A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections

Inclusion Criteria:

• Sexually active people

• People seeking medical services for symptoms consistent with a sexually transmittedinfection (STI) and/or known exposure to an STI

Exclusion Criteria:

• Previously enrolled in the study

• Unable to provide informed consent

• Currently pregnant

• Declines POC testing

• Presents for routine STI screening (asymptomatic)

• Use of antimicrobial agents active against CT, NG, or MG during the 21 days beforesample collection. Example of such antimicrobial agents include the following:Macrolides (e.g., azithromycin and erythromycin); Penicillins (e.g., amoxicillin);Tetracyclines (e.g., doxycycline); Fluoroquinolones (e.g., ciprofloxacin, ofloxacin,levofloxacin, and moxifloxacin); Cephalosporins (e.g., ceftriaxone and cefixime)

• Use of phenazopyridine-containing urinary pain relief medicines (ie, Azo orPyridium) within 2 days prior to sample collection

• Use of any over-the-counter feminine hygiene products (internally or externally),such as vaginal moisturizers, lubricants (e.g., Replens, RepHresh, etc.), andfeminine washes/vaginal douches, etc. within the 3 days prior to sample collection.The use of tampons or pads during menses is not an exclusionary criterion.

• Contraindication to vaginal swab sampling where vaginal swab sampling is the onlyoption available

• Urination within 1 hour prior to sample collection (for subjects providing urinesample)