This kit is only used for the in vitro qualitative detection of 2019-nCoV IgM and IgG antibodies from human serum or plasma. 

This kit is suitable for the auxiliary diagnosis of COVID-19, the results are for clinical reference only and cannot be used as  the sole basis for diagnosis and exclusion decision. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests and treatment responses. Positive test result needs to be further confirmed, negative result does not preclude 2019-nCoV infection.

This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the  techniques in the field of in vitro diagnostic procedures.  

The kit is immunochromatographic and uses capture method to detect 2019-nCoV IgM and IgG antibodies. 

During  detection, the specimens are loaded to the sample wells of the test card. When the concentration of 2019-nCoV antibody in  specimen is higher than the minimum detection limit, the viral antibody will form complexes with labeled antigen first.  Under chromatography, the complexes move forward along the nitrocellulose membrane till captured by pre-coated antihuman IgM antibody in IgM detection zone (T1) on nitrocellulose strip to form a pink/purple reaction line on the IgM detection zone (T1), at this point the result is positive for IgM; conversely, if there is no viral IgM antibody or the  concentration of IgM antibody in specimen is below the minimum detection limit, no pink/purple reaction line appears in  the IgM detection zone (T1), at this point the result is negative for IgM. Similarly, a pink/purple reaction line is finally  formed on the IgG detection zone (T2), at this point the result is positive for IgG; on the contrary, no pink/purple reaction  line appears in the IgG detection zone (T2), at this point the result is negative for IgG. 

Regardless of whether specimen contains 2019-nCoV IgM/IgG antibody or not, a pink/purple reaction line will appear in the quality control zone (C), the  pink/purple reaction line that appears in the quality control zone (C) is the criterion for determining if the chromatography  process is normal.