Abbott has received 510(k) clearance from the FDA to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the prevalent sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden.
Abbott had received independent 510(k) clearances for both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay and the Abbott m2000 System. They are required to be used together as a system for the detection of CT/NG from multiple specimen types including urine, urethral, vaginal and endocervical swabs.
Abbott said that the FDA had also cleared the Abbott multi-Collect Specimen Collection Kit, a device for collection and room-temperature transportation of multiple samples, including urine samples and endocervical, vaginal and male urethral swab specimens, in one collection device.
Abbott worked in collaboration with international STD researchers to develop the chlamydia test, which was introduced in the European Union in 2008 to address a newly discovered variant strain of the bacteria initially identified in Sweden.
According the Centers of Disease Control and Prevention (CDC), while there have been no reports of the variant strain in the US, chlamydia remains the most frequently reported bacterial sexually transmitted disease (STD).
Molecular or nucleic acid amplification tests (NAAT) are currently the standard method for detecting chlamydia and gonorrhea infections, and are widely used. The advantage of NAAT over traditional culture methods is that they are generally more sensitive and specific and can identify more positive specimens.
Torvald Ripa, assistant professor, department of Clinical Microbiology and Infection Control, Hospital of Halmstad, Sweden, who discovered the new strain, said: “New tests were needed to target additional parts of the chlamydia bacteria, and Abbott responded fast to our request for research test kits that would pick up the variant strain.”
Klara Abravaya, senior director of research and development at Abbott Molecular, said: “Because many people with chlamydia are co-infected with gonorrhea, it’s important to test for both diseases simultaneously. Left untreated, chlamydia and gonorrhea can lead to pelvic inflammatory disease, urethritis and sterility.”