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Abbott gets clearance for Chlamydia and Gonorrhea test

Abbott has received clearance from the U.S. Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two sexually transmitted diseases, gonorrhea and chlamydia.

Abbott received independent clearances for both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae 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.

Also cleared was the Abbott multi-Collect Specimen Collection Kit, a unique 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.

"Because many people with chlamydia are co-infected with gonorrhea, it's important to test for both diseases simultaneously,"said Klara Abravaya, Ph.D., senior director, research and development, Abbott Molecular.

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.

Source: Abott

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