Dataset Information

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in an STI population: performances of the Presto CT-NG assay, the Lightmix Kit 480 HT CT/NG and the COBAS Amplicor with urine specimens and urethral/cervicovaginal samples.

ABSTRACT:

Objectives

This study assessed the performances of the Presto CT-NG assay, the Lightmix Kit 480 HT CT/NG and the COBAS Amplicor for Chlamydia trachomatis and Neisseria gonorrhoeae detection.

Design

A cross-sectional study design.

Setting

Izore, Centre for Diagnosing Infectious Diseases in Friesland, the Netherlands, tested samples sent from regional sexually transmitted infection (STI) outpatient clinics and regional hospitals from the province Friesland, the Netherlands.

Participants

Samples were collected from 292 men and 835 women. These samples included 560 urine samples and 567 urethral/cervicovaginal samples.

Primary and secondary outcome measures

The primary outcome measure is C trachomatis infection. No secondary outcome measures are available.

Results

The sensitivity, specificity, positive predicative value (PPV) and negative predictive value (NPV) for C trachomatis detection in urine samples using the Presto CT-NG assay were 100%, 99.8%, 98.1% and 100%, respectively; for the Lightmix Kit 480 HT CT/NG: 94.2%, 99.8%, 96.1% and 99.4%, respectively; for the COBAS Amplicor: 92.3%, 99.6%, 96% and 99.2%, respectively. The sensitivity, specificity, PPV and NPV for C trachomatis detection in urethral/cervicovaginal swabs using the Presto CT-NG assay and the COBAS Amplicor were 100%, 99.8%, 97.7% and 100%, respectively; for the Lightmix Kit 480 HT CT/NG: 100%, 99.6%, 97.7% and 100%, respectively. Calculations for N gonorrhoeae could not be made due to a low prevalence.

Conclusions

All three assays had a high sensitivity, specificity, PPV and NPV for C trachomatis, with best performance for the Presto CT-NG assay.

SUBMITTER: Schuurs TA

PROVIDER: S-EPMC3884618 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Publications

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in an STI population: performances of the Presto CT-NG assay, the Lightmix Kit 480 HT CT/NG and the COBAS Amplicor with urine specimens and urethral/cervicovaginal samples.

Schuurs T A TA Verweij S P SP Weel J F L JF Ouburg S S Morré S A SA

BMJ open 20131230 12

<h4>Objectives</h4>This study assessed the performances of the Presto CT-NG assay, the Lightmix Kit 480 HT CT/NG and the COBAS Amplicor for Chlamydia trachomatis and Neisseria gonorrhoeae detection.<h4>Design</h4>A cross-sectional study design.<h4>Setting</h4>Izore, Centre for Diagnosing Infectious Diseases in Friesland, the Netherlands, tested samples sent from regional sexually transmitted infection (STI) outpatient clinics and regional hospitals from the province Friesland, the Netherlands.<h ...[more]

PMID: 24381252

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Project description: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.

Project description:OBJECTIVES:Syndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- and middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the Xpert Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) and OSOM Trichomonas vaginalis (TV) Test as part of a STI care model for young women in South Africa. DESIGN:Diagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017. SETTING:One large public healthcare facility in central Durban, KwaZulu-Natal, South Africa PARTICIPANTS: 247 women, aged 18-40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded. OUTCOMES:Diagnostic performance of the Xpert CT/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay. RESULTS:We obtained vaginal swabs from 247 women and found 96.8% (239/247) concordance between Xpert and Anyplex for CT and 100% (247/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0% (95% CI 10.5 to 19.4), NG 4.9% (2.2-7.5) and TV 3.2% (1.0-5.4). Sensitivity and specificity of Xpert CT/NG were 100% (100-100) and 97.6% (95.6-99.7) for CT and 100% (100-100) and 100% (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0% (45.0-100) and 100% (100-100). CONCLUSION:The Xpert CT/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs. TRIAL REGISTRATION NUMBER:NCT03407586; Pre-results.

Dataset Information

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in an STI population: performances of the Presto CT-NG assay, the Lightmix Kit 480 HT CT/NG and the COBAS Amplicor with urine specimens and urethral/cervicovaginal samples.

Objectives

Design

Setting

Participants

Primary and secondary outcome measures

Results

Conclusions

Publications

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in an STI population: performances of the Presto CT-NG assay, the Lightmix Kit 480 HT CT/NG and the COBAS Amplicor with urine specimens and urethral/cervicovaginal samples.

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