The findings and conclusions in these presentations have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy.

Wednesday, May 10, 2006

The Becton Dickinson ProbeTec ET System (BD ProbeTec) Detects Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) from Male Self Collected Glans/Urethral Specimens and Extends the Screening Strategy for Males

Dennis V. Ferrero1, Diane E. Schultz2, Nancy Burgess2, Stephen A. Willis2, and Stef Argintean1. (1) Department of Biological Sciences, University of the Pacific, 1004 Oakleaf Way, Stockton, CA, USA, (2) Public Health Laboratory, San Joaquin County Public Health Services, PO Box 2009, Stockton, CA, USA


Background:
Increasing CT rates and ever-present NG infections in women, have given rise to consideration of a national male CT/NG screening program in order to address the male reservoir. Effortlessly collected, non-invasive, self-collected male specimens that are stable and easy to transport would enhance the success of such a national program.

Objective:
To consider the effectiveness of male dry noninvasive self collected glans/urethral swab (SCS) specimens to detect CT and NG when compared to clinician collected swab (CCS) specimens and first catch urine (FCU) specimens.

Method:
284 male patients attending an STD clinic were tested for CT and NG using CCS, FCU and SCS. All patients enrolled signed an approved Investigational Review Board (IRB) consent. The three specimens collected per patient were processed according to the manufacturer's recommended procedure using the BD ProbeTec system.

Result:
There were a total of 51 specimens that were detected positive for either CT or NG. The CT prevalence was 12.0%. The NG prevalence was 5.6%. The overall sensitivity of SCS was 91% with a specificity of 99%. Sensitivity and specificity were based on an infected patient status of any two or more results being considered true results. There was an overall SCS agreement of 97.5% with CCS specimens and 98.1% with FCU specimens.

Conclusion:
Male dry self-collected glans/urethral swab specimens are a viable specimen choice. Dry swab specimens are easy to collect, transport and test using the BD ProbeTec system. The BD ProbeTec system showed high sensitivity and specificity for detection of CT/NG and high agreement when compared to CCS or FCU specimens.

Implications:
Simpler methods of collection and transport systems that produce reliable test results may increase the potential for screening difficult to test populations.