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.
Highlights
The diagnosis of acute human immunodeficiency virus (HIV) infection (AHI) plays a unique role in preventing the spread of HIV and ending the epidemic
In light of the 90-90-90 United Nations Joint Program on HIV/AIDS (UNAIDS) targets, identifying the estimated 19 million human immunodeficiency virus (HIV) positive individuals worldwide who are unaware of their HIV status remains a priority [1,2]
A recent study in South Africa demonstrated that a substantial number of individuals in the acute and early stage of HIV infection are misdiagnosed as negative upon initial screening with rapid antibody point of care tests [9], highlighting the need for rapid tests which can detect HIV earlier, preferably in outreach settings
Summary
In light of the 90-90-90 United Nations Joint Program on HIV/AIDS (UNAIDS) targets, identifying the estimated 19 million human immunodeficiency virus (HIV) positive individuals worldwide who are unaware of their HIV status remains a priority [1,2]. Detection of HIV infection is key to saving public health costs [3], and diagnosis of acute HIV infection (AHI) is gaining global attention. AHI is thought to contribute disproportionately to new infections, with modeling estimates suggesting that acute and early HIV infection account for up to 50% of all forward transmissions [5,6]. The benefits to detecting HIV during early infection include earlier treatment initiation ( WHO recommended), resulting in reductions in viral load [7]. Detection during AHI has public health implications for reducing forward transmission of HIV, in addition to management of symptoms of acute retroviral syndrome and lowering the viral. The additional value of detecting AHI must be taken into consideration, for ensuring timely treatment and controlling the spread of HIV
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