Zika IgG/IgM Rapid Test
NOVA test ® Zika IgM/IgG Test kit is used to qualitatively detect Zika IgM/IgG antibodies in human serum, plasma or whole blood, and is intended to be used as an aid in the diagnosis of ZIKA infection.
Intended Use
This NOVA test ® Zika antibody test kit is a lateral flow chromatographic immunoassay for the qualitative detection of IgM/IgG antibodies specific to zika virus in human serum, plasma or whole blood. It is intended to be used as a screening test device and as an aid in the diagnosis of infection with ZIKA disease. The Zika IgM/IgG test kit utilizes recombinant antigens derived from the structure protein of the Zika virus, and detects IgM/IgG anti-zika antibodies in patient blood specimens within 15 minutes.
This Zika test kit is recommended to be used by professionals, such as in the near-patient and point-of-care setting; and it is for in-vitro diagnostic use only.
Limitation of Zika Rapid Test
One Step Zika IgG/IgM Test can only indicate the presence of zika antibodies in the specimen, and it should not be used as the sole criteria for the diagnosis of Zika infection. Instead, before reaching a clinical conclusion, the health provider should take other clinical findings into consideration, such as physical examination testing result, symptoms, community epidemic situation etc.
The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Any shade of color in the test region should be considered positive. But, the substances level can not be determined by this qualitative test.
Quality control of Zika test kit
1. Internal procedural controls are included in this one step Zika rapid test kit. A colored band appearing in the control region (C) is considered an internal positive procedural control, which indicates the reagents in the test cassette is effective, proper specimen has been added, and proper testing procedures have been followed. If at the reading time, the C line doesn't develop, it tells the test performer the test kit failed to give a valid result. The testing process should be repeated with a new test device.
2. External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance of the test kit.