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Lancet Infect Dis. 2014 Mar;14(3):239-49. doi: 10.1016/S1473-3099(13)70250-0. Epub 2013 Dec 10.

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

Author information

1
Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA. Electronic address: pdrain@partners.org.
2
Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
3
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.
4
Edendale Hospital, Pietermaritzburg, South Africa.
5
Johns Hopkins University, Baltimore, USA; KwaZulu-Natal Research Institute for Tuberculosis and HIV, Durban, South Africa.
6
Daktari Diagnostics, Boston, MA, USA.

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.

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PMID:
24332389
PMCID:
PMC4016042
DOI:
10.1016/S1473-3099(13)70250-0
[Indexed for MEDLINE]
Free PMC Article
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