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Evaluation of the Performance of the Cobas CT/NG Test for Use on the Cobas 6800/8800 Systems for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male and Female Urogenital Samples.
J Clin Microbiol. 2019 04; 57(4)JC

Abstract

The clinical performance of the Cobas CT/NG assay on the Cobas 6800/8800 systems (Cobas) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae was established in a multisite, prospective collection study using male and female urogenital specimens; supportive data from archived specimens were also included. The results obtained with the Cobas assay were compared with the patient infected status derived from a combination of U.S. Food and Drug Administration-approved nucleic acid amplification tests to determine the sensitivity and specificity of detection from each sample type. The sensitivity of Cobas for the detection of C. trachomatis in female specimens was 95.6% (95% confidence interval [CI], 92.4% to 97.4%) for urine; 98.6% (95% CI, 95.2% to 99.6%) and 99.2% (95% CI, 95.4% to 99.9%) for clinician- and self-collected vaginal swab specimens, respectively; 93.3% (95% CI, 89.6% to 95.7%) for endocervical swabs; and 92.5% (95% CI, 88.7% to 95.1%) for cervical swab samples in PreservCyt. The specificity for the detection of C. trachomatis was ≥98.8% for all female sample types. Sensitivity and specificity estimates of Cobas for the detection of C. trachomatis in male urine samples were 100% (96.8% to 100.0%) and 99.7% (95% CI, 99.2% to 99.9%), respectively. The sensitivity of Cobas for the detection of N. gonorrhoeae in female specimens was 94.8% (95% CI, 89.6% to 97.4%) for urine; 100.0% (95% CI, 87.9% to 100.0%) and 100.0% (95% CI, 87.9% to 100.0%) for clinician- and self-collected vaginal swab specimens, respectively; 97.0% (95% CI, 91.5% to 99.0%) for endocervical swabs; and 96.6% (95% CI, 90.6% to 98.8%) for cervical samples in PreservCyt; the specificity for all female sample types was >99.0%. The sensitivity and specificity of Cobas for detecting N. gonorrhoeae in male urine were 100.0% (95% CI, 95.8% to 100.0%) and 99.5% (95% CI, 98.8% to 99.8%), respectively. Fully automated assays help fill the clinical need for a sensitive, high-throughput screening tool to aid public health efforts to control C. trachomatis and N. gonorrhoeae infections.

Authors+Show Affiliations

University of Alabama at Birmingham, Birmingham, Alabama, USA bvanderpol@uabmc.edu.Indiana University School of Medicine, Indianapolis, Indiana, USA.Louisiana State University, New Orleans, Louisiana, USA.Laboratory Corporation of America Holdings, Burlington, North Carolina, USA.Healthcare Clinical Data, Inc., North Miami, Florida, USA.Planned Parenthood of St. Louis Region and Southwest Missouri, St. Louis, Missouri, USA.Planned Parenthood Gulf Coast, Inc., Houston, Texas, USA.Planned Parenthood of Northern, Central and Southern New Jersey, Inc., Morristown, New Jersey, USA.Roche Molecular Systems, Inc., Pleasanton, California, USA.Roche Molecular Systems, Inc., Pleasanton, California, USA.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30651389

