ObjectiveAssessment of the performance of the PelvoCheck CT/NG test (Greiner-Bio-One GmbH) to detect Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in first-void urine (FVU) of females.DesignA cross-sectional study to compare the PelvoCheck CT/NG with COBAS TaqMan CT Test V.2.0 (Roche) for the detection of CT and with an in-house porA-based PCR for the detection of NG in FVU specimens. In addition, pools of 5 FVU specimens containing only CT-negative or 1 CT-positive and 4 CT-negative samples were tested. Abbott RealTime CT/NG was used as an additional test to resolve discordant results.SettingSamples sent from six laboratories were tested at the University Medical Center Hamburg.ParticipantsUrine samples were from 1622 female patients attending gynaecological practices for chlamydia screening, another 120 urine samples were from patients pretested for NG at Synlab, Medical Service Center, Weiden GmbH. In addition, 50 urine samples spiked with various concentrations of reference material were used.ResultsFor the detection of CT and NG, the sensitivity and specificity of the PelvoCheck CT/NG test were 98.8% and 100%, and 98.3% and 98.2%, respectively. The data obtained with the PelvoCheck CT/NG for pooled urine specimens resulted in a positive agreement of 90.9% and a negative agreement of 100%.ConclusionsThe PelvoCheck CT/NG assay is a suitable test method for the detection of CT and NG in female FVU samples, with sensitivity and specificity comparable with other Food and Drug Administration approved CT/NG nucleic acid amplification tests. To the best of our knowledge, this is the first commercial test system validated for the analysis of pooled urine specimens. No false-positive or invalid result was observed in 55 analysed pools. Nevertheless, 5 samples were false negative due to a target concentration below the limit of detection of the PelvoCheck CT/NG test as a consequence of pooling-associated dilution.
organisms. Analytical sensitivity was determined using titered, purified CT elementary bodies and cultured NG cells. Results The Xpert CT/NG assay detects all CT serovars, new variant CT, and 48 geographically diverse NG strains.The CT primers and probes do not cross-react with DNA or RNA from non-trachomal species. All non-gonococcal Neisseria species yielded negative results, including N. mucosa and N. cinerea, because both NG targets must be PCR positive for a "NG DETECTED" result.The LoDs for the Xpert CT/NG Assay for CT serovar D in male urine and vaginal swab matrix respectively were 75 and 84 Eb/mL; for CT serovar H, LoDs were 134 and 161 Eb/mL. In both matrices, the LoD for two NG strains was approximately 2 cfu/mL. Conclusion The Xpert CT/NG assay is highly specific and sensitive. The ease of use and fast time to result could lead to reduced time to treatment of CT and NG infections. Background Chlamydia trachomatis and Neisseria gonorrhoeae are among the most common causes of sexually transmitted bacterial infections worldwide. Infection with these organisms is mostly asymptomatic, however serious complications are also observed. Screening of the diseases is necessary to identify, treat and control the infection. In this study, we evaluated the performance of the triplex real-time PCR assay with internal control for detection of C. trachomatis and N. gonorrhoeae infections in urine and vaginal swabs. Methods The performance of TaqMan probe-based triplex real time PCR targeting the cryptic plasmids of C. trachomatis (pCHL1) and N. gonorrhoeae (pJD1) and beta-globin gene as an internal control was assessed using 188 urine specimens and 118 vaginal swabs. The triplex real time PCR was compared with the Roche COBAS AMPLICOR CT/NG assay. The urine specimens were further tested using real-time PCR targeting the N. gonorrhoeae porA pseudogene. Results For urine specimens, the sensitivity and specificity of the triplex real time PCR were 100% and 97.6%, respectively, for C. trachomatis, and 100% and 95.2%, respectively, for N. gonorrhoeae. For vaginal swabs, the sensitivity and specificity were 100% and 100%, respectively, for C. trachomatis, and 100% and 98.1%, respectively, for N. gonorrhoeae. There were 5 (2.84%) from 176 urine specimens that were negative for cryptic plasmid, but positive for N. gonorrhoeae porA pseudogene. Conclusion The performance of the triplex real time PCR assay was comparable to that of the Roche COBAS AMPLICOR CT/NG assay. This assay is easy to perform and the results can be achieved in 3-4 hours, including sample preparation. The estimated cost of triplex real time PCR was less than 20 USD. Taken together with using noninvasive urine sampling, this assay is convenient and suitable for epidemiological studies in screening large number of samples. At the Bordeaux University Hospital, among pregnant women aged less than 25 years-old the prevalence of C. trachomatis (CT) and N. gonorrhoeae (NG) is 12.5% and 2.4%, respectively for those requesting abortion by using the Abbott m2000 CT...
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