INTENDED USE

This kit is only used for the in vitro qualitative detection of 2019-nCoV IgG antibody 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 IgG antibody. 

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 anti-human IgG antibody in detection zone (T) on nitrocellulose strip to form a pink/purple reaction line on the detection zone (T), at this point the result is positive for IgG; conversely, if there is no viral IgG antibody or the concentration of IgG antibody in specimen is below the minimum detection limit, no pink/purple reaction line appears in the detection zone (T), at this point the result is negative for IgG. 

Regardless of whether specimen contains 2019-nCoV 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.

MAIN COMPONENTS

The test kit consists of test card, sample diluent.

Note：

1. Test cards are sealed together with desiccant in aluminum foil pouch.

2. Do not mix use different batches of test cards and sample diluent.