Roche announced that it has received clearance from the FDA for the use of four additional specimen types with cobas CT/NG v2.0 Test to aid in the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in symptomatic and asymptomatic patients.
The cobas CT/NG v2.0 Test is a qualitative in vitro test for the detection of CT/NG DNA in patient specimens. It uses amplification of target DNA by polymerase chain reaction (PCR) and nucleic acid hybridization to detect CT/NG in a single analysis.
This 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 in addition to the self-collected vaginal swabs and male urine specimens.
The VENUS Studies evaluated the performance of cobas CT/NG v2.0 Test in over 26,000 specimens from 6,004 patients across two clinical studies. The test is performed on the cobas 4800 System that offers primary viral loading for both CT/NG and HPV testing.
For more information call (800) 526-1247 or visit Roche.com.