Performance Characteristics of the Immunoglobulin G-Capture BED-Enzyme Immunoassay, an Assay To Detect Recent Human Immunodeficiency Virus Type 1 Seroconversion

Abstract

Recently, we developed an immunoglobulin G (IgG)-capture BED-enzyme immunoassay (BED-CEIA) to identify recent human immunodeficiency virus (HIV) type 1 (HIV-1) seroconversion for use in incidence estimates. We have established an algorithm for its use; developed quality control reagents to monitor the assay; and evaluated its performance for interrun, intrarun, and operator variability. Analysis of 144 individual plates, which involved multiple plate lots and several operators over more than a year, indicated that the coefficients of variation (CVs) were between 10 and 15% for raw optical density (OD) values in the dynamic range between 0.5 and 2.0 OD units; the CVs decreased to 5 to 10% when the OD was normalized (OD-n; OD-n ‫؍‬ specimen OD/calibrator OD). The intrarun CVs were generally in the range of 5 to 10% for specimens with ODs <0.5 and less than 5% for specimens with ODs >0.5. The level of concordance between multiple plate lots (n ‫؍‬ 6) and multiple operators (n ‫؍‬ 7) was quite high (R 2 > 0. 9). Comparison of the results of the initial and the confirmatory tests with specimens with OD-n values

Impact of HIV Subtype on Performance of the Limiting Antigen-Avidity Enzyme Immunoassay, the Bio-Rad Avidity Assay, and the BED Capture Immunoassay in Rakai, Uganda

“…Most cross-sectional HIV incidence assays measure characteristics of anti-HIV antibodies. 5,6 The 1 BED capture enzyme immunoassay (BED-CEIA) 7 is currently used in the United States 8,9 and other countries 10 to estimate HIV incidence and identify high-incidence populations. A modified version of the Bio-Rad 1/2 + O ELISA (Bio-Rad Avidity assay) 11 has also been used for cross-sectional incidence estimation.…”

HIV Diversity as a Biomarker for HIV Incidence Estimation: Including a High-Resolution Melting Diversity Assay in a Multiassay Algorithm

“…A 4-assay MAA was developed that provides accurate HIV incidence estimates in cohorts from the United States (4,7,8), where most infections are caused by subtype B HIV (9). This MAA includes CD4 cell count, the BED capture enzyme immunoassay (BED-CEIA) (10), the Bio-Rad Avidity assay (11), and viral load. An optimized MAA that includes the same four assays with different assay cutoffs was later identified by comparing the performance of Ͼ11,000 MAAs that included different combinations of the four assays and different assay cutoffs (Fig.…”

Short Communication: The Impact of Viral Suppression and Viral Breakthrough on Limited-Antigen Avidity Assay Results in Individuals with Clade B HIV Infection

“…10 This may reflect the fact that the LAg-Avidity assay and BED-CEIA use nearly identical target peptides. 3,5 Although the LAg-Avidity assay has a lower rate of misclassification than the BED-CEIA among elite suppressors and has a lower median decrease in OD-n values in virally suppressed individuals, the Lag-Avidity assay and BED-CEIA have similar patterns of misclassification in individuals with viral suppression and viral breakthrough. These results are supporting previously published data that suggested LAg Avidity fluctuated with viral load.…”

“…2 For example, the BED capture enzyme immunoassay (BED-CEIA), a commercial-based assay developed by the CDC, measures the proportion of IgG that is HIV specific. 3 The BioRad Avidity is based on a modification of the Genetic Systems HIV-1/HIV-2 plus O EIA (Bio-Rad Laboratories, Inc., Hercules, CA) and involves assessing the impact of a chaotropic agent on antibody binding to target antigens. 4 The newest commercially available form of this technology, also developed by the CDC, is a limiting antigen avidity enzyme immunoassay (LAg-Avidity) that measures the antigen-specific antibodies to very low concentration of recombinant gp41 peptide in the context of a chaotropic agent.…”