab Hematol 2015; Int J Lab Hematol 37(5):715.  
What we see as the essence: "Analysis of serous fluids on the XN-2000 showed that the absence of high fluorescence body fluid cells (HF-BF) could be used to exclude malignant samples: the negative predictive value was 92% at a cutoff of 2.1% and 95% at a cutoff of 17/µL."

Lippi G et al. (2013): Evaluation of the Fully Automated Hematological Analyzer Sysmex XE-5000 for Flow Cytometric Analysis of Peritoneal Fluid. J Lab Autom 2013;18(3):240.
What we see as the essence: "This evaluation of the XE-5000 for peritoneal fluid analysis showed excellent performance for all analyzed parameters. The performance of the XE-5000 was slightly better than that of the XE-2100."

Fleming C et al. (2012): Validation of the body fluid module on the new Sysmex XN-1000 for counting blood cells in cerebrospinal fluid and other body fluids. Clin Chem Med Lab 50: 1791-1798.
What we see as the essence: "The BF module on the XN-1000 is a suitable tool for fast and accurate quantification of WBC (differential) and RBC counts in CSF and other BFs in a diagnostic setting."

De Jonge R et al. (2010): Evaluation of the new body fluid mode on the Sysmex XE-5000 for counting leukocytes and erythrocytes in cerebrospinal fluid and other body fluids. Clin Chem Lab Med 48: 665–675.
What we see as the essence: "The body fluid mode on the Sysmex XE-5000 offers rapid and accurate RBC and WBC (differential) counts in clinically relevant concentration ranges in CSF and other fluids."

Paris A et al. (2010): Performance evaluation of the body fluid mode on the platform Sysmex XE-5000 series automated hematology analyzer. Int J Lab Hematol 32: 539–547.
What we see as the essence: "The XE-5000 count is trustworthy and can provide more precise and reliable information than the manual method using the Malassez chamber (1µL counting volume)."

Riedl JA et al. (2010): Automated morphological analysis of cells in body fluids by the digital microscopy system DM96. J Clin Pathol 63: 538–43.
What we see as the essence: "The 24 h available DM96 body fluid module reliably and accurately preclassifies five main cell categories in cytospin slides with a low CV and an agreement of 90% as compared with highly trained technicians, thereby contributing to quality improvement."

De Jonge R et al. (2006): Automated analysis of pleural fluid total and differential leukocyte counts with the Sysmex XE-2100. Clin Chem Med Lab 44: 1367–71.
What we see as the essence: "With some limitations, total and differential WBC counts in pleural fluid can be reliably determined using the XE-2100."

De Jonge R et al. (2004): Automated counting of white blood cells in synovial fluid. Rheumatol 43: 170–173.
What we see as the essence: "The WBC count in synovial fluid using the DIFF channel of the XE-2100 can be reliably determined more precisely and faster than by manual counting. The better precision may also improve the low confidence that clinicians have in these results at present."

Ly-X, Ly-Y, Ly-Z

Oehadian A et al. (2015): New parameters available on Sysmex XE-5000 hematology analyzers contribute to differentiating dengue from leptospirosis and enteric fever. Int J Lab Hematol 37(6):861
What we see as the essence: The detection of atypical lymphocytes, high-fluorescent lymphocytes and immature granulocytes on the XE-5000 supports the differentiation between common causes of febrile illnesses with thrombocytopenia in dengue areas.

Henriot l et al. (2015): New parameters on the hematology analyzer XN-10 (SysmexTM) allow to distinguish childhood bacterial and viral infections. Int J Lab Hematol early online
What we see as the essence: "New parameters from the Sysmex XN  allowed to differentiate between inflammation and infection in children. The parameter AS-LYMP (AUC=0.83) had the same discrimation power as procalcitonin (AUC=0.82) to distinguish between bacterial and viral infections."

Brisou G et al. (2015): Alarms and Parameters Generated by Hematology Analyzer: New Tools to Predict and Quantify Circulating Sezary Cells. J ClinLab Anal: 29(2): 153
What we see as the essence: "Combining the 'Blasts/Abn Lympho?' flag with the Ly-X and Ly-Y parameters it was possible to differentiate Sezary patients from control patients (sensitivity 89%; specificity 98%) or from patients with chronic lymphoproliferative diseases (sensitivity 89%; specificity 94%). The proposed algorithm may alert the microscopist that a sample likely contains Sezary cells."

Van Mirre E et al. (2011): Sensitivity and specificity of the high fluorescent lymphocyte count-gate on the Sysmex XE-5000 hematology analyzer for detection of peripheral plasma cells. Clin Chem Lab Med 49: 685–688.
What we see as the essence: "The Sysmex XE-5000 is suitable for screening blood samples for the presence of elevated numbers of plasma cells in peripheral blood."

Linssen J et al.(2007): Identification and quantification of high fluorescence-stained lymphocytes as antibody synthesizing/secreting cells using the automated routine hematology analyzer XE-2100. Cytometry B (Clin Cytometry) 72: 157–166. Reprinted in: Sysmex J Int 19(1): 19–25.
What we see as the essence: "The Sysmex high-fluorescence lymphocyte count  quantifies activated B-lymphocytes with high precision and reliability in patients without haematological systemic diseases, thus providing a potential screening and monitoring tool for a suspected infection."

Monocytes

Kawauchi S et al. (2014): Comparison of the Leukocyte differentiation Scattergrams Between the XN-Series and the XE-Series of Hematology Analyzers. Int J Lab Hematol 24(1): 1:
Free online (after free registration).
What we see as the essence: The paper explains the different effects of the WDF and DIFF reagents on leukocytes and why the WDF scattergram of the XN shows a better separation of the different cell populations, especially the separation between LYMPH and MONO is better.

Mazumdar R et al. (2013): The automated monocyte count is independently predictive of overall survival from diagnosis in chronic lymphocytic leukaemia and of survival following first-line chemotherapy. Leukemia  Research 2013; Jun;37(6):614-618.
What we see as the essence: "A monocyte count >0.91 × 109/L at the time of diagnosis was associated with a shortened overall and treatment-free survival in CLL patients."

General

Tailor H et al. (2017): Evaluation of the Sysmex XN-550, a Novel Compact Haematology analyser from the XN-L® series, compared to the XN-20 system.Int J lab Hematol; early online
What we see as the essence: Samples from adult patients (N=202) were measured on the XN-550 and compared with an XN-20. Good correlations and low bias was observed for all parameters except for BASO%. PLT-O from the XN-550 showed no significant bias compared to PLT-F from the XN-20.

Cao J et al. (2017): Establishing a Stand-Alone Laboratory Dedicated to the Care of Patients With Ebola Virus Disease.Lab Med; 48(2): 188
What we see as the essence: The pocH-100i was used in a laboratory dedicated to detection of Ebola virus disease. Its accuracy was verified by comparison with the XE-2100 in the main laboratory, and its precision and reportable range were also consistent with Sysmex's claims

Henriot I et al. (2017): New parameters on the hematology analyzer XN-10 (SysmexTM) allow to distinguish childhood bacterial and viral infections Int J Lab Hematol 39(1):14
What we see as the essence: New parameters from the Sysmex XN  allowed to differentiate between inflammation and infection in children. The parameter AS-LYMP (AUC=0.83) had the same discrimation power as procalcitonin (AUC=0.82) to distinguish between bacterial and viral infections.

Jo SY et al. (2017):  Performance evaluation of recently launched Sysmex XN-550 Automatic Hematology Analyzer. Int J Lab Hematol 39(1):e4 
What we see as the essence: "The XN-550 showed a good analytical performance and strong correlation with XE-2100 and XN-3000 analysers for routine CBC parameters."

Tamigniau A et al. (2016): From XE-2100 to XN-9000, from SIS Standard to GFHC recommendations for slide review: potential impact on review rate and turnaround time. Annales de biologie Clinique
What we see as the essence: Changing from the XE-2100 to XN-9000 and implementing the Biomedical Validation ruleset led to a significant reduction in review rate (from 35.8% to 25.9%) and TAT. In this hospital this resulted in a cost reduction of 7000 Euros over 6 months.

Cornet E et al. (2016):  Evaluation and optimization of the extended information process unit (E-IPU) validation module integrating the sysmex flag systems and the recommendations of the French-speaking cellular hematology group (GFHC).
What we see as the essence: "Using the biomedical validation criteria, 21.3% of samples triggered a smear review. Modification of four criteria reduced the number of smears from 21.3% to 15.0% without loss of clinical value. "

Van Dievoet MA et al. (2016):  Performance evaluation of the Sysmex® XP-300 in an oncology setting: evaluation and comparison of hematological parameters with the Sysmex® XN-3000.  Int J Lab Hematol early online
What we see as the essence: "The XP-300 showed very good precision and linearity results, comparable with the XN-3000 analyser."

Geara C et al. (2016): Comparative study of quantitative performances between the new Sysmex XN-L (XN-550) haematology analyser and the XN-9000 in a routine laboratory. Int J Lab Hematol 38(1):e10
What we see as the essence: "The XN-Series and XN-L Series were compared; correlations were good and the study showed that the XN-L Series provided the same high quality as the XN-Series. "

Takagi Y et al. (2015): Comparison of optical data from flow cytometry and microscopy of leukocytes after exposure to specific reagents. Microscopy (Oxf) 64(5):305
What we see as the essence: "Flow cytometry software and electron microscopy methods were used to confirm the positions and fluorescence intensity of WBC populations in the XN-WDF scattergram."

Bruegel M et al. (2015): Comparison of five automated hematology analyzers in a university hospital setting: Abbott Cell-Dyn Sapphire, Beckman Coulter DxH 800, Siemens Advia 2120i, Sysmex XE-5000, and Sysmex XN-2000.Clin Chem Lab Med 53(7): 1057
What we see as the essence: " A comparison of Abbott, Beckman Coulter, Siemens and Sysmex analysers found superior flagging performance of the XN-2000, especially for blasts and variant lymphocytes. Otherwise, the analysers were comparable."

Tabe Y et al. (2015): Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system. Clin Chem Lab Med 53(2): 281
What we see as the essence: " This performance evaluation of the digital imaging analyser DI-60 showed a good agreement between results from the DI-60 and manual microscopy. In addition, blasts were correctly classified with 95% sensitivity and 99% specificity."

Seo JY et al. (2015): Performance evaluation of the new hematology analyzer Sysmex XN-series. Int J Lab Hematol. 37(2): 155
What we see as the essence: " A good correlation was found between the XN- and XE-Series for all parameters. The XN-Series dramatically reduced the smear rate (by 58%). Even at counts below 500/µL the XN provided an accurate WBC count using the Low WBC mode."

Genevieve F et al. (2014): Smear microscopy revision: propositions by the GFHC. feuillets de Biologie VOL LVI N° 317
What we see as the essence: The GFHC reviewed in detail the criteria used within the CBC to generate blood smears and has decided on a number of minimum recommendations, defining threshold values and various situations in which the blood smear review is desirable.

