The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid(N) protein antigen from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab. It provides an aid in the diagnosis of infection with 2019-nCOV.
| Product Name | CI 97.58% Rapid 15 Minute Antigen Tests 25pcs Per Box For COVID-19 |
| Formats | Device(4mm) |
| Place of Origen | China |
| Specimen | Swab |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 1Test/Box |
| Storage | 2℃-30℃ |
[LIMITATIONS]
1. The COVID-19 Rapid Test Device is for in vitro diagnostic use only.
2. The test should be used for nasopharyngeal swab, oropharyngeal swab. Blood, serum, plasma, urine and other samples may cause abnormal results.
3. The intensity of the test line does not necessarily correlate to SARS-CoV-2 viral titer in the specimen.
4. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed
on the same sample.
5. Test results should be correlated with other clinical data available to the physician.
6. A positive or negative test result does not rule out co-infections with other pathogens such as other viral or bacterial infections.
7. Negative results are presumptive, do not rule out COVID-19 infection and it may be necessary to obtain additional testing with a molecular
assay, if needed for patient management.
8. A false negative result may occur if the level of antigen in a sample is below the detection limit of the test.
9. Incorrectly sample collected and handled, may cause a false negative result. Please make sure that a proper amount of sample is added for testing. Too much or too little sample may cause deviations in results.
