Advertisement

 

 

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

Performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay in Detecting "Recent" HIV Infection and Calculating Population Incidence.
Author Information (click to view)

Keating SM, Kassanjee R, Lebedeva M, Facente SN, MacArthur JC, Grebe E, Murphy G, Welte A, Martin JN, Little S, Price MA, Kallas EG, Busch MP, Pilcher CD,


Keating SM, Kassanjee R, Lebedeva M, Facente SN, MacArthur JC, Grebe E, Murphy G, Welte A, Martin JN, Little S, Price MA, Kallas EG, Busch MP, Pilcher CD, (click to view)

Keating SM, Kassanjee R, Lebedeva M, Facente SN, MacArthur JC, Grebe E, Murphy G, Welte A, Martin JN, Little S, Price MA, Kallas EG, Busch MP, Pilcher CD,

Advertisement

Journal of acquired immune deficiency syndromes (1999) 73(5) 581-588

Abstract
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.

Submit a Comment

Your email address will not be published. Required fields are marked *

11 + 19 =

[ HIDE/SHOW ]