First transmission of human immunodeficiency virus Type 1 by a cellular blood product after mandatory nucleic acid screening in Germany

Schmidt, Michael; Korn, Klaus; Nübling, C. Micha; Chudy, M.; Kreß, Julia; Horst, Heinz A.; Geusendam, G.; Hennig, Holger; Sireis, Walid; Rabenau, Holger F.; Doerr, H. W.; Berger, Annemarie; Hourfar, M. K.; Gubbe, Knut; Karl, Andreas; Fickenscher, Helmut; Tischer, B. Karsten; Babiel, Reiner; Seifried, Erhard; Gürtler, Lutz

doi:10.1111/j.1537-2995.2009.02203.x

Cited by 76 publications

(94 citation statements)

References 22 publications

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“…Rhesus is a seropositive monkey). (Schmidt et al 2009). In Singapore, it has been reported that a blood transfusion was the source of an HIV infection.…”

Section: Infectious Blood and Blood Products From Donors At The Seronmentioning

confidence: 99%

The HIV Seronegative Window Period: Diagnostic Challenges and Solutions

Jehuda-Cohen¹

2011

Recent Translational Research in HIV/AIDS

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“…Rhesus is a seropositive monkey). (Schmidt et al 2009). In Singapore, it has been reported that a blood transfusion was the source of an HIV infection.…”

Section: Infectious Blood and Blood Products From Donors At The Seronmentioning

confidence: 99%

The HIV Seronegative Window Period: Diagnostic Challenges and Solutions

Jehuda-Cohen¹

2011

Recent Translational Research in HIV/AIDS

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“…The cases were traceable to false-negative test results in the routine NAT assays due to new variants of the common HIV-1 subtype B missed by the assays' design. Recently, details of these 2 transmission cases and a number of related cases of false-negative HIV-1 NAT screening results have been published [8,9,10,11,12]. In addition, we must emphasize that cases of false-negative HIV-1 NAT based on low viral load combined with suboptimal NAT sensitivity in the screening of mini pools cannot be excluded.…”

Section: Introductionmentioning

confidence: 99%

Risk Minimization Measures for Blood Screening HIV-1 Nucleic Acid Amplification Technique Assays in Germany

Chudy

Kreß

Halbauer

et al. 2013

Transfus Med Hemother

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Background: Several publications describe HIV-1 RNA false-negative results or viral load underquantitation associated with Communauté Européenne(CE)-marked qualitative or quantitative nucleic acid amplification technique (NAT) assays. 6 cases occurred during blood screening in Germany, with 2 of them causing HIV-1 transmissions to recipients of blood components. The implicated NAT assays were mono-target assays amplifying in different viral genome regions (gag or long terminal repeat). Methods: Specimens characterized by HIV-1 NAT underquantitation or false-negative NAT results were comparatively investigated in CE-marked HIV-1 NAT systems of different design to identify potential reasons. The target regions of the viral nucleic acids were sequenced and these sequences compared to primers and probes of the assays. Potential risk minimization measures were considered for quantitative and blood-screening HIV-1 NAT systems. Results: Nucleotide sequencing of the viral target region in cases of HIV-1 RNA underquantitation or false-negative test results revealed new HIV-1 variants that were mismatched with primers and probes used in some mono-target assays. So far, dualtarget NAT assays have not been associated with mismatch-based false-negative test results. From 2015, the Paul Ehrlich Institute will request HIV-1 NAT assays of dual-target design or an analogous solution for further reducing the risk in blood screening. Conclusion: HIV differs from other blood-borne viruses with regard to its fast evolution of new viral variants. The evolution of new sequences is hardly predictable; therefore, NAT assays with only 1 target region appear to be more vulnerable to sequence variations than dual-target assays. The associated risk may be higher for HIV-1 NAT assays used for blood screening compared to quantitative assays used for monitoring HIV-1-infected patients. In HIV-1 screening NAT assays of dual-target design may adequately address the risk imposed by new HIV-1 variants.

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“…В 2009 году M. Schmidt и соавт. [43] опубликован случай передачи HIV при переливании реципиенту отмытых эритроцитов при отрицатель-ном результате NAT-тестирования донорской кро-ви. При проведении эпидемиологического рассле-дования было установлено, что чувствительность детекции HIV RNA автоматической ПЦР-станции в мини-пулах оказалась недостаточной для выявле-ния вирусной РНК.…”

Section: диагностика Hiv-инфекции у потенциальных доноров органов и тunclassified

The Problems of Providing Infectious Disease Safety for Organ and Tissue Donation by Screening Blood-Borne Viral Infections

Khubutiya¹,

Солонин²,

Годков³

2016

RJTAO

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ГБУЗ «Научно-исследовательский институт скорой помощи им. Н.В. Склифосовского», Москва, Российская Федерация Представлены данные о распространенности, клинической значимости и методах лабораторной диагнос-тики скрытых форм гемоконтактных вирусных инфекций (ГВИ). Рассмотрены причины возникновения таких форм инфекции и их значимость для клинической трансплантологии. Проанализирован существу-ющий алгоритм лабораторного обследования потенциального донора органов на ГВИ в РФ. Показано, что действующий алгоритм скрининга доноров на ГВИ не позволяет выявлять скрытые формы инфекции.Ключевые слова: скрытая HBV-инфекция, скрытая HCV-инфекция, потенциальный донор органов, трансплантация. THE PROBLEMS OF PROVIDING INFECTIOUS DISEASE SAFETY FOR ORGAN AND TISSUE DONATION BY SCREENING BLOOD-BORNE VIRAL INFECTIONS M.Sh. Khubutiya, S.A. Solonin, M.A. Godkov N.V. Sklifosovsky Clinical and Research Institute for Emergency Medicine, Moscow, Russian FederationIt provided data on the prevalence, clinical signifi cance and methods of laboratory diagnostics for occult forms of blood-borne viral infections (BBVIs). It considered causes of such forms of infection and their signifi cance for clinical transplantation. We analyzed the existing algorithm of laboratory screening of a potential organ donor for BBVIs in Russia. It is shown that the current screening algorithm doesn't allow detecting hidden forms of BBVIs.

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First transmission of human immunodeficiency virus Type 1 by a cellular blood product after mandatory nucleic acid screening in Germany

Cited by 76 publications

References 22 publications

The HIV Seronegative Window Period: Diagnostic Challenges and Solutions

The HIV Seronegative Window Period: Diagnostic Challenges and Solutions

Risk Minimization Measures for Blood Screening HIV-1 Nucleic Acid Amplification Technique Assays in Germany

The Problems of Providing Infectious Disease Safety for Organ and Tissue Donation by Screening Blood-Borne Viral Infections

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