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      Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urogenital and oral specimens using the cobas® 4800, APTIMA Combo 2® TMA, and ProbeTec™ ET SDA assays

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          Abstract

          This prospective, multicenter clinical trial was conducted to compare the performance of the cobas® 4800 CT/NG, APTIMA Combo 2®, and ProbeTec™ ET CT/GC assays for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in Japan. From 1274 male and female patients, more than 1900 urine, endocervical and throat specimens were collected. Positive and negative concordance rates for CT and NG results obtained for urine and endocervical samples collected from the same patient were high in all three assays (range 96.0–99.6%). The accuracy of the cobas® 4800 CT/NG test did not differ significantly from that of the APTIMA Combo 2® and ProbeTec™ ET CT/GC assays. The accuracy of the assays did not change depending on the order of collection of endocervical specimens. Concordance rates for results obtained for throat swabs and mouthwashes in the ProbeTec™ ET CT/GC and cobas® 4800 CT/NG assays, respectively, were 98.8% for CT and 95.1% for NG. These data suggest that the cobas®4800 CT/NG test is a reliable and highly accurate diagnostic tool for the detection of CT and NG in urine, genital, and oral specimens. Owing to the high correlation of urine and endocervical swab results and the ease of acquisition, urine samples are suggested as the specimen of choice for screening of CT and NG.

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          Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men.

          Several nucleic acid amplification tests (NAATs) are US Food and Drug Administration-cleared for detecting urogenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infection, but they have not been adequately evaluated for the relatively common oropharyngeal or rectal CT and GC infections in men who have sex with men (MSM). Multiple swabs were collected from the oropharynx and rectum of MSM attending a city sexually transmitted disease clinic. The specimens were tested by standard culture and the following NAATs: Roche's Amplicor (PCR), Becton Dickinson's ProbeTec (SDA), and Gen-Probe's APTIMA Combo 2 (AC2) for the detection of CT and GC. Confirmatory testing of specimens with discrepant results was done by NAATs using alternate primers. A total of 1110 MSM were enrolled. Based on initial findings on 205 MSM, PCR had a 78.9% GC specificity with oropharyngeal swabs. Thus, we discontinued PCR testing for the rest of the study. For oropharyngeal GC (89 infections detected), sensitivities were 41% for culture, 72% for SDA, and 84% for AC2. For rectal GC (88 infections detected), sensitivities were 43% for culture, 78% for SDA and 93% for AC2. For oropharyngeal CT (9 infections detected), sensitivities were 44% for culture, 67% for SDA, and 100% for AC2. For rectal CT (68 infections detected), sensitivities were 27% for culture, 63% for SDA, and 93% for AC2. Specificities of SDA and AC2 were > or =99.4% for both organisms and anatomical sites. AC2 and SDA were far superior to culture for the detection of CT or GC from the oropharynx and rectum with AC2 detecting twice as many infections as culture. Further analyses with larger pharyngeal samples are needed, but clearly NAATs can improve our ability to diagnose rectal and oropharyngeal infection with CT or GC in MSM.
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            Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections.

