Method Establishment And Clinical Performance Evaluation Of Immunofluorescence Detection Kit For Ureaplasma Urealyticum

The best reaction condition of the labeling processing and the best concentration of the monoclonal antibody of direct immunofluorescence assay for Ureaplasma Urealyticum (UU) were firstly researched. To evaluate the performance of the corresponding Ureaplasma Urealyticum detection kit (Immunofluorescence) through clinical trials, a parallel-controlled method was carried out, and the clinical specimens were tested by the immunofluorescence detection kit and also isolated culture, which was applied as gold standard. Total 1100 samples were tested, and the overall coincidence rate was 95.82%. The positive coincidence rate was 94.87%, and the negative coincidence rate was 96.26% 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 Ureaplasma Urealyticum immunofluorescence detection kit by Microprofit owns the potential of providing a rapid, accurate, simple and economical clinical detection method for Ureaplasma Urealyticum.