Nguyen VTP et al. (2013): Évaluation de l’automate d’hématologie Sysmex XN-2000® pour une utilisation en routine : comparaison avec l’Advia 2120i®. Immuno-analyse & Biologie Spécialisée 28: 125. Article in French.
What we see as the essence: Compared with the Advia 2120i, the XN-2000 provided reliable, repeatable and stable results and increased the laboratory efficiency because of its speed and the reduced manual slide review rate. The BF mode allowed rapid and precise RBC and WBC counts.

Kawauchi S et al.(2013): The Positions of Normal Leukocytes on the Scattergram of the Newly Developed Abnormal Cell-detection Channel of the XN-Series Multi-parameter Automated Hematology Analyzers. Sysmex J Int: 23(1):1-9 (free online, after free registration).
What we see as the essence: "Using purified leukocyte populations, the paper confirms the position of those populations within the WPC scattergrams.  Interestingly, two populations of lymphocytes with a different resistance to WPC reagents were found."

Briggs C et al. (2012): Performance evaluation of the Sysmex haematology XN modular system. J Clin Pathol 65:1024-30.
What we see as the essence: "The XN showed reduced sample turnaround time and reduced number of blood film reviews compared to the XE-2100 without loss of sensitivity and with more precise and accurate results for both platelets and low WBC counts."

XN Stem Cells

Grommé M et al. (2015): Multicenter study to evaluate a new enumeration method for hematopoietic stem cell collection management.Transfusion.;early online
What we see as the essence: The XN Stem cell method correlates well with the gold standard of CD34 flow cytometry during stem cell mobilisation phase to determine apheresis start time, during apheresis for real-time monitoring and for QC of the final stem cell harvest.

Park SH et al.(2015): The New Sysmex XN-2000 Automated Blood Cell Analyzer More Accurately Measures the Absolute Number and the Proportion of Hematopoietic Stem and Progenitor Cells Than XE-2100 When Compared to Flow Cytometric Enumeration of CD34(+) Cells. Ann Lab Med.;35(1):146 free online.
What we see as the essence: Stem cell counts from the XN-Series were more accurate than stem cell counts from the XE-Series when compared to CD34 flow cytometry.

 Peerschke El et al. (2015): Evaluation of new automated hematopoietic progenitor cell analysis in the clinical management of peripheral blood stem cell collections. Transfusion.55(8):2001
What we see as the essence: XN-Stem Cells is a functional equivalent of CD34 analysis and may be a surrogate for CD34 analysis to predict optimal timing of stem cell collections from mobilized peripheral blood.

Tanosaki R et al.(2014): Novel and rapid enumeration method of peripheral blood stem cells using automated hematology analyzer. Int J Lab Hematol;36(5):521.
What we see as the essence: This study found that CD34-positive cells fall in the XN stem cell gate in the WPC scattergram. The final yield of collected CD34-positive cells could be predicted from the XN-HPC value in pre-apheresis blood and apheresis products.

Red Blood Cells

FRC

Hervent AS et al. (2015): This performance evaluation showed that the CELLAVISION Advanced RBC Software Application is easy to use and provides a sensitive and reproducible measurement of schistocytes in peripheral blood.. Int J Lab Hematol 37(5):588
What we see as the essence: "This performance evaluation showed that the CELLAVISION Advanced RBC Software Application is easy to use and provides a sensitive and reproducible measurement of schistocytes in peripheral blood."

Lesesve JF et al. (2015): Fragmented red cells reference range for the Sysmex XN® -series of automated blood cell counters. Int J Lab Hematol 37(5):583.
What we see as the essence: "Normal values were determined on the XN-Series for the percentage fragmented red blood cells, FRC%: 0.14 +/- 0.35% (mean 0%). It was also found that HYPO-He correlates with FRC%; so samples with both a high HYPO-He and FRC% should be interpreted with care."

Lesesve JF et al. (2012): Fragmented red blood cells automated measurement is a useful parameter to exclude schistocytes on the blood film. Int J Lab Hematol 34(6):566.
What we see as the essence: "The automated FRC count offers a better degree of certainty than microscopy to exclude the presence of fragmented RBC."

Abe Y et al. (2009): The effectiveness of measuring for fragmented red cells using an automated hematology analyzer in patients with thrombotic microangiopathy. Clin Appl Thromb Hemost 15: 257–262.
What we see as the essence: "In conclusion, the FRC level is a simple and useful marker for thrombotic microangiopathy (TMA), and an FRC level of 1.2% is recommended as the cutoff value for the diagnosis of TMA."

Imoto S et al. (2009): Usefulness of sequential automated analysis of fragmented red blood cells for the differential diagnosis of TTP-hemolytic uremic syndrome following allogeneic hematopoietic cell transplantation. Lab Hematol 11: 131–136.
What we see as the essence: "Sequential monitoring of FRC% may be a reliable marker for a specific type of complication (TTP-HUS; thrombotic thrombocytopenic pupura haemolytic uraemic syndrome) after allogeneic haematopoietic precursor cell transplantation."

Banno S et al. (2005): Quantification of red blood cell fragmentation by the automated hematology analyzer XE-2100 in patients with living donor liver transplantation. Clin Lab Haematol 27: 292–296.
What we see as the essence: "The determination of FRC% by the XE-2100 enables early diagnoses and monitoring of TTP (thrombotic thrombocytopenic pupura) or TMA (thrombotic microangiopathy) and will be useful in the clinical field."

Jiang et al. (2001): Quantification of red blood cell fragmentation by automated haematology analyser XE-2100. Clin Lab Haematol 23: 167–172.
What we see as the essence: "Initial study showing that the automated FRC% measurement is promising.."

HYPO-He / HYPER-He / MicroR / MacroR

Schoorl M et al. (2012): Efficacy of Advanced Discriminating Algorithms for Screening on Iron-Deficiency Anemia and ß-Thalassemia Trait. Am J Clin Pathol 138: 300–304.
What we see as the essence:  "The authors conclude that the advanced algorithms, derived from extended RBC parameters provided by the Sysmex XE-5000 analyzer, are useful as laboratory devices for anaemia screening."

Persijn L et al. (2012): Screening for hereditary spherocytosis in routine practice: evaluation of a diagnostic algorithm with focus on non-splenectomised patients. Ann Hematol 91: 301–302.
What we see as the essence: "The hereditary spherocytosis diagnostic tool by Mullier et al. is useful and works, but needs fine-tuning to the local patient population."

Mullier F et al. (2011): Additional erythrocytic and reticulocytic parameters helpful for diagnosis of hereditary spherocytosis: results of a multicentre study. Ann Hematol 90: 759–768.
What we see as the essence: "Combining several RBC parameters allows to efficiently screen for hereditary spherocytosis even in mild cases."     

Urrechaga E et al. (2011): The role of automated measurement of RBC subpopulations in differential diagnosis of microcytic anemia and β-thalassemia screening. Am J Clin Pathol 135:374-379.
What we see as the essence: "Because of high sensitivity and specificity, the new index %MicroR-%HYPO-He was the most reliable index in the differential diagnosis of microcytic anaemias."

Urrechaga E. et al. (2011): Erythrocyte and reticulocyte parameters in iron deficiency and thalassemia. J Clin Lab Anal 25: 223–228.
What we see as the essence: "Beta-thalassaemia can be recognised through high RBC, small MCV, high %MicroR and moderately increased IRF, whereas iron deficiency shows high RDW and %HYPO-He."

Urrechaga E et al. (2011): The role of automated measurement of red cell subpopulations on the Sysmex XE-5000 analyzer in the differential diagnosis of microcytic anemia. Int J Lab Hematol 33: 30–36.
What we see as the essence: "Because of high sensitivity and specificity, the new index %MicroR-%HYPO-He was the most reliable index in the differential diagnosis of microcytic anaemias."

Urrechaga E et al. (2009): Potential utility of the new Sysmex XE 5000 red blood cell extended parameters in the study of disorders of iron metabolism. Clin Chem Lab Med 47: 1411–1416.
What we see as the essence: "The new parameters %HYPO-He/%HYPER-He and %MicroR/%MacroR appear to be sensitive for detecting small changes in the number of red cells with inadequate haemoglobinisation and volume in order to distinguish beta-thalassaemia from iron deficiency anaemia."

RET-He / RBC-He

Wirawan R et al. (2017): Concordance between Reticulocyte Hemoglobin Equivalent and Reticulocyte Hemoglobin Content in CKD Patients Undergoing Hemodialysis. Acta Med Indones.;49(1):34
What we see as the essence: A very strong correlation (r=0.91) and a good concordance was found between RET-He and CHr with a mean bias of 0.5 pg in chronic kidney disease patients undergoing haemodialysis. It indicates that RET-He and CHr can both be used for assessing iron status.

Toki Y et al. (2017): Evaluation of the hypochromic erythrocyte and reticulocyte hemoglobin content provided by the Sysmex XE-5000 analyzer in diagnosis of iron deficiency erythropoiesis. Int J Hematol; early online
What we see as the essence: RET- He was shown to be a clinically useful marker for determining iron deficiency in the general population and can also be used for the evaluation of the efficacy of iron administration.

Buttarello M et al. (2016): Evaluation of the hypochromic erythrocyte and reticulocyte hemoglobin content provided by the Sysmex XE-5000 analyzer in diagnosis of iron deficiency erythropoiesis. Clin Chem Lab Med; 54(12):1939
What we see as the essence: RET-He and %Hypo-He, measured on the XE-5000, allowed identification of patients with iron deficiency, especially those who had already developed anaemia. RET-He had a better sensitivity, presumably because it is more responsive to iron deficiency.

Weimann A et al. (2016): Delta-He, Ret-He and a New Diagnostic Plot for Differential Diagnosis and Therapy Monitoring of Patients Suffering from Various Disease-Specific Types of Anemia. Clin Lab;62(4):667
What we see as the essence: A diagnostic plot using RET-He and Delta-He was developed based on differences between different patient groups suffering from anaemia. Several case examples show the clinical utility of this plot for therapy monitoring.

Mehta S et al. (2016): Reticulocyte Hemoglobin vis-a-vis Serum Ferritin as a Marker of Bone Marrow Iron Store in Iron Deficiency Anemia. J Assoc Physicians India.;64(11):38.
Free online
What we see as the essence: This study showed that RET-He is a  better predictor of bone marrow iron stores in patients with severe anaemia than serum ferritin.

Urrechaga E et al. (2016): Percentage of hypochromic erythrocytes and reticulocyte hemoglobin equivalent predictors of response to intravenous iron in hemodialysis patients. Int J Lab Hematol 38(4):360.
What we see as the essence: "HYPO-He and RET-He are reliable parameters for the study of erythropoiesis status in hemodyalisis patients."

Al-Ghananim RT et al. (2016): Reticulocyte Hemoglobin Content During the First Month of Life in Critically Ill Very Low Birth Weight Neonates Differs From Term Infants, Children, and Adults. J Clin Lab Anal. 30(4):326
What we see as the essence: "RET-He values from the XE-2100 were lower in very low birth weight infants than in term infants, children and adults. RET-He was 31.8 pg within 24 hr after birth and subsequently declined to a steady-state level of 28.4 pg."

