Method Establishment and Clinical Performance Evaluation of Immunofluorescence Assay for Gardnerella Vaginalis

摘要

The best reaction condition of immunofluorescence assay for Gardnerella vaginalis (GV) was firstly studied. And then, to evaluate the performance of the corresponding Gardnerella vaginalis detection kit (Immunofluorescence) through clinical trials, a parallel-controlled method was carried out, and the clinical specimens were tested by immunofluorescence assay and also isolated culture, which was applied as gold standard. Total 1100 samples were tested, and the overall coincidence rate was 96.82%. The positive coincidence rate was 94.53%, and the negative coincidence rate was 97.51% respectively, and the Kappa value surpassed 0.8, which indicated that there was no significant difference between the results of the immunofluorescence detection kit and of isolated culture. The Gardnerella vaginalis immunofluorescence detection kit by Microproflt owns the potential of providing a rapid, accurate, simple and economical clinical detection method for Gardnerella vaginalis.