Clinical Laboratory Improvement Amendments (CLIA)-waived Strep A molecular point-of-care tests (mPOCTs) are a promising solution in settings where infrastructure and trained workforce for pathology testing are scarce. These tests return accurate results in under 30 minutes, which facilitates early antibiotic treatment to prevent Acute Rhematic Fever (ARF). However, little is known about the operational characteristics and practicality of these tools, especially in resource-constrained settings. We conducted a systematic review to identify CLIA-waived Strep A mPOCTs and evaluated their published performance and operational characteristics according to the REASSURED criteria, a widely accepted framework for assessing diagnostic tools in limited-resource settings.
A protocol was registered with PROSPERO (ID: CRD42024592726) in September 2024. Two electronic databases PubMed and Embase with no language and date restrictions were searched. We included studies that evaluated any commercially available CLIA-waived Strep A mPOCT across all settings. Outcomes assessed include the type of studies, and any REASSURED criteria reported. All included full-text studies were assessed for quality and risk of bias.
Of 4853 articles identified, 25 were included for full-text evaluation. Narrative synthesis will analyse performance and operational characteristics data using the REASSURED criteria as a framework. Results of these syntheses, including study-level findings, will be reported in detail.
Incorporating Strep A mPOCTs can strengthen ARF prevention but requires thoughtful implementation. Findings will outline strengths and limitations of these tests which contributes to informed test selection and implementation planning. Further, if adequate to prevent disease, efforts are needed to reduce costs and ensure global accessibility of these tests