INTENDED USE

This product is used to detect SARS-CoV-2 antigen in oropharyngeal swabs and

nasopharyngeal swabs samples of suspected pneumonia infected by SARS-CoV-2.

Antigen detection is generally used in the acute infection period, that is, the sample

detection within 7 days of the symptoms of the suspected population.

The positive results of antigen detection can be used for early shunting and rapid

management of suspected people,but the positive results only indicate that SARSCoV-

2 antigen exists in the samples, which can not be used as a diagnostic basis for

SARS-CoV-2 infection. Negative results can not exclude SARS-CoV-2 infection, nor

should it be used alone as a basis for treatment and disease management decisions.

Further nucleic acid test should be carried out for both positive and negative results of

antigen in suspected population.

This product is only used for the initial screening of SARS-CoV-2. The diagnosis

needs to be confirmed by virus nucleic acid detection and other methods.