Evaluation of two HIV antibody confirmatory assays: Geenius™ HIV1/2 Confirmatory Assay and the recomLine HIV-1 &amp; HIV-2 IgG Line Immunoassay

Friedrichs, I.; Buus, C.; Berger, Annemarie; Keppler, Oliver T.; Rabenau, Holger F.

doi:10.1016/j.jviromet.2015.08.015

Cited by 9 publications

(6 citation statements)

References 13 publications

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“…Geenius demonstrated significant advantages over WB in both confirming and excluding HIV infection. Its specificity of 93%, compared to 90% for WB, was equivalent to that of previously reported results (17, 18). The sensitivity of Geenius to confirm HIV-1 infection (100%), evaluated using a panel of serum samples that includes group B (2/3) and non-B (1/3) subtypes, was higher than that of WB (86%).…”

Section: Discussionsupporting

confidence: 86%

“…Using WB as a gold standard, Moon et al (21) obtained a sensitivity of 100% using Geenius, suggesting that Geenius did not miss any WB-positive sample. Compared to other confirmatory assays, such as Chiron RIBA, Inno-Lia, or multisport rapid test, Geenius presents excellent performance and has many advantages (11, 17, 19, 22, 23), especially in terms of specificity (99 to 100%) and sensitivity (96 to 100%). To our knowledge, only one study concluded that Geenius was less sensitive and less specific than Inno-Lia, mainly due to its short time of incubation (20 min compared to overnight for Inno-Lia) (20).…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as Part of a Confirmatory HIV Testing Strategy for Quebec, Canada: Comparison with Western Blot and Inno-Lia Assays

et al. 2019

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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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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as Part of a Confirmatory HIV Testing Strategy for Quebec, Canada: Comparison with Western Blot and Inno-Lia Assays

et al. 2019

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“…It reduces false gp140 reactivity but had no impact on identifying true HIV‐2 infections. It is well suited for the detection, confirmation and discrimination of HIV‐1‐and HIV‐2‐specific antibodies [9–11,13,34]. The performance of this new confirmatory assay to detect early infections, to reduce the rate of indeterminate status makes Geenius a potent reliable alternative to the Western blot [35].…”

Section: Discussionmentioning

confidence: 99%

“…The Bio‐Rad Geenius TM HIV 1/2 is a confirmatory test as powerful as the Western blot or immunoblot test in the confirmation diagnosis of HIV infection. In addition, unlike the Western blot which requires several hours to obtain the result, it gives access to it in less than 30 min thus allowing appropriate therapeutic management and avoids the loss of sight of the individual [9–13].…”

Section: Introductionmentioning

confidence: 99%

The use of the Geenius^TM HIV‐1/2 Rapid confirmatory test for the enrolment of patients and blood donors in the WHO Universal Test and Treat Strategy in Cameroon, Africa

et al. 2020

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Background and objective In the WHO Universal test and treat strategy, falsepositive HIV blood donors and patients may be unnecessarily put under antiretroviral treatment and false-negative subjects may be lost to follow-up. This study assessed the false positivity rate of the Cameroonian national HIV screening testing algorithm and the benefit of a confirmation test in the enrolment of patients and donors in the HIV care programme. Methods We included initial HIV reactive blood donors and patients in a crosssectional study conducted in two Cameroonian hospitals. Samples were retested according to the Cameroon national algorithm for HIV diagnosis. A positive or discordant sample was retested with the Geenius Bio-Rad HIV 1&2 (Bio-Rad, Marnes-la-Coquette, France) for confirmation. The Geenius HIV-1-positive results with 'poor' profiles were retested for RNA as well as the Geenius indeterminate results. Results Of the 356 participants, 190/225 (84Á4%) patients and 76/131 (58%) blood donors were declared positive with the national algorithm; 257 participants (96Á6%) were confirmed HIV-1-positive. The study revealed that about 34/1000 blood donors and patients are false-positive and unnecessarily put on treatment; 89/1000 blood donors and patients declared discordant could have been included immediately in the HIV care programme if confirmatory testing was performed. The second test of the algorithm had a false-negative rate of 3%. Eleven samples (3Á1%) were Geenius poor positive and NAT negative. Conclusion The universal test and treat strategy may identify and refer more individuals to HIV care if a third rapid confirmatory test is performed for discordant cases.

