Is confirmatory testing of Rochecobas4800 CT/NG testNeisseria gonorrhoeaepositive samples required? Comparison of the Rochecobas4800 CT/NG test with anopa/papduplex assay for the detection ofN gonorrhoeae

Perry, M. D.; Jones, Rachel; Corden, Sally

doi:10.1136/sextrans-2013-051410

Cited by 15 publications

(11 citation statements)

References 23 publications

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“…Previous studies have shown that the dual NAAT for chlamydia and gonorrhoea has high sensitivity and specificity, and does not require further confirmatory testing; 17 , 18 however, this recommendation is only valid in high‐prevalence populations. The Australian Public Health Laboratory Network guidelines recommend that cases identified by NAAT should be confirmed by supplementary testing in low‐prevalence populations, or the PPV of the test should exceed 90% 19 .…”

Section: Discussionmentioning

confidence: 99%

Gonorrhoea notifications and nucleic acid amplification testing in a very low‐prevalence Australian female population

Chow

Fehler

Read

et al. 2015

Medical Journal of Australia

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Section: Discussionmentioning

confidence: 99%

Gonorrhoea notifications and nucleic acid amplification testing in a very low‐prevalence Australian female population

Chow

Fehler

Read

et al. 2015

Medical Journal of Australia

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“…Overall agreement between screening versus confirmatory assay. Overall, the confirmatory assay was positive in 12 Abbott assay, 84.0% (95% CI, 82.2 to 85.6) with the Roche assay, and 65.9% (95% CI, 63.7 to 68.1) with the BD assay ( Table 2). Table 3 shows level of confirmation by each assay, with the screening and confirmatory assay according to sex, sampling year, validation status of sample, and specific sample type.…”

Section: Resultsmentioning

confidence: 99%

Factors That Influence Confirmation of Neisseria gonorrhoeae Positivity by Molecular Methods

et al. 2019

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Several Neisseria gonorrhoeae nucleic acid amplification tests (NAATs) with high sensitivity exist. However, the specificity of N. gonorrhoeae NAATs may be suboptimal, particularly for extragenital biospecimens. Consequently, confirmation with a second NAAT is common, although this represents a burden on resources. Furthermore, the rationale for confirmation is contentious. The objective of this work was to assess N. gonorrhoeae confirmation in over 13,000 N. gonorrhoeae screenpositive samples representing various biospecimens and three separate screening assays, the Abbott RealTime CT/NG (Abbott Molecular, Inc., Des Plaines, IL), the Cobas CT/NG test (Roche Molecular Systems Inc., Alameda, CA), and the BD ProbeTec ET CT/GC amplified DNA assay (BD Diagnostics, Sparks, MD). Factors predictive of confirmation were determined via logistic regression involving sex, year, whether the sample was formally validated, and sample site. Level of confirmation varied according to screening assay (96.2%, 86.0%, and 73.9% for the Abbott, Roche, and BD tests, respectively) in sample types formally included according to the manufacturers' instructions (i.e., validated). Sex did not affect confirmation for 2/3 assays, and the likelihood of confirmation of samples not formally included in manufacturer instructions (i.e., nonvalidated) was 89.1%, 82.1%, and 59.2% for the Abbott, Roche, and BD tests, respectively. Rectal swabs, which are nonvalidated samples, confirmed in 91.5%, 90.1%, and 87.4% of samples initially tested with the respective assays. The requirement to confirm N. gonorrhoeae in validated samples is not required for all NAATs, although initial assay-specific evaluation is justified given observed variability. Rectal samples represent robust biospecimens for N. gonorrhoeae NAAT testing and may not require confirmation when screened with the assays described.T he management of Neisseria gonorrhoeae infection represents an increasing and significant clinical burden in various settings, including the United Kingdom. ln Scotland in 2017, there were 2,610 episodes of gonorrhea, in comparison with only 1,073 cases in 2008 (1). Similar observations of an increase over the last decade have also been noted in England (2).Quantification of the magnitude of the increase as a result of changed sexual behaviors and/or shortfalls in management approaches is confounded by variability in indications for testing and the increased use of highly sensitive nucleic acid amplification tests (NAATs). Consistency of recommendations for testing practices and application of robust NAATs can support the more accurate measurement of genuine trends. Certainly, NAAT rather than culture of N. gonorrhoeae is recommended as a first-line test, and an increasing diversity of molecular tests exists. Assay-driven influences in NAAT confirmation of N. gonorrhoeae have been reported, including in a recent UK study, where 27% of samples from females did not confirm with a second-line test (3).

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“…Perry et al, 1 using a robust confirmatory strategy, have demonstrated that the Cobas 4800 NG test has a high specificity and, in their cohort, positive predicative value (PPV) of >90% and 88.6% for rectal and oropharyngeal swabs, respectively. In spite of local validation work, the proportion of confirmed rectal and pharyngeal results was much lower with our confirmatory strategy.…”

mentioning

confidence: 99%

“…We read with interest the paper by Perry et al 1 as we have just reviewed the performance of our own Neisseria gonorrhoea confirmatory testing strategy. We confirm extragenital samples positive for N. gonorrhoeae on the Cobas 4800NG using the CE-marked Duplicα real-time 2nd generation detection kit (Euroclone diagnostics).…”

mentioning

confidence: 99%

Neisseria gonorrhoeaeconfirmatory testing: helpful or a hindrance?

Moore¹,

Gaukrodger²,

Bignardi³

2014

Sex Transm Infect

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Is confirmatory testing of Rochecobas4800 CT/NG testNeisseria gonorrhoeaepositive samples required? Comparison of the Rochecobas4800 CT/NG test with anopa/papduplex assay for the detection ofN gonorrhoeae

Cited by 15 publications

References 23 publications

Gonorrhoea notifications and nucleic acid amplification testing in a very low‐prevalence Australian female population

Gonorrhoea notifications and nucleic acid amplification testing in a very low‐prevalence Australian female population

Factors That Influence Confirmation of Neisseria gonorrhoeae Positivity by Molecular Methods

Neisseria gonorrhoeaeconfirmatory testing: helpful or a hindrance?

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