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Multi-site comparison of Gen-Probe APTIMA Combo 2 assay with Abbott LCR and culture for the detection of Neisseria gonorrhoeae in men



Multi-site comparison of Gen-Probe APTIMA Combo 2 assay with Abbott LCR and culture for the detection of Neisseria gonorrhoeae in men



Abstracts of the General Meeting of the American Society for Microbiology 101: 198



Background: Males are essential contributors to STD morbidity; at present however, routine STD screening for asymptomatic men is rarely carried out. New technologies offer both greater sensitivity for pathogen detection, and permit non-invasive specimen collection. Objective: In this multi-site study we evaluated the Gen-Probe APTIMA Combo 2 Assay (AC2) for detection of N. gonorrhoeae (GC) in 1137 male participants using two specimen types: voided urine and urethral swabs. Methods: GC cultures were performed using urethral swabs and standard methods for selective media. AC2 and LCR assays were performed following manufacturers' instructions on urethral swabs, and on urine collected subsequent to swab specimens. Test performance was evaluated on the basis of infected patient status, defined as having a positive GC culture, and/or positive swab and urine LCR GC results. Results were evaluated in all participants and for asymptomatic males. Results: Of 1137 males enrolled, 331 (29.1%) tested positive for N. gonorrhoeae. The sensitivities, specificities, positive predictive values, and negative predictive values for the AC2 test for GC in the overall population were 99.1%, 97.8%, 94.9%, and 99.6% for urethral swabs and 98.5%, 99.6%, 99.1%, and 99.4% for voided urine. Among 378 asymptomatic participants, 15 (3.9%) were infected, all of whom were detected by the AC2 results for swab and urine specimens (2 patients had only swab specimens for evaluation). Conclusion: The APTIMA Combo 2 assay provides an accurate mechanism for detection of gonococcal infections in men using either urethral swab specimens or non-invasively using voided urine. The test is a sensitive means of screening asymptomatic men for occult gonococcal infections.

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Accession: 035349513

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