The US Food and Drug Administration (FDA) has granted 510(k) clearance to Roche’s cobas CT/NG test for the diagnosis of sexually transmitted infections.
Approved for use on the cobas 6800/8800 Systems, the assay enables direct identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in patients with or without any symptoms.
The test can be used to analyse male and female urine samples, vaginal and endocervical specimens, and cervical samples collected in PreservCyt Solution.
Roche Molecular Diagnostics head Uwe Oberlaender said: “Sexually transmitted infection rates are rising worldwide and the cobas CT/NG helps labs meet increasing testing volumes with highest throughput solution on the market today.
“With exceptional performance, exemplary workflow and a flexible testing solution, the CT/NG helps labs free up staff to perform other tasks while still ensuring clinicians receive accurate and rapid results to aid in patient management.”
The company is in the process of developing additional assays to detect other types of sexually transmitted diseases on the fully automated cobas 6800/8800 platform.
Launched in 2015, the cobas 6800/8800 Systems also support blood sample screening by viral load monitoring tests to detect HIV, hepatitis B and C, cytomegalovirus, monkeypox, West Nile virus and Zika infections.
The systems are based on polymerase chain reaction (PCR) and can run up to 96 results in approximately three hours. They are said to feature high throughput, quick turnaround time and full track connectivity.