Background/introduction The BD MAX™ CT/GC and CT/GC/TV assays performed on the BD MAX™ System are qualitative multiplex assays designed for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV) DNA in female urine, endocervical, and vaginal specimens, or CT and GC DNA in male urine specimens.
Aim(s)/objectives This study evaluated the performance of the BD MAX™ CT/GC and CT/GC/TV assays in the presence of interfering substances commonly found in vaginal swab and urine specimen.
Methods Vaginal and Urine specimen pool suspensions prepared in BD MAX™ UVE Sample Buffer were inoculated with (44) different biological, chemical, and bacterial substances at a concentration that may be found in urogenital specimens. Suspensions containing interfering substances were subsequently triple-spiked with quantitated cultures of CT, GC, and TV at 2X the Limit of Detection (LOD) for positive specimen. Negative specimens were not spiked with organism. All pools were inoculated into BD MAX™ UVE Sample Buffer Tubes, heated on the BD MAX™ Pre-warm Heater and tested on the BD MAX™ System.
Interference was determined as non-conforming positive or negative test results.
Results Interference was not identified with any of the 31 substances tested for urine. No interference was observed in vaginal swab specimens with the exception of contraceptive foams and gels (>25 µL/mL), metronidazole cream (>2.5 µL/mL) and whole blood (>0.66 µL/mL).
Discussion/conclusion These results demonstrate that the BD MAX™CT/GC and CT/GC/TV assays detect the presence of Neisseria gonorrhoea, Trichomonas vaginalis, and Chlamydia trachomatis in in the presence of interfering substances common in urine and vaginal swab specimen.
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