Evaluation of Dried Blood Spots with a Multiplex Assay for Measuring Recent HIV-1 Infection

Curtis, Kelly A.; Ambrose, Krystin M.; Kennedy, Melanie S.; Owen, S. Michele

doi:10.1371/journal.pone.0107153

Cited by 11 publications

(8 citation statements)

References 30 publications

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“…Specimens from 30 subjects (n = 166) were obtained from the AIDSVAX B/B Phase III Vaccine Trial (VAX004; ClinicalTrials.gov identifier NCT00002441) [ 34 ]. A total of nine longitudinal seroconversion panels (n = 81) were obtained through the Seroconversion Incidence Panel Project (SIPP) in collaboration with SeraCare Life Sciences, Inc. [ 18 ]. Inclusion criteria for all seroconversion panels selected for this study were as follows: [ 1 ] each panel must have at least 4 consecutive observations, and [ 2 ] the interval of time between the last negative and first positive antibody test must be <240 days.…”

Section: Methodsmentioning

confidence: 99%

“…Although several non-serological methods are in the early stages of development [ 15 – 17 ], the benefits of serological biomarkers continue to support the use of antibody-based assays for determining recent infection. Antibody is a remarkably stable biomarker in plasma or dried blood spots (DBS) and levels of virus-specific antibody follow a relatively predictable pattern of maturation post-seroconversion [ 13 , 18 ]. However, there are well-documented limitations associated with antibody-based incidence assays; e.g.…”

Section: Introductionmentioning

confidence: 99%

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Performance characteristics of an antibody-based multiplex kit for determining recent HIV-1 infection

et al. 2017

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The availability of reliable laboratory methods for determining recent HIV infection is vital for accurate estimation of population-based incidence. The mean duration of recent infection (MDRI) and false recent rate (FRR) are critical parameters for HIV incidence assays, as they impact HIV incidence estimates and provide a measure of assay performance. The HIV-1 Multiplex assay is an in-house developed, magnetic bead-based assay that measures virus-specific antibody levels and avidity to multiple analytes. To ensure quality control and to facilitate transfer of the assay to external laboratories or testing facilities, the in-house assay has been adapted and produced in kit form. Here, we describe the performance characteristics of the multiplex kit and demonstrate the stability of the kit components over a one-year period. Two statistical methods were employed to estimate the MDRI of the individual analytes and five different algorithms, combining multiple analyte values. The MDRI estimates for the individual analytes and five algorithms were all between 200 and 300 days post-seroconversion, with no notable difference between the two statistical approaches. All five algorithms exhibited a 0% FRR with specimens from long-term, subtype B HIV-1-infected individuals. The assay parameters described in this study provide the necessary tools to implement the HIV-1 multiplex assay and improves the utility of the assay for field use.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Performance characteristics of an antibody-based multiplex kit for determining recent HIV-1 infection

et al. 2017

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“…In project areas that implemented a p-RTA, all participants received both RT-1 and RT-2 concurrently and DBS was also collected from participants that had any reactive RT and consented to blood storage. DBS were collected following a standard protocol, dried for a minimum of 4 h and up to 24 h at ambient temperature, and then placed in sealable bags with desiccants and a humidity indicator card [16]. The bagged DBS were stored in a dry environment at ambient temperature for up to a week before shipping to CDC.…”

