title: Diagnostic point-of-care tests in resource-limited settings.
abstract: The aim of diagnostic point-of-care testing is to minimise the time to obtain a test result, thereby allowing clinicians and patients to make a quick clinical decision. Because point-of-care tests are used in resource-limited settings, the benefits need to outweigh the costs. To optimise point-of-care testing in resource-limited settings, diagnostic tests need rigorous assessments focused on relevant clinical outcomes and operational costs, which differ from assessments of conventional diagnostic tests. We reviewed published studies on point-of-care testing in resource-limited settings, and found no clearly defined metric for the clinical usefulness of point-of-care testing. Therefore, we propose a framework for the assessment of point-of-care tests, and suggest and define the term test efficacy to describe the ability of a diagnostic test to support a clinical decision within its operational context. We also propose revised criteria for an ideal diagnostic point-of-care test in resource-limited settings. Through systematic assessments, comparisons between centralised testing and novel point-of-care technologies can be more formalised, and health officials can better establish which point-of-care technologies represent valuable additions to their clinical programmes.
authors: Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA. Electronic address: pdrain@partners.org.
authors: Paul K
authors: PK
authors: Drain
authors: Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: Emily P
authors: EP
authors: Hyle
authors: Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA; The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA; Tufts Clinical and Translational Science Institute, Tufts University, Boston, USA.
authors: Farzad
authors: F
authors: Noubary
authors: Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: Kenneth A
authors: KA
authors: Freedberg
authors: Edendale Hospital, Pietermaritzburg, South Africa.
authors: Douglas
authors: D
authors: Wilson
authors: Johns Hopkins University, Baltimore, USA; KwaZulu-Natal Research Institute for Tuberculosis and HIV, Durban, South Africa.
authors: William R
authors: WR
authors: Bishai
authors: Daktari Diagnostics, Boston, MA, USA.
authors: William
authors: W
authors: Rodriguez
authors: Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
authors: Ingrid V
authors: IV
authors: Bassett
mesh_terms: D003955:Diagnostic Tests, Routine / Q000191:economics / Q000379:methods* / Q000592:standards; D006295:Health Resources / Q000191:economics*; D006801:Humans; D019095:Point-of-Care Systems / Q000191:economics* / Q000592:standards