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Diagnostic point-of-care tests in resource-limited settings

期刊

LANCET INFECTIOUS DISEASES
卷 14, 期 3, 页码 239-249

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ELSEVIER SCI LTD
DOI: 10.1016/S1473-3099(13)70250-0

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资金

  1. Harvard Global Health Institute, Boston, MA, USA
  2. Fogarty International Clinical Research Scholars and Fellows Program at Vanderbilt University, Nashville, TN, USA [R24 TW007988]
  3. NIH Program for AIDS Clinical Research Training [T32 AI007433]
  4. National Institutes of Health [R01 MH090326, R01 AI062476, R01 AI079590, R01 AI097138]
  5. Howard Hughes Medical Institute, Chevy Chase, MD, USA

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The aim of diagnostic point-of-care testing is to minimise the time to obtain a test result, thereby allowing dinicians 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 dearly 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.

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