IgG and IgM Antibody test for SARS-Cov-2 blood test

For professional and in vitro diagnostic use only.

[INTENDED USE]
COVID-19 IgG/IgM Antibody Rapid Test Kit is a rapid test intended for the qualitative detection of the IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood sample from patients suspected of COVID-19 infection. The test Kit for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. But to be attention the test Results from this test kit should not be used as the sole basis for diagnosis. The test provides preliminary test results.

[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.

[SUMMARY]

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.