Please note: Authors from the Paul-Ehrlich-Institut are highlighted in bold. For online abstracts or full text publications, please follow the links.
Abdurrahman G, Samukange W, Lyoko N, Shonhiwa NO, Kafere C, Nübling CM, Peeling RW, Reinhardt J (2023): Regulation of blood-screening in vitro diagnostics in sub-Saharan African countries remains a challenge.
Front Med Sec Hematology Oct 3 [Epub ahead of print].
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Puyskens A, Bayram F, Sesver A, Michel J, Krause E, Bourquain D, Filomena A, Esser-Nobis K, Steffanowski C, Nübling CM, Scheiblauer H, Schaade L, Nitsche A (2023): Performance of 20 rapid antigen detection tests to detect SARS-CoV-2 B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants using a clinical specimen panel from January 2022, Berlin, Germany.
Euro Surveill 28: 2200615.
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Baylis SA, Nübling CM (2022): Nucleic Acid Testing of Viral Pathogens: Traceability of the International Unit.
Clin Chem 68: 257-258.
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Knezevic I, Mattiuzzo G, Page M, Nuebling CM, Griffiths E, Minor P (2022): Complexity of serological assays and misunderstandings of WHO International Units.
Clin Chem Lab Med 60: e223-e224.
Online-Abstract
Knezevic I, Mattiuzzo G, Page M, Minor P, Griffiths E, Nübling CM, Moorthy V (2022): WHO International Standard for evaluation of the antibody response to COVID-19 vaccines: call for urgent action by the scientific community.
Lancet Microbe 3: e235-e240.
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Mbunkah H, Kafere C, Samukange W, Nübling CM, Reinhardt J (2022): Congress report: Online workshop on assessment of technical files for blood screening in vitro diagnostics for sub-Sahara African countries.
Transfus Med 32: 467-474.
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Scheiblauer H, Nübling CM, Wolf T, Khodamoradi Y, Bellinghausen C, Sonntagbauer M, Esser-Nobis K, Filomena A, Mahler V, Maier TJ, Stephan C (2022): Antibody response to SARS-CoV-2 for more than one year − kinetics and persistence of detection are predominantly determined by avidity progression and test design.
J Clin Virol 146: 105052.
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Baylis S, Nübling CM, Dimech W: Standardization of diagnostic assays.
In: Bamford DH, Zuckerman M (Hrsg.), Encyclopedia of Virology (Fourth Edition): Academic Press, 2021. S. 52-63, ISBN 978-0-12-814516-6
Baylis SA, Nübling CM (2021): Nucleic Acid Testing of Viral Pathogens: Traceability of the International Unit.
Clin Chem 68: 257-258.
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Janssen MP, Nuebling CM, Lery FX, Maryuningsih YS, Epstein JS (2021): A WHO tool for risk-based decision making on blood safety interventions.
Transfusion 61: 503-515.
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Puyskens A, Krause E, Michel J, Nübling CM, Scheiblauer H, Bourquain D, Grossegesse M, Valusenko R, Corman VM, Drosten C, Zwirglmaier K, Wölfel R, Lange C, Kramer J, Friesen J, Ignatius R, Müller M, Schmidt-Chanasit J, Emmerich P, Schaade L, Nitsche A (2021): Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021.
Euro Surveill 26: 2100442.
Online-Abstract
Samukange WT, Kluempers V, Porwal M, Mudyiwenyama L, Mutoti K, Aineplan N, Gardarsdottir H, Mantel-Teeuwisse AK, Nuebling CM (2021): Implementation and performance of haemovigilance systems in 10 sub-saharan African countries is sub-optimal.
BMC Health Serv Res 21: 1258.
Online-Abstract
Scheiblauer H, Filomena A, Nitsche A, Puyskens A, Corman VM, Drosten C, Zwirglmaier K, Lange C, Emmerich P, Müller M, Knauer O, Nübling CM (2021): Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021.
Euro Surveill 26: 2100441.
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Kempster SL, Almond N, Dimech W, Grangeot-Keros L, Huzly D, Icenogle J, Sittana El Mubarak H, Mulders MN, Nübling M (2020): WHO international standard for anti-rubella: learning from its application.
Lancet Infect Dis 20: E17-E19.
Online-Abstract
Kress J, Vermeulen M, Chudy M, Reissinger A, Hanschmann KM, Saville A, Nübling CM (2020): Reliability of CE-marked NATs for HIV-1 subtype C detection and quantitation.
J Clin Virol 132: 104649.
Online-Abstract
Mbunkah HA, Reinhardt J, Kafere C, Scheiblauer H, Prat I, Nübling CM (2021): In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme.
Vox Sang 116: 3-12.
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Ovanesov MV, Williams SC, Nübling CM, Dodt J, Hilger A, Maryuningsih Y, Gray E (2020): Summary of the WHO hearing on the development of product-specific reference materials for coagulation factor VIII and factor IX products.
Biologicals 67: 88-93.
