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CDC Issues New STD Guidelines; Recommends Nucleic Acid Tests for Trich

NEW YORK (GenomeWeb) – The US Centers for Disease Control and Prevention today updated its sexually transmitted diseases treatment guidelines to help healthcare professionals better manage the more than 20 million cases of STDs in the US annually.

The Sexually Transmitted Diseases and Treatment Guidelines, 2015 provides the first update since 2010. It notably includes recommendations for use of nucleic acid amplification tests, or NAATs, for Trichomonas vaginalis and routine trichomonas screening for high-risk populations.

A "dear colleague" letter to clinicians sent today from the CDC also details, among other items, new guidance for treatment of gonorrhea, chlamydia during pregnancy, and genital warts, and has new screening recommendations for gonorrhea and chlamydia, and for men who have sex with men.

Trichomonas affects about 3.7 million people each year. It is a protozoan parasite that can live for months to years in the urogenital tracts of men and women, and as many as 85 percent of infected people have minimal symptoms.

Importantly, trichomonas infection is associated with up to a three-fold increase risk of contracting HIV. It is also linked to preterm birth, other adverse pregnancy outcomes, and pelvic inflammatory disease in women with HIV.

The CDC previously recommended trichomonas testing for women seeking care for vaginal discharge, and screening could be considered for high-risk women ― those who have new or multiple partners, have a history of STDs, exchange sex for payment, or use injection drugs ― and all HIV positive women

Now, the agency suggests routine screening also be considered in high-prevalence settings, such as STD clinics and correctional facilities.

The agency points out that it is unknown whether routine screening will affect health outcomes, and decisions may be informed by epidemiology.

Importantly, the CDC also now encourages the use of "highly sensitive and specific tests" for both women and men, as opposed to the less sensitive microscopy method, called a wet prep, and culture.

The agency specifically calls out two US Food and Drug Administration-cleared NAATs.

The Aptima Trichomonas vaginalis test from Hologic was FDA cleared in 2013. It detects RNA in urine, vaginal, or endocervical specimens from both symptomatic and asymptomatic women. The assay can also be used as an analyte-specific reagent on urine or urethral swabs from men, if validated in a CLIA lab.

The Becton Dickinson BD ProbeTec TV Qx Amplified DNA test was also cleared by the FDA in 2013 for use on specimens from women. The firm recently obtained CE marking for a test detecting chlamydia, gonorrhea, and trichomonas from a single specimen, with an anticipated US launch in 2016.

The new guidelines further mention two specific antigen detection and nucleic acid probe-hybridization tests.

There is only one other in vitro molecular diagnostic cleared by the FDA to detect T. vaginalis: the Quidel AmpliVue Trichomonas test, approved in March of this year and hyped by the firm at the recent Clinical Virology Symposium.

Although the test is not specifically mentioned in the new guidelines, Kim Workowski, lead author of the guidelines, said this was because the recommendations had already been drafted and reviewed by the time it was cleared. "We plan on future updates and will plan to examine this product for inclusion into the next updated guidance," she said in an email to GenomeWeb.

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