USFDA clears Abbott’s test to detect four sexually transmitted infections simultaneously

Abbott's multiplex test runs on its most advanced molecular PCR platform, the Alinity m system, which provides fast results in high volumes – detecting four infections simultaneously

Abbott announced it has received USFDA clearance for its Alinity m STI Assay. The test simultaneously detects and differentiates four common sexually transmitted infections (STIs). STIs, when left untreated, can lead to severe health complications, including increased risk of getting certain cancers and infertility.

The 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) require 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. This test can help healthcare providers save time, increase efficiency and better serve patients.

"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."