Archer NM et al. (2015): Diagnosis of iron-deficient states. Crit Rev Clin Lab Sci. 52(5):256.
What we see as the essence: "This review gives an overview of the haematological, biochemical and genetic markers for identifying iron deficiency. RBC-He, RET-He, Delta-He, HYPO-He and MicroR are mentioned besides the standard RBC indices. "

Peerschke E et al. (2014): Using the Hemoglobin Content of Reticulocytes (RET-He) to Evaluate Anemia in Patients With Cancer. Am J Clin Pathol 142:506-512
What we see as the essence: "RET-He values above 31 or 32 pg could be used to rule out iron deficiency in cancer patients. In the present study the use of RET-He would have reduced the number of biochemical iron studies by 66% (from 209 to 70). "

Schoorl M et al. (2012): Effects of iron supplementation on red blood cell hemoglobin content in pregnancy. Hematology Reports 4: e24.
What we see as the essence: "Ret-He and Ret-He/RBC-He ratio are sensitive markers for screening when a decrease in red blood cell haemoglobin content is observed and for monitoring short-term effects of iron supplementation. The authors recommend integrating these parameters into the protocol for anaemia screening and monitoring during pregnancy. "

Schoorl M et al. (2012): Temporary impairment of reticulocyte haemoglobin content in subjects with community-acquired pneumonia. Int J Lab Hematol 34: 390–395.
What we see as the essence: "In patients with community-acquired pneumonia, acute inflammation results in decreased RET-He values at an early stage, reflecting acute erythropoietic dysfunction."

Urrechaga E et al. (2012): Erythrocyte and reticulocyte indices in the assesment of erythropoiesis activity and iron availability. Int J Lab Hematol 35: 144–149.
What we see as the essence: "RET-He and %HYPO-He are helpful in assessing erythropoiesis and iron status."

Maier-Redelsperger M et al. (2010): Strong association between a new marker of hemolysis and glomerulopathy in sickle cell anemia. Blood Cell Mol Dis 45: 289–92.
What we see as the essence: "A special algorithm combining RBC-He, RET-He and lactate dehydrogenase bears the potential as a marker of haemolysis strongly correlated with albuminuria in sickle cell anaemia patients."

Jonckheere S et al. (2010): Erythrocyte indices in the assessment of iron status in dialysis-dependent patients with end-stage renal disease on continuous erythropoietin receptor activator versus epoetin beta therapy. Acta Haematol 124: 27–33.
What we see as the essence: "Due to fluctuations of iron status parameters, a fixed time point should be used for iron status monitoring during erythropoietin therapy."

Leers MP et al. (2010): The value of the Thomas-plot in the diagnostic work up of anemic patients referred by general practitioners. Int J Lab Hematol 32: 572–81.
What we see as the essence: "The Thomas-plot is helpful in diagnosing patients referred from general practitioners and differentiating functional iron deficiency from classical iron deficiency."

Schoorl M et al. (2010): Changes in red blood cell hemoglobinization during pregnancy. Ned Tijdschr Klin Chem Labgeneesk 35: 206–208.
Reprinted in Sysmex J Int 20(1): 12–14.
What we see as the essence: "RET-He is a useful sensitive and early indicator of iron status in the second half of pregnancy and should ideally be measured in combination with zinc protoporphyrin (ZPP) and IRF."

Van Wyck DB et al. (2010): Analytical and biological variation in measures of anemia and iron status in patients treated with maintenance hemodialysis. Am J Kidney Diseases 56: 540–546.
What we see as the essence: "RET-He could prove superior to transferrin saturation (TSAT) and ferritin in monitoring iron status of haemodialysis patients due to a lower biological variation."

Maconi M et al. (2009): Erythrocyte and reticulocyte indices in iron deficiency in chronic kidney disease: comparison of two methods. Scand J Clin Lab Invest 69: 365–370.
What we see as the essence: "RET-He and CHr correlate and agree well in evaluating CKD patients needing iron support."

Miwa N et al. (2009): Usefulness of measuring reticulocyte hemoglobin equivalent in the management of haemodialysis patients with iron deficiency. Int J Lab Hematol 32: 248–255.
What we see as the essence: "RET-He is equivalent to CHr and useful in managing haemodialysis patients with iron deficiency as it responds more rapidly than HGB."

Mast A et al. (2008): Reticulocyte hemoglobin content. Am J Hematol 83: 307–310
What we see as the essence: "Reticulocyte haemoglobin can be used to differentiate iron deficiency from other causes of anaemia and as an early marker to monitor the therapy."

Thomas C et al. (2006): The diagnostic plot: a concept for identifying different states of iron deficiency and monitoring the response to epoetin therapy. Med Oncol 23: 23–36.
What we see as the essence: "The Thomas-plot incl. RET-He can be used for the differential diagnosis of anaemia and also gives therapy options."

Brugnara C et al. (2006): Reticulocyte hemoglobin equivalent (Ret He) and assessment of iron-deficient states. Clin Lab Haematol 28: 303–308.
What we see as the essence: "RET-He is a reliable marker of cellular haemoglobin content and can be used to identify iron-deficient states, particularly in dialysis patients. RET-He and CHr are in good agreement."

Schoorl M et al. (2006): Erythropoiesis activity, iron availability and reticulocyte hemoglobinization during treatment with hemodialysis and in subjects with uremia. Clin Lab 52: 621–629.
What we see as the essence: "Biochemical parameters reflecting functional iron availability and haematological parameters reflecting haemoglobinisation are interdependent."

Thomas L et al. (2005): Reticulocyte hemoglobin measurement -- comparison of two methods in the diagnosis of iron-restricted erythropoiesis. Clin Chem Lab Med 43: 1193–1202.
What we see as the essence: "RET-He can replace CHr in the diagnostic Thomas-plot without loss of sensitivity or specificity."

Canals C et al. (2005): Clinical utility of the new Sysmex XE 2100 parameter - reticulocyte hemoglobin equivalent - in the diagnosis of anemia. Haematologica 90: 1133–1134.
What we see as the essence: "RET-He is useful for the differential diagnosis of iron deficiency anaemia vs anaemia of chronic disease and could also be helpful in the identification of thalassaemia patients."

Buttarello M et al. (2004): The new reticulocyte parameter (RET-Y) of the Sysmex XE 2100: its use in the diagnosis and monitoring of posttreatment sideropenic anemia. Am J Clin Pathol 121: 489–495.
What we see as the essence: "RET-Y closely correlates with CHr and can be used for diagnosis and early monitoring after the administration of intravenous iron."

RET / IRF

Morkis IVC et al. (2015): Assessment of immature platelet fraction and immature reticulocyte fraction as predictors of engraftment after hematopoietic stem cell transplantation. Int J Lab Hematol 37(2): 259.
What we see as the essence: "Both IRF% and IPF% can be used to predict neutrophil and platelet recovery, respectively. Work was done on XE-5000. "

Yesmin S et al. (2011): Immature reticulocyte fraction as a predictor of bone marrow recovery in children with acute lymphoblastic leukaemia on remission induction phase. Bangladesh Med Res Council Bull 37(2): 57-60
What we see as the essence: "In 52% of paediatric ALL patients, IRF% values rose before NEUT# values during recovery after chemotherapy. Therefore, monitoring of both parameters may be beneficial. "

Goncalo AP et al. (2011): Predictive value of immature reticulocyte and platelet fractions in hematopoietic recovery of allograft patients. Transplant Proc 43: 241–3.
What we see as the essence: "The immaturity fractions IRF and IPF offer an easy and early evaluation method of posttransplantational recovery of the bone marrow."

Torres Gomez A et al. (2003): Utility of reticulocyte maturation parameters in the differential diagnosis of macrocytic anemias. Clin Lab Haematol 25: 283–288.
What we see as the essence: "Reticulocyte maturation parameters (measured here on ABX Pentra) can support differential diagnosis of macrocytic anaemias."

General

Schapkaitz E et al. (2017): Evaluation of the InteRRliner automated erythrocyte sedimentation rate analyzer for a large academic laboratory. Int J Lab Hematol; 39(3):e66-e69.
What we see as the essence: Indicated by the high correlation coefficient of 0.96 the InteRRliner showed an excellent comparability to the HumaSed ESR method.

Tailor H et al. (2017): Evaluation of the Sysmex XN-550, a Novel Compact Haematology analyser from the XN-L® series, compared to the XN-20 system.Int J lab Hematol; early online
What we see as the essence: Samples from adult patients (N=202) were measured on the XN-550 and compared with an XN-20. Good correlations and low bias was observed for all parameters except for BASO%. PLT-O from the XN-550 showed no significant bias compared to PLT-F from the XN-20.

Cao J et al. (2017): Establishing a Stand-Alone Laboratory Dedicated to the Care of Patients With Ebola Virus Disease.Lab Med; 48(2): 188
What we see as the essence: The pocH-100i was used in a laboratory dedicated to detection of Ebola virus disease. Its accuracy was verified by comparison with the XE-2100 in the main laboratory, and its precision and reportable range were also consistent with Sysmex's claims

Jo SY et al. (2017): Performance evaluation of recently launched Sysmex XN-550 Automatic Hematology Analyzer. Int J Lab Hematol 39(1):e4
What we see as the essence: "The XN-550 showed a good analytical performance and strong correlation with XE-2100 and XN-3000 analysers for routine CBC parameters."

Tamigniau A et al. (2016): From XE-2100 to XN-9000, from SIS Standard to GFHC recommendations for slide review: potential impact on review rate and turnaround time. Annales de biologie Clinique
What we see as the essence: Changing from the XE-2100 to XN-9000 and implementing the Biomedical Validation ruleset led to a significant reduction in review rate (from 35.8% to 25.9%) and TAT. In this hospital this resulted in a cost reduction of 7000 Euros over 6 months.

Cornet E et al. (2016): Evaluation and optimization of the extended information process unit (E-IPU) validation module integrating the sysmex flag systems and the recommendations of the French-speaking cellular hematology group (GFHC).
What we see as the essence: "Using the biomedical validation criteria, 21.3% of samples triggered a smear review. Modification of four criteria reduced the number of smears from 21.3% to 15.0% without loss of clinical value. "

Van Dievoet MA et al. (2016): Performance evaluation of the Sysmex® XP-300 in an oncology setting: evaluation and comparison of hematological parameters with the Sysmex® XN-3000.              Int J Lab Hematol early online
What we see as the essence: "The XP-300 showed very good precision and linearity results, comparable with the XN-3000 analyser. "

Berda-Haddad Y et al. (2016): Increased mean corpuscular haemoglobin concentration: artefact or pathological condition? Int J Lab Hematol early online
What we see as the essence: "The use of the optical RBC parameters from the XN-Series can save time and help in the determination of the cause of increased MCHC."

Egele A et al. (2016): Classification of several morphological red blood cell abnormalities by DM96 digital imaging.Int J Lab Hematol 38(5):e98
What we see as the essence: The authors report the cutoff values for most of the RBC abnormalities that can be detected by the Advanced RBC Morphology software.

Egele A et al. (2015): Automated detection and classification of teardrop cells by a novel RBC module using digital imaging/microscopy. Int J Lab Hematol 37(6):e153 
What we see as the essence: The authors report excellent detection of teardrop cells in samples from patients with myelofibrosis and MDS, using the Advanced RBC Morphology software.