Section: Nhbs Hiv Testing and Data Collectionmentioning

confidence: 99%

Evaluation of Rapid Testing Algorithms for Venue-based Anonymous HIV Testing among Non-HIV-Positive Men Who Have Sex with Men, National HIV Behavioral Surveillance (NHBS), 2017

et al. 2020

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HIV rapid testing algorithms (RTAs) using any two orthogonal rapid tests (RTs) allow for on-site confirmation of infection. RTs vary in performance characteristics therefore the selection of RTs in an algorithm may affect identification of infection, particularly if acute. National HIV Behavioral Surveillance (NHBS) assessed RTAs among men who have sex with men recruited using anonymous venue-based sampling. Different algorithms were evaluated among participants who self-reported never having received a positive HIV test result prior to the interview. NHBS project areas performed sequential or parallel RTs using whole blood. Participants with at least one reactive RT were offered anonymous linkage to care and provided a dried blood spot (DBS) for testing at CDC. Discordant results (RT-1 reactive/RT-2 non-reactive) were tested at CDC with lab protocols modified for DBS. DBS were also tested for HIV-1 RNA (VL) and antiretroviral (ARV) drug levels. Of 6500 RTAs, 238 were RT-1 reactive; of those, 97.1% (231/238) had concordant results (RT-1/RT-2 reactive) and 2.9% (7/238) had discordant results. Five DBS associated with discordant results were available for confirmation at CDC. Four had non-reactive confirmatory test results that implied RT-1 false reactivity; one had ambiguous confirmatory test results which was non-reactive in further testing. Regardless of order and type of RT used, RTAs demonstrated high concordant results in the population surveyed. Additional laboratory testing on DBS following discordant results confirmed no infection. Implementing RTAs in the context of anonymous venue-based HIV testing could be an option when laboratory follow-up is not practicable.

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“…This makes IgG3 an attractive biomarker for the identification of recent HIV infections [ 55 , 56 , 57 ], since high IgG3 levels are associated with a high HIV-1 viral load [ 58 ]. The HIV-1 Bio-Plex assay is one method that specifically measures the p24-specific IgG3 responses [ 59 ]. Although IgG3 has been observed to decline over time, about one-third of individuals exhibit relatively high IgG3 levels in the late stage of HIV-1 infection [ 59 ].…”

Section: Serological Tests Of Recent Hiv Infectionmentioning

confidence: 99%

“…The HIV-1 Bio-Plex assay is one method that specifically measures the p24-specific IgG3 responses [ 59 ]. Although IgG3 has been observed to decline over time, about one-third of individuals exhibit relatively high IgG3 levels in the late stage of HIV-1 infection [ 59 ].…”

Section: Serological Tests Of Recent Hiv Infectionmentioning

confidence: 99%

Identifying Recent HIV Infections: From Serological Assays to Genomics

Moyo

Wilkinson

Novitsky

et al. 2015

Viruses

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In this paper, we review serological and molecular based methods to identify HIV infection recency. The accurate identification of recent HIV infection continues to be an important research area and has implications for HIV prevention and treatment interventions. Longitudinal cohorts that follow HIV negative individuals over time are the current gold standard approach, but they are logistically challenging, time consuming and an expensive enterprise. Methods that utilize cross-sectional testing and biomarker information have become an affordable alternative to the longitudinal approach. These methods use well-characterized biological makers to differentiate between recent and established HIV infections. However, recent results have identified a number of limitations in serological based assays that are sensitive to the variability in immune responses modulated by HIV subtypes, viral load and antiretroviral therapy. Molecular methods that explore the dynamics between the timing of infection and viral evolution are now emerging as a promising approach. The combination of serological and molecular methods may provide a good solution to identify recent HIV infection in cross-sectional data. As part of this review, we present the advantages and limitations of serological and molecular based methods and their potential complementary role for the identification of HIV infection recency.

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Evaluation of Dried Blood Spots with a Multiplex Assay for Measuring Recent HIV-1 Infection

Cited by 11 publications

References 30 publications

Performance characteristics of an antibody-based multiplex kit for determining recent HIV-1 infection

Performance characteristics of an antibody-based multiplex kit for determining recent HIV-1 infection

Evaluation of Rapid Testing Algorithms for Venue-based Anonymous HIV Testing among Non-HIV-Positive Men Who Have Sex with Men, National HIV Behavioral Surveillance (NHBS), 2017

Identifying Recent HIV Infections: From Serological Assays to Genomics

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