A systematic review of limiting antigen avidity enzyme immunoassay for detection of recent HIV-1 infection to expand supported applications

Lau, Joseph; Murdock, Nicholas; Murray, Jeffrey; Justman, Jessica; Parkin, Neil; Miller, Veronica

doi:10.1016/j.jve.2022.100085

Cited by 7 publications

(4 citation statements)

References 48 publications

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“…Most laboratory tests that distinguish between recent and longstanding HIV-1 infection rely on the well-characterized evolution of the humoral antibody (Ab) response to HIV infection and are reviewed elsewhere. [31][32][33][34][35][36][37][38][39] One important challenge to the interpretation of tests for recent infection is the inherent biological variability in the kinetics of Ab maturation during infection between individuals; this can be influenced by particular host, viral, and external characteristics, including sex, pregnancy status, HIV-1 subtype, ART status, etc. Therefore, recent infection testing performed for the purpose of estimating incidence in a population requires a probabilistic approach, based on the test performance described by two key parameters: the mean duration of recent infection (MDRI) and false recency ratio (FRR; sometimes referred to as the false recent rate, or proportion false recent).…”

Section: Differentiating Between Recent and Chronic Hiv Infectionmentioning

confidence: 99%

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Facilitating Next‐Generation Pre‐Exposure Prophylaxis Clinical Trials Using HIV Recent Infection Assays: A Consensus Statement from the Forum HIV Prevention Trial Design Project

Parkin

Gao

Grebe

et al. 2023

Clin Pharma and Therapeutics

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Standard‐of‐care HIV pre‐exposure prophylaxis (PrEP) is highly efficacious, but uptake of and persistence on a daily oral pill is low in many settings. Evaluation of alternate PrEP products will require innovation to avoid the unpractically large sample sizes in noninferiority trials. We propose estimating HIV incidence in people not on PrEP as an external counterfactual to which on‐PrEP incidence in trial subjects can be compared. HIV recent infection testing algorithms (RITAs), such as the limiting antigen avidity assay plus viral load used on specimens from untreated HIV positive people identified during screening, is one possible approach. Its feasibility is partly dependent on the sample size needed to ensure adequate power, which is impacted by RITA performance, the number of recent infections identified, the expected efficacy of the intervention, and other factors. Screening sample sizes to support detection of an 80% reduction in incidence for 3 key populations are more modest, and comparable to the number of participants in recent phase III PrEP trials. Sample sizes would be significantly larger in populations with lower incidence, where the false recency rate is higher or if PrEP efficacy is expected to be lower. Our proposed counterfactual approach appears to be feasible, offers high statistical power, and is nearly contemporaneous with the on‐PrEP population. It will be important to monitor the performance of this approach during new product development for HIV prevention. If successful, it could be a model for preventive HIV vaccines and prevention of other infectious diseases.

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Section: Differentiating Between Recent and Chronic Hiv Infectionmentioning

confidence: 99%

“…Most laboratory tests that distinguish between recent and longstanding HIV‐1 infection rely on the well‐characterized evolution of the humoral antibody (Ab) response to HIV infection and are reviewed elsewhere 31–39 …”

Section: Differentiating Between Recent and Chronic Hiv Infectionmentioning

confidence: 99%

Facilitating Next‐Generation Pre‐Exposure Prophylaxis Clinical Trials Using HIV Recent Infection Assays: A Consensus Statement from the Forum HIV Prevention Trial Design Project

Parkin

Gao

Grebe

et al. 2023

Clin Pharma and Therapeutics

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“…Human immunodeficiency virus type one (HIV-1) is an important agent that is responsible for acquired immunodeficiency syndrome (AIDS): approximately 38 million people globally live with this virus, and nearly 650,000 people died from AIDS-related illnesses in 2021, according to the Joint United Nations Programme on HIV/AIDS (UNAIDS) ( Bernstein and Wegman, 2018 ; Eisinger and Fauci, 2018 ; UNAIDS, 2022 ). HIV-1 infection remains a global public health concern, the UNAIDS initiated the global project termed “95-95-95” to end the global HIV/AIDS epidemic by 2030, stressing the importance of diagnostic tests and aiming for 95% of people living with HIV-1 to know their status, 95% of people with diagnosed HIV-1 infection to receive sustained treatment, and 95% of people on treatment to achieve viral load suppression ( Rojas-Celis et al, 2019 ; Kin-On et al, 2022 ). Developing an advanced testing system is crucial to meet these goals and timely control the transmission of the disease.…”

Section: Introductionmentioning

confidence: 99%

Rapid and visual identification of HIV-1 using reverse transcription loop-mediated isothermal amplification integrated with a gold nanoparticle-based lateral flow assay platform

Chen

Zhao³

et al. 2023

Front. Microbiol.

