Abbott Receives FDA Clearance for Self-Collected STI Molecular Test

Original from: 360dx

Abbott last week received 510(k) clearance from the US Food and Drug Administration for its self-collected molecular test for sexually transmitted infections.

The Simpli-COLLECT STI Test is intended for self-collection of urogenital specimens in home settings and testing in a clinical laboratory for detection of nucleic acids from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC), according to the FDA's website. It also screens for Trichomonas vaginalis and Mycoplasma genitalium.

The test will require a prescription from a healthcare provider, an Abbott spokesperson noted via email.

Abbott also currently offers the FDA-cleared molecular Alinity M STI assay to detect and differentiate between C. trachomatis, N. gonorrhoeae, T. vaginalis, and M. genitalium.

Source: Abbott Receives FDA Clearance for Self-Collected STI Molecular Test