INTRODUCTION

The REAGEN TriClear CA / TV / GV Antigen Combo Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Candida Albicans(CA), Trichomonas Vaginalis(TV) and Gardnerella Vaginalis(GV) antigens from vaginal swab specimens. It is intended to be used by healthcare professionals as a screening test to aid in the diagnosis of multiple vaginal infection.

INTENDED USE

The test kit is a qualitative membrane strip based immunoassay for the detection of Candida Albicans(CA), Trichomonas Vaginalis(TV) and Gardnerella Vaginalis(GV) antigen in vaginal swab specimens. In this test procedure, CA/TV/GV antibody is immobilized in the test line region of the test card. After a vaginal swab specimen is placed in the sample well, it reacts with CA/TV/GV 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/TV/GV antibody. If the sample contains CA or TV or GV antigen, a colored line will appear in the test line region indicating a positive result. If the sample does not contain CA or TV or GV 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.