Development and evaluation of a modified fourth-generation human immunodeficiency virus enzyme immunoassay for cross-sectional incidence estimation in Clade B populations

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Abstract

Background: Accurate methods for cross-sectional incidence estimation are needed for HIV surveillance and prevention research. We developed an avidity assay based on the fourth-generation Genetic Systems HIV Combo Ag/Ab EIA (Bio-Rad Combo assay) and evaluated its performance. Materials and Methods: The Bio-Rad Combo assay was modified incubating samples with and without 0.025 M diethylamine (DEA). The avidity index (AI) was calculated as the ratio of the DEA-treated to untreated result for a specific sample. We analyzed 2,140 samples from 808 individuals from the United States with known duration of HIV infection. The mean duration of recent infection (MDRI) and the false-recent rate (FRR, fraction of samples from individuals known to be infected >2 years misclassified as recent) were calculated for AI cutoffs of 20%-90% for the avidity assay alone and in combination with a viral load assay (VL, limit of detection 400 copies/ml). Factors associated with misclassification of samples collected ≥2 years after infections were also evaluated. Results: The MDRI for the Bio-Rad Combo Avidity assay ranged from 50 days using an AI cutoff of 20% to 276 days using an AI cutoff of 90%; the FRR ranged from 0% to 9%. When samples with a VL 80%. In adjusted analysis, viral suppression and low CD4 cell count were significantly associated with misclassification among individuals infected >2 years. Conclusions: This modified Bio-Rad Combo Avidity assay may be a useful tool for cross-sectional HIV incidence estimation. Further research is needed to evaluate use of this assay in combination with other assays to accurately estimate population-level HIV incidence.

Original languageEnglish (US)
Pages (from-to)756-762
Number of pages7
JournalAIDS Research and Human Retroviruses
Volume32
Issue number8
DOIs
StatePublished - Aug 1 2016

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Immunoenzyme Techniques
HIV
Incidence
Population
Infection
CD4 Lymphocyte Count
Viral Load
Research
HIV Infections
Limit of Detection
diethylamine

ASJC Scopus subject areas

  • Immunology
  • Virology
  • Infectious Diseases

Cite this

@article{cf9c46011cf54f5885fcfd2e597470f0,
title = "Development and evaluation of a modified fourth-generation human immunodeficiency virus enzyme immunoassay for cross-sectional incidence estimation in Clade B populations",
abstract = "Background: Accurate methods for cross-sectional incidence estimation are needed for HIV surveillance and prevention research. We developed an avidity assay based on the fourth-generation Genetic Systems HIV Combo Ag/Ab EIA (Bio-Rad Combo assay) and evaluated its performance. Materials and Methods: The Bio-Rad Combo assay was modified incubating samples with and without 0.025 M diethylamine (DEA). The avidity index (AI) was calculated as the ratio of the DEA-treated to untreated result for a specific sample. We analyzed 2,140 samples from 808 individuals from the United States with known duration of HIV infection. The mean duration of recent infection (MDRI) and the false-recent rate (FRR, fraction of samples from individuals known to be infected >2 years misclassified as recent) were calculated for AI cutoffs of 20{\%}-90{\%} for the avidity assay alone and in combination with a viral load assay (VL, limit of detection 400 copies/ml). Factors associated with misclassification of samples collected ≥2 years after infections were also evaluated. Results: The MDRI for the Bio-Rad Combo Avidity assay ranged from 50 days using an AI cutoff of 20{\%} to 276 days using an AI cutoff of 90{\%}; the FRR ranged from 0{\%} to 9{\%}. When samples with a VL 80{\%}. In adjusted analysis, viral suppression and low CD4 cell count were significantly associated with misclassification among individuals infected >2 years. Conclusions: This modified Bio-Rad Combo Avidity assay may be a useful tool for cross-sectional HIV incidence estimation. Further research is needed to evaluate use of this assay in combination with other assays to accurately estimate population-level HIV incidence.",
author = "Kirkpatrick, {Allison R.} and Patel, {Eshan U.} and Celum, {Connie L.} and Moore, {Richard D} and Blankson, {Joel N} and Mehta, {Shruti Hemendra} and Kirk, {Gregory D} and Margolick, {Joseph Bernard} and Quinn, {Thomas C} and Susan Eshleman and Laeyendecker, {Oliver B.}",
year = "2016",
month = "8",
day = "1",
doi = "10.1089/aid.2015.0198",
language = "English (US)",
volume = "32",
pages = "756--762",
journal = "AIDS Research and Human Retroviruses",
issn = "0889-2229",
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TY - JOUR

T1 - Development and evaluation of a modified fourth-generation human immunodeficiency virus enzyme immunoassay for cross-sectional incidence estimation in Clade B populations

AU - Kirkpatrick, Allison R.