Ferrero-Vacher C et al. (2015): Utilisation des paramètres érythrocytaires Sysmex dans un cas d’hémolyse sévère (Erythrocytic parameters Sysmex in a case of severe haemolysis. Annales de Biologie Clinique 73(6):729 Article in French: 
What we see as the essence: Case report of severe haemolytic anaemia with cold agglutinins, identified by increased MCHC and qualitative alarms. The RBC-O and HGB-O parameters from the RET channel, and the RBC most frequent volume (R-MFV) allowed to report the correct results.

Archer NM et al. (2015): Technology and New Fluorescence Flow Cytometry Parameters
in Hematological Analyzers. J Clin Lab Anal: 29(3): 175
What we see as the essence: "This paper gives a good overview of the technology behind the XE-Series and the benefits of flow cytometry and automatic cell counting. It shows that the XE-5000 delivers faster accurate results than older analysers. "

Genevieve F et al. (2014): Smear microscopy revision: propositions by the GFHC. feuillets de Biologie VOL LVI N° 317
What we see as the essence: The GFHC reviewed in detail the criteria used within the CBC to generate blood smears and has decided on a number of minimum recommendations, defining threshold values and various situations in which the blood smear review is desirable.

Wang H et al. (2013): Use of RBC-O and S-MCV Parameters of Sysmex XE-2100 in a Patient with RBC Cold Agglutination Clin Lab.;59: 217
What we see as the essence: A combination of sample dilution and the use of RBC parameters from the RET channel on the XE-2100 is described to obtain accurate RBC parameters from samples with RBC cold agglutination without heating of the sample.

Godon A et al. (2012): Anomalies et erreurs de détermination de l’hémogramme avec les automates d’hématologie cellulaire Partie 3. Hémoglobine, hématies, indices érythrocytaires, réticulocytes*. Ann Biol Clin 2012; 70(2): 155 Article in French - Free online.
What we see as the essence: A summary report about potential interferences of CBC parameters with focus on situations leading to abnormal HGB, RBC and MCV, resulting in abnormal calculated RBC indices, e.g. MCHC. Alternative strategies may support management of interferences.

Platelets

IPF

Ferreira FLB et al. (2017): Evaluation of the immature platelet fraction contribute to the differential diagnosis of hereditary, immune and other acquired thrombocytopenias. Sci Rep.7(1):3355
What we see as the essence: The authors evaluated the use of IPF in the differential diagnosis between ITP and hereditary macrothrombocytopenia (HM). The IPF values were higher In HM than in ITP as already demonstrated by other studies.

Freynhofer MK et al. (2017): Platelet turnover predicts outcome after coronary intervention. Thromb Haemost. 117(5):923
What we see as the essence: An elevated platelet turnover independently predicts major adverse cardiovascular events after percutaneous coronary intervention. The optimal cut-off-value was at IPF=3.35 %.

McQueen BC et al. (2017): The immature platelet fraction: creating neonatal reference intervals and using these to categorize neonatal thrombocytopenias. J Perinatol; early online
What we see as the essence: Neonatal reference intervals for IPF and IPF# were reported according to gestational age, and during the first 90 days after birth. Moreover, neonates with hyporegenerative thrombocytopenias had lower IPF and IPF# than neonates with consumptive ones.

Buoro S et al. (2017): Abnormal leukocyte scattergrams and immature platelet fraction on Sysmex XN-9000 analyzer: a new diagnostic tool for altered megakaryopoiesis? Scand J Clin Lab Invest.;77(1):73
What we see as the essence: This case report shows how a high IPF, combined with abnormal WNR, WDF and WPC scattergrams could be used as a marker of dysmegakaryopoiesis, and led to the diagnosis of MDS type 2-refractory anaemia with excess blasts (REAB-2) in a nine year-old girl.

Stratz C et al. (2016): Comparison of Immature Platelet Count to Established Predictors of Platelet Reactivity During Thienopyridine Therapy. J Am Coll Cardiol.; 68(3):286 Free online.
What we see as the essence: IPF# is a strong independent platelet-derived predictor of antiplatelet response to thienopyridine treatment.

Jaing TH et al. (2016): Assessment of platelet activation and immature platelet fraction as predictors of platelet engraftment after hematopoietic stem cell transplantation.,Cell Transplant 25: 1259
What we see as the essence: "The study showed that IPF (XE-2100) can be used to assess thrombopoietic recovery after stem cell transplantation. Patients in the cord blood group had a higher IPF than the peripherial blood group on day 56 and day 97 post-transplantation."

Cremer M et al. (2016): Thrombocytopenia and platelet transfusion in the neonate. Seminars in Fetal & Neonatal Medicine2016,Vol 21(1):10
What we see as the essence: "The review summarises the pathophysiology and current management (including platelet transfusion thresholds) of neonatal thrombocytopenia. Novel index score for bleeding risk in thrombocytopenic neonates is proposed (including IPF#)."

Moraes D et al. (2016):Immature platelet fraction in hypertensive pregnancy. Platelets 27(4):333
What we see as the essence: IPF% measured on the XE-5000 in pregnant women suffering hypertensive disorders was higher than in control group (3.8, 2.4–5.1%; 8.6, 5.8–10.6%; 7.3, 4.2–10.2%; p < 0.001 for control group, preeclampsia syndrome and non-proteinuric hypertension, resp.).

Hong H et al. (2015): Absolute immature platelet count dynamics in diagnosing and monitoring the clinical course of thrombotic thrombocytopenic purpura. Transfusion. 55(4):756
What we see as the essence: The absolute IPF (from XE-5000) is useful to diagnose and to monitor the clinical course of therapeutic plasma exchange in TTP patients. Routine analysis of the absolute IPF is recommended for diagnosis and to better assess the need for adjustment of treatment.

Sakuragi M et al. (2015): Clinical significance of IPF% or RP% measurement in distinguishing primary immune thrombocytopenia from aplastic thrombocytopenic disorders. Int J Lab Hematol: 101(4):369.
What we see as the essence: "IPF% from the XN-1000 and RP% obtained by immuno flow cytometry had a comparable diagnostic value for the distinction between controls, immune thrombocytopenia (due to platelet destruction) and aplastic thrombocytopenia."

Mao W et al. (2015): Immature platelet fraction values predict recovery of platelet counts following liver transplantation. Clin Res Hepatol Gastroenterol; 39(4):469
What we see as the essence: "IPF% value predict recovery of PLT counts after liver transplantation. PLT counts reached the pre-transplant levels at 3-4 days after the IPF% peak value."

Miyazaki K et al. (2015): Immature platelet fraction measurement is influenced by platelet size and is a useful parameter for discrimination of macrothrombocytopenia. Hematology; 20(10):587-92
What we see as the essence: "The IPF% values were about five times higher in May-Hegglin disorders (IPF 48.6 ± 1.9%) and about twice as high in other macrothrombocytopenias (IPF 18.4 ± 2.1%) than in ITP patients with similar platelet counts (IPF 9.2 ± 0.3%)."

Fleming C et al. (2015): Liposomal interference on Sysmex XN-series body fluid mode. Clin Chem Lab Med.; 54(1):e19
What we see as the essence: "Liposomal particles from DepoCyt chemotherapy treatment may be misclassified as polymorphonuclear cells by the XN body fluid mode (software version 18). The authors worked together with Sysmex to develop an alert, available from software version 20."

Adly AA et al. (2015): Evaluation of the immature platelet fraction in the diagnosis and prognosis of childhood immune thrombocytopenia. Platelets: 26(7):645.
What we see as the essence: "IPF% obtained from the XE-2100 was increased in immune thrombocytopenia patients but not in patients with haematological malignancies. Therefore, IPF% may be used to evaluate the thrombopoietic state of the bone marrow."

Ibrahim H et al. (2014): Association of Immature Platelets With Adverse Cardiovascular Outcomes. J Am Coll Cardiol 64:2122
What we see as the essence: "IPF# (XE-2100) allows for stratification of patients with coronary artery disease in terms of risk for future adverse events. Patients with an IPF# level >=7,632/µl were more likely to experience an adverse event (hazard odds ratio: 4.65; p < 0.002)."

Dadu T et al. (2014): Evaluation of the IPF as an indicator of PLT recovery in dengue patients. Int J Lab Hematol: Vol 36(5): 499.
What we see as the essence: "IPF can be used to monitor the thrombocytopenia in patients with dengue fever. Furthermore it can predict the recovery of PLT and so avoid unnecessary blood transfusions."

Morkis IVC et al. (2014): Assessment of immature platelet fraction and immature reticulocyte fraction as predictors of engraftment after hematopoietic stem cell transplantation.Int J Lab Hematol: 37(2):259.
What we see as the essence: "Both IRF% and IPF% can be used to predict neutrophil and platelet recovery, respectively. Work was done on XE-5000."

Everett TR et al. (2014): Immature platelet fraction analysis demonstrates a difference in thrombopoiesis between normotensive and preeclamptic pregnancies. Thromb Haemost: 111(6):1177.
What we see as the essence: "The study illustrates the potential utility of IPF as a parameter to distinguish between normotensive and preeclamptic pregnant women. The authors suggest that IPF is a far better parameter than MPV, which has previously been suggested for this purpose, and can distinguish between the two groups even at normal platelet counts."

Van der Linden N et al. (2014): Immature platelet fraction (IPF) measured on the Sysmex XN haemocytometer predicts thrombopoietic recovery after autologous stem cell transplantation. Eur J Haematol 93(2): 150
What we see as the essence: "IPF is a promising predictor of platelet recovery in patients after autologous SCT." "The proposed cut-off value of 5,3% can theoretically be used to decide whether or not to give a platelet transfusion."

Greene LA et al. (2014): Beyond the platelet count: immature platelet fraction and thromboelastometry correlate with bleeding in patients with immune thrombocytopenia. Br J Haematol; 166(4):592
What we see as the essence: "IPF# demonstrated stronger correlation with the acute bleeding score than platelet counts. The strongest correlation was seen for paediatric patients with platelet counts <30 x 10^9/L. High IPF# was associated with low bleeding score."

Bat T et al. (2013): Measurement of the absolute immature platelet number reflects marrow production and is not impacted by platelet transfusion.Transfusion 53(6):1201.
What we see as the essence: "Absolute IPF is a good parameter to assess the megakaryocitic activity of the bone marrow in transfusion-dependent thrombocytopenic patients."

Cesari F et al. (2013): Reticulated platelets predict cardiovascular death in acute coronary syndrome patients. Insights from the AMI-Florence 2 Study. Thrombosis and Haemostasis 109: 846–53.
What we see as the essence: "Reticulated (immature) platelets may be independent predictors of cardiovascular death and may potentially be useful in improving risk stratification for acute coronary syndrome patients."

Cremer M et al. (2013): Low immature platelet fraction suggests decreased megakaryopoiesis in neonates with sepsis or necrotizing enterocolitis. J Perinatol  33(8): 622-626.
What we see as the essence: "Low absolute IPF values during the course of neonatal sepsis/necrotizing enterocolitis suggest suppression of megakaryopoietic activity."

