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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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.

Related collections

Most cited references 8

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Measurement error correction for logistic regression models with an "alloyed gold standard".

B. McDermott, D Spiegelman, S Schneeweiss (1997)

Recently, some authors have questioned the validity of methods which correct relative risk estimates for measurement error and misclassification when the "gold standard" used to obtain information about the measurement error process is itself imperfect. When such an "alloyed" gold standard is used to validate the usual exposure measurement, the bias in the "regression calibration" (Rosner et al., Stat Med 1989; 8:1051-69) measurement-error correction factor for relative risks estimated from logistic regression models is derived. This quantity is a function of the correlations of the "alloyed" gold standard (X) and the usual exposure assessment method (Z) with the truth, of the ratio of the variances of X and Z, and of the correlation between the errors in the "alloyed" gold standard and the errors in the usual exposure assessment method. In this paper, it is proven that if the errors between Z and X are uncorrelated, the regression calibration method has no bias even when the gold standard is "alloyed." When a third method of exposure assessment is available and it is reasonable to assume that the errors in this method are uncorrelated with the errors in the other two exposure assessment methods, point and interval estimates of the correlation between the errors in X and Z are derived. These methods are illustrated here with data on the measurement of physical activity, vitamins A and E, and poly- and monounsaturated fat. In addition, when a third exposure assessment method is available, a modification of standard regression calibration is derived which can be used to calculate point and interval estimates of relative risk that are corrected for measurement error in both X and Z. This new method is illustrated here with data from the Health Professionals Follow-up Study, a study investigating the associations between physical activity and colon cancer incidence and between vitamin E intake and coronary heart disease. It is shown that in these examples, correlations of the errors in X and Z tended to be small. Even when moderate, estimates of relative risk corrected for error in both X and Z were not very different from the estimates which assumed that X was a true gold standard.

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Risk of acquiring gonorrhea and prevalence of abnormal adnexal findings among women recently exposed to gonorrhea.

R Platt, P. A. Rice, W. M. McCormack (1983)

We determined the conditions of 26 women who had recently been exposed to Neisseria gonorrhoeae. Infection was more common among women with more than one exposure (13/14) than among those with one exposure (6/12). Gonococcal infection was significantly associated with the presence of findings on physical examination suggestive of upper genital tract inflammation. Nine of 19 infected women had such findings; no uninfected women did. Among infected women, the prevalence of abnormal physical findings was 47% +/- 23% (95% confidence interval). These findings suggest that upper genital tract involvement is a common early complication of gonococcal infection.

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Evaluation of the Abbott RealTime CT/NG assay in comparison to the Roche Cobas Amplicor CT/NG assay.

Nadzariah Cheng, Sue Kirby, Q Qian (2011)

Several commercial methods exist for the molecular detection of Chlamydia trachomatis and Neisseria gonorrhoeae in clinical samples. Here we evaluated the performance characteristics of the newly FDA-cleared Abbott RealTime CT/NG assay (where "CT" stands for Chlamydia trachomatis and "NG" stands for Neisseria gonorrhoeae) that uses the automated m2000 molecular platform. Results were compared to those of the Roche Cobas Amplicor CT/NG assay. A total of 926 cervical swab, 45 female urine, 6 male urethral swab, and 407 male urine specimens from 1,384 patients were examined. After resolving all Roche N. gonorrhoeae-positive results with two additional real-time PCR assays, we found that the agreement between the assays was excellent. For urine samples, there was 99.6% positive agreement and 97.7% negative agreement for C. trachomatis, and for male urine samples, there was 100% positive agreement and 99.7% negative agreement for N. gonorrhoeae. For cervical swab samples, there was 98.8% positive agreement and 98.5% negative agreement for C. trachomatis, and there was 96.6% positive agreement and 99.8% negative agreement for N. gonorrhoeae. In limiting dilution analyses, we found that the Abbot assay was more sensitive than the Roche assay for both C. trachomatis and N. gonorrhoeae. In addition, there appeared to be an enhanced ability of the Abbott assay to detect dual infections, especially in the presence of large amounts of N. gonorrhoeae and small amounts of C. trachomatis organisms. In summary, we conclude that the Abbott RealTime CT/NG assay is an accurate and automated new addition to the available testing options for C. trachomatis and N. gonorrhoeae.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2013

Publication date (Electronic): 24 December 2013

Volume: 3

Issue: 12

Electronic Location Identifier: e003607

Affiliations

[1 ]Izore, Centre for Infectious Diseases Friesland , Leeuwarden, The Netherlands

[2 ]Laboratory of Immunogenetics, Department of Medical Microbiology and Infection Control, VU University Medical Center , Amsterdam, The Netherlands

[3 ]Faculty of Health, Medicine & Life Sciences, Department of Genetics and Cell Biology, Research Institute GROW, Institute of Public Health Genomics, University of Maastricht , Maastricht, The Netherlands

Author notes

[Correspondence to ] Dr S A Morré; samorretravel@ 123456yahoo.co.uk

TAS and SPV contributed equally.

Article

Publisher ID: bmjopen-2013-003607

DOI: 10.1136/bmjopen-2013-003607

PMC ID: 3884618

SO-VID: 61a7db44-5d7f-4b04-94a5-f46521e0c810

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

History

Date received : 19 September 2013

Date revision received : 18 November 2013

Date accepted : 19 November 2013

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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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Abstract

Objectives

Design

Setting

Participants

Primary and secondary outcome measures

Results

Conclusions

Related collections

Point-of-Care Testing for Infectious Diseases Super Collection

Most cited references 8

Measurement error correction for logistic regression models with an "alloyed gold standard".

Risk of acquiring gonorrhea and prevalence of abnormal adnexal findings among women recently exposed to gonorrhea.

Evaluation of the Abbott RealTime CT/NG assay in comparison to the Roche Cobas Amplicor CT/NG assay.

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Cited by 2

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