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HISCL SARS-CoV-2 S-IgG Assay Kit
The solution for high-volume antibody testing
- Targets and accurately quantifies IgG antibodies against the receptor-binding domain (RBD) in the spike protein of SARS-CoV-2
- To be used on the HISCL™-5000 immunoassay analyser
- For human serum or plasma samples
- Quick results already after 17 minutes
- High throughput of 200 samples/h
- Excellent performance and result quality
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.
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:
| 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 |
Sysmex Europe GmbH
Bornbarch 1
22848 Norderstedt
Germany
+49 (40) 527 26 0
+49 (40) 527 26 100
