Performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay in Detecting 'Recent' HIV Infection and Calculating Population Incidence

Autor: Esper G. Kallas, Reshma Kassanjee, Sheila M. Keating, Alex Welte, Mila Lebedeva, Jeffrey N. Martin, Jeffrey C. MacArthur, Eduard Grebe, Christopher D. Pilcher, Gary Murphy, Susan J. Little, Matthew Price, Shelley N. Facente, Michael P. Busch
Rok vydání: 2016
Předmět:
0301 basic medicine
Human immunodeficiency virus (HIV)
HIV Infections
HIV Antibodies
medicine.disease_cause
HIV incidence
Chromatography
Affinity
0302 clinical medicine
Theoretical
Models
Cutoff
Pharmacology (medical)
030212 general & internal medicine
education.field_of_study
Chromatography
biology
Incidence (epidemiology)
Incidence
3. Good health
Infectious Diseases
Public Health and Health Services
HIV/AIDS
Antibody
Infection
Algorithms
Brazil
Population
Clinical Sciences
03 medical and health sciences
recent HIV infection
Antigen
Diagnostic Tests
Clinical Research
Virology
medicine
Routine
Seroconversion
education
Retrospective Studies
Diagnostic Tests
Routine
business.industry
Epidemiology and Prevention
Retrospective cohort study
Models
Theoretical
United States
030104 developmental biology
Affinity
Immunology
HIV-2
Africa
biology.protein
HIV-1
rapid turn-around time
business
Zdroj: Journal of acquired immune deficiency syndromes (1999), vol 73, iss 5
Journal of Acquired Immune Deficiency Syndromes (1999)
Popis: Objective HIV seroconversion biomarkers are being used in cross-sectional studies for HIV incidence estimation. Bio-Rad Geenius HIV-1/2 Supplemental Assay is an immunochromatographic single-use assay that measures antibodies (Ab) against multiple HIV-1/2 antigens. The objective of this study was to determine whether the Geenius assay could additionally be used for recency estimation. Design This assay was developed for HIV-1/2 confirmation; however, quantitative data acquired give information on increasing concentration and diversity of antibody responses over time during seroconversion. A quantitative threshold of recent HIV infection was proposed to determine "recent" or "nonrecent" HIV infection; performance using this cutoff was evaluated. Methods We tested 2500 highly characterized specimens from research subjects in the United States, Brazil, and Africa with well-defined durations of HIV infection. Regression and frequency estimation were used to estimate assay properties relevant to HIV incidence measurement: mean duration of recent infection (MDRI), false-recent rate, and assay reproducibility and robustness. Results Using the manufacturer's proposed cutoff index of 1.5 to identify "recent" infection, the assay has an estimated false-recent rate of 4.1% (95% CI: 2.2 to 7.0) and MDRI of 179 days (155 to 201) in specimens from treatment-naive subjects, presenting performance challenges similar to other incidence assays. Lower index cutoffs associated with lower MDRI gave a lower rate of false-recent results. Conclusions These data suggest that with additional interpretive analysis of the band intensities using an algorithm and cutoff, the Geenius HIV-1/2 Supplemental Assay can be used to identify recent HIV infection in addition to confirming the presence of HIV-1 and HIV-2 antibodies.
Databáze: OpenAIRE
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