Diagnostics Rapid Antigen Test Kit SARS-CoV-2 Antigen swab device

Intend Use

CoV-19 Antigen Rapid Self Test Kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal of secretion. Testing result of the antigen test can be used for early isolation of patients with suspected infection, but it cannot be used as diagnosis basis of SARS-CoV-2 infection. Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.

Product Advantage

• Simplicity: It is extremely easy to use with simple to understand instructions.
• Fast: After the extraction of the sample, it will take just 10-15 mins for the result to be reflected on the testing device.
• Reliable: CE, ISO13485 Certificated, Stric quality control, High quality

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.