Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection

Curtis, Kelly A.; Rudolph, Donna L.; Pan, Yi; Delaney, Kevin P.; Anastos, Kathryn; DeHovitz, Jack; Kassaye, Seble; Hanson, Carl V.; French, Audrey L.; Golub, Elizabeth T.; Adimora, Adaora A.; Ofotokun, Igho; Bolívar, Héctor; Kempf, Mirjam Colette; Peters, Philip J.; Switzer, William M.

doi:10.1371/journal.pone.0242641

Cited by 12 publications

(12 citation statements)

References 32 publications

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“…Although we currently lack ideal methods for estimating changes in HIV incidence in response to decreases in diagnosis delay, objective measures of recency will be key moving forward. Objective measures of recency include recency assays [28–32], identification of Stage 0 HIV infection (new diagnosis with a negative HIV test in the prior 6 months prior), and identification of acute HIV infection (antigen positive/antibody negative) [33]. First, as suggested by Song et al .…”

Section: Discussionmentioning

confidence: 99%

Assessing the reliability of the CD4 depletion model in the presence of ending the HIV epidemic initiatives

Tang

Goyal

Anderson

et al. 2023

Aids

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Background: Accurate estimates of HIV incidence are necessary to monitor progress towards Ending the HIV Epidemic (EHE) initiative targets (90% decline by 2030). U.S. incidence estimates are derived from a CD4 depletion model (CD4 model). We performed simulation-based analyses to investigate the ability of this model to estimate HIV incidence when implementing EHE interventions that have the potential to shorten the duration between HIV infection and diagnosis (diagnosis delay). Methods: Our simulation study evaluates the impact of three parameters on the accuracy of incidence estimates derived from the CD4 model: rate of HIV incidence decline, length of diagnosis delay, and sensitivity of using CD4+ cell counts to identify new infections (recency error). We model HIV incidence and diagnoses after the implementation of a theoretical prevention intervention and compare HIV incidence estimates derived from the CD4 model to simulated incidence. Results: Theoretical interventions that shortened the diagnosis delay (10–50%) result in overestimation of HIV incidence by the CD4 model (10–92%) in the first year and by more than 10% for the first 6 years after implementation of the intervention. Changes in the rate of HIV incidence decline and the presence of recency error had minimal impact on the accuracy of incidence estimates derived from the CD4 model. Conclusion: In the setting of EHE interventions to identify persons with HIV earlier during infection, the CD4 model overestimates HIV incidence. Alternative methods to estimate incidence based on objective measures of incidence are needed to assess and monitor EHE interventions.

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Section: Discussionmentioning

confidence: 99%

Assessing the reliability of the CD4 depletion model in the presence of ending the HIV epidemic initiatives

Tang

Goyal

Anderson

et al. 2023

Aids

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“…Use of testing history alone could be a pragmatic approach to correct for seroconversion in countries lacking detailed clinical or serological information. Where collected, information from diagnostic tests could also provide a useful proxy for recency, as recent studies have shown correlation between a 'recent' limiting antigen result and a signal-tocut-off ratio <250 in the widely-used Abbott Architect Ag/Ab assay [45,46].…”

Section: Discussionmentioning

confidence: 99%

Re‐assessing the late HIV diagnosis surveillance definition in the era of increased and frequent testing

Kirwan

Croxford²,

Aghaizu³

et al. 2022

HIV Medicine

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Objectives Late HIV diagnosis (CD4<350 cells/mm 3 ) is a key public health metric. In an era of more frequent testing there is greater likelihood of HIV diagnosis occurring during seroconversion, when CD4 counts may dip below 350. We apply a correction, considering markers of recent infection and reassess one-year mortality following late diagnosis. Methods We used national epidemiological and laboratory surveillance data on all persons diagnosed with HIV in England, Wales, and Northern Ireland (EW&NI). Persons with a baseline CD4<350 were reclassified as “not-late” if they had evidence of recent infection (recency test and/or negative test within 24 months). A correction factor (CF) was the number reclassified divided by the number with CD4<350. Results Of the 32,227 people diagnosed with HIV in EW&NI between 2011-2019 with a baseline CD4 (81% of total), 46% had a CD4<350 (uncorrected late diagnosis rate): 34% of gay and bisexual men (GBM), 65% of heterosexual men, and 56% of heterosexual women. Accounting for recency test and/or prior negative tests gave a “corrected” late diagnosis rate of 39% and corresponding CF of 14%. The CF increased from 10% to 18% during 2011-2015, then plateaued, and was larger among GBM (25%) than heterosexual men and women (6% and 7%, respectively). One-year mortality among persons diagnosed late was 329 per 10,000 after reclassification (an increase from 288/10,000). Conclusions The case-surveillance definition of late diagnosis increasingly over-estimates late presentation, the extent of which differs by key populations. Adjustment of late diagnosis is recommended, particularly for frequent testers such as GBM.

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“…64 The approved intended use of this test is as a qualitative aid to diagnosis of HIV infection; however, the quantitative information contained in the signal to cutoff ratio has been used in research to discriminate recent from long-term infections. [64][65][66] Because this test relies in part on anti-HIV antibody levels, it is also subject to false classification of infection as recent when viral replication is suppressed and should be used in combination with VL tests in a RITA to reduce the FRR. Relatively less is known about the optimal threshold to use when implementing a RITA using ARCHITECT, compared to the LAg assay.…”

Section: Types Of Recency Testsmentioning

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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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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Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection

Cited by 12 publications

References 32 publications

Assessing the reliability of the CD4 depletion model in the presence of ending the HIV epidemic initiatives

Assessing the reliability of the CD4 depletion model in the presence of ending the HIV epidemic initiatives

Re‐assessing the late HIV diagnosis surveillance definition in the era of increased and frequent testing

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

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