The Food and Drug Administration (FDA) has granted clearance to Alinity™ m STI Assay to simultaneously detect and differentiate 4 commonly sexually transmitted infections (STIs).

The Alinity m STI Assay is a 4-in-1 multiplex test that uses in vitro reverse polymerase chain reaction technology with high sensitivity to detect and differentiate STIs from symptomatic and asymptomatic individuals. The test requires a swab sample or a urine sample collected in a health care setting.

The assay may be used to test the following specimens for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis: endocervical swab specimens, clinician-collected vaginal swab specimens, self-collected vaginal swab specimens (in a clinical setting), gynecological specimens collected in ThinPrep PreservCyt solution, female urine, and male urine. The assay may also be used to test endocervical swab specimens for Mycoplasma genitalium.

“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, PhD, global director of scientific affairs innovation in Abbott’s diagnostics business. “This 4-plex STI test gives health care 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.”

Guidance on the pharmacological management of STIs can be found here.

References

  1. Abbott obtains FDA Clearance for first test that simultaneously detects four common sexually transmitted infections (STIs) as cases are on the rise. News release. Abbott. Accessed May 4, 2022. https://www.prnewswire.com/news-releases/abbott-obtains-fda-clearance-for-first-test-that-simultaneously-detects-four-common-sexually-transmitted-infections-stis-as-cases-are-on-the-rise-301539566.html
  2. Alinity m STI Assay. Abbott. Accessed May 4, 2022. https://www.molecular.abbott/int/en/products/infectious-disease/alinity-m-sti-assay