Online-Abstract
Baylis SA, Wallace P, McCulloch E, Niesters HGM, Nübling CM (2019): Standardization of nucleic acid amplification tests: the approach of the World Health Organization.
J Clin Microbiol 57: e01056-18.
Online-Abstract
Hourfar K, Eberle J, Müller M, Nübling M, Chudy M, Kress J, Gürtler L, Mayr-Wohlfart U, Schrezenmeier H, Hellmann I, Luhm J, Kraas S, Ringwald J, Gubbe K, Frank K, Karl A, Tonn T, Jaeger M, Sireis W, Seifried E, Schmidt M (2018): Human immunodeficiency virus 1 dual-target nucleic acid technology improves blood safety: 5 years of experience of the German Red Cross blood donor service Baden-Württemberg-Hessen.
Transfusion 58: 2886-2893.
Online-Abstract
Chua A, Prat T, Nübling CM, Wood D, Moussy F (2017): Update on Zika Diagnostic Tests and WHO's Related Activities.
PLoS Negl Trop Dis 11: e0005269.
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Chudy M, Nübling CM, Blümel J, Daas A, Costanzo A (2017): Establishment of the Ph. Eur. Hepatitis A virus RNA for NAT testing BRP batch 1.
Pharmeur Bio Sci Notes 2017: 29-43.
Online-Abstract
Hassemer M, Finkernagel M, Peiffer KH, Glebe D, Akhras S, Reuter A, Scheiblauer H, Sommer L, Chudy M, Nübling CM, Hildt E (2017): Comparative characterization of hepatitis B virus surface antigen derived from different hepatitis B virus genotypes.
Virology 502: 1-12.
Online-Abstract
Baylis SA, Corman VM, Ong E, Linnen JM, Nübling CM, Blümel J (2016): Hepatitis E viral loads in plasma pools for fractionation.
Transfusion 56: 2532-2537.
Online-Abstract
Zhang W, Li L, Deng X, Blümel J, Nübling CM, Hunfeld A, Baylis SA, Delwart E (2016): Viral nucleic acids in human plasma pools.
Transfusion 56: 2248-2255.
Online-Abstract
Baylis SA, Chudy M, Nübling CM (2015): Standardization of NAT for Blood-Borne Pathogens.
Transfus Med Hemother 42: 211-218.
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Laperche S, Nübling CM, Stramer SL, Brojer E, Grabarczyk P, Yoshizawa H, Kalibatas V, El Elkyabi M, Moftah F, Girault A, van Drimmelen H, Busch MP, Leile M (2015): Sensitivity of hepatitis C virus core antigen and antibody combination assays in a global panel of window period samples.
Transfusion 55: 2489-2498.
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Nübling CM, Baylis SA, Hanschmann KM, Montag-Lessing T†, Chudy M, Kreß J, Ulrych U, Czurda S, Rosengarten R, Mycoplasma Collaborative Study Group (2015): World Health Organization International Standard to Harmonize Assays for Detection of Mycoplasma DNA.
Appl Environ Microbiol 81: 5694-5702.
Online-Abstract
Peiffer KH, Akhras S, Himmelsbach K, Hassemer M, Finkernagel M, Carra G, Nuebling M, Chudy M, Niekamp H, Glebe D, Sarrazin C, Zeuzem S, Hildt E (2015): Intracellular accumulation of subviral HBsAg particles and diminished Nrf2 activation in HBV genotype G expressing cells lead to an increased ROI level.
J Hepatol 62: 791-798.
Online-Abstract
Rabenau HF, Bannert N, Berger A, Mantke OD, Eberle J, Enders M, Fickenscher H, Grunert HP, Gürtler L, Heim A, Huzly D, Kaiser R, Korn K, Nick S, Kücherer C, Nübling CM, Obermeier M, Panning M, Zeichhardt H (2015): Nachweis einer Infektion mit Humanem Immundefizienzvirus (HIV): Serologisches Screening mit nachfolgender Bestätigungsdiagnostik durch Antikörper-basierte Testsysteme und/oder durch HIV-Nukleinsäure-Nachweis.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 58: 877-886.
Rägo L, Padilla Marroquin AM, Nübling CM, Sawyer J (2015): Treating snake bites—a call for partnership.
The Lancet 386: 2252.
Online-Abstract
Chudy M, Kress J, Halbauer J, Heiden M, Funk MB, Nübling CM (2014): Risk Minimization Measures for Blood Screening HIV-1 Nucleic Acid Amplification Technique Assays in Germany.
Transfus Med Hemother 41: 45-51.
Online-Abstract
Nübling CM, Nick S (2014): Rechtsgrundlagen und Praxis bei der Prüfung von kritischen In-vitro-Diagnostika.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 57: 1203-1208.
Online-Abstract
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Pignatti F, Ehmann F, Hemmings R, Jonsson B, Nuebling CM, Papaluca-Amati M, Posch M, Rasi G (2014): Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.
Clin Cancer Res 20: 1458-1468.
