Evaluation of the Bio-Rad Geenius HIV-1/2 test as a confirmatory assay

ABSTRACT The rapid confirmatory Bio-Rad Geenius HIV 1/2 assay was evaluated as an alternative to the HIV-1 Western blot (WB) confirmatory assay. A total of 370 retrospective samples collected from 356 patients were tested. Sensitivity of the Geenius assay to detect HIV-1 and HIV-2 infections was 100% and 97%, respectively, and that of the WB assay was 86% and 39%, respectively. Geenius reduced the number of indeterminate results by 85% and exhibited a differentiation capacity for HIV-1 and HIV-2 of 100% and 89%, respectively. Three of 10 patients presenting with an early HIV infection (1 to 2 weeks before seroconversion by WB) were positive using Geenius. None of the HIV-negative samples were positive using Geenius or WB. However, 7% and 10% of them were indeterminate with Geenius and WB, respectively, leading to a specificity rate of 93% for Geenius and 90% for WB. Ninety cadaveric samples (54 negative, 23 HIV-1 positive, and 3 HIV-1 indeterminate) were tested with Geenius, leading to a sensitivity of 100%, a specificity of 96%, and an indeterminate rate of 4%. Our results indicate that the Bio-Rad Geenius HIV 1/2 rapid test exhibits better sensitivity to detect HIV-1 infections and better performance than WB to confirm and differentiate between HIV-1 and HIV-2 infections. The performance of this new confirmatory assay to detect early infections, to reduce the rate of indeterminate status, and to confirm HIV-1 infection in cadaveric blood samples makes Geenius a potent reliable alternative to the WB.

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Comparative evaluation of the Bio-Rad Geenius HIV-1/2 Confirmatory Assay and the Bio-Rad Multispot HIV-1/2 Rapid Test as an alternative differentiation assay for CLSI M53 algorithm-I

Journal of Clinical Virology ◽

10.1016/j.jcv.2013.08.008 ◽

2013 ◽

Vol 58 ◽

pp. e85-e91 ◽

Cited By ~ 41

Author(s):

L. Malloch ◽

K. Kadivar ◽

J. Putz ◽

P.N. Levett ◽

J. Tang ◽

...

Keyword(s):

Comparative Evaluation ◽

Rapid Test ◽

Confirmatory Assay ◽

Hiv 1

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Staging of recent HIV-1 infection using Geenius rapid confirmatory assay compared to INNO-LIA, New Lav and Blot 2.2 assays

Journal of Clinical Virology ◽

10.1016/j.jcv.2017.08.003 ◽

2017 ◽

Vol 95 ◽

pp. 47-51 ◽

Cited By ~ 8

Author(s):

E. Tuaillon ◽

A. Sanosyan ◽

A. Pisoni ◽

J. Liscouët ◽

A. Makinson ◽

...

Keyword(s):

Confirmatory Assay ◽

Hiv 1

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Difficulties of Identifying the Early HIV Antibody Seroconversion Period Depending on the Confirmatory Assay

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa140 ◽

2020 ◽

Vol 7 (5) ◽

Author(s):

Karl Stefic ◽

Nadia Mahjoub ◽

Céline Desouche ◽

Marie Laure Néré ◽

Damien Thierry ◽

...

Keyword(s):

Hiv Infection ◽

Early Stage ◽

Inclusion Criteria ◽

Multicenter Studies ◽

Recent Infection ◽

Western Blots ◽

Confirmatory Assay ◽

Single Use ◽

Recent Hiv Infection ◽

Hiv 1

Abstract Background Identification of HIV infection at the early stage is valuable for patient management, for prevention, and for research purposes. In practice, identification of a recent HIV infection at diagnosis proves challenging after HIV antibody seroconversion but can be suspected using Western blots (WBs) or immunoblots (IBs) as confirmatory assays. Methods Five commercially available confirmatory assays were compared using 43 samples from recently infected individuals. This included 2 WBs (New LAV Blot I, Biorad, and HIV Blot 2.2, MP Biomedicals), 2 IBs (INNO-LIA HIV I/II, Fujirebio, and RecomLine HIV-1 & HIV-2, Mikrogen Diagnostik), and 1 immunochromatographic single-use assay (Geenius HIV1/2 supplemental assay, Biorad). Results Following the manufacturer’s recommendations for interpretation, the 2 WBs led to indeterminate results for 30% and 42% of the samples, suggesting recent infection, compared with 2%–7% for the 3 other assays. When interpreted based on the Fiebig classification, concordant stages were observed in 42% of samples, and only 49% were classified as early seroconversion by all 5 assays. For the remaining specimens, the distinction with chronic infection was highly variable depending on the assay (5%–100%). Conclusions Clinical laboratories must consider this variability, which must be kept in mind both for initial diagnosis and for multicenter studies for which inclusion criteria refer to serological profiles by confirmatory assays.

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Evaluation of Geenius HIV-1/2 Confirmatory Assay for the confirmatory and differential diagnosis of HIV-1/HIV-2 in Japan and reliability of the Geenius Reader in the diagnosis of HIV-2

BMC Infectious Diseases ◽

10.1186/s12879-021-06291-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Shigeru Kusagawa ◽

Ai Kawana-Tachikawa ◽

Keiji Matsubayashi ◽

Yuji Hoshi ◽

Ken Ishimaru ◽

...

Keyword(s):

Cross Reactivity ◽

Confirmatory Test ◽

Hiv Positive ◽

Immunodeficiency Virus ◽

Confirmatory Tests ◽

Confirmatory Assay ◽

Combination Test ◽

Visual Reading ◽

Anti Hiv ◽

Hiv 1

Abstract Background NEW LAV BLOT I and II (LAV I and LAV II), they were only option for human immunodeficiency virus (HIV) confirmatory test, following HIV screening test using HIV Ag/Ab combination test in Japan. We evaluated the performance of Geenius HIV-1/2 Confirmatory Assay (Geenius), both as a confirmatory test and for differentiation between HIV-1 and HIV-2, in comparison with LAV I and LAV II. Methods Eighty-nine HIV-1-positive plasma specimens, one anti-HIV-1 low-titer performance panel, 10 seroconversion panels, and two anti-HIV-1/2 combo performance panels were tested. The results were read with the Geenius Reader and by visual reading. Results All 89 HIV-1-positive plasma specimens were identified as HIV-1-positive using Geenius; this 100% success rate was superior to that with LAV I (95.5% using WHO criteria, 98.9% using CDC criteria). The HIV-1-positive specimens showed low cross-reactivity with HIV-2 lines in Geenius. The sensitivity of Geenius for HIV-1 detection was the same as or greater than that of LAV I, but less than that of Genscreen HIV Ag-Ab ULT, in our analysis of the commercial performance and seroconversion panels. In contrast, five of the 13 HIV-2-positive specimens that had been identified as HIV-positive untypable by visual reading because of their cross-reactivity to HIV-1 lines were successfully identified by the Geenius Reader as HIV-2-positive with cross-reactivity. Conclusions Geenius provides strong performance for HIV confirmatory tests and HIV-1 differentiation tests. However, when visual reading is used, its performance in HIV-2 differentiation is less reliable. Because HIV-2 infection has been sporadically reported in Japan, the use of the Geenius Reader is preferable to ensure more reliable HIV-1/HIV-2 differentiation.

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