Prevalence of new variants of Chlamydia trachomatis escaping detection by the Aptima Combo 2 assay, England, June to August 2019

Roberts, David J., Davis, Grahame S., Cole, Michelle J., Naik, Dixita, Maru, Hitiksha, Woodford, Neil, Muir, Peter, Horner, Paddy, Simms, Ian, Thickett, George, Crook, Paul, Foster, Kirsty, Andrews, Nick, Saunders, John, Fifer, Helen, Folkard, Kate, Gill, O. Noel and , on behalf of the incident management team (2019) Prevalence of new variants of Chlamydia trachomatis escaping detection by the Aptima Combo 2 assay, England, June to August 2019. Eurosurveillance, 24 (38).

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Abstract

At the end of April 2019, Public Health England (PHE) was alerted, via an international Epidemic Intelligence System-Sexually Transmitted Infections (EPIS-STI) post from Finland, of false-negative Chlamydia trachomatis (CT) test results using the Aptima Combo 2 (AC2) assay (Hologic Inc., San Diego, California, United States (US)), a nucleic acid amplification test (NAAT) for CT (target: 23S rRNA) and Neisseria gonorrhoeae (GC) (target: 16S rRNA). Discrepant results between the AC2 assay and the Aptima Chlamydia trachomatis assay (ACT) (target: 16S rRNA) were reported to have occurred primarily in specimens that had AC2 relative light units (RLU) from 20 to 84 [1]. These false-negative AC2 results [2,3] were attributed to a C1515T mutation in the CT 23S rRNA gene. In early June 2019, Hologic Inc. issued a Field Safety Notice (FSN) to AC2-using laboratories, recommending ACT reflex retesting of AC2 CT-negative with RLU ≥ 15, CT-equivocal, or GC-equivocal/-positive (if CT-negative/equivocal) specimens to ensure detection of the Finnish new variant CT strain (F-nvCT) [3]. A European Centre for Disease Prevention and Control (ECDC) rapid risk assessment recommended countries estimate the spread of F-nvCT to inform the need for patient recall and retesting [4]. Here we report results from an investigation coordinated by a multiagency incident management team (IMT) to ascertain the prevalence of new variants of Chlamydia trachomatis escaping detection by the Aptima Combo 2 assay in England.

Item Type: Article
Uncontrolled Keywords: sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Related URLs:
Depositing User: LivePure Connector
Date Deposited: 04 Feb 2022 10:30
Last Modified: 07 Feb 2022 01:05
URI: https://ueaeprints.uea.ac.uk/id/eprint/83285
DOI: 10.2807/1560-7917.ES.2019.24.38.1900557

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