Introduction Rapid detection of Shiga toxin-producing Escherichia coli (STEC) enables appropriate treatment. Numerous commercially available molecular tests exist, but they vary in clinical performance. This systematic review aims to synthesise available evidence to compare the clinical performance of enzyme immunoassay (EIA) and nucleic acid amplification tests (NAATs) for the detection of STEC. Methods and analysis The following databases will be searched employing a standardised search strategy: Medline, Embase, Cochrane CENTRAL Register of Controlled Trials, Cochrane Database of Systematic Reviews, PubMed, Scopus and Web of Science. Grey literature will be searched under advice from a medical librarian. Independent reviewers will screen titles, abstracts and full texts of retrieved studies for relevant studies. Data will be extracted independently by two reviewers, using a piloted template. Quality Assessment of Diagnostic Accuracy Studies-2 will be employed to assess the risk of bias of individual studies, and the quality of evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation approach. A bivariate random-effects model will be used to meta-analyse the sensitivity and specificity of commercial STEC diagnostic tests, and a hierarchical summary receiver operator characteristic curve will be constructed. Studies of single test accuracy of EIA and NAATs and studies of comparative accuracy will be analysed separately. Ethics and dissemination Ethics approval was not required for this systematic review and meta-analysis. Findings will be disseminated in conferences, through a peer-reviewed journal and via personal interactions with relevant stakeholders. PROSPERO registration number CRD42018099119.
Bibliographical noteFunding Information:
This review is supported by a 2018 Systematic Review Grant from the Alberta Emergency Strategic Clinical Network grant number RES0039208. The Alberta SPOR Support Unit Knowledge Translation Platform is providing in-kind methodological and biostatistical support for the design, conduct and analysis of the review. Dr. Stephen Freedman is supported by the Alberta Children’s Hospital Foundation Professorship in Child Health and Wellness. APPETITE is supported by an Alberta Innovates Team Collaborative Research Innovation Opportunity Grant.
SBF has previously received in-kind grant support from BioMérieux and Luminex. LC received funding from TechLab for a previous study on SHIGA TOXIN QUICK CHEK and SHIGA TOXIN CHEK. PIT has served as a consultant to BioRad.
- Shiga toxin-producing Escherichia coli