Next Article in Journal
Psychological and Behavioral Impact of Participation in Ovarian Cancer Screening
Next Article in Special Issue
Analytical Tools to Improve Optimization Procedures for Lateral Flow Assays
Previous Article in Journal
Subtypes of Ovarian Cancer and Ovarian Cancer Screening
Previous Article in Special Issue
Exploring the Case for a Global Alliance for Medical Diagnostics Initiative
Article Menu

Export Article

Open AccessCommentary
Diagnostics 2017, 7(1), 13; doi:10.3390/diagnostics7010013

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)
View Full-Text   |   Download PDF [195 KB, uploaded 4 March 2017]

Abstract

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).

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

MDPI and ACS Style

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.

Show more citation formats Show less citations formats

Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Related Articles

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Diagnostics EISSN 2075-4418 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top