Objectives Infections due to Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are among the most common bacterial sexually transmitted infections worldwide, most of which are asymptomatic. Detection of infection using a variety of specimen types in symptomatic and asymptomatic subjects is important to effectively combat CT/NG infections. The performance of the cobas CT/NG v2.0 test was assessed for urogenital swabs, urine and cervical cytology samples collected in PreservCyt Solution from 5266 symptomatic and asymptomatic women (including 202 who were pregnant), and urine from 738 men.
Methods Sensitivity and specificity were estimated compared with a patient infected status determined using two US Food and Drug Administration–cleared nucleic acid amplification tests.
Results Among 6004 participants, 487 CT (8.1%) and 159 NG (2.6%) infections were identified. Sensitivity estimates for CT for women ranged from 91.2% to 97.6% depending on specimen type, and the estimate for male urine specimens was 98.4%. Specificity for CT ranged from 99.2% to 99.7%. Sensitivity estimates for NG ranged from 95.6% to 100.0% for women, and the estimate for men was 100.0%. Specificity for NG ranged from 99.3% to 100.0%.
Conclusions The cobas CT/NG v2.0 test performs well using urogenital swabs, urine and cervical samples collected in PreservCyt solution.
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Handling editor Catherine A Ison
Contributors All authors collaborated in the writing of the manuscript. ML and OL were also involved in the design and management of the study. The study was performed by MBN, SY, SNT, RAL, BAB, CE, EWH III and BVDP. Statistical analyses were performed by John Duncan and Shaowu Tang. All authors contributed to the analysis and interpretation of results.
Funding This study was funded by Roche Molecular Systems, Pleasanton, CA.
Competing interests BVDP discloses consulting honoraria or research funding received from Atlas Genetics, BD Diagnostics, Beckman Coulter, Cepheid, Rheonix and Roche Molecular Systems. EWH III has received research support from Roche Molecular Systems, BD Diagnostics, Hologic Gen-Probe Inc., Siemens and Cepheid. SNT discloses research support from Roche Molecular Systems, BD Diagnostics, Hologic Gen-Probe Inc. and Cepheid. BAB discloses being former employee and officer of Laboratory Corporation, Holdings (LabCorp) and advisory board service and contracts for laboratory work for Roche Diagnostics for which LabCorp was compensated and advisory board service for Roche Molecular Systems for which LabCorp was compensated. She has current consulting contracts with LabCorp, Qiagen, Inc. and Meridian Biosciences, Inc. JO, ML and OL are employees of Roche Molecular Diagnostics. No other authors disclose conflicts of interest.
Patient consent Obtained
Ethics approval All procedures in the VENUS II study, including use of the cobas v2.0 assay, were approved by different Institutional Review Boards (IRBs) depending on the testing or collection site: CGIRB (IRB00001313), Indiana University—Office of Research Administration (IRB00004961, IRB00000222), Independent IRB (IRB00003563), LSU Health Sciences Center—New Orleans IRB (IRB00000177, IRB00000179), University of New Mexico Health Sciences Center, Human Research Review Committee (Committee 1 IRB00000591, Committee 2 IRB00000592, Committee 3 IRB00001775, Committee 4 IRB00001776), Western IRB (IRB00000533), Copernicus Group IRB (IRB00001313), New England IRB (IRB00000755), Los Angeles County Public Health IRB (IRB00000864), Johns Hopkins Medicine IRB (IRB000735558), Maryland Department of Health IRB (IRB00000785) and Office of Human Research Ethics IRB University of North Carolina (Committee 1 IRB00000538, Committee 2 IRB00000539, Committee 3 IRB00001648, Committee 4 IRB00001649).
Provenance and peer review Not commissioned; externally peer reviewed.
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