Ko Y et al. (2013): Establishment of reference interval for immature platelet fraction. Int J Lab Hematol 35(5) 528-533.
What we see as the essence: "The study provides reference intervals for PLT, IPF% and absolute IPF from more than 2000 healthy individuals and from umbilical cord blood, according to the CLSI guideline. These results could be used as fundamental data for clinical use as well as future researches."

Sinclair L (2012): The immature platelet fraction: where is it now? Aust J Med Sci. 2012; Feb 33(1):10
What we see as the essence: "This is a clear and concise review of 53 original publications concerning the clinical value of IPF.  The diagnostic and prognostic potential of IPF in various conditions, and also advantages and limitations of IPF are described."

Sinclair L (2012): The immature platelet fraction: an assessment of its application to a routine clinical laboratory. Aust J Med Sci. 2012; Feb 33(2):48
What we see as the essence: "The purpose of the review is to assess the suitability of the IPF% as a routine test. Productivity rather than clinical value is discussed. Reference ranges are given."

Psaila B et al. (2012): In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation. Blood 119: 4066-4072.
What we see as the essence: "IPF% was higher in patients with ITP than the controls, reflecting the increased platelet production. Treatment with eltrombopag led to increased platelet counts, platelet size, and absolute IPF, but no significant change in IPF%."

Funck-Jensen K et al. (2012): Increased platelet aggregation and turnover in the acute phase of ST-elevation myocardial infarction. Platelets 24(7): 528-537.
What we see as the essence: "Increased platelet turnover, indicated by IPF and MPV, was observed in the acute phase of ST-elevated myocardial infarction and may partly explain reduced efficacy of oral antiplatelet drugs."

Parco S et al. (2012): Application of reticulated platelets to transfusion management during autologous stem cell transplantation. OncoTargets and Therapy 5: 1–5.
What we see as the essence: "Using IPF-rich platelet transfusions reduces the number of transfusions and bleedings after stem cell transplantation in paediatric patients."

Zucker ML et al. (2012): Mechanism of thrombocytopenia in chronic hepatitis C as evaluated by the immature platelet fraction. Int J Lab Hematol 34: 525–532.
What we see as the essence: "IPF% can support the differentiation between platelet destruction and bone marrow failure in hepatitis C patients." 

Goncalo A et al. (2011): Predictive value of immature reticulocyte and platelet fractions in hematopoietic recovery of allograft patients. Transplant Proc 43: 241–243.
What we see as the essence: "The immaturity fractions IPF and IRF offer an easy and early evaluation method of posttransplantational recovery of the bone marrow." 

Barsam SJ et al. (2011): Platelet production and platelet destruction: assessing mechanisms of treatment effect in immune thrombocytopenia. Blood 117: 5723–5732.
What we see as the essence: "The absolute immature platelet count (IPF#) can be used to assess the effect of different treatments of immune thrombocytopenia and could in such cases be more useful than IPF%." 

Strauss G et al. (2010): Immature Platelet Count: A Simple Parameter for Distinguishing Thrombocytopenia in pediatric acute lymphocytic leukemia from immune thrombocytopenia. Pediatr Blood Cancer 57(4):641-7
What we see as the essence: "Both IPF% and IPF# parameters should become a standard for evaluating the respective pathophysiologies underlying both congenital and acquired thrombocytopenias.

Cesari F et al. (2010): High platelet turnover and reactivity in renal transplant recipients patients. Thrombosis and Haemostasis 104: 804–810.
What we see as the essence: "Renal transplant recipients showed significantly higher values of reticulated platelets (IPF) than healthy control subjects, especially in those not on aspirin treatment. An elevated IPF% could be an additional hint for a mechanism involved in the increased cardiovascular risk profile of those patients."

Yamaoka G et al. (2010): The immature platelet fraction is a useful marker for predicting the timing of platelet recovery in patients with cancer after chemotherapy and hematopoietic stem cell transplantation. Int J Lab Hematol 32: e208–e216.
What we see as the essence: "An IPF% of above 10% is a useful marker for predicting the timing of platelet recovery after chemotherapy and haematopoietic stem cell transplantation and has the potential to facilitate optimal platelet transfusion."

Cremer M et al. (2009): Immature platelet fraction as novel laboratory parameter predicting the course of neonatal thrombocytopenia. Br J Haematol 144: 619–621.
What we see as the essence: "If the IPF is high, thrombocytopenic neonates are likely to recover on their own."

Takami A et al. (2007): Immature platelet fraction for prediction of platelet engraftment after allogeneic stem cell transplantation. Bone Marrow Transplant 39: 501–507.
What we see as the essence: "IPF counting can provide an accessible marker of engraftment after transplantation, especially of thrombopoietic activity."

Abe Y et al. (2006): A simple technique to determine thrombopoiesis level using immature platelet fraction (IPF). Thromb Res 118: 463–469.
What we see as the essence: "The results show that the IPF reflects the pathology of thrombocytopenic disorders (i.e. consumptive versus productive). Measurement of the IPF is useful for the differential diagnosis and analysis of platelet kinetics and significantly more so than the mean platelet volume (MPV)."

Briggs C et al. (2006): Immature platelet fraction measurement: a future guide to platelet transfusion requirement after haematopoietic stem cell transplantation. Transfus Med 16: 101–109.
What we see as the essence: "The automated IPF is a useful parameter in the clinical evaluation of the thrombocytopenic patient and has the potential to allow optimal transfusion of platelet concentrates."

Kickler T et al. (2006): A clinical evaluation of high fluorescent platelet fraction percentage in thrombocytopenia. Am J Clin Pathol 125: 282–287.
What we see as the essence: "The IPF (here named HFPF for ‘high fluorescence platelet fraction’) was predictive in the evaluation of thrombocytopenia. An elevated IPF is found with increased platelet production, particularly associated with platelet destruction, and in disorders associated with decreased platelet production the IPF is normal."

Briggs C et al. (2004): Assessment of an immature platelet fraction (IPF) in peripheral thrombocytopenia. Br J Haematol 126: 93–99.
What we see as the essence: "Automated IPF% measurement should become a standard parameter in evaluating the thrombocytopenic patient."

PLT-O

Briggs C et al. (2014): The most accurate platelet count on the Sysmex XE-2100. Optical or impedance? Clin Lab Haematol 26: 157–158.
What we see as the essence: "The accuracy of the XE-2100 platelet counting on chemotherapy samples with low counts is excellent when the switching algorithm is used. The optical count is not always the most accurate and the overriding of the algorithm is not good practice. "

PLT-F

Tantanate C et al. (2017): Performance Evaluation of Automated Impedance and Optical Fluorescence Platelet Counts Compared With International Reference Method in Patients With Thalassemia. Arch Pathol Lab Med; early online
What we see as the essence: PLT-I, PLT-O and PLT-F in thalassemia patients were compared with CD41/CD61 immune flow cytometry. PLT-O and PLT-F had better correlations with flow cytometry than PLT-I. PLT-F had a better specificity for detection of PTL counts below 100,000/µL

Park SH et al. (2014): The Sysmex XN-2000 Hematology Autoanalyzer Provides a Highly Accurate Platelet Count than the Former Sysmex XE-2100 System Based on Comparison with the CD41/CD61 Immunoplatelet Reference Method of Flow Cytometry. Ann Lab Med. 2014 Nov;34(6):471-4
What we see as the essence: "PLT-F counts from the XN-Series were more accurate than PLT-O counts from the XE-Series  when compared with the CD41/CD61 immunoplatelet reference method.

Tailor H et al. (2014): Evaluating platelet counting on a new automated analyser. Hospital Health Care Europe(HHE) 2014; 181-184.
What we see as the essence: "The PLT-F channel of the XN-Series shows excellent precision and accuracy even in abnormal samples or samples with fragmented red cells, large platelets and low PLT counts when compared to the reference flow cytometric method."

Tanaka Y et al. (2014): Performance Evaluation of Platelet Counting by Novel Fluorescent Dye Staining in the XN-Series Automated Hematology Analyzers. J Clin Lab Anal 28(5): 341.
What we see as the essence: "Compared to PLT-I and PLT-O counts, PLT-F had the best correlation with CD61-immunoplatelet counts. PLT-F counts were not affected by WBC fragments in two acute leukaemia patients or by RBC fragments and microcytes in a burn injury patient."

Schoorl M et al. (2013): New fluorescent method (PLT-F) on Sysmex XN2000 hematology analyzer achieved higher accuracy in low platelet counting. Am J Clin Pathol 140: 495–499.
What we see as the essence: "The PLT-F method of the XN-2000 demonstrated excellent reproducibility in samples with low platelet counts. Therefore, it is recommended for making decisions about platelet transfusions. "

Briggs C et al. (2012): Performance evaluation of the Sysmex haematology XN modular system. J Clin Pathol 65:1024-30.
What we see as the essence: "The XN showed reduced sample turnaround time and reduced number of blood film reviews compared to the XE-2100 without loss of sensitivity and with more precise and accurate results for both platelets and low WBC counts. "

General PLT

Tailor H et al. (2017): Evaluation of the Sysmex XN-550, a Novel Compact Haematology analyser from the XN-L® series, compared to the XN-20 system.Int J lab Hematol; early online
What we see as the essence: Samples from adult patients (N=202) were measured on the XN-550 and compared with an XN-20. Good correlations and low bias was observed for all parameters except for BASO%. PLT-O from the XN-550 showed no significant bias compared to PLT-F from the XN-20.

Cao J et al. (2017): Establishing a Stand-Alone Laboratory Dedicated to the Care of Patients With Ebola Virus Disease.Lab Med; 48(2): 188
What we see as the essence: The pocH-100i was used in a laboratory dedicated to detection of Ebola virus disease. Its accuracy was verified by comparison with the XE-2100 in the main laboratory, and its precision and reportable range were also consistent with Sysmex's claims

Jo SY et al.(2017): Performance evaluation of recently launched Sysmex XN-550 Automatic Hematology Analyzer. Int J Lab Hematol 39(1):e4
What we see as the essence: "The XN-550 showed a good analytical performance and strong correlation with XE-2100 and XN-3000 analysers for routine CBC parameters. "

Tamigniau A et al. (2016): From XE-2100 to XN-9000, from SIS Standard to GFHC recommendations for slide review: potential impact on review rate and turnaround time. Annales de biologie Clinique
What we see as the essence: Changing from the XE-2100 to XN-9000 and implementing the Biomedical Validation ruleset led to a significant reduction in review rate (from 35.8% to 25.9%) and TAT. In this hospital this resulted in a cost reduction of 7000 Euros over 6 months.

