Rapid Antibody Test Kit ISO Qualitative Detection Rapid IgG IgM Test

For professional and in vitro diagnostic use only.

[INTENDED USE]
The COVID-19 IgG/IgM Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Novel coronavirus.

[COMPOSITION]

The test contains a membrane strip coated with Mouse anti-Human IgM antibody and Mouse anti-Human IgG antibody on the test line, and a dye pad which contains colloidal gold coupled with Novel coronavirus recombinant antigen.

The quantity of tests was printed on the labeling.

Materials Provided

• Test device •Package insert

• Buffer

Materials Required But Not Provided

• Specimen collection container •Timer

[INTERPRETATION OF RESULTS]

Positive: Control line and at least one test line appear on the membrane. The

appearance of IgG test line indicates the presence of Novel coronavirus specific IgG antibodies. The appearance of IgM test line indicates the presence of Novel coronavirus specific IgM antibodies. And if both IgG and IgM line appear, it indicates that the presence of both Novel coronavirus specific IgG and IgM antibodies. The IgM line appears a little weak, not as strong as the IgG line, because the IgM antibody concentration is lower than the IgG antibody in blood.

Negative: One colored line appears in the control region(C). No apparent colored line appears in the test line region.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device.