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“…Moon ve arkadaşları, Geenius ile %100 duyarlılık elde etmiş ve testin, WB pozitif hiçbir örneği kaçırmadığını saptamışlardır 7 . Chiron RIBA, INNO LIA ® ve multispot hızlı test ile karşılaştıran çalışmalarda, Geenius'un %99-100 özgüllük ve %96-100 duyarlılık ile bu testlerden üstün olduğu saptanmıştır 1,[8][9][10][11] . LIA ile karşılaştırıldığı bir diğer çalışmada, duyarlılık ve özgüllüğün daha düşük olduğu belirtilmiştir 12 .…”

Section: Discussionunclassified

İki Anti-HIV Doğrulama Testinin Karşılaştırılması: Rekombinant HIV 1/2 “Line İmmunoassay” ve Geenius HIV 1/2 Doğrulama Testi

et al. 2020

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İnsan immün yetmezlik virüsü (HIV) enfeksiyonu tanısında temel amaç, hızlı ve doğru bir şekilde HIV enfeksiyonuna sahip kişilerin saptanmasıdır. Uluslararası ve ulusal rehberlerin klasik algoritmalarında tekrarlayan şekilde reaktif bulunan örneklerin doğrulanması/desteklenmesi gerektiği önerilmektedir. Uzun yıllardan beri kullanılan rekombinant "line immünoassay testi (LIA)", maliyet ve emek etkin olması için biriktirilerek çalışılmaktadır. Bu çalışmada, rutin tanıda uzun süredir kullandığımız rekombinan HIV 1/2 LIA (INNO-LIA ® , Fujirebio, Ghent, Belçika) ile daha hızlı sonuç verebilen, HIV-1 ve HIV-2 enfeksiyonu tanısının doğrulanması ve ayırt edilmesi için kullanılan immünokromatografik bir test olan Geenius™ HIV 1/2 doğrulama testi (Bio-Rad Laboratories, Marnes-la-Coquette, Fransa)nin karşılaştırılması amaçlanmıştır. Ege Üniversitesi Tıp Fakültesi Hastanesi Tıbbi Viroloji Laboratuvarına HIV serolojisinin değerlendirilmesi için gönderilen örneklerden anti-HIV 1/2 ve p24 antijen pozitif ve sınır değer saptanan 150 serum örneği ile HIV-1 pozitif olduğu bilinen üç dış kalite kontrol örneği olmak üzere toplam 153 örnek çalışmaya dahil edilmiştir. Enzim immün testlerle çalışılan örnekler, Geenius™ HIV 1/2 doğrulama (Bio-Rad Laboratories, Marnes-la-Coquette, Fransa) ve rekombinant HIV 1/2 LIA (INNO-LIA ® , Fujirebio, Ghent, Belçika) testleri ile çalışıldı. HIV-1 viral yük sonuçları, plazma örneklerinde gerçek zamanlı HIV-1 testi ile Abbott m200sp sistem (Abbott Molecular, Wiesbaden, Almanya)'inde çalışılarak elde edilmiştir. Her iki doğrulama testinde sonuçlar 147 (%96.08) örnekte uyumlu bulunmuştur. Uyumsuz saptanan altı örneğin birinde LIA HIV-1 pozitif ve Geenius belirsiz, ikisinde LIA belirsiz ve Geenius HIV-1 pozitif, diğer üçünde de LIA belirsiz ve Geenius negatif saptanmıştır. HIV antikoru pozitif olan örneklerde LIA iki (2/97, %2.6) ve negatif olan üç (3/53, %5.66) örnekte belirsiz sonuç vermiştir. Geenius testi ise HIV antikoru pozitif ve negatif olan örnekleri doğru saptamıştır. Yeni kullanılmaya başlanan immünokromatografik test; uygulanma süresinin kısalığı, emek yoğun olmaması, HIV-1/2 ayrımını yapa-

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Evaluation of two HIV antibody confirmatory assays: Geenius™ HIV1/2 Confirmatory Assay and the recomLine HIV-1 & HIV-2 IgG Line Immunoassay

Cited by 9 publications

References 13 publications

Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as Part of a Confirmatory HIV Testing Strategy for Quebec, Canada: Comparison with Western Blot and Inno-Lia Assays

Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as Part of a Confirmatory HIV Testing Strategy for Quebec, Canada: Comparison with Western Blot and Inno-Lia Assays

The use of the Geenius^TM HIV‐1/2 Rapid confirmatory test for the enrolment of patients and blood donors in the WHO Universal Test and Treat Strategy in Cameroon, Africa

İki Anti-HIV Doğrulama Testinin Karşılaştırılması: Rekombinant HIV 1/2 “Line İmmunoassay” ve Geenius HIV 1/2 Doğrulama Testi

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Evaluation of two HIV antibody confirmatory assays: Geenius™ HIV1/2 Confirmatory Assay and the recomLine HIV-1 & HIV-2 IgG Line Immunoassay

Cited by 9 publications

References 13 publications

Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as Part of a Confirmatory HIV Testing Strategy for Quebec, Canada: Comparison with Western Blot and Inno-Lia Assays

Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as Part of a Confirmatory HIV Testing Strategy for Quebec, Canada: Comparison with Western Blot and Inno-Lia Assays

The use of the GeeniusTM HIV‐1/2 Rapid confirmatory test for the enrolment of patients and blood donors in the WHO Universal Test and Treat Strategy in Cameroon, Africa

İki Anti-HIV Doğrulama Testinin Karşılaştırılması: Rekombinant HIV 1/2 “Line İmmunoassay” ve Geenius HIV 1/2 Doğrulama Testi

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The use of the Geenius^TM HIV‐1/2 Rapid confirmatory test for the enrolment of patients and blood donors in the WHO Universal Test and Treat Strategy in Cameroon, Africa