            Vaginal swabs were recently U.S. Food and Drug Administration-cleared for detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) using Gen-Probe Incorporated's APTIMA COMBO2 Assay (AC2). We assessed the APTIMA CT Assay (ACT) for CT, APTIMA GC Assay (AGC) for GC, and AC2 for both organisms using patient- and clinician-collected vaginal swabs. Women attending family planning, obstetrics and gynecology, or sexually transmitted disease (STD) clinics had first-catch urines (FCUs), patient-collected vaginal swabs, clinician-collected vaginal swabs, and endocervical swabs tested by ACT, AGC, and AC2. A second endocervical swab and FCU were tested using BD ProbeTec (Becton Dickinson) for CT and GC. We calculated sensitivity and specificity using vaginal swabs to detect CT and GC. Of 1,464 subjects enrolled, 180 had CT and 78 GC. ACT sensitivities and specificities for patient-collected vaginal swabs were 98.3% and 96.5%, respectively; for clinician-collected vaginal swabs, 97.2% and 95.2%, respectively. AGC sensitivities and specificities for patient-collected vaginal swabs were 96.1% and 99.3%, respectively; for clinician-collected vaginal swabs, 96.2% and 99.3%, respectively. AC2 results were similar. If an FCU tested positive for CT or GC, >94% of matching vaginal swabs were positive. Positive endocervical swabs showed slightly less concordance (>90% and >88%, respectively). More infected patients were identified using vaginal swabs than FCUs. With AC2, 171 CT-infected patients were identified using FCUs and 196 using patient-collected vaginal swabs. This difference was more pronounced for CT than for GC. Vaginal swab specimens allowed sensitive and specific detection of CT and GC in the APTIMA assays. Vaginal swabs identified as many infected patients as endocervical swabs and more than FCUs, and may well be the specimen of choice for screening.
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              Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.

              A multicenter clinical study was conducted to evaluate the performance characteristics of the Abbott RealTime CT/NG assay, a multiplex real-time PCR assay, for simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae. The specimens were collected from a total of 3,832 male and female subjects at 16 geographically diverse sites. Specimens included male and female urine samples, male urethral swabs, female endocervical swabs, and self-collected and clinician-collected vaginal swabs. Specimens were tested with the automated Abbott RealTime CT/NG assay, Aptima Combo 2 assay (Gen-Probe), ProbeTec ET CT/GC assay (Becton Dickinson), and culture for N. gonorrhoeae. The Aptima Combo 2 assay, the ProbeTec assay, and the N. gonorrhoeae culture were used as the reference assays. For each subject, a patient infected status (PIS) was determined based on the combined results from the reference assays. The overall prevalence in female subjects was 8.9% for C. trachomatis and 3.8% for N. gonorrhoeae. The overall male prevalence was 18.2% for C. trachomatis and 16.7% for N. gonorrhoeae. The overall sensitivity and specificity of the Abbott RealTime CT/NG assay were 92.4% and 99.2% for C. trachomatis and 96.9% and 99.7% for N. gonorrhoeae, respectively. In comparison, the sensitivity and specificity, respectively, for the Aptima Combo 2 assay were 94.5% and 99.0% for C. trachomatis and 96.1% and 99.5% for N. gonorrhoeae, and those for the ProbeTec ET assay were 90.3% and 99.5% for C. trachomatis and 92.0% and 97.3% for N. gonorrhoeae in this study. The Abbott RealTime CT/NG assay offers C. trachomatis and N. gonorrhoeae dual detection with high sensitivity and specificity. The automated assay provides a useful alternative nucleic acid amplification assay for clinical laboratories and clinicians.
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                Author and article information

                Journal
                1886
                122234
                European Journal of Microbiology and Immunology
                Akadémiai Kiadó
                2062-509X
                2062-8633
                1 June 2012
                11 April 2012
                : 2
                : 2 ( otherID: K022535X4502 )
                : 121-127
                Affiliations
                [ 1 ] Sapporo Medical University Hokkaido Japan
                [ 2 ] University of Occupational and Environmental Health Fukuoka Japan
                [ 3 ] Kobe University Hospital Hyogo Japan
                [ 4 ] 2-6-5 Fushimi Tyuo-ku Sapporo City Hokkaido 064-0942 Japan
                Article
                L9032323J0147812
                10.1556/eujmi.2.2012.0001
                3956960
                24672680
                4966a719-5cc6-4bab-aad6-9fa6a0ec2942
                Categories
                Original Articles

                Medicine,Immunology,Health & Social care,Microbiology & Virology,Infectious disease & Microbiology
                urogenital,nucleic acid amplification test, Neisseria gonorrhoeae ,oral, Chlamydia trachomatis

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