INTENDED USE
The Zika IgM/IgG Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM/IgG anti-zika virus (ZIKA) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with ZIKA. Any reactive specimen with the Zika IgM/IgG Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY AND EXPLANATION THE TEST
Zika virus (Zika): mainly transmitted through the bite of Aedes mosquito,mother and child, blood transfusion and sexual transmission.Because there is no vaccine at present,people is generally susceptible to infection. IgG/IgM antibody is produced one week after onset, so the detection of IgG/IgM is of great significance for the early diagnosis of Zika virus. Zika is diagnosed based on serological analysis and viral isolation in mice or tissue culture. An IgM immunoassay is the most practical lab test method. The zika IgM/IgG Rapid Test utilizes recombinant antigens derived from its structure protein, it detects IgM/IgG anti-zika in patient serum or plasma within 15 minutes. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment.

PRINCIPLE
The Zika IgM/IgG Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold (Zika conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (M and G bands) and a control band (C band). The M band is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-Zika, G band is pre-coated with reagents for the detection of IgG anti-Zika, and the C band is pre-coated with goat anti rabbit IgG.

When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Anti-Zika IgM if present in the specimen will bind to the Zika conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored M band, indicating a Zika IgM positive test result.
Anti-Zika IgG if present in the specimen will bind to the Zika conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored G band, indicating a Zika IgG positive test result.
Absence of any test bands (M and G) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.