AU - Patel, Eshan U.

AU - Celum, Connie L.

AU - Moore, Richard D

AU - Blankson, Joel N

AU - Mehta, Shruti Hemendra

AU - Kirk, Gregory D

AU - Margolick, Joseph Bernard

AU - Quinn, Thomas C

AU - Eshleman, Susan

AU - Laeyendecker, Oliver B.

PY - 2016/8/1

Y1 - 2016/8/1

N2 - Background: Accurate methods for cross-sectional incidence estimation are needed for HIV surveillance and prevention research. We developed an avidity assay based on the fourth-generation Genetic Systems HIV Combo Ag/Ab EIA (Bio-Rad Combo assay) and evaluated its performance. Materials and Methods: The Bio-Rad Combo assay was modified incubating samples with and without 0.025 M diethylamine (DEA). The avidity index (AI) was calculated as the ratio of the DEA-treated to untreated result for a specific sample. We analyzed 2,140 samples from 808 individuals from the United States with known duration of HIV infection. The mean duration of recent infection (MDRI) and the false-recent rate (FRR, fraction of samples from individuals known to be infected >2 years misclassified as recent) were calculated for AI cutoffs of 20%-90% for the avidity assay alone and in combination with a viral load assay (VL, limit of detection 400 copies/ml). Factors associated with misclassification of samples collected ≥2 years after infections were also evaluated. Results: The MDRI for the Bio-Rad Combo Avidity assay ranged from 50 days using an AI cutoff of 20% to 276 days using an AI cutoff of 90%; the FRR ranged from 0% to 9%. When samples with a VL 80%. In adjusted analysis, viral suppression and low CD4 cell count were significantly associated with misclassification among individuals infected >2 years. Conclusions: This modified Bio-Rad Combo Avidity assay may be a useful tool for cross-sectional HIV incidence estimation. Further research is needed to evaluate use of this assay in combination with other assays to accurately estimate population-level HIV incidence.

AB - Background: Accurate methods for cross-sectional incidence estimation are needed for HIV surveillance and prevention research. We developed an avidity assay based on the fourth-generation Genetic Systems HIV Combo Ag/Ab EIA (Bio-Rad Combo assay) and evaluated its performance. Materials and Methods: The Bio-Rad Combo assay was modified incubating samples with and without 0.025 M diethylamine (DEA). The avidity index (AI) was calculated as the ratio of the DEA-treated to untreated result for a specific sample. We analyzed 2,140 samples from 808 individuals from the United States with known duration of HIV infection. The mean duration of recent infection (MDRI) and the false-recent rate (FRR, fraction of samples from individuals known to be infected >2 years misclassified as recent) were calculated for AI cutoffs of 20%-90% for the avidity assay alone and in combination with a viral load assay (VL, limit of detection 400 copies/ml). Factors associated with misclassification of samples collected ≥2 years after infections were also evaluated. Results: The MDRI for the Bio-Rad Combo Avidity assay ranged from 50 days using an AI cutoff of 20% to 276 days using an AI cutoff of 90%; the FRR ranged from 0% to 9%. When samples with a VL 80%. In adjusted analysis, viral suppression and low CD4 cell count were significantly associated with misclassification among individuals infected >2 years. Conclusions: This modified Bio-Rad Combo Avidity assay may be a useful tool for cross-sectional HIV incidence estimation. Further research is needed to evaluate use of this assay in combination with other assays to accurately estimate population-level HIV incidence.

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U2 - 10.1089/aid.2015.0198

DO - 10.1089/aid.2015.0198

M3 - Article

C2 - 26988426

AN - SCOPUS:84979978344

VL - 32

SP - 756

EP - 762

JO - AIDS Research and Human Retroviruses

JF - AIDS Research and Human Retroviruses

SN - 0889-2229

IS - 8

ER -