Sexually Transmitted Diseases Clinical Trial
Official title:
Evaluation of Abbott RealTime CT/NG for the Detection of Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] From the Pharynx, Rectum & Urethra of Men Who Have Sex With Men [MSM]
Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain reaction [PCR] assay (which is a nucleic acid amplification test [NAAT]) for detecting two sexually transmitted bacteria, Chlamydia trachomatis [CT] and Neisseria gonorrhoeae [NG], using urine samples and swabs from the throat and rectum of men who have sex with men [MSM]. Using this test on these swabs is experimental because it has not been approved by the Food & Drug Administration.
For each subject enrolled in the study, the following clinical data information will be
obtained: 1) reason for exam, 2) subject's signs and symptoms and 3) clinical assessment.
For each subject enrolled in the study, two clinician-collected pharyngeal swabs, two
clinician-collected rectal swabs, and a first catch urine specimen (approximately 25 ml)
will be obtained. The collection order of the clinician-collected swabs will be randomized.
Two pharyngeal swabs will be tested at the research laboratory using: 1) APTIMA COMBO 2®
[AC2](Gen-Probe Inc, San Diego, CA); and 2) Abbott RealTime CT/NG [RealTime](Abbott
Molecular, Des Plains, IL). Two rectal swabs will be tested at the research laboratory
using: 1) AC2; and 2) RealTime.
A first-catch urine [FCU] specimen will be split out at San Francisco Department of Public
Health laboratory and sent to the Chlamydia Research Laboratory for analysis using: 1)AC2;
and 2) RealTime.
All NAAT specimens are collected in the manufacturer's recommended NAAT transport medium.
After specimen processing, samples will be frozen at -70ºC for discrepant analysis.
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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