Diagnostic Infectious Diseases Testing Outside Clinics: A Global Systematic Review and Meta-Analysis

Background: Most people around the world do not have access to facility-based diagnostic testing and the gap in availability of diagnostic tests is a major public health challenge. Self-testing, self-sampling, and institutional testing outside conventional clinical settings are transforming infectious disease diagnostic testing in a wide range of low- and middle-income countries (LMICs). We examined the delivery models of infectious disease diagnostic testing outside clinics to assess impact on test uptake and linkage to care. Methods: We conducted a systematic review and meta-analysis, searching six databases and including original research manuscripts comparing testing outside clinics with conventional testing. Main outcomes were test uptake and linkage to care, delivery models and adverse outcomes. Data from studies with similar interventions and outcomes were pooled and the quality of evidence was assessed using GRADE. Findings: We identified 10,386 de-duplicated citations and 76 studies were included. Studies focused on HIV (48 studies), chlamydia (eight studies), and multiple diseases (20 studies). HIV self-testing increased test uptake compared with facility-based testing (11 studies, pooled OR 1·4, 95% CI 1·36 – 1·46, moderate quality). STI self-sampling increased test uptake compared with facility-based testing (six studies in five countries, pooled OR 3·60, 95% CI 3·28 – 3·96, moderate quality). Interpretation: Testing outside of clinics increased test uptake without significant adverse outcomes. These testing approaches provide an opportunity to expand access and empower patients. Further implementation research, scale-up of effective service delivery models, and policies in LMIC settings are needed. Funding Statement: Foundation for Innovative New Diagnostics (FIND). Declaration of Interests: The authors declare that we have no conflict of interest. Ethics Approval Statement: This study was registered in PROSPERO (CRD42019140828).