Rapid Point-of-Care Testing for Nine Sexually Transmitted Diseases
Methods: A Sexually Transmitted Disease (STD) Panel was designed for the FilmArray device to detect the following organisms: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Treponema pallidum (TP), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), Ureaplasma urealyticum (UU), Haemophilus ducreyi, and herpes simplex viruses (HSV1, HSV2). Several sets of PCR primers for the detection of each of these pathogens were multiplexed and validated with laboratory strains or plasmids. Pathogen detections were confirmed by melt curve analysis. The STD panel test results were compared to standard clinical tests including gram stain, CT/GC amplification (Roche Aptima), wet mount examination, HSV PCR, and serum syphilis IgG/TP-PA with RPR staging.
Results: 293 symptomatic subjects were consented and enrolled at the Salt Lake Valley STD clinic, providing 296 directly comparable specimens including urine (N=183), vaginal (35), rectal (31), ulcer (28), cervical (16), and urethral swabs (3). STD pathogen detections by FilmArray included CT (47), GC (19), TP (10), TV (9), MG (26), UU (56), HSV1 (6), HSV2 (5), and none (178). The concordances between the FilmArray® STD panel and standard PCR testing were CT (kappa = 0.93), NG (0.95), HSV1 (1.00), and HSV-2 (1.00). FilmArray detections of the reportable STD pathogens were immediately referred for contact notification and treatment.
Conclusion: Point-of-care STD testing using the FilmArray was feasible and well accepted in our STD clinic. The test was useful, easy to run, and it provided timely results for the patients and providers. This rapid multiplex PCR detection method offers the prospect of improved clinical care for symptomatic patients presenting to an STD clinic.
Biofire, Inc.: Grant Investigator, Research support
C. Barrus, None
M. Vaughn, Biofire, Inc.: Employee, Salary
R. Crisp, Biofire, Inc.: Employee and Grant Investigator, Research grant and Salary
See more of: Poster Abstract Session