Cornet E et al. (2016): Evaluation and optimization of the extended information process unit (E-IPU) validation module integrating the sysmex flag systems and the recommendations of the French-speaking cellular hematology group (GFHC).
What we see as the essence: "Using the biomedical validation criteria, 21.3% of samples triggered a smear review. Modification of four criteria reduced the number of smears from 21.3% to 15.0% without loss of clinical value. "

Van Dievoet MA et al. (2016): Performance evaluation of the Sysmex® XP-300 in an oncology setting: evaluation and comparison of hematological parameters with the Sysmex® XN-3000.              Int J Lab Hematol early online
What we see as the essence: "The XP-300 showed very good precision and linearity results, comparable with the XN-3000 analyser. "

SEO JY et al. (2015): Performance evaluation of the new hematology analyzer Sysmex XN-series. Int J Lab Hematol. 37(2): 155
What we see as the essence: "A good correlation was found between the XN- and XE-Series for all parameters. The XN-Series dramatically reduced the smear rate (by 58%). Even at counts below 500/µl the XN provided an accurate WBC count using the Low WBC mode. "

Arneth B et al. (2015): Technology and New Fluorescence Flow Cytometry Parameters in Hematological Analyzers. J Clin Lab Anal: 29(3): 175
What we see as the essence: "This paper gives a good overview of the technology behind the XE-Series and the benefits of flow cytometry and automatic cell counting. It shows that the XE-5000 delivers faster accurate results than older analysers. "

Genevieve F et al. (2014): Smear microscopy revision: propositions by the GFHC. feuillets de Biologie VOL LVI N° 317
What we see as the essence: The GFHC reviewed in detail the criteria used within the CBC to generate blood smears and has decided on a number of minimum recommendations, defining threshold values and various situations in which the blood smear review is desirable.

Tailor H et al. (2014): Evaluating platelet counting on a new automated analyser. Hospital Health Care Europe(HHE) 2014; 181-184.
What we see as the essence: "The PLT-F channel of the XN-Series shows excellent precision and accuracy even in abnormal samples or samples with fragmented red cells, large platelets and low PLT counts when compared to the reference flow cytometric method."

Body Fluids

Cerebrospinal Fluid (CSF)

Buoro S et al. (2017): Two-site evaluation of the diagnostic performance of the Sysmex XN Body Fluid (BF) module for cell count and differential in Cerebrospinal Fluid. Int J Lab Hematol; early online
What we see as the essence: The XN Body Fluid mode provides rapid and accurate counts from of cerebrospinal fluid samples in clinically relevant ranges. It was found to provide a good alternative to conventional microscopic analysis.

Fleming C et al. (2015): Liposomal interference on Sysmex XN-series body fluid mode. Clin Chem Lab Med.; 54(1):e19
What we see as the essence: "Liposomal particles from DepoCyt chemotherapy treatment may be misclassified as polymorphonuclear cells by the XN body fluid mode (software version 18). The authors worked together with Sysmex to develop an alert, available from software version 20."

Fleming C et al. (2015): Clinical relevance and contemporary methods for counting blood cells in body fluids suspected of inflammatory disease. Clin Chem Lab Med 53(11):1689
What we see as the essence: "Excellent review on body fluid analysis. Several different analysers were compared, including the XE-5000, XN-Series and UF-Series."

Bottini PV et al. (2014): Comparison between automated and microscopic analysis in body fluids cytology.Int J Lab Hematol.;37(2):e16.
What we see as the essence: "The authors describe a performance evaluation of the XE-5000 body fluid mode for peritoneal and serous fluids. A good correlation between the XE-5000 and microscopy was found as well as good precision and low carryover."

Li A et al. (2014): Automated white blood cell counts in cerebrospinal fluid using the body fluid mode on the platform Sysmex XE-5000. Scand J Clin Lab Invest.; 74(8):673.
What we see as the essence: “In the present study, we found that the open body fluid mode of the Sysmex XE-5000 was a favourable method for determination of WBC counts and for differentiation between MNCs and PMNs, compared to manual counting."

Cho YU et al. (2013): Body fluid cellular analysis using the Sysmex XN-2000 automatic hematology analyzer: focusing on malignant samples. Int J Lab Hematol.; 37(3):346
What we see as the essence: "It was found that cell counts obtained from the XN-2000 body fluid mode were comparable to counts obtained from microscopy. The authors recommend that samples with highly fluorescent cells (HF-BF) should be further analysed."

Fleming C et al. (2013): Improved software on the Sysmex XE-5000 BF mode for counting leukocytes in cerebrospinal fluid. Clin Chem Lab Med 51: e61–63.
What we see as the essence: "This study reports an improved correlation between manual counts and XE-5000 counts of WBC and PMN in CSF when comparing software v10 to software v6. However, a significant positive bias remained for PMN."

Fleming C et al. (2012): Validation of the body fluid module on the new Sysmex XN-1000 for counting blood cells in cerebrospinal fluid and other body fluids. Clin Chem Med Lab 50: 1791-1798.
What we see as the essence: "The BF module on the XN-1000 is a suitable tool for fast and accurate quantification of WBC (differential) and RBC counts in CSF and other BFs in a diagnostic setting."

Zimmermann M et al. (2011): Automated vs. manual cerebrospinal fluid cell counts: a work and cost analysis comparing the Sysmex XE-5000 and the Fuchs-Rosenthal manual counting chamber. Int J Lab Hematol 33: 629–37.
What we see as the essence: "Using the XE-5000 for automated counting in CSF is trustworthy especially for severely pathological cell counts, but also below. The study demonstrates specific and significant savings in terms of time and money (about 6 ×)."

Zur B et al. (2011): Evaluation of 2 Hematology Analyzers in Body Fluid Mode versus Flow Cytometry Immunophenotyping of Mainly Neurosurgical Cerebrospinal Fluid Samples. Cen Eur Neurosurg 73: 93–8.
What we see as the essence: "Determination of CSF cells with the XE-5000 is presently the best automated method for counting leukocytes of blood-stained CSF."

De Jonge R et al. (2010): Evaluation of the new body fluid mode on the Sysmex XE-5000 for counting leukocytes and erythrocytes in cerebrospinal fluid and other body fluids. Clin Chem Lab Med 48: 665–675.
What we see as the essence: "The body fluid mode on the Sysmex XE-5000 offers rapid and accurate RBC and WBC (differential) counts in clinically relevant concentration ranges in CSF and other fluids."

Paris A et al. (2010): Performance evaluation of the body fluid mode on the platform Sysmex XE-5000 series automated hematology analyzer. Int J Lab Hematol 32: 539–547.
What we see as the essence: "The XE-5000 count is trustworthy and can provide more precise and reliable information than the manual method using the Malassez chamber (1µL counting volume)."

Sandhaus LM et al. (2010): Automated cerebrospinal fluid cell counts using the Sysmex XE-5000: is it time for new reference ranges? Am J Clin Pathol 134: 734–738.
What we see as the essence: "The correlation between XE-5000 and Fuchs-Rosenthal chamber over the entire range of data was very good. Studies are needed to determine method-specific reference intervals for white blood cells in CSF."

Riedl JA et al. (2010): Automated morphological analysis of cells in body fluids by the digital microscopy system DM96. J Clin Pathol 63: 538–43.
What we see as the essence: "The 24 h available DM96 body fluid module reliably and accurately preclassifies five main cell categories in cytospin slides with a low CV and an agreement of 90% as compared with highly trained technicians, thereby contributing to quality improvement."

Boer K et al. (2009): Evaluation of the XE-5000 for the automated analysis of blood cells in cerebrospinal fluid. Clin Biochem 42: 684–691.
What we see as the essence: "Most patients were classified correctly using the XE-5000 which is thus suitable for automated quantification of white blood cells in CSF in a defined diagnostic setting. This could significantly improve automation of CSF diagnostics."

Oncology

sentinel lymph node localisation

Breast Cancer Research and Treatment (2016): Karakatsanis A. et al. The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc99 and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies
Core message: “SPIO is an effective method for the detection of SN in patients with breast cancer. It is comparable to the standard technique and seems to simplify logistics.”

European Journal of Cancer (2016): Karakatsanis et al. The use of superparamagnetic iron oxide (SPIO) as sole method for the detection of sentinel node (SN) in breast cancer. The MONOS study
Core message: “SPIO is a safe and effective method in SN biopsy. It does not have the known drawbacks of the dual standard. … No adverse effects were noted; however, patients who will undergo breast conserving surgery should be informed about the possibility of skin staining.”

Annals of Surgical Oncology (2016): Teshome M. et al. Use of a Magnetic Tracer for Sentinel Lymph Node Detection in Early-Stage Breast Cancer Patients: A Meta-analysis
Core message: Sentinel Lymph node detection with Sienna+® revealed non-inferior performance to the standard method in breast cancer patients with clinically node-negative status.

Journal of Surgical Oncology (2015): Houpeau J.L. et al. Sentinel lymph node identification using superparamagnetic iron oxide particles versus radioisotope: The French Sentimag feasibility trial
Core message: Sentinel lymph node detection with Sienna+ is seen as a feasible method and a promising alternative to radiotracer. A beneficial potential was identified for ambulatory surgery or sites without nuclear medicine departments.

European Journal of Cancer Care (2015): Ghilli M. et al. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment
Core message: Sentimag® was identified as safe with non-inferior performance compared to the radiotracer. The Sentimag® technique can be applied after a minimum learning curve. Especially when nuclear medicine units are not available, the magnetic detection provides an effective treatment of breast cancer patients.

European Journal of Surgical Oncology (2015): Piñero-Madrona et al. The superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: A comparative non-inferiority study
Core message: This study showed non-inferiority of the Sentimag technique compared to radiotracer. Ex-vivo and intraoperative detection rates at the node level were found to be slightly higher with Sentimag.

European Journal of Surgical Oncology (2014): Rubio I.T. et al. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer
Core message: Detection of SLNs with SPIO was not inferior to radiotracer. Procedure is safe, reliable and facilitates patients and OR management.

The Breast (2014): Thill M. et al.: The Central-European SentiMag study Sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope
Core message: “We obtained convincing results that magnetic SLNB can be performed easily, safely and equivalently well in comparison to the radiotracer method.”

Annals of Surgical Oncology (2013): Douek M. et al. Sentinel Node Biopsy Using a Magnetic Tracer Versus Standard Technique: The SentiMAG Multicentre Trial
Core message: Sentimag/Sienna+ is a feasible technique for SLNB. The identification rate is not inferior to the standard.

sentinel lymph node analysis

Breast Cancer

The Breast (2017): Peg V. et al. Role of total tumour load of sentinel lymph node on survival in early breast cancer patients
Core message: “SLN TTL permits the differentiation between two patient groups in terms of DFS and OS, independently of axillary staging (pN), age and tumour characteristics (size, grade, lymphovascular invasion). This new data confirms the clinical value of low axillary involvement and could partially replace the information that staging of the entire axilla provides in patients on whom no axillary lymph node dissection is performed.”

PLoS One  (2017): Terrenato I. et al. A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients
Core message: “Logistic regression models indicated that the cut-off of 2150 copies better discriminates patients with node negative or positive in comparison with the conventional OSNA cut-off (p<0.0001). This cut-off identifies false positive and false negative cases and true-positive and true negative cases very efficiently, and therefore better identifies which patients really need an ALND and which patients can avoid one. This is why we suggest that the negative cut-off should be raised from 250 to 2150. Furthermore, we propose that for patients with a copy number that ranges between 2150 and 5000, there should be a multidisciplinary discussion concerning the clinical and bio-morphological features of primary breast cancer before any decision is taken on whether to perform an ALND or not.”

