Comparative evaluation of the Geenius HIV 1/2 Confirmatory Assay and the HIV-1 and HIV-2 Western blots in the Japanese population

Kondo, Makiko; Sumii, Koji; Sano, Takako; Kawahata, Takuya; Itoda, Ichiro; Iwamuro, Shinya; Yoshimura, Yukihiro; Tachikawa, Natsuo; Kojima, Yoshiyuki; Mori, Haruyo; Fujiwara, Hiroshi; Hasegawa, Naoki; Kato, Shingo

doi:10.1371/journal.pone.0198924

Cited by 12 publications

(13 citation statements)

References 21 publications

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“…While false positive HIV tests occasionally occur, both the ARCHITECT® and ADVIA Centaur® Ag/Ab are robust screening assays and have reported specificity of over 99% [10][11][12]. The Bio-Rad Geenius™ confirmatory assay has been evaluated for HIV-1 and HIV-2 confirmatory testing and discrimination in a variety of populations [8,[13][14][15][16]. The manufacturer's instructions provided with the test claim over 99% specificity, however the results of studies in target populations vary with specificity reported to be between 93 and 99% [8,[13][14][15][16].…”

Section: Discussionmentioning

confidence: 99%

Repeated false reactive ADVIA centaur® and bio-rad Geenius™ HIV tests in a patient self-administering anabolic steroids

et al. 2020

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Background: An individual is considered HIV positive when a confirmatory HIV-1/HIV-2 differentiation test returns positive following an initial reactive antigen/antibody combination screen. Falsely reactive HIV screens have been reported in patients with various concomitant infectious and autoimmune conditions. Falsely positive confirmatory HIV differentiation assays are seen less frequently, but have been observed in cases of pregnancy, pulmonary embolism, and malaria. Case presentation: A healthy 27 year-old man was referred after a reactive ADVIA Centaur® HIV Ag/Ab screen and positive Bio-Rad Geenius™ HIV 1/2 Confirmatory assay, suggesting HIV-1 infection. The patient's HIV viral load was undetectable prior to initiation of antiretroviral therapy, and remained undetectable on subsequent testing after initiation of antiretroviral therapy. Both Centaur® and Geenius™ tests were repeated and returned reactive. As this patient was believed to be at low risk of acquiring HIV infection, samples were additionally run on Genscreen™ HIV-1 Ag assay and Fujirebio Inno-LIA™ HIV-1/2 score, with both returning non-reactive. For confirmation, the patient's proviral HIV DNA testing was negative, confirming the initial results as being falsely positive. The patient disclosed that he had been using a variety of anabolic steroids before and during the time of HIV testing. Discussion and conclusions: The erroneous diagnosis of HIV can result in decreased quality of life and adverse effects of antiretroviral therapy if initiated, hence the importance of interpreting the results of HIV testing in the context of an individual patient. This reports suggests a potential association between the use of anabolic steroids and falsely-reactive HIV testing.

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Section: Discussionmentioning

confidence: 99%

Repeated false reactive ADVIA centaur® and bio-rad Geenius™ HIV tests in a patient self-administering anabolic steroids

et al. 2020

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“…Abbate et al [ 11 ] and Wong et al [ 12 ] reported that the sensitivity of the test for acute HIV-1 infection was low. Kondo et al reported that seven of 20 specimens from the acute phase of HIV-1 infection were identified as HIV-1-positive [ 13 ]. In addition, two of 130 HIV-negative specimens and two of 10 Determine HIV-1/2 (Alere Medical, Chiba, Japan)-positive and HIV-1 nucleotide amplification test-negative (HIV pseudo-positive) specimens cross-reacted with HIV-1-specific lines [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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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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“…The WB assay detects the HIV-1 antibodies that bind to fixed HIV-1 proteins. Globally, it is the most commonly used method for clinical confirmation of HIV-1 infection (Centers for Disease Control [CDC], 2014; Liu et al, 2016; Kondo et al, 2018) and positive WB result is a prerequisite for antiretroviral therapy and laboratory follow-up including CD4 count and HIV-1 viral load test in many low- and middle-income countries. Although HIV-1 nucleic acid testing (NAT) has been recommended for HIV-1 screening, particularly for individuals with acute HIV-1 infection and late-stage AIDS (Tang et al, 2008; Patel et al, 2012; Centers for Disease Control [CDC], 2014; Liu et al, 2016), it is not commonly used for diagnosis due to its cost and technology threshold.…”

Section: Discussionmentioning

confidence: 99%

Estimation of the Seroconversion Duration of HIV-1 Antibodies in Individuals With Recent Infection in China

et al. 2019

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The identification of recent HIV-1 infection is clinically important for the effective treatment and prevention of transmission. However, the window period for seroconversion with respect to various HIV-1 antibodies is not well characterized. In addition, the routine HIV testing algorithms are not particularly appropriate for the identification of recent HIV-1 infection. In this study, we enrolled individuals who showed seroconversion from negative Western blot (WB) or indeterminate WB results and analyzed the window periods for appearance of HIV-1 antibodies. A total of 10,934 individuals with suspected HIV infection were tested by Wuhan CDC between 2012 and 2017; of these, 40 individuals with initial negative WB and 102 individuals with initial indeterminate WB who showed positive WB results within 100 days were included in the analysis. The mean time for seroconversion was 43.90 (95% confidence interval [CI]: 37.30–50.50) days and 42.15 (95% CI: 37.99–46.30) days, respectively. The time duration for p31 seroconversion among people with negative WB and indeterminate WB was 58.11 (95% CI, 44.30–71.92) days and 51.91 (95% CI, 44.55–59.28) days, respectively, both of which were significantly longer ( p = 0.0169) than those in people without p31 seroconversion. A similar difference was observed with respect to p66 seroconversion, with a window time of 53.53 (95% CI, 43.54–63.52) days and 47.87 (95% CI, 43.16–52.57) days among people with negative WB and indeterminate WB, respectively. These data suggest that HIV-1 antibody p66, like p31, may serve as a potential serological marker for distinguishing Fiebig stage V and stage VI at day 70 post-infection.

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Comparative evaluation of the Geenius HIV 1/2 Confirmatory Assay and the HIV-1 and HIV-2 Western blots in the Japanese population

Cited by 12 publications

References 21 publications

Repeated false reactive ADVIA centaur® and bio-rad Geenius™ HIV tests in a patient self-administering anabolic steroids

Repeated false reactive ADVIA centaur® and bio-rad Geenius™ HIV tests in a patient self-administering anabolic steroids

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

Estimation of the Seroconversion Duration of HIV-1 Antibodies in Individuals With Recent Infection in China

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