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Multicenter clinical trial performance of the new Gen-Probe APTIMATM Combo 2 assay for detecting Chlamydia trachomatis in female endocervical and urine specimens



Multicenter clinical trial performance of the new Gen-Probe APTIMATM Combo 2 assay for detecting Chlamydia trachomatis in female endocervical and urine specimens



Abstracts of the General Meeting of the American Society for Microbiology 101: 197-198



We evaluated a second generation Transcription-Mediated Amplification (TMA) assay (Gen-Probe) that incorporates target capture in a Dual Kinetic Assay chemiluminescent detection system for detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae from endocervical swabs and first catch urine (FCU). Four endocervical swabs and one matched FCU specimen were collected from 1391 female patients attending STD and family planning clinics. Specimens were tested by the APTIMATM Combo 2 (Combo), ligase chain reaction (LCR), and polymerase chain reaction (PCR) assays for CT. Combo was compared to "infected patient status," which defined a patient as infected whenever any two comparator results were positive. The prevalence of CT from endocervical swab specimens was 14.9% and 15.0% from FCU specimens. Overall sensitivity for endocervical swabs when compared to infected patient status was 94.2% (195/207), with a specificity of 97.6% (1154/1182). The positive and negative predictive values were 87.4% and 99.0%, respectively. Overall sensitivity for FCU when compared to infected patient status was 94.7% (197/208), with a specificity of 98.9% (1170/1183). The positive and negative predictive values were 93.8% and 99.1%, respectively. Symptomatic and asymptomatic patients were further analyzed on an infected patient status. Sensitivities for Combo endocervical swabs and FCU specimens from symptomatic patients were 92.4% (133/144) and 93.8% (136/145) with specificities of 96.7% (653/675) and 98.8% (668/676), respectively. Sensitivities for Combo endocervical swabs and FCU specimens from asymptomatic patients were 98.4% (61/62) and 96.8% (60/62) with specificities of 98.8% (501/507) and 99.0% (502/507), respectively. The APTIMATM Combo 2 assay exhibited excellent performance. Of interest is the particularly good performance of FCU specimens compared with endocervical swabs.

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Accession: 035349744

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