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THP 61 Comparing Home-Collected Versus Clinic-Collected Specimens for the Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Extragenital Sites

Thursday, September 22, 2016
Galleria Exhibit Hall
Kristie Gordon, BA1, Mark McGrath, MPH2, Rosalba Castro, BA3, Lauren Natoli, BA3, Laura Anderson, MPH4, Adam Cohen, PhD, MPH3 and Jeffrey Klausner, MD, MPH5, 1David Geffen School of Medicine at UCLA, Los Angeles, CA, 2Public Health Division, AIDS Healthcare Foundation, Los Angeles, CA, 3AIDS Healthcare Foundation, Los Angeles, CA, 4University of California, Los Angeles (UCLA), Los Angeles, CA, 5Division of Infectious Diseases and Program in Global Health, David Geffen School of Medicine and Fielding School of Public Health, Los Angeles, CA

Background: The majority of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae(NG) infections are asymptomatic. Several studies have verified the performance of nucleic acid amplification tests (NAATs) for the detection of CT or NG at extragenital sites, however no NAAT is FDA-approved for extragenital testing. This study aimed to verify the Xpert CT/NG assay (Cepheid, Sunnyvale, CA) for in-home self-collection of pharyngeal, rectal, and urethral specimens.  

Methods: Forty-one subjects were enrolled at a free sexually transmitted disease (STD) clinic in Hollywood, CA. Urine samples were collected at the clinic for routine testing (Aptima Combo 2, Hologic Inc., Bedford, MA). In addition, pharyngeal and rectal samples were collected at the clinic for the Xpert® CT/NG testing. Lastly 24-48 hours after leaving the clinic, pharyngeal, rectal, and urethral samples were self-collected by the patient at home and then mailed to the laboratory for Xpert® CT/NG testing. We compared mailed results with clinic collected specimens to determine the concordance and 95% confidence interval. 

Results: A total of 40 paired pharyngeal, 40 paired rectal, 41 paired penile meatal-urine specimens were analyzed. The proportion concordant were: CT rectal 97.7% (CI: 87.7%-99.9%), NG rectal 97.7% (CI: 87.7%-99.9%), CT urethral 97.6% (CI: 87.1%-99.9%), NG urethral 97.6% (CI: 87.1%-99.9%), CT pharyngeal 100% (CI: 92.0%-100%) and NG pharyngeal 100% (CI: 92.0%-100%). The number of specimens positive in the Xpert CT/NG NAAT for samples collected in clinic were: 3 CT rectal, 3 NG rectal, and 3 NG pharyngeal while the number of positive specimens collected at home were: 2 CT rectal, 2 NG rectal, 3 NG pharyngeal, 1 CT urethral and 2 NG urethral and the number of specimens positive by Aptima testing were: 2 CT urine and 1 NG urine.

Conclusions: The performance of the mailed home-collected specimens for extragenital CT and NG detection was similar to clinic-collected specimens.

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