The performance of the Alere HIV combo point-of-care test on stored serum samples; useful for detection of early HIV-1 infections?

Tienen, Carla van; Rugebregt, Sharona; Scherbeijn, Sandra; Götz, Hannelore M; Kessel, Corine Geurts van

doi:10.1136/sextrans-2016-052818

Cited by 14 publications

(16 citation statements)

References 10 publications

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“…Field studies of the US Food and Drug Administration (FDA)‐approved rapid Alere Determine™ HIV‐1/2 Ag/Ab Combo have shown that antigen is rarely detected in whole blood specimens, with poor sensitivity for detection of AHI. The re‐formulated Alere TM HIV Combo has shown much improved sensitivity for detection of p24 antigen , however, further evaluation of its use in clinical practice is required. Other options include diagnostic platforms for RNA testing, such as the Alere™ q HIV‐1/2 Detect which has been validated for RNA detection among infants and children, the Cepheid GeneXpert ® , the technology for which already has an existing presence in sub‐Saharan Africa where it is predominantly used for tuberculosis testing , and SAMBA which is a dipstick‐based nucleic acid assay for the detection of HIV in whole blood developed for monitoring and diagnostic use in LMIC settings.…”

Section: Discussionmentioning

confidence: 99%

Challenges of HIV diagnosis and management in the context of pre‐exposure prophylaxis (PrEP), post‐exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review

et al. 2019

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Introduction Knowledge of HIV status relies on accurate HIV testing, and is the first step towards access to HIV treatment and prevention programmes. Globally, HIV‐status unawareness represents a significant challenge for achieving zero new HIV infections and deaths. In order to enhance knowledge of HIV status, the World Health Organisation (WHO) recommends a testing strategy that includes the use of HIV‐specific antibody point‐of‐care tests (POCT). These POCTs do not detect acute HIV infection, the stage of disease when viral load is highest but HIV antibodies are undetectable. Complicating things further, in the presence of antiretroviral therapy (ART) for pre‐exposure prophylaxis (PrEP) or post‐exposure prophylaxis (PEP), other currently available testing technologies, such as viral load detection for diagnosis of acute HIV infection, may yield false‐negative results. In this scoping review, we evaluate the evidence and discuss alternative HIV testing algorithms that may mitigate diagnostic dilemmas in the setting of increased utilization of ART for immediate treatment and prevention of HIV infection. Discussion Missed acute HIV infection prevents people living with HIV (PLHIV) from accessing early treatment, increases likelihood of onward transmission, and allows for inappropriate initiation or continuation of PrEP, which may result in HIV drug resistance. While immediate ART is recommended for all PLHIV, studies have shown that starting ART in the setting of acute HIV infection may result in a delayed or complete absence of development of HIV‐specific antibodies, posing a diagnostic challenge that is particularly pertinent to resource‐limited, high HIV burden settings where HIV‐antibody POCTs are standard of care. Similarly, ART used as PrEP or PEP may supress HIV RNA viral load, complicating current HIV testing algorithms in resource‐wealthy settings where viral detection is included. As rollout of PrEP continues, HIV testing algorithms may need to be modified. Conclusions With increasing use of PrEP and ART in acute infection we anticipate diagnostic challenges using currently available HIV testing strategies. Research and surveillance are needed to determine the most appropriate assays and optimal testing algorithms that are accurate, affordable and sustainable.

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Section: Discussionmentioning

confidence: 99%

Challenges of HIV diagnosis and management in the context of pre‐exposure prophylaxis (PrEP), post‐exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review

et al. 2019

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“…Since our review of the Determine Combo rapid test, four published studies have evaluated the new Alere HIV Combo test [24,25,26,27]. All four studies are case-control designs.…”

Section: The Alere Hiv Combo Test: a Summary Of Evaluationsmentioning

confidence: 99%

“…All four studies are case-control designs. The studies were conducted in Switzerland (this study did not compute accuracy estimates e.g., sensitivity, specificity) [27], United Kingdom [24], Japan [25], and the Netherlands [26]. So far, the Alere HIV Combo test has shown improvements in p24 antigen sensitivity compared to the Determine HIV Combo rapid test [24,25].…”

Section: The Alere Hiv Combo Test: a Summary Of Evaluationsmentioning

confidence: 99%

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

Smallwood

Pai

2017

Diagnostics

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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.

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“…Van Tienen and colleagues assess the potential of the Alere Combo point of care test (POCT) for HIV in the detection of early HIV infection—an important priority in partner notification and transmission prevention 2. The value of a molecular POCT for gonorrhoea and chlamydia is evaluated by Causer and colleagues in a large number of ‘remote’ health services serving Aboriginal populations.…”

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Cassell

2018

Sex Transm Infect

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The performance of the Alere HIV combo point-of-care test on stored serum samples; useful for detection of early HIV-1 infections?

Cited by 14 publications

References 10 publications

Challenges of HIV diagnosis and management in the context of pre‐exposure prophylaxis (PrEP), post‐exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review

Challenges of HIV diagnosis and management in the context of pre‐exposure prophylaxis (PrEP), post‐exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review

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

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