INTENDED USE
The Zika NS1 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of Zika virus antigen 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 viruses. Any reactive specimen with the Zika Ag 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 NS1 Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti-zika NS1 antibody conjugated with colloid gold (Zika Ab conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with rabbit anti-zika NS1 antibody, and the C band is pre-coated with goat anti-mouse IgG antibody. The antibodies to Zika antigen recognize the antigens from all the four serotypes of the Zika virus.
When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the test cassette.Zika NS1 Ag if present in the specimen will bind to the Zika Ab conjugates. The immunocomplex is then captured on the membrane by the pre-coated rabbit anti-zika NS1 antibody, forming a burgundy colored T band, indicating a Dengue Ag positive test result.
Absence of the T band 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-mouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid and the specimen must be retested with another device.