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AIDS Res Hum Retroviruses. 2019 Jul;35(7):615-627. doi: 10.1089/AID.2019.0033. Epub 2019 May 13.

Evaluation of the Performance of Three Biomarker Assays for Recent HIV Infection Using a Well-Characterized HIV-1 Subtype C Incidence Cohort.

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1 Division of Global HIV and TB, Centers for Disease Control and Prevention, Harare, Zimbabwe.
2 DST-NRF Center of Excellence in Epidemiological Modeling and Analysis (SACEMA), Faculty of Science, Stellenbosch University, Stellenbosch, South Africa.
3 Division of Global HIV and TB, Centers for Disease Control and Prevention, Atlanta, Georgia.
4 Department of Laboratory Services, Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.
5 Department of Laboratory Services, ICAP at University of Columbia, Mailman Public Health, Baltimore, Maryland.
6 Department of Laboratory Services, Centers for Disease Control and Prevention, Atlanta, Georgia.
7 Departments of Epidemiology, Infectious Diseases and Microbiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania.
8 Department of Medicine and Center for Infectious Diseases, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
9 Departments of Epidemiology and International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
10 Division of Medical Virology, Faculty of Medicine and Health Sciences, Stellenbosch University and National Health Laboratory Service, Cape Town, South Africa.


Biomarkers for detecting early HIV infection and estimating HIV incidence should minimize false-recent rates (FRRs) while maximizing mean duration of recent infection (MDRI). We compared HIV subtypes B, E and D (BED) capture enzyme immunoassay (BED), Sedia limiting antigen (LAg) avidity enzyme immunoassay, and Bio-Rad avidity incidence (BRAI) assays using samples from Zimbabwean postpartum women infected with clade C HIV. We calculated MDRIs using 590 samples from 351 seroconverting postpartum women, and FRRs using samples from 2,825 women known to be HIV positive for >12 months. Antibody kinetics were more predictable with LAg and had higher precision compared with BED or BRAI. BRAI also exhibited more variability, and avidity reversal in some cases. For BED, LAg, and BRAI, used alone or with viral load, MDRI values in days were: BED-188 and 170 at normalized optical density (ODn) 0.8; LAg-104 and 100 at ODn cutoff 1.5; BRAI-135 and 134 at avidity index cutoff 30%. Corresponding FRRs were: BRAI 1.1% and 1.0% and LAg 0.57% and 0.35%: these were 3.8-10.9 times lower than BED values of 4.8% and 3.8%. BRAI and LAg have significantly lower FRRs and MDRIs than in published studies, and much lower than BED and could be used to estimate incidence in perinatal women and to measure population-level HIV incidence in HIV control operations in Africa.


biomarker; incidence; laboratory


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