Journal of Experimental & Clinical Cancer Research (2016): Di Filippo F et al. Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
Core message: ”The results of the study confirm that OSNA nomogram may help surgeons make an intraoperative decision on whether to perform ALND or not in case of positive sentinel nodes, and the patient to accept this decision based on a reliable estimation on the true percentage of NSN involvement. The use of this nomogram achieves two main gools: 1) the choice of the right treatment during the operation, 2) to avoid for the patient a second surgery procedure.”

Molecular and Clinical Oncology (2016): Parada D. et al. Intraoperative molecular analysis of sentinel lymph nodes following neoadjuvant chemotherapy in patients with clinical node negative breast cancer: An institutional study
Core message: “The OSNA assay is a highly sensitive, specific and reproducible diagnostic technique that can be used to analyse SLNs following NAC. The total tumoral load may assist with predicting additional non SLN metastases.”

The Breast (2016): Espinosa-Bravo M. et al. Intraoperative assessment of sentinel lymph node by one-step nucleic acid amplification in breast cancer patients after neoadjuvant treatment reduces the need for a second surgery for axillary lymph node dissection
Core message: The accurate and standardized intraoperative SLN analysis by OSNA decreases the need of a second surgery in 18.5% of breast cancer patients with a positive SLN after neoadjuvant therapy.

Surgery Today (2016): Shimazu K. et al. Clinical significance of breast cancer micrometastasis in the sentinel lymph node
Core message: The OSNA method shows the benefit of reproducibility among different institutions and the capability of analysing a whole lymph node in only 30-40 minutes.

Molecular and Clinical Oncology (2016): Kubota M et al. One-step nucleic acid amplification assay for intraoperative prediction of advanced axillary lymph node metastases in breast cancer patients with sentinel lymph node metastasis
Core message: The Total Tumour Load (TTL) determined by OSNA analysis can predict further axillary lymph node metastases in breast cancer patients. The TTL can be assessed intra-operatively, thus it can be used during surgery to determine the need for axillary lymph node dissection.

European Journal of Surgical Oncology (2016): Banerjee SM et al. The use of one-step nucleic acid amplification (OSNA) and tumour related factors in the treatment of axillary breast cancer: A predictive model
Core message: A predictive model combining Total Tumour Load (TTL) determined by OSNA analysis with lymphovascular invasion can identify breast cancer patients who require additional axillary treatment, i.e. axillary lymph node dissection or other adjuvant measures.

Histopathology (2016): Vieites B. et al. CK19 expression in breast tumours and lymph node metastasis after neoadjuvant therapy
Core message: The expression of CK19 protein is preserved after neoadjuvant therapy. This indicates that OSNA is a suited approach for lymph node analysis also upon neoadjuvant treatment.

Revista de Senología y Patología Mamaria (2015): Bernet L. et al. A multiparametric predictive model of axillary status in patients with breast cancer: total tumoral load and molecular signature. A multicenter study
Core message: “The inclusion of PM in the multivariate model improved the AUC, especially when the total number of sentinel nodes were included. Differences were observed in the impact of the CTT among the different molecular profiles subtypes.”

Journal of Experimental & Clinical Cancer Research (2015): Di Filippo F. et al. Elaboration of a nomogram to predict non sentinel node status in breast cancer patients with positive sentinel node, intra-operatively assessed with one step nucleic acid amplification method
Core message: The nomogram described by Di Filippo et al. is a very useful tool for predicting non-SLN status in breast cancer patients with positive SLNs assessed intra-operatively by OSNA.

The Breast (2014): Piñero-Madrona A. et al. Tumoral load quantification of positive sentinel lymph nodes in breast cancer to predict more than two involved nodes
Core message: In this study, the OSNA result clearly correlates with the risk of having two or more metastatic non-SLNs in breast cancer patients.

Breast Cancer Research and Treatment (2014): Rubio IT. et al. Nomogram including the total tumoral load in the sentinel nodes assessed by one-step nucleic acid amplification as a new factor for predicting nonsentinel lymph node metastasis in breast cancer patients
Core message: The nomogram described by Rubio et al. incorporates the Total Tumour Load (TTL) assessed by OSNA and can be used to predict non-SLN positivity. This useful tool can support clinicians in decision-making.

Journal of Clinical Pathology (2014): Deambrogio C. et al. A new clinical cut-off of cytokeratin 19 mRNA copy number in sentinel lymph node better identifies eligible for axillary lymph node dissection in breast cancer
Core message: The CK19 mRNA copy number represents a useful tool to predict the probability of nodal involvement and thus, it can be applied for the selection of patients in which axillary lymph node dissection could be recommended due to the high risk of further axillary lymph node metastases.

Annals of Oncology (2013): Klingler S. et al. Using one-step nucleic acid amplification (OSNA) for intraoperative detection of lymph node metastasis in breast cancer patients avoids second surgery and accelerates initiation of adjuvant therapy
Core message: The intraoperative SLN analysis by OSNA reduces the need of a second surgery in breast cancer patients and allows a prompt initiation of adjuvant therapy.

European Journal of Surgical Oncology (2013): Espinosa-Bravo M. et al. Prediction of non-sentinel lymph node metastasis in early breast cancer by assessing total tumoral load in the sentinel lymph node by molecular assay
Core message: Intraoperatively assessed Total Tumour load (TTL) in SLNs of clinically node negative breast cancer patients predicts for further non-SLN metastasis. TTL helps decision-making on performing or not axillary lymph node dissection.

European Journal of Cancer (2013): Osako T. et al. Sentinel node tumour burden quantified based on cytokeratin 19 mRNA copy number predicts non-sentinel node metastases in breast cancer: molecular whole-node analysis of all removed nodes
Core message: The CK19 mRNA copy number determined by OSNA predicts non-SLN metastases. This study further support the predictive value of the OSNA result.

British Journal of Cancer (2013): Osako T et al. Molecular detection of lymph node metastasis in breast cancer patients treated with preoperative systemic chemotherapy: a prospective multicentre trial using the one-step nucleic acid amplification assay
Core message: “The OSNA assay can detect the residual tumour burden as accurately as conventional pathology, although chemotherapy-induced histological changes are present.”

European Journal of Surgical Oncology (2013): Navarro-Cecilia J. et al. Intraoperative sentinel node biopsy by one-step nucleic acid amplification (OSNA) avoids axillary lymphadenectomy in women with breast cancer treated with neoadjuvant chemotherapy
Core message: The OSNA result can predict the axillary status with a high accuracy also in clinically node negative patients at initial presentation who underwent neoadjuvant therapy.

Breast Cancer Research and Treatment (2013): Peg V. et al. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients
Core message: The Total Tumour Load (TTL) determined by OSNA is an independent predictor of the nodal status and can support clinicians in personalising surgical treatment.

Journal of Breast Cancer (2013): Sagara Y. et al. Clinical application of the one-step nucleic acid amplification method to detect sentinel lymph node metastasis in breast cancer
Core message: The OSNA assay allows the accurate analysis of SLN and the prediction of non-SLN metastases. Moreover, applying this technique reduces pathologist’s workload.

Journal of Cancer Research and Clinical Oncology (2013): Helimann T. et al.: Intra-operative use of one-step nucleic acid amplification (OSNA) for detection of the tumor load of sentinel lymph nodes in breast cancer patients
Core message: OSNA is a very useful tool for supporting intra-operative decision-making about further axillary surgery, thus reducing the risk of second surgeries. Moreover, the CK19 copy number allows the prediction of further lymph node involvement and might help to find adequate adjuvant treatment options.

British Journal of Cancer (2012): Ohi Y. et al. Whole sentinel lymph node analysis by a molecular assay predicts axillary node status in breast cancer
Core message: The CK19 mRNA copy number in the SLN is the most significant predictor of non-SLN involvement.

International Journal of Cancer (2012): Le Frère-Belda MA. et al. Diagnostic performance of one-step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients
Core message: The OSNA method shows a higher sensitivity than intraoperative histological evaluation, and thus its use possibly leads to a decrease of the number of women who require a second surgical procedure for axillary lymph node dissection.

Journal of Clinical Pathology (2012): Cserni G. Intraoperative analysis of sentinel lymph nodes in breast cancer by one-step nucleic acid amplification
Core message: Cserni et al. describes in this review current literature and concerns related to the OSNA method.

Annals of Surgery (2012): Castellano I. et al. Reliability of whole sentinel lymph node analysis by one-step nucleic acid amplification for intraoperative diagnosis of breast cancer metastases
Core message: Whole SLN analysis by OSNA provides objective and reproducible results that help treatment decision making and accurate characterisation of SLN staging.

Journal of Breast Cancer Research and Treatment (2012): Godey F. et al. Sentinel lymph node analysis in breast cancer: contribution of one-step nucleic acid amplification (OSNA)
Core message: The intraoperative analysis of SLN by OSNA enables the surgeon to perform, when necessary, axillary lymph node dissection during the same procedure.

Histopathology (2011): Bernet L. et al. Diagnosis of the sentinel lymph node in breast cancer: a reproducible molecular method: a multicentric Spanish study
Core message: OSNA is a very sensitive, specific and reproducible method that enables standardisation of the SLN diagnostic procedure.

British Journal of Surgery (2011): Snook KL. et al. Multicentre evaluation of intraoperative molecular analysis of sentinel lymph nodes in breast carcinoma
Core message: OSNA allows accurate intraoperative evaluation of SLN and show excellent concordance with histology. This promising approach will become the standard method for analysis of SLN and axillary LNs.

Virchows Archiv (2009): Schem C. et al. One-step nucleic acid amplification – a molecular method for the detection of lymph node metastases in breast cancer patients; results of the German study group
Core message: OSNA is a reliable and standardized tool for the intraoperative detection of lymph node metastases and its adoption may lead to a benefit for the patients since unnecessary second surgeries are avoided.

International Journal of Cancer (2008): Visser M. et al. Intra-operative rapid diagnostic method based on CK19 mRNA expression for the detection of lymph node metastases in breast cancer
Core message: OSNA enables whole lymph node analysis and therefore, sampling errors, which are related to histological techniques, are avoided. Moreover, the automated procedure leads to a high degree of standardization and objectivity.

Clinical Cancer Research (2007): Tsujimoto M. et al. One-step nucleic acid amplification for intraoperative detection of lymph node metastasis in breast cancer patients
Core message: CK19 mRNA copy number cut-off values enable to distinguish among macrometastasis, micrometastasis, and non-metastasis. The clinical findings indicate that the OSNA assay is a useful intraoperative detection method for the detection of lymph node metastasis in breast cancer patients.

 

Colon Cancer

Journal of Translational Medicine (2017): Rakislova N. et al. Lymph node pooling: a feasible and efficient method of lymph node molecular staging in colorectal carcinoma
Core message: “LN pooling makes it possible to analyze a high number of LNs from surgical colectomies with few molecular tests per patient. This approach enables a feasible means to integrate LN molecular analysis from CC specimens into pathology diagnosis and provides a more accurate LN pathological staging with potential prognostic implications.”

