A rapid test for the qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 (formerly known as 2019-nCoV) in serum, plasma, or whole and fingertip blood. For professional in vitro diagnostic use only.
The SARS-CoV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma, or whole and fingertip blood. It is intended for use as an aid in identifying individuals with an adaptive immune response to SARS- CoV-2, indicating recent or prior infection. At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The SARS-CoV-2 IgG/IgM Rapid Test should not be used to diagnose acute SARS-CoV-2 infection.
Results are for the detection of antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. False positive results for the SARS-CoV-2 IgG/IgM Rapid Test may occur due to cross-reactivity from pre- existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgG or IgM assay.
The SARS-CoV-2 IgG/IgM Rapid Test is a qualitative membrane based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma or whole blood. The membrane is pre- coated with anti-human IgM antibody and anti-human IgG antibody. During testing, SARS-CoV-2 antibodies, if present in the specimen, will react with the SARS-CoV-2 antigen-coated particles, which have been pre- coated on the test strip.
The test cassette contains SARS-CoV-2 recombination antigens coated particles, anti-human IgM and anti- human IgG are coated on the membrane.
| Feature | Specification |
|---|---|
| Test Format(s) | Cassette |
| Specimen Format(s) | Serum/Plasma/Whole Blood from Venous or Fingerstick |
| Detects | IgG/IgM antibodies to SARS-CoV-2 |
| Sample Volume | Serum/ Plasma: 10 μL Whole Blood: 15 μL |
| Sensitivity | ≥99.1% |
| Specificity | ≥98.3% |
| Accuracy | 98.5% Accuracy (95% Confidence Intervals) |
| Test Time | 15–20 minutes Shelf Life 12 Months |
| Storage Temperature | 2–30 °C |
| Package Includes | Cassette, Disposable specimen application, Buffers, Package Insert |
| Tests/Kit | 25 Test/Kits |
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Accurate Results
High Sensitivity and Specificity
Multiple sample types
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