May 31, 2019—The Food and Drug Administration cleared Roche’s Cobas TV/MG test for use on the Cobas 6800/8800 systems for the detection of Trichomonas vaginalis and/or Mycoplasma genitalium DNA in symptomatic and asymptomatic patients. Laboratories can now simultaneously process from a single sample a combination of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.
“The addition of Mycoplasma genitalium and Trichomonas vaginalis detection to the Cobas 6800/8800 systems is an important step forward in the ability to diagnose sexually transmitted infections,” Barbara Van Der Pol, PhD, associate professor of medicine, School of Medicine, University of Alabama at Birmingham, said in a release from Roche. “These new analytes, in conjunction with the approved Chlamydia trachomatis and Neisseria gonorrhoeae molecular diagnostic assays, will support a more thorough assessment of the potential pathogens responsible for discharge-causing STI. As a result, clinicians can more easily identify co-infections and utilize appropriate treatment strategies earlier in the patient management process.”
The TV/MG test has been validated for use with broad specimen types, including sample types comparable to those available for use with the Cobas CT/NG test: male/female urine; endocervical swabs and vaginal swabs (clinician collected and patient collected in a clinical setting).