Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]

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.

Inclusion Criteria:

- A subject must be MSM. Subjects must provide verbal consent, must be able to submit
all required specimens and must not have urinated within 1 hr prior to providing a
study urine specimen.

Exclusion Criteria:

- Subjects are excluded if they do not have sex with men, refuse to give verbal consent
or refuse to allow such consent to be documented in their chart, are unable to
provide all required specimens and minimum specimen volume, have been on antibiotic
therapy within the last 21 days, have urinated within 1 hr prior to submitting study
specimens, and have already been evaluated as part of this trial. Subjects will be
excluded if specimens are mishandled or inappropriately stored.