Profile of the triplex assay for detection of chlamydia, gonorrhea and trichomonas using the BD MAX™ System

Abstract

Chlamydia, gonorrhea and trichomonas are the most common curable STI. improved access to testing could reduce infection rates and prevent sequelae. nucleic acid amplification tests are the recommend class of diagnostic assay for these infections which are often asymptomatic. Areas covered: A description of the BD MAX™ System (MAX) and the BD MAX CT/GC/TV assay is provided along with data from a large US clinical trial. The capacity of the system for other tests and for lab developed assays is also described. Expert commentary: The CT/GC/TV assay on the MAX is a triplex PCR assay suitable for use with female urine and vaginal or endocervical swab samples. Male urine can be tested by ordering the CT/GC results but has not yet been evaluated for trichomonas. The assay performance characteristics are similar to those of assays run on high-throughput platforms with sensitivity ≥91.5% and specificity ≥98.6% for all analytes. Screening with the CT/GC/TV assay can be combined with testing for vaginitis which would provide a greater depth of coverage for common co-infections. The throughput is moderate (1-48 samples per 8-hour shift) but the menu includes assays beyond STI pathogens making this a suitable platform for moderate volume laboratories.

<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.…”

Syndromic and Point-of-Care Molecular Testing

“…For the ePlex system, the specimen in a buffer solution is added to the ePlex panel in which all liquid handling steps are performed by digital microfluidics technology (electrowetting) [14]. Electrochemical detection of ferrocene-labeled PCR amplicons occurs via capture probes that have been immobilized on gold-plated electrodes [15].…”

“…Overall, both of the assays listed in Table 1 outperform traditional methods, including Chlamydia trachomatis culture and microscopic screening for bacterial vaginosis, candidiasis, and trichomoniasis. In one study that evaluated the performance of the BD MAX CT/GC/TV assay, the sensitivities for detection of all three analytes were 91.5% or greater and the specificities were 98.6% or greater [14]. According to clinical trial data of the BD MAX Vaginal Panel, the sensitivities for analytes ranged from 75.9% (analyte [collection method]: Candida glabrata [clinician-collected specimens]) to 100% (C glabrata [simulated specimens] and Candida krusei [simulated specimens]) and specificities ranged from 84.5% (bacterial vaginosis [self-collected specimens]) to 100% (C glabrata [simulated specimens] and C krusei [self-collected and simulated specimens]) [44].…”