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Human immunodeficiency virus type one (HIV-1) infection remains a major public health problem worldwide. Early diagnosis of HIV-1 is crucial to treat and control this infection effectively. Here, for the first time, we reported a novel molecular diagnostic assay called reverse transcription loop-mediated isothermal amplification combined with a visual gold nanoparticle-based lateral flow assay (RT-LAMP-AuNPs-LFA), which we devised for rapid, specific, sensitive, and visual identification of HIV-1. The unique LAMP primers were successfully designed based on the pol gene from the major HIV-1 genotypes CRF01_AE, CRF07_BC, CRF08_BC, and subtype B, which are prevalent in China. The optimal HIV-1-RT-LAMP-AuNPs-LFA reaction conditions were determined to be 68°C for 35 min. The detection procedure, including crude genomic RNA isolation (approximately 5 min), RT-LAMP amplification (35 min), and visual result readout (<2 min), can be completed within 45 min. Our assay has a detection limit of 20 copies per test, and we did not observe any cross-reactivity with any other pathogen in our testing. Hence, our preliminary results indicated that the HIV-1-RT-LAMP-AuNPs-LFA assay can potentially serve as a useful point-of-care diagnostic tool for HIV-1 detection in a clinical setting.

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“…Generally, HIV incidence among high-risk groups from AIDS surveillance sentinels is calculated in a province to reduce bias (12). LAg-Avidity-EIA has been widely used in many countries, especially in developing countries, to estimate HIV incidence in high-risk populations (13)(14)(15)(16). In this study, the LAg-Avidity-EIA method was used to detect recent HIV infections in AIDS sentinel surveillance surveys in Jiangsu province from 2016 to 2021 to observe the trends of HIV incidence and to determine the factors associated with recent HIV infection among MSM.…”

Section: Introductionmentioning

confidence: 99%

Sustained high HIV incidence among men who have sex with men in Jiangsu province, China: based on the limiting-antigen avidity EIA method and six consecutive surveys, 2016–2021

Zhou,

Chen,

et al. 2023

Front. Public Health

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BackgroundThe epidemic of HIV infection among men who have sex with men (MSM) is a major public health concern in some parts of China, but data on trends in HIV incidence are limited. This study aimed to examine the trends in HIV incidence and factors associated with recent HIV infection among MSM in Jiangsu province, China, based on the limiting-antigen avidity enzyme immunoassay (LAg-Avidity-EIA) method.MethodsSix consecutive surveys were implemented among MSM throughout Jiangsu province from 2016 to 2021. Participants were recruited in three ways. Socio-demographic and behavioral information were collected through face-to-face interviews. Venous blood samples were taken to test for HIV and syphilis. HIV incidence was estimated using the LAg-Avidity-EIA method. Chi-square trend tests were used to observe trends over the years. Multivariate regression analyses were used to identify factors associated with recent HIV infection.ResultsA total of 15,401 participants were enrolled in the study. The prevalence of HIV infection ranged from 8.0 to 9.8%, with no consistent rise or fall over the years (P = 0.189). HIV incidence ranged from 5.0 to 9.0%, and no uptrend or downtrend was shown (P = 0.418). MSM who lived locally for more than 2 years (aOR = 1.366, P = 0.019), had a lack of comprehensive HIV knowledge (aOR = 1.643, P = 0.031), had engaged in unprotected anal intercourse (UAI) in the past 6 months (aOR = 7.373, P < 0.001), had been tested for HIV within 12 months (aOR = 1.292, P = 0.035), and tested positive for syphilis (aOR = 2.840, P < 0.001) were likely to be recently infected with HIV.ConclusionsHIV incidence among MSM has remained at a high level in Jiangsu province. In China, health education, condom use, and HIV/syphilis testing should continue to be top priorities for HIV prevention among MSM to reduce HIV transmission.

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A systematic review of limiting antigen avidity enzyme immunoassay for detection of recent HIV-1 infection to expand supported applications

Cited by 7 publications

References 48 publications

Facilitating Next‐Generation Pre‐Exposure Prophylaxis Clinical Trials Using HIV Recent Infection Assays: A Consensus Statement from the Forum HIV Prevention Trial Design Project

Facilitating Next‐Generation Pre‐Exposure Prophylaxis Clinical Trials Using HIV Recent Infection Assays: A Consensus Statement from the Forum HIV Prevention Trial Design Project

Rapid and visual identification of HIV-1 using reverse transcription loop-mediated isothermal amplification integrated with a gold nanoparticle-based lateral flow assay platform

Sustained high HIV incidence among men who have sex with men in Jiangsu province, China: based on the limiting-antigen avidity EIA method and six consecutive surveys, 2016–2021

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