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Open AccessCommentary
Diagnostics 2017, 7(1), 13;

Improving the Quality of Diagnostic Studies Evaluating Point of Care Tests for Acute HIV Infections: Problems and Recommendations

Division of Clinical Epidemiology & Infectious Diseases, Department of Medicine, McGill University, Montreal, QC H3A 0G4, Canada
Author to whom correspondence should be addressed.
Academic Editor: Paul Drain
Received: 15 November 2016 / Revised: 28 February 2017 / Accepted: 2 March 2017 / Published: 4 March 2017
(This article belongs to the Special Issue Novel Point-of-Care Technologies in Diagnostics)
Full-Text   |   PDF [195 KB, uploaded 4 March 2017]


The diagnosis of acute human immunodeficiency virus (HIV) infection (AHI) plays a unique role in preventing the spread of HIV and ending the epidemic. Acutely infected individuals are thought to contribute substantially to forward transmissions of HIV; however, diagnosing AHI in resource-limited settings has proven to be a challenge. While fourth generation antigen-antibody combination assays have been successful in high-resource settings, rapid point of care (POC) versions of these assays have yet to demonstrate high sensitivity to detect AHI. Newer RNA/DNA based POC technologies are being validated, but the challenge to understand the additional value of these devices depends on the quality of study evaluations, in particular choice of study designs and case mix of included populations. In this commentary, we aimed to review the quality of studies evaluating a new fourth generation rapid test for detecting AHI, to identify general methodological limitations and biases in diagnostic accuracy studies, and to recommend strategies for avoiding them in future evaluations. The new studies that were evaluated continued to report the same weaknesses and biases that were seen in previous evaluations of fourth generation rapid tests. We recommend that investigators design future studies carefully, keeping in mind how diagnostic performance may be influenced by prevalence, population, patient case mixes, and reference standards. Care must be taken to avoid biases specific to diagnostic accuracy studies (spectrum, verification, incorporation and reference standard biases). To improve on quality, reporting checklists and guidelines such as Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) and Standards for Reporting Diagnostic accuracy studies (STARD) should be reviewed prior to conducting studies. View Full-Text
Keywords: quality; diagnostics; acute HIV infection; recommendations; point of care quality; diagnostics; acute HIV infection; recommendations; point of care
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Smallwood, M.; Pant Pai, N. Improving the Quality of Diagnostic Studies Evaluating Point of Care Tests for Acute HIV Infections: Problems and Recommendations. Diagnostics 2017, 7, 13.

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