Description
The SARS-CoV-2 Rapid Antigenic Test (Nasal Swab) is a rapid chromatographic immune test for the qualitative detection of the novel coronavirus SARS-CoV-2 in nasal secretions of humans. This product is for self-testing. The test is designed to detect the virus core protein (N protein), which is a conserved structural protein found in all mutant strains of SARS-CoV-2. Our rapid test can thus be used to detect all mutant strains of the SARS-CoV-2 virus. The minimum age for users is 18 years old.
- listed on the EU HSC Common List of RATs
- listed in BfArM for self-test (laymen)
- favorable opinion of the Paul Erlich Institute
- Approved for sale in pharmacies in Germany (DE) and the Netherlands (NL), this offers the possibility of sale in Germany, in pharmacies, supermarkets, etc., so that laymen can test themselves
Principle
The SARS-CoV-2 rapid antigen test is used to detect SARS-CoV-2 antigens. Anti-SARS-CoV-2 antibodies are applied to the test line and combined with colloidal gold. During the test, the sample reacts with the anti-SARS-CoV-2 antibody complex in the test strip. Due to the capillary effect, the mixture then migrates to membrane chromatography and reacts with other anti-SARS-CoV-2 antibodies in the test area. The complex forms a colored line in the area of the test line.
Comparison with a benchmark commercial PCR test on 210 samples.
| Method | PCR | Total | ||
| Positive | Negative | |||
| COVID-19 rapid test | Positive | 103 | 0 | 103 |
| on nasal sample | Negative | 7 | 100 | 107 |
| Total | 110 | 100 | 210 | |
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: cassette + nasal swab + collection tube + extraction buffer + dropper
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. XG001, 1 Test / Set
