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HISCL SARS-COV-2 AG ASSAY KIT

Simple workflow, high usability

The HISCL SARS-CoV-2 Ag Assay Kit provides laboratories with a robust solution that quickly delivers reliable results and increases their testing capacity. This helps smooth the SARS-CoV-2 testing workflow and further assists local healthcare systems in their efforts against the pandemic.

Features

Illustration of the possible workflow variations for the different sample types

 

Excellent performance

The HISCLTM SARS-CoV-2 Antigen test offers excellent sensitivity and specificity, and superb correlation with RT-PCR ct values, so you can have confidence in the results.

Comparison of the HISCL SARS-CoV-2 Ag Assay cut-off index with RT-PCR ct values in 141 positive samples and 153 negative samples (nasopharyngeal and nasal swab samples) demonstrated 100% clinical sensitivity (ct ≤ 30) and 100% clinical specificity.

Days after the onset of symptoms

RT-PCR Cut-off

RT-PCR positive (n)

HISCL positive (n)

Sensitivity

95% CI

 0–7 days

ct ≤ 30

57

57

100%

94.9%–100%

 8–35 days

ct ≤ 30

16

16

100%

82.9%–100%

 All

ct ≤ 30*

80

80

100%

96.3%–100%

 All

All*

141

105

74.50%**

66.4%–81.4%   

*  To the present date, a common understanding has evolved that patients having a viral load corresponding to ct values > 30 are unlikely to infect others.

** All samples considered positive by RT-PCR incl. samples with a ct > 30 (RT-PCR ct values 30–40)

Total (n)

RT-PCR cut-off

RT-PCR negative (n)

HISCL negative (n)

Specificity

95% CI

 294

ct > 40

153

153

100%

98.1%–100%


Requirements

The HISCL SARS-CoV-2 Ag Assay Kit is to be used on the HISCL-5000 fully automated, random-access immunochemistry analyser. The assay kit and the reagents in conjunction with the HISCL technology help clinical laboratories to cope with demanding SARS-CoV-2 testing workloads.

Reagent name Item number Package size
HISCL SARS-CoV-2 Ag Assay Kit BC29960 100 tests
HISCL SARS-CoV-2 Ag Calibrator AH270120 2 vials (1 x NC and 1 x PC)* x 1 mL (4–5 tests per vial)
HISCL SARS-CoV-2 Ag Control BK261298 4 vials (2 x level 1 and 2 x level 2) x 3 mL (12–15 tests per vial)
Extract solution AD578612 5 x 10 prefilled tubes + filter tips

*NC and PC correspond to two different levels required for the calibration of this assay to calculate the cut-off values.

 

 

 

Technical Specifications

Test technology

chemiluminescence enzyme immunoassay (CLEIA)

Dedicated instrument

fully automated, random-access immunochemistry analyser HISCL-5000

Throughput

up to 200 tests/h on the HISCL-5000

Time to result

17 minutes to the first result on the HISCL-5000

Sample type

nasal and nasopharyngeal swabs – transport as dry swabs or swabs in transport media (e.g. UTM)

Sample volume

minimum 200 µL (= 5 drops) of the sample (extracted solution)

Measurement tubes

conical 4-mL sample cup (no barcode possible) or
standard sample tube (13–16 mm diameter, 75–100 mm height) with the option of barcode labelling

 

Contacts

Sysmex Middle East FZ-LLC

Dubai Healthcare City

City Pharmacy Building C/P 72, Office 304

P.O. Box 505119 Dubai, U.A.E.

+971 4 4370515

+971 4 4370516

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