Citation

Van Der Pol, Barbara, et al. "Evaluation of the Performance of the Cobas CT/NG Test for Use On the Cobas 6800/8800 Systems for Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Male and Female Urogenital Samples." Journal of Clinical Microbiology, vol. 57, no. 4, 2019.
Van Der Pol B, Fife K, Taylor SN, et al. Evaluation of the Performance of the Cobas CT/NG Test for Use on the Cobas 6800/8800 Systems for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male and Female Urogenital Samples. J Clin Microbiol. 2019;57(4).
Van Der Pol, B., Fife, K., Taylor, S. N., Nye, M. B., Chavoustie, S. E., Eisenberg, D. L., Crane, L., Hirsch, G., Arcenas, R., & Marlowe, E. M. (2019). Evaluation of the Performance of the Cobas CT/NG Test for Use on the Cobas 6800/8800 Systems for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male and Female Urogenital Samples. Journal of Clinical Microbiology, 57(4). https://doi.org/10.1128/JCM.01996-18
Van Der Pol B, et al. Evaluation of the Performance of the Cobas CT/NG Test for Use On the Cobas 6800/8800 Systems for Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Male and Female Urogenital Samples. J Clin Microbiol. 2019;57(4) PubMed PMID: 30651389.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the Performance of the Cobas CT/NG Test for Use on the Cobas 6800/8800 Systems for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male and Female Urogenital Samples. AU - Van Der Pol,Barbara, AU - Fife,Kenneth, AU - Taylor,Stephanie N, AU - Nye,Melinda B, AU - Chavoustie,Steven E, AU - Eisenberg,David L, AU - Crane,LaShonda, AU - Hirsch,Gregory, AU - Arcenas,Rodney, AU - Marlowe,Elizabeth M, Y1 - 2019/03/28/ PY - 2018/12/19/received PY - 2019/01/11/accepted PY - 2019/1/18/pubmed PY - 2020/6/27/medline PY - 2019/1/18/entrez KW - Chlamydia trachomatis KW - Cobas CT/NG assay KW - Neisseria gonorrhoeae KW - PCR KW - genital infection KW - molecular diagnostics KW - nucleic acid amplification test KW - sexually transmitted infection JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 57 IS - 4 N2 - The clinical performance of the Cobas CT/NG assay on the Cobas 6800/8800 systems (Cobas) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae was established in a multisite, prospective collection study using male and female urogenital specimens; supportive data from archived specimens were also included. The results obtained with the Cobas assay were compared with the patient infected status derived from a combination of U.S. Food and Drug Administration-approved nucleic acid amplification tests to determine the sensitivity and specificity of detection from each sample type. The sensitivity of Cobas for the detection of C. trachomatis in female specimens was 95.6% (95% confidence interval [CI], 92.4% to 97.4%) for urine; 98.6% (95% CI, 95.2% to 99.6%) and 99.2% (95% CI, 95.4% to 99.9%) for clinician- and self-collected vaginal swab specimens, respectively; 93.3% (95% CI, 89.6% to 95.7%) for endocervical swabs; and 92.5% (95% CI, 88.7% to 95.1%) for cervical swab samples in PreservCyt. The specificity for the detection of C. trachomatis was ≥98.8% for all female sample types. Sensitivity and specificity estimates of Cobas for the detection of C. trachomatis in male urine samples were 100% (96.8% to 100.0%) and 99.7% (95% CI, 99.2% to 99.9%), respectively. The sensitivity of Cobas for the detection of N. gonorrhoeae in female specimens was 94.8% (95% CI, 89.6% to 97.4%) for urine; 100.0% (95% CI, 87.9% to 100.0%) and 100.0% (95% CI, 87.9% to 100.0%) for clinician- and self-collected vaginal swab specimens, respectively; 97.0% (95% CI, 91.5% to 99.0%) for endocervical swabs; and 96.6% (95% CI, 90.6% to 98.8%) for cervical samples in PreservCyt; the specificity for all female sample types was >99.0%. The sensitivity and specificity of Cobas for detecting N. gonorrhoeae in male urine were 100.0% (95% CI, 95.8% to 100.0%) and 99.5% (95% CI, 98.8% to 99.8%), respectively. Fully automated assays help fill the clinical need for a sensitive, high-throughput screening tool to aid public health efforts to control C. trachomatis and N. gonorrhoeae infections. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/30651389/Evaluation_of_the_Performance_of_the_Cobas_CT/NG_Test_for_Use_on_the_Cobas_6800/8800_Systems_for_Detection_of_Chlamydia_trachomatis_and_Neisseria_gonorrhoeae_in_Male_and_Female_Urogenital_Samples_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=30651389 DB - PRIME DP - Unbound Medicine ER -