LIMITATIONS OF THE TEST

1. The test results of this kit are only for the reference of clinicians and should not be used as the sole basis for clinical diagnosis and treatment. Clinical management of patients should be considered in the context of their symptoms/signs, medical history, other laboratory tests and response to treatment.

2. Sample collection and sample processing have a greater impact on the detection of pathogens, and a negative test result does not exclude the possibility of a viral infection.

3. Due to methodological limitations of antigen-based test, the analytical sensitivity of immunochromatographic method is generally lower than that of nucleic acid-based test. Therefore, the test provider should pay more attention to the negative results and make a comprehensive judgment based on other test results. It is suggested that the negative results in suspected patients should be checked by nucleic acid test or virus culture identification.

4. When the result of test kit is positive, it is recommended to combine the results of other methods (such as PCR and CT imaging) for further confirmation, and consult with local public health prevention institutions for treatment.

5. Analysis of the likelihood of false-negative results.

(i) Improper sample collection, transport and processing, and low viral titers in the sample may lead to false negative results.

(ii) The optimal sample type and the optimal sampling time after infection (peak viral titer) have not been validated, therefore, multiple sampling at multiple sites in the same patient may avoid false negatives.