INTRODUCTION

This kit is suitable for the in vitro qualitative testing of Candida Albicans(CA) antigen in female cervical secretions swabs. It is used for the auxiliary diagnosis of infection with the above pathogens.

INTENDED USE

The test kit is a qualitative membrane strip based immunoassay for the detection of Candida Albicans(CA) antigen in female cervical secretions swabs samples. In this test procedure, CA antibody is immobilized in the test line region of the test card. After a female cervical secretions swabs sample is placed in the sample well, it reacts with CA antibody 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 CA antibody. If the sample contains CA antigen, a colored line will appear in the test line region indicating a positive result. If the sample does not contain CA antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of sample has been added and membrane wicking has occurred.