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BioRad BioPlex® HIV Ag-Ab assay: Incidence of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm.

ABSTRACT: BACKGROUND:The BioPlex® HIV Ag-Ab assay, unlike other HIV 1/2 antigen/antibody immunoassays, is capable of differentiating positive HIV-1 antibodies (Groups M and O) from HIV-2 antibodies and/or HIV-1 p24 antigen in a single test. OBJECTIVE:The Alaska State Virology Laboratory (ASVL) adopted the BioPlex® HIV Ag-Ab assay early 2017 and can report on its performance in terms of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm recommended by the Centers for Disease Control and Prevention (CDC). STUDY DESIGN:Specimens received between March 2017 and August 2018 were screened using the BioPlex® HIV Ag-Ab assay. Specimens screening positive for HIV antibodies or antigen were further confirmed using the Geenius™ HIV 1/2 Supplemental Assay and/or HIV RNA testing. RESULTS:Of the 12,338 sera screened by the BioPlex assay for HIV, 35 specimens were positive. Only 22 of the specimens were confirmed by supplemental testing and were considered to be truly positive (PPV, 62.9%). RNA was not detected in these cases suggesting initial false positivity on the BioPlex® HIV Ag-Ab assay. True positive results had index values (IDX) of >180 whereas false positive IDX's were between 1 and 4, with the exception of one specimen. CONCLUSIONS:We suggest that specimens demonstrating positivity with low IDX values <4 on the BioPlex® HIV Ag-Ab assay proceed directly to RNA testing, essentially bypassing supplemental antibody confirmation tests, to reduce turnaround time and cost of HIV confirmation.

SUBMITTER: Parker J

PROVIDER: S-EPMC6557666 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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BioRad BioPlex® HIV Ag-Ab assay: Incidence of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm.

Parker Jayme J Carrasco Ana Fiorella AF Chen Jack J

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology 20190406

<h4>Background</h4>The BioPlex® HIV Ag-Ab assay, unlike other HIV 1/2 antigen/antibody immunoassays, is capable of differentiating positive HIV-1 antibodies (Groups M and O) from HIV-2 antibodies and/or HIV-1 p24 antigen in a single test.<h4>Objective</h4>The Alaska State Virology Laboratory (ASVL) adopted the BioPlex® HIV Ag-Ab assay early 2017 and can report on its performance in terms of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm recom ...[more]

PMID: 30981082

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Project description:UnlabelledHuman immunodeficiency virus (HIV) incidence is an important measure for monitoring the epidemic and evaluating the efficacy of intervention and prevention trials. This study developed a high-throughput, single-measure incidence assay by implementing a pyrosequencing platform. We devised a signal-masking bioinformatics pipeline, which yielded a process error rate of 5.8 × 10(-4) per base. The pipeline was then applied to analyze 18,434 envelope gene segments (HXB2 7212 to 7601) obtained from 12 incident and 24 chronic patients who had documented HIV-negative and/or -positive tests. The pyrosequencing data were cross-checked by using the single-genome-amplification (SGA) method to independently obtain 302 sequences from 13 patients. Using two genomic biomarkers that probe for the presence of similar sequences, the pyrosequencing platform correctly classified all 12 incident subjects (100% sensitivity) and 23 of 24 chronic subjects (96% specificity). One misclassified subject's chronic infection was correctly classified by conducting the same analysis with SGA data. The biomarkers were statistically associated across the two platforms, suggesting the assay's reproducibility and robustness. Sampling simulations showed that the biomarkers were tolerant of sequencing errors and template resampling, two factors most likely to affect the accuracy of pyrosequencing results. We observed comparable biomarker scores between AIDS and non-AIDS chronic patients (multivariate analysis of variance [MANOVA], P = 0.12), indicating that the stage of HIV disease itself does not affect the classification scheme. The high-throughput genomic HIV incidence marks a significant step toward determining incidence from a single measure in cross-sectional surveys.ImportanceAnnual HIV incidence, the number of newly infected individuals within a year, is the key measure of monitoring the epidemic's rise and decline. Developing reliable assays differentiating recent from chronic infections has been a long-standing quest in the HIV community. Over the past 15 years, these assays have traditionally measured various HIV-specific antibodies, but recent technological advancements have expanded the diversity of proposed accurate, user-friendly, and financially viable tools. Here we designed a high-throughput genomic HIV incidence assay based on the signature imprinted in the HIV gene sequence population. By combining next-generation sequencing techniques with bioinformatics analysis, we demonstrated that genomic fingerprints are capable of distinguishing recently infected patients from chronically infected patients with high precision. Our high-throughput platform is expected to allow us to process many patients' samples from a single experiment, permitting the assay to be cost-effective for routine surveillance.

Dataset Information

BioRad BioPlex® HIV Ag-Ab assay: Incidence of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm.

Publications

BioRad BioPlex® HIV Ag-Ab assay: Incidence of false positivity in a low-prevalence population and its effects on the current HIV testing algorithm.

Similar Datasets

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