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 HISCL^TM 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