GB SARS-CoV-2 Ab
Semi-quantitative ELISA for SARS-CoV-2 Spike/N antibodies (IgG/IgM) with 100% sensitivity & specificity. 10 µL sample, 105-minute assay.
PRODUCT DESCRIPTION
This product is a semi-quantitative ELISA reagent designed for detection of IgG and IgM antibodies to SARS-CoV-2 Spike or N protein in human serum or plasma. It uses a direct sandwich ELISA format on a 96-well plate. The test requires only 10 µL of sample and has a 105-minute incubation time with a 450 nm readout. Clinical validation shows 100% sensitivity and 100% specificity. Non-Reactive results indicate no detectable anti-SARS-CoV-2 antibodies; Reactive results signify presence of antibodies, to be interpreted alongside vaccination or infection history.
SPECIFICATION
| Number of wells | 96 |
| Principle | Direct Sandwich |
| Assay format | Semi-Quantitative |
| Total incubation time | 105 minutes |
| Sample type | Serum or Plasma |
| Sample volume | 10 μL |
| Reading wavelength | 450nm |
| Storage | 2-8°C |
| Certification | RUO |
PERFORMANCE
5 serum samples collected from RT-PCR confirmed COVID-19 patients were tested. 139 normal healthy patients with samples collected before COVID-19 outbreak were tested. The results are as follows：
The diagnostic sensitivity is 100%；The diagnostic specificity is 100%
| Inter-assay precision CV | < 10% | Inter-assay precision CV | < 20% |
|---|
COMPARISON
| Negative (n=89) | Positive (n=5) | ||||||
|---|---|---|---|---|---|---|---|
| Company A | Company A | ||||||
| Pos | Neg | total | Pos | Neg | total | ||
| GBC | Pos | 0 | 0 | 0 | 4 | 1 | 5 |
| Neg | 2 | 87 | 89 | 0 | 0 | 0 | |
| total | 2 | 87 | 89 | 4 | 1 | 5 | |
| Sensitivity | GBC | 100% | |||||
| Company A | 80% | ||||||
| Specificity | GBC | 100% | |||||
| Company A | 97.7% | ||||||
ORDERING INFORMATION
| Catalogue No. | Product |
|---|---|
| 4ECO001 | GB SARS-COV-2 Ab ELISA – 96T |
| 4ECO002 | GB SARS-COV-2 Ab ELISA – 480T |