Infectious disease test kit

IgGIgMcoronavirus

The 2019-New Coronavirus IgM/IgG Rapid Test Cassette is a qualitative membrane strip-based immunoassay for the detection of 2019-New Coronavirus antibodies (IgM/IgG) in human whole blood, serum, and plasma. The test cassette consists of: 1) a burgundy colored conjugate pad containing 2019-New Coronavirus recombinant antigens conjugated with colloid gold (2019-New Coronavirus conjugates), 2) a nitrocellulose membrane strip containing two test lines (IgM and IgG) and a control line (C line). The IgM line is pre-coated with the Mouse anti-Human IgM antibody, IgG line is coated with Mouse anti-Human IgG antibody. When an adequate volume of test specimen is added into the sample well of the test cassette, the specimen migrates by capillary action across the pre-coated membrane. The 2019-New Coronavirus IgM antibody if present in the specimen will bind to the 2019-New Coronavirus conjugates. The immunocomplex is then captured by the reagent coated on the IgM line, forming a burgundy colored IgM line, indicating a 2019-New Coronavirus IgM positive test result and suggesting a fresh infection. The 2019-New Coronavirus IgG antibody if present in the specimen, will bind to the 2019-New Coronavirus conjugates. The immunocomplex is then captured by the reagent pre-coated on the IgG band, forming a burgundy colored IgG line, indicating a 2019-New Coronavirus IgG positive test result and suggesting a recent or repeat infection. Absence of any T lines (IgM and IgG) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.