TY - JOUR
T1 - Diagnostic point-of-care tests in resource-limited settings
AU - Drain, Paul K.
AU - Hyle, Emily P.
AU - Noubary, Farzad
AU - Freedberg, Kenneth A.
AU - Wilson, Douglas
AU - Bishai, William R.
AU - Rodriguez, William
AU - Bassett, Ingrid V.
N1 - Funding Information:
This Review was supported by the Harvard Global Health Institute, Boston, MA, USA (PKD); the Fogarty International Clinical Research Scholars and Fellows Program at Vanderbilt University, Nashville, TN, USA ( R24 TW007988; PKD ); an NIH Program for AIDS Clinical Research Training ( Grant T32 AI007433; PKD, EPH ); National Institutes of Health grants R01 MH090326 (IVB), R01 AI062476 (KAF), R01 AI079590 (WRB), and R01 AI097138 (WRB) , and a grant from Howard Hughes Medical Institute, Chevy Chase, MD, USA (WRB). The corresponding author had access to all the data in the study, and had final responsibility to submit for publication. The funding sources had no role in the conception, design, or reporting of this report.
PY - 2014/3
Y1 - 2014/3
N2 - 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.
AB - 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.
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U2 - 10.1016/S1473-3099(13)70250-0
DO - 10.1016/S1473-3099(13)70250-0
M3 - Review article
C2 - 24332389
AN - SCOPUS:84894312020
VL - 14
SP - 239
EP - 249
JO - The Lancet Infectious Diseases
JF - The Lancet Infectious Diseases
SN - 1473-3099
IS - 3
ER -