Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay.

Keating, Sheila M

Rountree, Wes

Grebe, Eduard

Pappas, Andrea L

Stone, Mars

Hampton, Dylan

Todd, Christopher A

Poniewierski, Marek S

Sanchez, Ana

Porth, Cassandra G

Denny, Thomas N

Busch, Michael P

EQAPOL Limiting Antigen (LAg) Incidence Assay External Quality Assurance (EQA) Program

Kumar, Sanjai

2019-11-04T20:24:49Z

2019-11-04T20:24:49Z

2019-01

2019-11-04T20:24:46Z

Laboratory assays for identifying recent HIV-1 infections are widely used for estimating incidence in cross-sectional population-level surveys in global HIV-1surveillance. Adequate assay and laboratory performance are required to ensure accurate incidence estimates. The NIAID-supported External Quality Assurance Program Oversight Laboratory (EQAPOL) established a proficiency testing program for the most widely-used incidence assay, the HIV-1 Limiting Antigen Avidity EIA (LAg), with US Centers for Disease Control and Prevention (CDC)-approved kits manufactured by Sedia Biosciences Corporation and Maxim Biomedical. The objective of this program is to monitor the performance of participating laboratories. Four rounds of blinded external proficiency (EP) panels were distributed to up to twenty testing sites (7 North American, 5 African, 4 Asian, 2 South American and 2 European). These panels consisted of ten plasma samples: three blinded well-characterized HIV-1-seropositive samples that were included as replicates and an HIV-negative control. The seropositive samples spanned the dynamic range of the assay and are categorized as either recent or long-term infection. Participating sites performed the assay according to manufacturers' instructions and completed an online survey to gather information on kit manufacturer, lot of kit used, laboratory procedures and the experience of technicians. On average, fifteen sites participated in each round of testing, with an average of four sites testing with only the Maxim assay, seven testing with only the Sedia assay and five sites utilizing both assays. Overall, the Sedia and Maxim assays yielded similar infection status categorization across the laboratories; however, for most of the nine HIV+ samples tested, there were significant differences in the optical density readouts, ODn (N = 8) and OD (N = 7), between LAg kit manufacturers (p < 0.05 based on mixed effects models. The EQAPOL LAg program is important for monitoring laboratory performance as well as detecting variations between manufacturers of HIV-1incidence assays.

PONE-D-19-14662

1932-6203

1932-6203

https://hdl.handle.net/10161/19470

eng

Public Library of Science (PLoS)

PloS one

10.1371/journal.pone.0222290

EQAPOL Limiting Antigen (LAg) Incidence Assay External Quality Assurance (EQA) Program

Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay.

Journal article

e0222290

9

Staff

Duke

School of Medicine

Duke Human Vaccine Institute

Institutes and Centers

Duke Global Health Institute

University Institutes and Centers

Institutes and Provost's Academic Units

Medicine, Duke Human Vaccine Institute

Medicine

Clinical Science Departments

Published

14