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- The SARS-CoV-2 Antigen Rapid Test Cassette is an acute-phase screening test for qualitative detection. Sample collected may contain antigen titles below the reagent’s sensitivity threshold, so a negative test result does not exclude infection with SARS-CoV-2.
- The SARS-CoV-2 Antigen Rapid Test Cassette detects viable and non-viable SARS-CoV-2 nucleoprotein. Test performance depends on nucleoprotein load in the sample and may not correlate with cell culture or other assays performed on the same sample.
- A positive test does not rule out the possibility that other pathogens may be present and does not rule out co-infections with other pathogens. Results must be compared with all other available clinical and laboratory information to make an accurate diagnosis.
- A negative test result may occur if the level of extracted antigen in a specimen is below the sensitivity of the test or if a poor-quality specimen is obtained.
- Performance of the test has not been established for monitoring antiviral treatment of SARS-CoV-2.
- Negative test results are not intended to rule in other coronavirus infections, only SARS-CoV-2.
- A negative result may occur if the concentration of nucleoprotein in a specimen is below the detection limit of the test or if the specimen was collected or transported improperly, therefore a negative test result does not eliminate the possibility of SARS-CoV-2 infection and should be confirmed by viral culture, NAAT molecular assay or ELISA.
- The accuracy of the test depends on the sample collection process. Improper sample collection, improper storage and repeated freezing and thawing of samples will affect the test results.
- The test results of this kit are only for clinicians’ reference and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be comprehensively considered in combination with their symptoms / signs, medical history, other laboratory tests and treatment reactions.