Roche announced has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the use of four additional specimen types with the cobas CT/NG v2.0 test to help physicians diagnose Chlamydia trachomatis (CT) and Neisseria Gonorrhoeae (NG) infections in symptomatic and asymptomatic patients.
In addition to self-collected vaginal swabs (collected in a clinical setting) and male urine specimens, the test may now be used with endocervical and clinician-collected vaginal specimens, female urine specimens collected in cobas PCR media, and cervical specimens collected in PreservCyt solution.
The clinical performance of the cobas CT/NG v2.0 test using the additional specimen types was validated in the VENUS studies, which included 6,004 patients (5,266 females and 738 males), representing over 26,000 specimens collected in two clinical studies.
Roche Molecular Diagnostics head Paul Brown noted with the addition of these specimen types, the cobas CT/NG v2.0 test now provides US labs with a comprehensive offering for chlamydia and gonorrhea testing.
"This will enable more labs running the cobas® 4800 System to combine CT/NG and HPV testing onto a single automated platform and further optimize their workflow," Brown added.
The test is performed on the cobas 4800 system, which is currently the only FDA-approved system to offer primary vial loading for both CT/NG and HPV testing. The streamlined workflow can help labs reduce cost, improve turnaround time and free staff to spend time on other critical tasks.
The cobas CT/NG v2.0 test is a qualitative in-vitro test for the detection of CT/NG DNA in patient specimens. It utilizes amplification of target DNA by polymerase chain reaction (PCR) and nucleic acid hybridization for the detection of CT/NG in a single analysis.
The cobas 4800 system offers true walk-away automation of nucleic acid purification, PCR set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas HPV Test, the cobas BRAF V600 mutation test and the cobas EGFR mutation test.