Rapid Point-of-Care Testing for Nine Sexually Transmitted Diseases

Background: Delays in the reporting of STD testing sometimes result in inappropriate patient care where a patient must be called back in for treatment.   Some STDs may be missed because not all specimens are tested in a comprehensive manner.  A multiplex PCR-based point-of-care test was developed using the FilmArray® system capable of detecting 9 STD pathogens from a single specimen in about an hour.

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, herpesvirus culture, and serum syphilis IgG/TP-PA with RPR staging.

Results: Ninety-two symptomatic subjects were consented and enrolled at the Salt Lake Valley STD clinic, providing 90 analyzable specimens including urine (N=71), vaginal/cervical swabs (10), urethral swabs (2), ulcer swabs (5), and rectal swabs (2). STD pathogen detections included CT (19), GC (3), TP (1), TV (6), MG (7), UU (18), HSV1 (2), HSV2 (4), and none (43).  Comparison of detections between the FilmArray® STD panel and standard testing (as available) was: CT (18/17), NG (3/4), HSV1 (2/0), HSV-2 (4/3),  and T. vaginalis (5/1).  FilmArray detections of the reportable STD pathogens were immediately referred for contact notification and treatment.

Conclusion: Point-of-care STD testing using the FilmArray is feasible 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.