Performance of the cobas CT/NG test compared to the Aptima AC2 and Viper CTQ/GCQ assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae - PubMed (original) (raw)

Comparative Study

Performance of the cobas CT/NG test compared to the Aptima AC2 and Viper CTQ/GCQ assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae

Barbara Van Der Pol et al. J Clin Microbiol. 2012 Jul.

Abstract

The next-generation amplification test for Chlamydia trachomatis and Neisseria gonorrhoeae (Roche cobas 4800), a fully automated system, was compared head to head, using female samples, to Gen-Probe Aptima Combo 2 and BD ProbeTec using Viper. Endocervical swabs, female urine, and endocervical samples in liquid-based cytology medium were run on at least two of three platforms. A total of 4,316 samples were evaluated, and 281 chlamydial and 69 gonococcal infections were identified. Estimates of sensitivity and specificity were obtained relative to the patient infection standard (PIS) and using latent class analysis (LCA). Chlamydia sensitivity estimates ranged from 86.9 to 95.6% using PIS and 97.6 to 98% using LCA. Specificity was ≥ 99.6% for all sample types. Sensitivity ranged from 95.6 to 100% using PIS and 96.9 to 100% using LCA for the detection of gonococcal infections. Specificity for gonococcal infections was ≥ 99.8%. cobas 4800 performance was equivalent to the comparator assays (all P values, >0.05), and the fully automated system provides high laboratory efficiency.

PubMed Disclaimer

Figures

Fig 1

Fig 1

Venn diagrams comparing C. trachomatis-positive results across three assays of endocervical swabs (A), liquid-based cytology (B), and urine specimens (C) obtained from female subjects. A total of 4,223 (endocervical swabs), 4,186 (liquid based cytology), and 4,254 (urine specimens) subjects had valid results from c4800, AC2, and CT/GCQ assays.

Fig 2

Fig 2

Venn diagrams comparing N. gonorrhoeae-positive results across three assays of endocervical swabs (A), liquid-based cytology (B), and urine specimens (C) obtained from female subjects. A total of 4,221 (endocervical swabs), 4,187 (liquid-based cytology), and 4,255 (urine specimens) subjects had valid results from c4800, AC2, and CT/GCQ assays.

Fig 3

Fig 3

Hypothetical PPV based on changing population prevalence for C. trachomatis (A) and N. gonorrhoeae (B) results.

Similar articles

Cited by

References

    1. Baughman AL, et al. 2008. Utility of composite reference standards and latent class analysis in evaluating the clinical accuracy of diagnostic tests for pertussis. Clin. Vaccine Immunol. 15:106–114 - PMC - PubMed
    1. Bjorkman J, Jonsson L, Nilsson P. 2007. Prevalence of the new genetic variant of Chlamydia trachomatis in Sodra Alvsborg County, Vastra Gotaland Region, Sweden. Euro Surveill. 12:E070614.4. - PubMed
    1. Castle P, et al. 2011. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the Athena study. Lancet Oncol. 12:880–890 - PubMed
    1. Centers for Disease Control and Prevention 2010. Laboratory diagnostic testing for Chlamydia trachomatis and Neisseria gonorrhoeae. American Public Health Laboratories, Centers for Disease Control and Prevention, Atlanta, GA: http://www.aphl.org/aphlprograms/infectious/std/documents/ctgclabguideli...
    1. Centers for Disease Control and Prevention 2010. Sexually transmitted diseases treatment guidelines, 2010. Morb. Mortal. Wkly. Rep. 59:1–112

Publication types

MeSH terms

LinkOut - more resources