CE Covid-19 Uncut Sheet Rapid Test For Rtk Antigen Test Kit

uncut sheet for covid-19 Antigen Rapid Test Kit with CE Certificate

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.

LIMITATIONS

• The result of the test should not be taken as a confirmed diagnosis, for clinical reference only. Judgement should be made along with RT-PCR results, clinical symptoms, epidemiological information, and further clinical data.

• The 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.

• The test must be equilibrated to room temperature (18℃~26℃) before used, otherwise the results may be incorrect

• A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.

• Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.

• React less than 10 minutes may lead a false negative result; React more than 10 minutes may lead a false positive result.

• Positive test results do not rule out co-infections with other pathogens.

• Negative test results are not intended to rule in other viral or bacterial infections.

• Negative results should be treated as presumptive and confirmed with a molecular assay.

• Clinical performance was evaluated with fresh samples.

• Users should test specimens as quickly as possible after specimen collection.