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HISCL SARS-CoV-2 S-IgG Assay Kit

Quantification of SARS-CoV-2 S-IgG antibodies

The HISCL SARS-CoV-2 S-IgG Assay Kit for HISCL-5000 aims to help healthcare providers in monitoring and analysing temporal immunological profiles of SARS-CoV-2 infection and SARS-CoV-2 vaccine effectiveness in different population groups and areas.

More details

The assay targets IgG antibodies against the receptor-binding domain (RBD) portion situated in the S1 domain of the SARS-CoV-2 spike protein (S-protein), which play an important role in the neutralisation activity of the virus* (see figure).

 

Excellent clinical performance

The assay has a clinical sensitivity of 100% (≥ 21 days post onset of symptoms in 99 COVID patients) and a clinical specificity of 99.8% (477 samples from healthy individuals collected before the COVID-19 pandemic started), proving it to be accurate, reliable and of high clinical performance.

Sensitivity:

Days post onset of symptoms Total number Number of positive results Number of negative results PPA
(95% C.I.)
≥ 21 99 99 0 100%
(96.3 – 100)

 

Specificity:

  Total number Number of positive results Number of negative results NPA
(95% C.I.)
Pre-COVID-19 477 1 476 99.8%
(98.8 – 100)

 

Requirements
The HISCL SARS-CoV-2 S-IgG Assay Kit is to be used on the HISCL-5000 fully automated, random-access immunochemistry analyser. Reagents needed to perform the test:

Reagent name Item number Package size
HISCL SARS-CoV-2 S-IgG Assay Kit AP682349 100 tests
HISCL SARS-CoV-2 S-IgG Calibrator AR235730 5 vials (1 x each levels 1, 2, 3, 4 and 5) x 1 mL (4–5 tests per vial)
HISCL SARS-CoV-2 S-IgG Control CZ361947 6 vials (2 x each levels 1, 2 and 3) x 3 mL (12–15 tests per vial)
HISCL Diluent CJ667474 100 tests

 

*Sources:

Noda K, Matsuda K, Yagishita S et al (2021): A novel highly quantitative and reproducible assay for the detection of anti-SARS-CoV-2 IgG and IgM antibodies. Sci Rep 11, 5198.

Mazzini et al (2021): Comparative analyses of SARS-CoV-2 binding (IgG, IgM, IgA) and neutralizing antibodies from human serum samples. Journal of Immunological Methods, Volume 489, article no. 112937, ISSN 0022-1759.

Technical specifications
Analyte S-IgG antibodies to SARS-CoV-2
Test technology chemiluminescence enzyme immunoassay (CLEIA)
Dedicated instrument automated immunoassay system HISCL-5000
Throughput 200 tests/h on the HISCL-5000
Time to result 17 minutes to the first result on the HISCL-5000
Sample type serum / plasma
Sample volume 10–30 µL
Expression of results BAU/mL quantitative (calibrated against WHO international reference standard)
Cut-off value 20 BAU/mL
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

 

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