Description
The Covid 19 (SARS-CoV-2) Antigen Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected Covid 19.
An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
Principle of the Covid 19 antigenic test
SARS-CoV-2 (Covid 19) antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does
not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Comparison of the antigenic test with a reference commercial PCR test
(test on 204 samples)
| Method | PCR | Total | ||
| Positive | Negative | |||
| COVID-19 IgG/IgM | Positive | 80 | 1 | 81 |
| rapid test | Negative | 3 | 120 | 123 |
| Total | 83 | 121 | 204 | |
Material necessary for the antigenic test
Materials provided with the autotest: 20 Test cassettes, 20 sterile swabs, 20 extraction buffer, 20 extraction tubes and tips, Workstation, procedure card
Materials required but not provided: Timer
Ref. C61RT1037, 20 tests
