Development of a New Limiting-Antigen Avidity Dot Immuno-Gold Filtration Assay for HIV-1 Incidence

Gao, Zhiyun; Yan, Huan; Xia, Feng; Wu, L. T.; Qiu, Maofeng; Xing, Wenge; Zhang, Guiyun; Zhi, Zhang; Jiang, Yan

doi:10.1371/journal.pone.0161183

Cited by 7 publications

(4 citation statements)

References 25 publications

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“…Two major manufacturers supply versions of the assay: Maxim Biomedical (Bethesda, MD) and Sedia Biosciences Corporation (Portland, OR), with both manufacturers currently utilizing multisubtype HIV-1 recombinant antigen supplied by the CDC. A third manufacturer, Beijing King Hawk Pharmaceutical Co. (Beijing, PRC), has recently entered the market, but without US CDC involvement [11].…”

Section: Introductionmentioning

confidence: 99%

Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance

et al. 2019

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Background Two manufacturers, Maxim Biomedical and Sedia Biosciences Corporation, supply CDC-approved versions of the HIV-1 Limiting Antigen Avidity EIA (LAg) for detecting ‘recent’ HIV infection in cross-sectional incidence estimation. This study assesses and compares the performance of the two assays for incidence surveillance. Methods We ran both assays on a panel of 2,500 well-characterized HIV-1-infected specimens. We analysed concordance of assay results, assessed reproducibility using repeat testing and estimated mean durations of recent infection (MDRIs) and false-recent rates (FRRs) for a range of normalized optical density (ODn) thresholds, alone and in combination with viral load thresholds. We defined three hypothetical surveillance scenarios, similar to the Kenyan and South African epidemics, and a concentrated epidemic. These scenarios allowed us to evaluate the precision of incidence estimates obtained by means of various recent infection testing algorithms (RITAs) based on each of the two assays. Results The Maxim assay produced lower ODn values than the Sedia assay on average, largely as a result of higher calibrator readings (mean OD of 0.749 vs. 0.643), with correlation of normalized readings lower ( R 2 = 0.908 vs. R 2 = 0.938). Reproducibility on blinded control specimens was slightly better for Maxim. The MDRI of a Maxim-based algorithm at the ‘standard’ threshold (ODn ≤1.5 & VL >1,000) was 201 days (95% CI: 180,223) and for Sedia 171 (152,191). The difference Differences in MDRI were estimated at 32.7 (22.9,42.8) and 30.9 days (21.7,40.7) for the two algorithms, respectively. Commensurately, the Maxim algorithm had a higher FRR in treatment-naive subjects (1.7% vs. 1.1%). The two assays produced similar precision of incidence estimates in the three surveillance scenarios. Conclusions Differences between the assays can be primarily attributed to the calibrators supplied by the manufacturers. Performance for surveillance was extremely similar, although different thresholds were optimal (i.e. produced the lowest variance of incidence estimates) and at any given ODn threshold, different estimates of MDRI and FRR were obtained. The two assays cannot be treated as interchangeable: assay and algorithm-specific performance characteristic estimates must be used for survey planning and incidence estimation.

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Section: Introductionmentioning

confidence: 99%

Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance

et al. 2019

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“…We performed the test using four formats. Format one had been previously used to detect other diseases such as Leptospirosis 36 , food allergen 37 , HIV-1 38 , etc.…”

Section: Discussionmentioning

confidence: 99%

Development of rapid and cost-effective top-loading device for the detection of anti-SARS-CoV-2 IgG/IgM antibodies

Ibrahim

Ghramh

Kilany

2021

Sci Rep

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Infection with SARS-CoV-2, the Betacoronavirus, caused a pandemic that affected the globe negatively. The gold method, RT-PCR, can detect SARS-CoV-2 but it is time-consuming and needs sophisticated equipment and professional personnel. On the other hand, rapid tests offer fast results and can detect anti-SARS-CoV-2 antibodies (Abs). The aim of this study is to develop a new rapid and cost-effective method for the detection of anti-SARS-CoV-2 IgG/IgM Abs. A new top-loading detection device was developed and composed of a small piece of plastic (25 × 25 × 0.5 mm) with an opening in the center, a piece of nitrocellulose (NC) membrane enough to block the opening from one side and adhesive tape to affix the NC to the plastic piece. The NC is blotted with anti-human IgG/IgM and rabbit serum. The device was evaluated against a commercially available IgG/IgM ELISA detection kit using normal, Covid-19-positive, HCV, HBV, and Cytomegalovirus-positive sera. Outcomes demonstrated simplicity, reproducibility, and accuracy of the new device and results can be obtained in less than 5 min. We anticipate our developed assay method to be used widely in point of care before deciding on the use of expensive nucleic acid assays.

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Section: Introductionmentioning

confidence: 99%

Performance of the Maxim and Sedia Limiting Antigen Avidity assays for population-level HIV incidence surveillance

Sempa

Welte

Busch

et al. 2019

Preprint

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Background: Two manufacturers, Maxim Biomedical and Sedia Biosciences Corporation, supply US CDC-approved versions of the HIV-1 Limiting Antigen Avidity EIA (LAg assay) for detecting 'recent' HIV infection in cross-sectional incidence estimation. This study assesses and compares the performance of the Maxim and Sedia LAg assays for incidence surveillance. Methods: We ran both assays on a panel of 2,500 well-characterized HIV-1-infected specimens, most with estimated dates of (detectable) infection. We analysed concordance of assay results, assessed reproducibility using repeat testing and estimated the critical performance characteristics of a test for recent infection-mean duration of recent infection (MDRI) and false-recent rate (FRR)-for a range of normalized optical density (ODn) recency discrimination thresholds, alone and in combination with viral load thresholds. We further defined three hypothetical surveillance scenarios and evaluated overall performance for incidence surveillance, defined as the precision of incidence estimates, by estimating context-specific performance characteristics. Results: The Maxim assay produced lower ODn values than the Sedia assay on average, largely as a result of higher calibrator readings (mean calibrator OD of 0.749

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Development of a New Limiting-Antigen Avidity Dot Immuno-Gold Filtration Assay for HIV-1 Incidence

Cited by 7 publications

References 25 publications

Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance

Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance

Development of rapid and cost-effective top-loading device for the detection of anti-SARS-CoV-2 IgG/IgM antibodies

Performance of the Maxim and Sedia Limiting Antigen Avidity assays for population-level HIV incidence surveillance

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