Evaluation of a Sensitive/Less-Sensitive Testing Algorithm Using the 3A11-LS Assay for Detecting Recent HIV Seroconversion among Individuals with HIV-1 Subtype B or E Infection in Thailand

Parekh, Bharat; Hu, Dale J.; Vanichseni, Suphak; Satten, Glen A.; Candal, Debra; Young, Nancy L.; Kitayaporn, Dwip; Srisuwanvilai, La-Ong; Rakhtam, Suwanee; Janssen, Robert S.; Choopanya, Kachit; Mastro, Timothy D.

doi:10.1089/088922201750102562

Cited by 57 publications

(40 citation statements)

References 13 publications

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“…However, blinded comparisons of the different assays to identify recent HIV-1 infections in panels of well-characterized serum samples would be very useful in the future. Recent studies demonstrated that the ability of the S/LS EIA strategy to detect recent seroconversions differs between different HIV-1 subtypes (15,28,39). Our evaluation was done with serum samples from patients residing in France, most of who were infected by subtype B variants.…”

Section: Vol 43 2005 Immunoassay For Recent Hiv-1 Infections 4445mentioning

confidence: 99%

Development and Validation of an Immunoassay for Identification of Recent Human Immunodeficiency Virus Type 1 Infections and Its Use on Dried Serum Spots

et al. 2005

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The objective was to develop and to validate an immunossay to identify recent human immunodeficiency virus type 1 (HIV-1) infections that can be used on dried serum spots (DSS). A single, indirect enzyme-linked immunosorbent assay was developed to quantify antibodies toward four HIV-1 antigens: consensus peptides of the immunodominant epitope of gp41 (IDE), consensus V3 peptides, recombinant integrase, and recombinant p24. The parameters of the logistic regression used to classify the samples were estimated on a training sample (210 serum samples) using resampling techniques to get stable estimates and then applied to a validation sample (761 serum samples). The IDE and V3 peptides were the best able to discriminate between the antibodies present in serum from recently (<6 months) infected individuals and those with long-lasting infection. Combined quantification of antibody binding to these two synthetic antigens allowed us to identify recent infections with an area under the receiver operating characteristic curve of 0.949 and a sensitivity of 88.3%, with a specificity of 97.6% in patients with long-term infection (but not AIDS) and 86.0% in patients suffering from AIDS with a threshold of 0.50 in the validation sample. This simple immunoassay can be used to identify recently HIV-1-infected patients. Its performance is compatible with its use in population-based studies including DSS.The human immunodeficiency virus (HIV) epidemic is generally assessed by monitoring seroprevalence i.e., the proportion of persons with HIV antibodies (including recently infected people and people who were infected several years previously). To understand recent changes in the HIV epidemic, it is necessary to estimate the incidence, i.e., the number of newly infected subjects in a defined period. A strategy based on a sensitive/less sensitive testing algorithm was recently used to identify serum samples from recently infected individuals (16). This strategy that uses both a sensitive and a less-sensitive enzyme immunoassay (S/LS EIA), also called a detuned assay, was applied to various situations, providing estimates of HIV incidence (12,14,16,18,24,33,35). One of the major drawbacks of this strategy is that the test is an adaptation of a commercial EIA, which poses problems for long-term availability. It is therefore necessary to develop and to validate simple immunoassays that can continuously be used independent of any commercial source. The knowledge of the anti-HIV type 1 (anti-HIV-1) antibody response (5,8,20,38) and recent studies aimed at identifying antigens to distinguish recent infections (27, 30) allowed us to design a candidate assay to assess persons with recent infection. We report the development and the validation of this assay for the identification of recent HIV-1 infections (EIA-RI) and its application to dried blood spots.

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Section: Vol 43 2005 Immunoassay For Recent Hiv-1 Infections 4445mentioning

confidence: 99%

Development and Validation of an Immunoassay for Identification of Recent Human Immunodeficiency Virus Type 1 Infections and Its Use on Dried Serum Spots

et al. 2005

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“…17,19 The performance of serologic HIV incidence assays has been shown to vary by HIV subtype. [20][21][22][23] For example, among individuals infected for 2 or more years, being misclassified as assay positive is more likely in subtype D infection than subtype A infection. 18,24 In addition, among those with long-standing subtype D infection, women are significantly more likely to be misclassified as assay positive than men.…”

Section: Introductionmentioning

confidence: 99%

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

Longosz

Serwadda

Nalugoda

et al. 2014

AIDS Research and Human Retroviruses

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Previous studies demonstrated that individuals with subtype D HIV infection who had been infected for 2 or more years were frequently misclassified as assay positive using cross-sectional incidence assays. Samples from 510 subjects (212 subtype A, 298 subtype D) who were infected for 2.2 to 14.5 years (median 5.4 years) and were not virally suppressed were tested using an LAg-Avidity enzyme immunoassay (LAg-Avidity EIA), Bio-Rad Avidity assay, and BED capture enzyme immunoassay (BED-CEIA). The performance of these three assays was evaluated using various assay cutoff values [LAg-Avidity EIA: < 1.0 OD-n and < 2.0 OD-n; Bio-Rad Avidity assay: < 40% avidity index (AI) and < 80% AI; BED-CEIA: < 0.8 OD-n]. The mean LAg-Avidity EIA result was higher for subtype A than D (4.54 -0.95 vs. 3.86 -1.26, p < 0.001); the mean Bio-Rad Avidity assay result was higher for subtype A than D (88.9% -12.5% vs. 75.1 -30.5, p < 0.001); and the mean BED-CEIA result was similar for the two subtypes (2.2 -1.2 OD-n for subtype A, 2.2 -1.3 OD-n for subtype D, p < 0.9). The frequency of misclassification was higher for individuals with subtype D infection compared to those with subtype A infection, using either the LAg-Avidity EIA with a cutoff of < 2.0 OD-n or the Bio-Rad Avidity assay with cutoffs of < 40% or < 80% AI. No subtype-specific differences in assay performance were observed using the BED-CEIA. Sex and age were not significantly associated with misclassification by any assay. The LAg-Avidity EIA with a cutoff < 1.0 OD-n had the lowest frequency of misclassification in this Ugandan population.

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“…This simple algorithm involving sensitive or LS assays provided a tool that could be used to test a single specimen to detect recent HIV seroconversion. However, the three-step, labor-intensive process of diluting the specimen 1/20,000, the need for dedicated equipment, the subtype-dependent assay performance (7), and the lack of availability of the assay resulted in the evaluation of other approaches, including a less sensitive modification of a 96-well HIV-1 enzyme immunoassay (EIA; Vironostika HIV-1 EIA; Organon Teknika Corp., Durham, N.C.). Although the LS Vironostika EIA works reasonably well with samples from HIV-1 subtype B-infected individuals (3), it does not address the issues related to 1/20,000 dilution and subtype-dependent performance (15).…”

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confidence: 99%

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

et al. 2004

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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

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Evaluation of a Sensitive/Less-Sensitive Testing Algorithm Using the 3A11-LS Assay for Detecting Recent HIV Seroconversion among Individuals with HIV-1 Subtype B or E Infection in Thailand

Cited by 57 publications

References 13 publications

Development and Validation of an Immunoassay for Identification of Recent Human Immunodeficiency Virus Type 1 Infections and Its Use on Dried Serum Spots

Development and Validation of an Immunoassay for Identification of Recent Human Immunodeficiency Virus Type 1 Infections and Its Use on Dried Serum Spots

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

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

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