INTRODUCTION

This kit is uses immunochromatography for the qualitative detection of Rotavirus antigen in feces sample.

INTENDED USE

The Zika NS1 Antigen Rapid Test Kit is a qualitative membrane-based immunoassay for the detection of Zika NS1 antigen in whole blood, serum, or plasma. During the test procedure, capture reagent is immobilized in the test line region (T) of the test. After specimen is added to the specimen well (S) of the device, the specimen reacts with Zika NS1 antibody-conjugate in the test cassette. The Gold antibody conjugate will bind to Zika NS1 antigen in the specimen sample which in turn will bind with Anti-Zika NS1 coated on the membrane. As the reagent moves across the membrane, the Zika NS1 antibody on the membrane will bind the antibody-antigen complex causing a dark red or pink line to form at the test line region of the test membrane. The intensity of the lines will vary depending upon the amount of antigen present in the sample. If the specimen contains Zika NS1 antigen, a colored line will appear in the test line region (T), indicating a positive result. If the specimen does not contain Zika NS1 antigen, a colored line will not appear in this region, indicating a negative result.

An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line,regardless of whether there is a test line or not.