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. We are developing a multiplex point of care test to fill this clinical need. This fully automated system is capable of detecting ten PCR targets from a single specimen in <1 h.
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, Trichomonas vaginalis, Mycoplasma genitalium, Ureaplasma urealyticum, Ureaplasma parvum, Haemophilus ducreyi, and herpes simplex viruses (HSV-1 and 2). Multiple PCR primers for each of these organisms were multiplexed and validated with the appropriate laboratory strains or plasmids.
Results Three hundred twenty-four subjects have been enrolled from the Salt Lake Valley Health Department STD clinic patient population, providing 600+ specimens for analysis. Ninety-nine clinical specimens have been tested so far. The STD panel test results were compared to the standard CDC recommended clinical tests run in parallel on duplicate specimens. Standard testing included gram staining, CT/GC amplification, wet mount examination, viral culture, and serum syphilis IgG. Sample types included urine (44), vaginal/cervical swabs (7), urethral swabs (5), ulcer swabs (7), oral swabs (20), and rectal swabs (16). Concordance between the new STD panel and standard testing was: C trachomatis (79/81, 98%), N gonorrhoeae (81/81, 100%), HSV1 (6/6, 100%), HSV-2 (6/6, 100%), and T vaginalis (5/6, 83%). The STD Panel detected T pallidum in four samples from patients who were subsequently diagnosed with syphilis by serology. Ureaplasma spp. were detected in 28 of 99 (28%) and M genitalium in three of 99 (3%) specimens. In patients with chronic dysuria where standard clinical testing failed to reveal a cause, we were able to detect infectious agent in 8 of 14 specimens (two HSV-1, five Ureaplasma spp., one M genitalium) see Abstract P3-S5.05 table 1.
Conclusions Point of care STD testing based on the FilmArray platform is a robust clinical diagnostic tool that has the potential to improve public health by providing sensitive and rapid results. This may improve clinical care for persons suspected of infections with STD organisms.
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