Description
The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions, and
saliva specimen. For professional in vitro diagnostic use only.
- listed on the HSC EU common list of RAT
- listed at BfArM for professional use (thus approved for sale in Germany)
- positive P.E.I. (Paul Erlich Institute) evaluation
- able to detect all new strains, including Delta
PRINCIPLE
The SARS-CoV-2 Antigen Rapid Test is for detection of SARS-CoV-2 antigens. Anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region. The SARS-CoV-2 Antigen Rapid Test contains anti-SARS-CoV-2 monoclonal antibodies conjugated particles and another anti-SARS-CoV-2 monoclonal antibodies are coated in the test line regions.
Comparison with a benchmark commercial PCR test on 391 samples.
| Method | PCR | Total | ||
| Positive | Negative | |||
| COVID-19 rapid test | Positive | 87 | 0 | 87 |
| on nasal/saliva sample | Negative | 4 | 300 | 304 |
| Total | 91 | 300 | 391 | |
The LoD (limit of detection) of the test for the N protein of SARS-CoV-2 is approximately 0.2 to 0.5 ng / ml.
MATERIALS
Material supplied with the self-test:
- Foil pouches, with test cassettes and desiccant
- Assay buffer tubes
- Sterile swabs and specimen collection tubes
- Instruction for use
Materials required but not provided: timer
The test can be stored at room temperature or in the refrigerator (2-30 ° C). The test strip is stable until the expiration date printed on the sealed pouch. The test strip should only be removed from the sealed pouch during use. DO NOT FREEZE. Do not use beyond the expiration date. The test remains stable for 18 months under these storage conditions.
Ref. YMC050G -1, 1 Test / Set
