QuikPacII Covid-19 Serum Antibody Test Kit
The QuikPac II 2019-nCoV IgM and IgG Test is a qualitative test for the detection of IgM and IgG antibodies to 2019-nCoronavirus in human serum, plasma or whole blood. The test provides a differential detection of anti-2019-nCoV IgM and anti-2019-nCoV IgG antibodies and can be used for the presumptive distinction between a primary and secondary Coronavirus infection. This test is for in-vitro diagnostic use only.
TEST PRINCIPLE
Serum, plasma or whole blood samples may be used with this test. When a specimen is added to the test, anti-2019 nCoV IgG and IgM antibodies in the specimen sample react with recombinant coronavirus nucleocapsid proteins of colloidal gold conjugates and form a complex of antibodies and colloidal gold conjugates.
As this mixture moves along the length of the test strip by capillary action, the anti-coronavirus IgG or IgM complex is captured by the relevant anti-human IgG and or IgM immobilized in two lines across the test strip and generates a colored line. The appearance of purple color in a specific test region (IgG or IgM) should be considered as positive for that particular antibody type (IgG or IgM). A purple procedural control line should always develop on the test strip to indicate that the test has been performed properly.
INTENDED USE:
The QuikPac II 2019-nCoV IgM and IgG Test provides an excellent methodology for specifically detecting anti-2019nCoV IgG and IgM antibodies. The presence of high titers of IgG antibodies does not interfere with the detection of IgM antibodies in the sample. By using a mixture of recombinant nucleocapsid protein and spike proteins, the test is able to detect 2019 nCoronavirus infection.
This test detects the presence of antibodies to Coronavirus in the specimen and should not be used as the sole criterion for the diagnosis of a Coronavirus infection.
This test is for in vitro diagnostic use only.
In early infections and some secondary infections, detectable levels of IgM antibodies may be low. Some patients may not produce detectable levels of antibody within the first seven to ten days of infection. If symptoms persist, a fresh sample should be drawn from the patient 3-4 days after the first testing date and the new specimen should be tested.
As with all diagnostic tests, the result must be correlated with clinical findings. If the test result is negative and a Coronavirus infection suspicion still exists, additional follow-up testing using other clinical methods is recommended.
If the test results are negative and clinical symptoms persist, additional follow-up testing using other clinical methods are recommended. A negative result does not preclude the possibility of any early infection of Coronavirus.