Abbott’s latest FDA clearance will enable the company to detect four common sexually transmitted infections with the Alinity m assay.
The Abbott Park, IL-based company said the assay is a first-of-its-kind multiplex test will help address increasing STI rates, after disruptions in delivery of care during the pandemic contributed to a decline in routine STI screening and an increase in cases.
The Alinity m STI test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) requires one swab sample or a urine sample collected in a healthcare setting by either a clinician or by the patient. The test runs on Abbott's Alinity m system — the company's most advanced high-volume laboratory molecular instrument. Alinity m uses polymerase chain reaction (PCR) technology, with high sensitivity in detecting infectious diseases.
"Over the past several years, STI cases have been on the rise, and we expect to see increasing rates as people resume testing after delaying during the pandemic," said Kathryn Becker, Ph.D., global director of scientific affairs innovation in Abbott's diagnostics business. "With that comes an increased need for effective and efficient testing. This four-plex STI test gives healthcare providers a more holistic picture of someone's health in a single test, helping to support the best treatment plan to address these common STIs individually or as co-infections."