FDA clears STI assays for throat, rectal samples

May 28, 2019 8:57 AM | Anonymous

May 28, 2019, MedPage Today 

Two diagnostic tests for gonorrhea and chlamydia infection may be used with throat and rectal samples, the U.S. Food and Drug Administration said on May 23. Hologic's Aptima Combo 2 Assay and the Cepheid Xpert CT/NG had previously been cleared for diagnostic testing to detect Chlamydia trachomatis and Neisseria gonorrhoeae in urine, vaginal and endocervical samples. The FDA noted that no chlamydia or gonorrhea tests had been cleared for use on samples from the throat and rectum. 

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