The US Food and Drug Administration (FDA) has granted 510(k) clearance for Roche Molecular Diagnostics' cobas CT/NG test, used to detect chlamydia trachomatis (CT) and neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self-collected vaginal swabs.
Roche Molecular Diagnostics head Paul Brown said the new test will provide US clinicians an efficient solution for screening chlamydia and gonorrhea infections using the preferred specimen types.
The test is a polymerase chain reaction (PCR)-based multiplex dual probe assay that runs on the automated cobas 4800 System, complementing the cobas HPV (human papillomavirus) test. The cobas 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information and can run up to 282 tests in less than 12 hours, enabling rapid analysis of screening tests.
The FDA and CE-marked cobas HPV test is the only clinically validated assay which simultaneously provides pooled results on high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18.
Indiana University School of Public Health Epidemiology assisstant professor Barbara Van der Pol said the assay will lower the burden of disease by providing accurate results from easy to obtain samples, self-collected vaginal swabs from women and first catch urine from males.
The registrational trial for the cobas CT/NG test also confirmed that self-collected vaginal specimens and male urine specimens provide increased sensitivity and specificity when compared with alternative specimen types across patient populations with both low and high disease prevalence.
According to the report, from the US Association of Public Health Laboratories and Centers for Disease Control and Prevention, male urine and self-collected vaginal swabs are the preferred specimen types for CT and NG testing, as they show high sensitivity and may help promote screening compliance.
Image: Roche cobas CT/NG test has received FDA approval for screening chlamydia trachomatis and neisseria gonorrhoeae. Photo: FDA.