Performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay in Detecting "Recent" HIV Infection and Calculating Population Incidence. (15th December 2016)

• Record Type: Journal Article
• Authors: Keating, Sheila M.; Kassanjee, Reshma; Lebedeva, Mila; Facente, Shelley N.; MacArthur, Jeffrey C.; Grebe, Eduard; Murphy, Gary; Welte, Alex; Martin, Jeffrey N.; Little, Susan; Price, Matthew A.; Kallas, Esper G.; Busch, Michael P.; Pilcher, Christopher D.
• Is Part Of: Journal of acquired immune deficiency syndromes. Volume 73:Number 5(2017)
• Publication Date: 2016-12-15
• Subjects: rapid turn-around time -- recent HIV infection -- HIV incidence; AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome -- Periodicals; AIDS (Disease); Periodicals; 616.9792005
• DOI: 10.1097/QAI.0000000000001146
• Languages: English
• ISSNs: 1525-4135

Abstract

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.