Virchows Archiv (2016) Aldecoa I. et al. Molecularly determined total tumour load in lymph nodes of stage I-II colon cancer patients correlates with high-risk factors. A multicentre prospective study
Core message: OSNA allows the identification of tumour burden (undetected by hystology) in lymph nodes of early colon cancer patients. Moreover, the Total Tumour Load (TTL) determined by OSNA correlates with high-risk factors and may be used for a better selection of stage I–II patients at risk of recurrence.

Surgical Endoscopy (2016): Aldecoa I. et al. Endoscopic tattooing of early colon carcinoma enhances detection of lymph nodes most prone to harbor tumor burden
Core message: Endoscopic tattooing clearly improves identification of lymph nodes. Moreover, this method allows the detection of those lymph nodes most prone to carry tumor burden as demonstrated by the Total Tumour Load (TTL) values.

Annals of Surgical Oncology (2016): Yamamoto H. et al. OSNA-Assisted Molecular Staging in Colorectal Cancer: A Prospective Multicenter Trial in Japan
Core message: High concordance between OSNA and histology. Besides, the TTL values determined by OSNA show to increase as the number of metastatic lymph node increases showing a trend compatible to the current pathological diagnosis system.

Annals of Surgical Oncology (2014): Vogelaar FJ. et al. The diagnostic value of one-step nucleic acid amplification (OSNA) for sentinel lymph nodes in colon cancer patients
Core message: The OSNA method shows a performance comparable to multilevel fine pathological examination. Since it enables whole lymph node analysis, sampling bias can be avoided leading to a more accurate tumour staging.

British Journal of Cancer (2014): Croner RS. et al. Molecular staging of lymph node-negative colon carcinomas by one-step nucleic acid amplification (OSNA) results in upstaging of a quarter of patients in a prospective, European, multicentre study
Core message: More than 25% of initially pN0 patients were upstaged by OSNA suggesting that this standardized and accurate method may improve staging.

 Japanese Journal of Clinical Oncology (2013): Yamamoto N. et al. An optimal mRNA marker for OSNA (One-step nucleic acid amplification) based lymph node metastasis detection in colorectal cancer patients
Core message: A CK19 mRNA copy number cut-off of 75-500 copies/µl leads to a high sensitivity and specificity of the OSNA method.

Cancer (2012): Güller U. et al. Molecular investigation of lymph nodes in colon cancer patients using one-step nucleic acid amplification (OSNA): a new road to better staging?
Core message: The OSNA method shows comparable performance such as intensive histopathological evaluation and may lead to upstaging of more than 15% of colon cancer patients.

Annals of Surgical Oncology (2011): Yamamoto H. et al. OSNA-based novel molecular testing for lymph node metastases in colorectal cancer patients: results from a multicenter clinical performance study in Japan
Core message: OSNA can be considered a novel molecular examination tool for the staging of colon cancer patients.

Journal of Translational Medicine (2010): Croner RS. et al. One step nucleic acid amplification (OSNA) - a new method for lymph node staging in colorectal carcinomas
Core message: The OSNA method allows the rapid analysis of the whole node and can applied as tool to determine nodal status in colon cancer patients.

Faecal immunochemical test for colorectal cancer screening

International Journal of Cancer (2017): Brenner H. et al. Strong subsite-specific variation in detecting advanced adenomas by fecal immunochemical testing for haemoglobin
Core message: FOB-Gold was applied prior to colonoscopy by 3.466 participants of the German screening colonoscopy program. The goal was to proof the subsite specific sensitivity for various types of colorectal neoplasms by comparing FIT results with findings at screening colonoscopy. The iFOBT FOB-Gold showed a sensitivity of 95-100% and therefore an excellent performance in detecting CRC.

Gastroenterology (2017): Toes-Zoutendijk E. et al. Real-Time Monitoring of Results During First Year of Dutch Colorectal Cancer Screening Program and Optimization by Altering Fecal Immunochemical Test Cut-Off Levels
Core message: Data were collected from the first year of the Dutch screening program (2014) with biennial FITs by real-time monitoring (529.056 people participating). Because of the higher than predicted positivity rate (10.6%) and the lower PPV (42.1%) after some months the FOB-Gold test cut-off was increased (from 15 to 47 µg Hb/g feces), resulting finally in 6.7% positivity rate and 49.1% PPV. It has been concluded that for optimization of screening performance (test cut-off adjustments) a close monitoring of the implementation program is needed.

European Journal of Cancer Prevention (2016): Dancourt V. et al. Influence of sample return time and ambient temperature on the performance of an immuno-chemical faecal occult blood test with a new buffer for colorectal cancer screening
Core message: Investigation on the effects of sample return time and of season on the FOB-Gold performance with a new buffer (study included 20.371 participants from French SP). The positivity rates were 4.1, 4.1 and 4.6% for a sample return time of up to 3 days, 4-5 days and 6-7 days. At 20°C there was a decrease in Hb concentration of 5.1% after 7 days, at 30°C of 20.5%. As result at 20°C after 7 days 100% of the samples of participants with CRC (4/4) and 97% of samples of participants with advanced adenomas (38/39) remained positive. It was concluded that a delay in sample return and season did not affect the diagnostic yield of FOB-Gold.

Gut (2016): Grobbee E.J. et al. A randomised comparison of two faecal immuno-chemical tests in population-based colorectal cancer screening
Core message: Comparison of two iFOBTs (FOB-Gold and OC-Sensor) on Dutch screening population (n=19.291; 60-74 years old). Both iFOBTs were equally acceptable to the participants. The test performance regarding detection of colorectal advanced neoplasia was comparable for both tests, as well as the positive predictive value. In conclusion, the OC-Sensor and FOB-Gold perform similar in population-based screening.

Clinical Gastroenterology and Hepatology (2016): Chen H. et al. Fresh vs Frozen Samples and Ambient temperature have Little Effect on Detection of Colorectal Cancer or Adenomas by a Fecal Immunochemical Test in a Colorectal Cancer Screening Cohort in Germany
Core message: Comparison of detection of CRCs and colorectal neoplasms by FOB-Gold using fresh samples vs frozen samples and assessment of the influence of seasonal variations (temperatures) on test performance. 3.466 FIT sample results from the German colonoscopy screening program were assessed. 12.8% of frozen stool samples and 8.7% of fresh stool samples had positive results by FIT. After adjusting the test cut-off to achieve the same %age of positive results, both sample cohorts showed similar levels of sensitivity and specificity for colorectal neoplasms. In addition no differences in detection of neoplasms during different seasons (different outdoor temperatures) were observed. It has been concluded that the use of fresh vs frozen samples only slightly affected positivity rates at the recommended test cut-off.

United European Gastroenterology Journal (2016): Dvir R. et al. SENTIFIT 270 SYSTEM CLINICAL PERFORMANCE EVALUATION COMPARED WITH OC SENSOR DIANA, FOR THE DETECTION OF HUMAN HAEMOGLOBIN AS FAECAL OCCULT BLOOD (FOB)
Core message: The study goal was to compare the clinical performances of SENTiFIT FOB-Gold (SENTiFIT270 system) with the OC-SENSOR DIANA system. A good concordance between the SENTiFIT and the DIANA assay was observed: SENTiFIT assay is a valid quantitative FIT.

IFCC WorldLab Istanbul (2014) Poster Presentation: Soliera A.R. et al. Automated Faecal Imunoassay Testing (FIT) for Hemoglobin on a new dedicated analyzer
Core message: The SENTiFIT® 270 system with SENTiFIT® pierceTube for the quantitative determination of faecal occult blood was subjected to a performance evaluation based on CLSI standards. All of the manufacturer's data with respect to the analytical performance, linearity, prozone effect and reagent and calibration stability could be confirmed with a high accuracy.

IFCC WorldLab Istanbul (2014) Poster Presentation: Correale M. et al. SENTiFIT® - FOB Gold® latex Fecal Immunoassay Test (FIT) evaluation on SENTiFIT® 270 analyzer
Core message: The SENTiFIT® 270 system with SENTiFIT® pierceTube for the immunochemical quantitative determination of faecal occult blood was subjected to a performance evaluation based on CLSI standards. All of the manufacturer's data with respect to the analytical performance, linearity, prozone effect and reagent and calibration stability could be confirmed with a high accuracy. The system is user friendly and easy to use. The new, pierceable sample tube improves the measurement accuracy, reduces the input and leads to a complete automation of the FIT.

Clin Chem Lab Med (2014): Gnatta E. et al. A new sampling device for faecal immuno-chemical testing: haemoglobin stability is still an open issue
Core message: Evaluation of the Hb stability in faeces collected with FOB-Gold Tube Screen and Tube NG that contain different buffers (buffer H, BH). 15 true positive samples were collected with both buffers, portioned and incubated at 4, 21 and 32°C for 10 days. Endpoint was the percentage of cumulative faecal Hb decrease (HbCD%). The results showed that no significant difference was visible between BH and BN in HbCD% at 4°C. At 21 and 32°C the HbCD% was lower in BH than in BN samples whereas no difference was found between samples stored in BH at 4 and 21°C.

AACC ANNUAL MEETING & CLINICAL LAB EXPO (Chicago) (2014): Anelli MC. et al. SENTiFIT®-FOB Gold® latex Fecal Immunoassay Test (FIT) evaluation on SENTiFIT® 270 analyzer in CoreLab at the AUSL Modena Nuovo S.Agostino Estense hospital in Emilia Romagna Region
Core message: The aim of this study was to compare two quantitative FITs: SENTiFIT270 and OC-Sensor Diana. Both systems showed a high concordance (95.8%), sensitivity (100%) and specificity (95.2%).

European Journal of Cancer (2013): Hamza S. et al. Diagnostic yield of a one sample immunochemical test at different cut-off values in an organised screening programme for colorectal cancer
Core message: The objective target of this evaluation was to check the performance of the quantitative immunochemical test FOB-Gold and to propose a possible strategy for an organized screening programme. Result of this study: a one-sample strategy is preferred and with a recommended cut-off, the overall positivity rate would be manageable in EU countries.

European Journal of Cancer (2012): Faivre J. et al. Comparison between a guaiac and three immunochemical faecal occult blood tests in screening for colorectal cancer
Core message: The objective of this study was to evaluate a guaiac-based (G-) FOBT (Hemoccult-II) versus 3 immunochemical (I-)FOBTs (FOB-Gold, OC-Sensor, Magstream) within the French population-based organized screening programme. The study outcome reveals additional proof that I-FOBTs are superior to the selected G-FOBT whereas none of the 3 applied I-FOBTs pointed out any significant performance advantages towards the others.

Digestive and Liver Disease (2012): Faivre J. et al. Positivity rates and performances of immunochemical faecal occult blood tests at different cut-off levels within a colorectal cancer screening programme
Core message: The goal of this study was to investigate the following approaches: on the one hand a 2-sample strategy with at least one positive test and on the other hand a 1-sample strategy implying various cut-off values for one of the two I-FOBTs (FOB-Gold or OC-Sensor) performed in combination with a G-FOBT (Hemoccult-II). It turned out that using I-FOBTs, an acceptable strategy (for the French CRC screening programme) would be 2-day sampling with at least one positive test at a cut-off between 150-200 ng/mL (OC-Sensor) and 176-234 ng/mL (FOB-Gold).

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