Combined Testing for Chlamydia, Gonorrhea, and Trichomonas by Use of the BD Max CT/GC/TV Assay with Genitourinary Specimen Types

Abstract

The BD Max CT/GC/TV (MAX) assay is a true multiplex assay for simultaneous detection of chlamydia (CT), gonorrhea (GC), and trichomonas (TV). We evaluated assay performance for women using endocervical and vaginal swabs as well as urine specimens. A total of 1,143 women were tested for CT, GC, and TV and, subsequently, another 847 (1,990 total women) for CT and GC only, with positivity rates for CT, GC, and TV of 7.1%, 2.3%, and 13.5%, respectively. In men, the performance for CT and GC was determined using only urine specimens. TV performance was not assessed in male urine samples. Among men, 181/830 (21.8%) and 108/840 (12.9%) chlamydia and gonorrhea infections, respectively, were identified. Comparator assays included BD ProbeTec Chlamydia trachomatis Q x (CTQ)/Neisseria gonorrhoeae Q x (GCQ), Hologic Aptima Combo 2 (AC2) and Aptima TV (ATV), trichomonas microscopy, and culture. MAX CT sensitivity was 99.3% (95% confidence interval [CI], 96.1% to 99.9%), 95.7% (90.8% to 98.0%), 91.5% (85.8% to 95.1%), and 96.1% (92.2% to 98.1%) for vaginal swabs, endocervical swabs, female urine samples, and male urine samples, respectively. MAX GC sensitivity was 95.5% (84.9% to 98.7%), 95.5% (84.9% to 98.7%), 95.7% (85.5% to 99.8%), and 99.1% (94.9% to 99.8%) in the same order. MAX TV sensitivity was 96.1% (91.7% to 98.2%) for vaginal swabs, 93.4% (88.3% to 96.4%) for endocervical swabs, and 92.9% (87.8% to 96.0%) for female urine samples. Specificity for all organisms across all sample types was Ն98.6%. Performance estimates for the MAX assays were consistent with estimates calculated for the comparator assays (all P values were Ͼ0.1). The availability of a CT/GC/TV multiplexed assay on a benchtop instrument with a broad menu has the potential to facilitate local sexually transmitted infection (STI) testing at smaller laboratories and may encourage expanded screening for these highly prevalent infections.

Comparison between DiaPlexQ™ STI6 and GeneFinder™ STD I/STD II multiplex Real‐time PCR Kits in the detection of six sexually transmitted disease pathogens

“…Numerous studies have shown that multiplex real‐time PCR assays were sensitive and useful modality for the diagnosis of STIs . Chung et al recently evaluated the performance of two commercial multiplex real‐time PCR assays including the GeneFinder assay for six STD pathogens and reported excellent agreement between the two assays ( κ = 0.87) .…”

“…Numerous studies have shown that multiplex real-time PCR assays were sensitive and useful modality for the diagnosis of STIs. 5,8,9,11,13 Chung et al recently evaluated the performance of two commercial multiplex real-time PCR assays including the GeneFinder assay for six STD pathogens and reported excellent agreement between the two assays (κ = 0.87). 13 In the present study, there was excellent concordance between the results of the DiaPlexQ assay and the GeneFinder assay for each microorganism regardless of The main limitation of this study was the lack of a reference standard and the retrospective nature of the study.…”

“…Moreover, multiplex molecular assays have an additional advantage in screening and diagnosis since they enable simultaneous diagnosis of several sexually transmitted infections (STIs). Several commercial multiplex PCR kits have been developed, and a few studies have evaluated their performance …”

<p>Simultaneous detection of eleven sexually transmitted agents using multiplexed PCR coupled with MALDI-TOF analysis</p>

“…[32][33][34][35] In addition, several emerging nucleic acid amplification platforms combined with fully and partially automated instrumentation are available for targeting multiple microorganisms in a single test reaction. 12,14,30,36,37 However, these platforms are low throughput or have a high cost per sample, preventing rapid screening of large numbers of specimens. Compared to other diagnostic strategies, STI-MS using MALDI-TOF MS technologies are generally more reliable and can be more easily automated.…”

“…One possible cause for the higher number of discrepancies in the clinical specimens for causative agents of STIs may be due to target pathogens with a low concentration, as reported by Van et al in an evaluation of BD MAX assay. 37 Digital PCR has been successfully applied in the field of pathogen detection 46,47 and is particularly suited to the low-level detection of nucleic acid even with a highly complex background. 47,48 In the arbitration stage, ultrasensitive digital PCR was performed to resolve discordant results.…”