INTRODUCTION

This kit is used for qualitative detection of Enterovirus 71 (EV71)IgM antibody and Coxsackievirus A16 (CA16)IgM antibody in human serum, plasma and whole blood in vitro.

INTENDED USE

This kit is a qualitative membrane strip based immunoassay for the detection of EV71 IgM antibody and CA16 IgM antibody in human serum, plasma and whole blood. In this test procedure, EV71, CA16, antigen is immobilized in the test line region of the device. After an adequate volume of test sample is placed in the sample well, it reacts with EV71, CA16, antigen coated particles that have been applied to the sample pad. This mixture migrates chromatographically along the length of the test strip and  interacts with the immobilized EV71, CA16, antigen. If the sample contains EV71 IgM antibody or CA16 IgM antibody, a red line will appear in the test line region, indicating a positive result. If the sample does not contain EV71 IgM antibody or CA16 IgM antibody, red line will not appear in this region, indicating a negative result. To serve as a procedural control, a red line will always appear at the control line region indicating that proper volume of sample has been added and membrane wicking has occurred.