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.
