ADS Biotec offers SARS-CoV-2 Antigen Quantitative Enzyme-linked Immunoassay (ELISA) Assays, designed to help diagnose SARS-CoV-2 antigens from serum and plasma. Kits are authorized for sale under CE-IVD in the European Union, and they are backed by our company’s full commitment to continued supply, service and support.
The SARS-CoV-2 Antigen ELISA Assays include 1 plate / 96 wells.
SARS-CoV-2 Antigen quantitative assay based on Enzyme-linked Immunoassay (ELISA). The test is authorized for sale under CE-IVD in the EU.
Sample Type: Serum, Plasma
Performance index:
Detection Sensitivity: 1.0pg/mL
Linear Range: the correlation coefficient (r) is not less than 0.9900 in the concentration range of 5.75-347.25pg/mL.
Precision: CV=1.5%-11.4%
SARS-CoV-2 Antigen Test Specificity
| Group | Research samples | No. of positive samples |
No. of samples | Specificity |
|---|---|---|---|---|
| 1 | Infection by other respiratory pathogens | 0 | 369 | 100% |
| 2 | Pregnancy examination | 0 | 100 | 100% |
| 3 | Elevated rheumatoid factor | 0 | 119 | 100% |
| 4 | Health examiner Hemolysis sample | 0 | 45 | 100% |
| SUM | / | 0 | 633 | 100% |
Sample Source: 633 people with negative PCR results.
SARS-CoV-2 Antigen Test Sensitivity
| Group | Days from onset | Total number of samples |
Number of antigen positive samples |
Sensitivity |
|---|---|---|---|---|
| 1 | ≤ 3 days | 32 | 30 | 93.4% |
| 2 | 4 ~ 7 days | 38 | 38 | 100% |
| 3 | 8 ~ 14 days | 31 | 28 | 90.3% |
| SUM | / | 101 | 96 | 95.0% |
Sample source: PCR confirmed COVID-19 patients serum samples.
For full integration and efficient high-volume processing, select from ADS Biotec automated systems including the QuickGene 24S and QuickGene 12S Nucleic Acid Extraction Systems.
The SARS-CoV-2 Antigen Quantitative Enzyme-linked Immunoassay (ELISA) Assay Kit includes 1 plate / 96 wells.
SARS-CoV-2 Antigen Quantitative Assay Kit – CE-IVD Declaration of Conformity
SARS-CoV-2 Antigen Quantitative Assay Kit – Brochure – US
SARS-CoV-2 Antigen Quantitative Assay Kit – Brochure – EU
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