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

Barbara Van Der Pol, Kenneth Fife, Stephanie N. Taylor, Melinda B. Nye, Steven E. Chavoustie, David L. Eisenberg, La Shonda Crane, Gregory Hirsch, Rodney Arcenas, Elizabeth M. Marlowe

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
JournalJournal of clinical microbiology
Volume57
Issue number4
DOIs
StatePublished - Apr 1 2019

Fingerprint

Neisseria gonorrhoeae
Chlamydia trachomatis
Confidence Intervals
Urine
Sensitivity and Specificity
Nucleic Acid Amplification Techniques
United States Food and Drug Administration
Public Health

Keywords

  • Chlamydia trachomatis
  • Cobas CT/NG assay
  • genital infection
  • molecular diagnostics
  • Neisseria gonorrhoeae
  • nucleic acid amplification test
  • PCR
  • sexually transmitted infection

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

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. / Van Der Pol, Barbara; Fife, Kenneth; Taylor, Stephanie N.; Nye, Melinda B.; Chavoustie, Steven E.; Eisenberg, David L.; Crane, La Shonda; Hirsch, Gregory; Arcenas, Rodney; Marlowe, Elizabeth M.

In: Journal of clinical microbiology, Vol. 57, No. 4, 01.04.2019.

Research output: Contribution to journalArticle

Van Der Pol, Barbara ; Fife, Kenneth ; Taylor, Stephanie N. ; Nye, Melinda B. ; Chavoustie, Steven E. ; Eisenberg, David L. ; Crane, La Shonda ; Hirsch, Gregory ; Arcenas, Rodney ; Marlowe, Elizabeth M. / 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. In: Journal of clinical microbiology. 2019 ; Vol. 57, No. 4.
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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.",
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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.

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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.

AB - 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.

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KW - Cobas CT/NG assay

KW - genital infection

KW - molecular diagnostics

KW - Neisseria gonorrhoeae

KW - nucleic acid amplification test

KW - PCR

KW - sexually transmitted infection

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