Roche has launched CT/NG on the cobas 6800/8800 Systems in markets accepting the CE mark.
The systems are intended for the direct identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in individuals with symptoms.
Roche claims that the Cobas NT/CG is the first CE-IVD cleared molecular test for CT/NG to receive claims for testing anorectal and oropharyngeal samples, offering a broader access to high risk patient population.
The inclusion of extragenital specimen testing is required in several patient populations as over half of CT and NG infections could be missed when only testing traditional urogenital specimens.
The expanded claims are in addition to claims for male and female urine specimens, endocervical swab specimens, clinician-collected and clinician-instructed patient self-collected vaginal swab specimens. They are all collected in Cobas PCR media – cervical specimens collected in PreservCyt solution.
The Cobas 6800/8800 systems are automated solutions that have introduced a new standard for routine molecular testing in areas of viral load monitoring, donor screening, women’s health and microbiology.
The systems are based on PCR technology and have been designed to offer full automation, increased throughput and faster turnaround time.
Roche molecular diagnostics head Uwe Oberlaender said: "The addition of cobas CT/NG to our expanding cobas 6800/8800 Systems menu provides laboratories with the highest throughput solution for the testing of CT/NG on the market.
"The efficiency that cobas CT/NG enables by providing exceptional assay performance, exemplary workflow and an extremely flexible testing solution, frees up laboratory staff to perform other tasks, and ensures that accurate and rapid results are reported to clinicians to aid in improved patient management."
Chlamydia trachomatis (CT) is a common bacterial sexually transmitted disease (STD), which is highly prevalent among the youth. Routine screening of young women has shown to reduce infection rates.
Neisseria gonorrhoeae (NG) is also a very common bacterial sexually transmitted disease (STD) in the US. Infections in men are generally symptomatic and infected people seek evaluation by clinician for identification and treatment before the onset of serious complications.