SARS-CoV-2 Antigen Quantitative Assay Kit (ELISA)

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.

SKU: YIG-AN-0010 Category:

Description

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.

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Specifications

The SARS-CoV-2 Antigen Quantitative Enzyme-linked Immunoassay (ELISA) Assay Kit includes 1 plate / 96 wells.

Documents

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

Helpful Resources

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