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ABSTRACT
Introduction: 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.
Declaration of interest
B. Van Der Pol has received consulting fees, honorarium or research support from Atlas Genetics, BD Diagnostics, Beckman Coulter, Cepheid, Click Diagnostics, Great Basin Scientific, Hologic, Luminex and Roche Molecular. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.