A profile of the cobas® TV/ MG test for the detection of Trichomonas vaginalis and Mycoplasma genitalium

ABSTRACT

Introduction: Trichomonas vaginalis and Mycoplasma genitalium are highly prevalent sexually transmitted pathogens that may be asymptomatic or may cause cervicitis and pelvic inflammatory disease in women and urethritis in men. Our limited understanding of the epidemiology of these infections has been hampered by a lack of diagnostic capacity, but the new cobas® TV/MG assay runs on the cobas® 6800/8800 platform offers a solution to this gap in our current diagnostic capacity.

Areas covered: This article will describe what we know about the epidemiology and impact of untreated infections with these organisms as well as current recommendations for testing. The features and performance of the cobas 6800/8800 and the TV/MG assay will be described based on the emerging data related to this assay.

Expert commentary: Molecular diagnostics for trichomonas and mycoplasma that can be performed on a high-throughput system with the flexibility to order only those tests required are needed in order to reduce the burden of disease and of consequences of undiagnosed infections caused by these pathogens. As a result of the complexities in the needs for testing in different populations, sample-specific flexibility in test ordering is an absolute need in the molecular laboratory.

KEYWORDS:

• Trichomonas vaginalis
• mycoplasma genitalium
• molecular diagnostics
• sexually transmitted infections
• laboratory diagnostics

Article highlights

• T. vaginalis and M. genitalium rates are likely underestimated due to the previous lack of availability of highly accurate, commercially available molecular diagnostic tools. The cobas TV/MG assay, run on the cobas 6800/8800 platform, offers a solution that can fill this need.

• Samples used for chlamydia/gonorrhea testing can be used for trichomonas and mycoplasma testing, when appropriate, in the same run thus generating a more comprehensive assessment of the potential causes of urethritis, cervicitis, or PID which will improve patient management and outcomes.

• Screening in asymptomatic populations is appropriate for trichomonas in some settings, but is not recommended in any population for mycoplasma and care needs to be taken when providers order these tests.

• Resistance markers for mycoplasma need to be included in future versions of the assay or LDTs should be developed locally to run on the system as a reflex test. Development of such an LDT is facilitated by the cobas 6800/8800 system due to the use of standardized reagents and cycling parameters that support the rapid optimization of new primers and probes.

Declaration of interest

BVDP discloses that she has received grant support to her institution or consulting/honorarium fees from the following: Abbott Molecular, Becton Dickinson, binx health, BioFire Molecular, Cepheid, Hologic, NeuMoDx, Rheonix, Roche Molecular and SpeeDx. 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.