Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as an Alternative to the INNO-LIA HIV 1/2 Assay for Confirmation of HIV Infection

Mor, Orna; Mileguir, Fernando; Michaeli, Michal; Levy, Itzchak

doi:10.1128/jcm.01184-14

Cited by 30 publications

(20 citation statements)

References 8 publications

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“…Results were considered reactive if S/CO ≥ 1.0 on the Architect or ≥ 0.25 on the Vidas (for antigen or antibody detection). Confirmation in the NHRL was performed using the FDA approved HIV‐1/2 immunochromatographic confirmatory assay for in‐vitro diagnostic use (Geenius, Bio‐Rad laboratories) which enables differentiation of antibodies to HIV‐1 and HIV‐2, although not cleared for blood donor screening in the USA. In cases where final HIV‐1/2 status could not be defined by NAT and Geenius, the molecular Xpert Qual HIV‐1 assay (Xpert Qual), with 95% limit of detection of 203 copies/ml (95% CI: 181–225 copies/mL) for whole blood samples, was used on a new whole blood sample.…”

Section: Methodsmentioning

confidence: 99%

HIV‐1/2 screening in blood centers: implementing a two‐step serological screening assay approach to reduce donor deferral

et al. 2019

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BACKGROUND Screening blood donations for human immunodeficiency virus 1/2 (HIV‐1/2) infection in blood centers is often done with a highly sensitive 3rd‐generation immunoassay which may cause false‐positive results. Donations found repeatedly reactive (RR) are discarded regardless of negative HIV‐1/2 nucleic acid testing (NAT) and confirmatory assays results. These donors are notified and deferred if RR in a subsequent donation. We evaluated the introduction of a secondary 4th‐generation serological assay to the overall algorithm performance. METHODS All donations collected between January 2016 and May 2018 (574,338) were screened using 3rd‐generation immunoassay (PRISM HIV O Plus) and NAT (Procleix Ultrio/Ultrio Elite). Serology RR donations were tested with 4th‐generation Architect HIV Ag/Ab Combo and Vidas HIV Duo Ultra and a confirmatory assay (Geenius HIV‐1/2). RESULTS The two 4th‐generation assays found that 86% (179/209 on Architect) and 94% (182/193 on Vidas) of the 3rd‐generation immunoassay RR were negative for HIV‐1/2, which were also negative by confirmatory assay. Only 14% (30/209 on Architect) and 6% (11/193 on Vidas) that were 3rd‐generation HIV‐1/2 RR required confirmation, of which eight donors were confirmed as HIV positive. The probability of missing an HIV‐1 infected donor by this algorithm is one in a million RR cases. CONCLUSION The introduction of a two‐step serological screening algorithm in blood centers whereby 4th‐generation assay will be performed for all 3rd‐generation RR blood donors will reduce the number of donations requiring confirmation, save time and money, and most importantly, reduce the number of discarded blood donations and allow re‐entry processes.

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Section: Methodsmentioning

confidence: 99%

HIV‐1/2 screening in blood centers: implementing a two‐step serological screening assay approach to reduce donor deferral

et al. 2019

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“…In 2013, the U.S. Centers for Disease Control and Prevention (CDC) proposed the use of the Multispot test on samples that were reactive with third-or fourth-generation EIAs in order to confirm and differentiate HIV-1 and HIV-2 infections (44). Bio-Rad recently developed the Geenius HIV-1/2 supplemental assay to replace the Multispot assay (43,45,46). The new Geenius assay uses a closed lateral flow cartridge with a dual-path platform (DPP) to detect antibodies to recombinant or synthetic peptides for HIV-1 (p41, gp160, p24, and p31) and HIV-2 (gp36 and gp140) ( Fig.…”

Section: Supplemental Confirmatory Testsmentioning

confidence: 99%

Diagnosis of Human Immunodeficiency Virus Infection

Parekh

Fonjungo

et al. 2018

Clin Microbiol Rev

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SUMMARY HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy. They are also useful in surveillance and outbreak responses, allowing for assessment of disease burden and identification of vulnerable populations and transmission “hot spots,” thus enabling planning, appropriate interventions, and allocation of appropriate funding. HIV diagnostics are critical in achieving epidemic control and require a hybrid of conventional laboratory-based diagnostic tests and new technologies, including point-of-care (POC) testing, to expand coverage, increase access, and positively impact patient management. In this review, we provide (i) a historical perspective on the evolution of HIV diagnostics (serologic and molecular) and their interplay with WHO normative guidelines, (ii) a description of the role of conventional and POC testing within the tiered laboratory diagnostic network, (iii) information on the evaluations and selection of appropriate diagnostics, (iv) a description of the quality management systems needed to ensure reliability of testing, and (v) strategies to increase access while reducing the time to return results to patients. Maintaining the central role of HIV diagnostics in programs requires periodic monitoring and optimization with quality assurance in order to inform adjustments or alignment to achieve epidemic control.

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“…Among confirmatory tests replacing the Western blot are the INNO-LIA HIV I/II Score (Innogenetics, Gent, Belgium) [62] and a newer rapid test, the Bio-Rad™ Geenius HIV 1/2 Assay (Bio-Rad Laboratories, Inc.). These diagnostics provide similar semiquantitative information and can distinguish EHI from long-standing infections [55,63•] if such information is sought. Updated staging systems, which rely on diagnostics currently in use, are urgently needed.…”

Section: Detecting Postantibody Early Hiv Infectionmentioning

confidence: 99%

How can we better identify early HIV infections?

Rosenberg

Pilcher

Busch

et al. 2015

Current Opinion in HIV and AIDS

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Purpose of review Detection of early HIV infections (EHIs), including acute HIV infection (AHI), is important for individual health, prevention of HIV transmission, and measurement of HIV incidence. We describe markers of EHI, diagnostic strategies for detecting these markers, and ways to incorporate these strategies into diagnostic and HIV incidence algorithms. Recent findings For individual diagnosis in the United States and Europe, laboratory-based diagnostic algorithms increasingly incorporate fourth-generation HIV antigen tests, allowing for earlier detection. In some sub-Saharan African settings, symptom-based screening is being explored to identify subsets of persons at high risk for AHI. Point-of-care diagnostics designed for AHI detection are in the pipeline and, if validated, represent an opportunity for real-time AHI diagnosis. At the population level, multiassay algorithms are promising new strategies for estimating HIV incidence on the basis of several assays applied to cross-sectional samples. These algorithms can be developed to optimize performance, in addition to cost and logistical considerations. Summary There are important recent advances in detection of EHIs at the individual and population levels. Applying optimal combinations of tests in diagnostic and HIV incidence algorithms is urgently needed to support the multiple goals derived from enhanced detection and discrimination of EHIs.

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Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as an Alternative to the INNO-LIA HIV 1/2 Assay for Confirmation of HIV Infection

Cited by 30 publications

References 8 publications

HIV‐1/2 screening in blood centers: implementing a two‐step serological screening assay approach to reduce donor deferral

HIV‐1/2 screening in blood centers: implementing a two‐step serological screening assay approach to reduce donor deferral

Diagnosis of Human Immunodeficiency Virus Infection

How can we better identify early HIV infections?

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