| Title: |
Prevalence of new variants of Chlamydia trachomatis escaping detection by the Aptima Combo 2 assay, England, June to August 2019 |
| Authors: |
Roberts, D; Davis, G; Cole, M; Naik, D; Maru, H; Woodford, N; Muir, P; Horner, P; Simms, I; Thickett, G; Crook, P; Foster, K; Andrews, N; Saunders, J; Fifer, H; Folkard, K; Gill, N |
| Source: |
Eurosurveillance , 24 (38) , Article pii=1900557. (2019) |
| Publisher Information: |
European Centre for Disease Prevention and Control |
| Publication Year: |
2019 |
| Collection: |
University College London: UCL Discovery |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10081949/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10081949/1/Hughes_eurosurv-24-38-1.pdf; https://discovery.ucl.ac.uk/id/eprint/10081949/ |
| Rights: |
open |
| Accession Number: |
edsbas.C470DD20 |
| Database: |
BASE |