Online-Abstract
Baylis SA, Blümel J, Mizusawa S, Matsubayashi K, Sakata H, Okada Y, Nübling CM, Hanschmann KM (2013): World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA.
Emerg Infect Dis 19: 729-735.
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Chudy M, Scheiblauer H, Hanschmann KM, Kress J, Nick S, Wend U, Schüttler C, Nübling CM, Gerlich WH (2013): Performance of hepatitis B surface antigen tests with the first WHO international hepatitis B virus genotype reference panel.
J Clin Virol 58: 47-53.
Online-Abstract
Müller B, Nübling CM, Kress J, Roth WK, De Zolt S, Pichl L (2013): How safe is safe: new human immunodeficiency virus Type 1 variants missed by nucleic acid testing.
Transfusion 53: 2422-2430.
Online-Abstract
Chudy M, Hanschmann KM, Kress J, Nick S, Campos R, Wend U, Gerlich W, Nübling CM (2012): First WHO International Reference Panel containing hepatitis B virus genotypes A-G for assays of the viral DNA.
J Clin Virol 55: 303-309.
Online-Abstract
Chudy M, Weber-Schehl M, Pichl L, Jork C, Kress J, Heiden M, Funk MB, Nübling CM (2012): Blood screening nucleic acid amplification tests for human immunodeficiency virus Type 1 may require two different amplification targets.
Transfusion 52: 431-439.
Online-Abstract
Baylis SA, Hanschmann KM, Blümel J, Nübling CM, HEV Collaborative Study Group (2011): Standardization of hepatitis E virus (HEV) nucleic acid amplification technique-based assays: an initial study to evaluate a panel of HEV strains and investigate laboratory performance.
J Clin Microbiol 49: 1234-1239.
Online-Abstract
Miller GW, Myers GL, Gantzer LM, Kahn SE, Schönbrunner ER, Thienpont LM, Bunk DM, Christenson RH, Eckfeldt JH, Lo SF, Nübling CM, Sturgeon CM (2011): Roadmap for harmonization of clinical laboratory measurement procedures.
Clin Chem 57: 1108-1117.
Online-Abstract
Baylis SA, Nick S, Blümel J, Nübling CM (2010): Hepatitis E virus and blood donors in Germany.
Vox Sang 98: 479.
Online-Abstract
Pruss A, Caspari G, Krüger DH, Blümel J, Nübling CM, Gürtler L, Gerlich W (2010): Tissue donation and virus safety: more nucleic acid amplification testing is needed.
Transplant Infect Dis 12: 375-386.
Online-Abstract
Nübling CM, Heiden M, Chudy M, Kress J, Seitz R, Keller-Stanislawski B, Funk MB (2009): Experience of mandatory nucleic acid test (NAT) screening across all blood organizations in Germany: NAT yield versus breakthrough transmissions.
Transfusion 49: 1850-1858.
Online-Abstract
Schmidt M, Korn K, Nübling CM, Chudy M, Kress J, Horst HA, Geusendam G, Hennig H, Sireis W, Rabenau H, Doerr HW, Berger A, Hourfar MK, Gubbe K, Karl A, Fickenscher H, Tischer K, Babiel R, Seifried E, Gürtler L (2009): First transmission of human immunodeficiency virus Type 1 by a cellular blood product after mandatory nucleic acid screening in Germany.
Transfusion 49: 1836-1844.
Online-Abstract
Seitz R, Beekes M, Blümel J, Burger R, von Dewitz C, Gröner A, Heiden M, Kretzschmar H, Nübling M, Schlenkrich U, Schottstedt V, Strobel J, Willkommen H, Wirsing von König CH, Zerr I (2009): Report of the Working Group 'Overall Blood Supply Strategy with Regard to Variant Creutzfeldt-Jakob Disease (vCJD)'.
Transfus Med Hemother 36: 79-93.
Nübling CM, Unkelbach U, Chudy M, Seitz R (2008): Effect of viral nucleic acid testing on contamination frequency of manufacturing plasma pools.
Transfusion 48: 822-826.
Online-Abstract
Pfleiderer C, Blümel J, Schmidt M, Roth WK, Houfar K, Eckert J, Chudy M, Menichetti E, Lechner S, Nübling CM (2008): West Nile virus and blood product safety in Germany.
J Med Virol 80: 557-563.
Online-Abstract
Pruß A, Caspari G, Krüger DH, Blümel J, Nübling M, Quenzel EM, Kalus U, Gerlich W, Gürtler L (2008): Nukleinsäure-Amplifikationstests für HIV, HBV und HCV bei Gewebespendern: Sinnvoll oder überflüssig?.
Transfus Med Hemother 35: 421-430.
Online-Abstract
Seitz R, Heiden M, Nübling CM, Unger G, Löwer J (2008): The harmonization of the regulation of blood products: a European perspective.
Vox Sang 94: 267-276.
Online-Abstract
Kretzschmar E, Chudy M, Nübling CM, Ross RS, Kruse F, Trobisch H (2007): First case of hepatitis C virus transmission by a red blood cell concentrate after introduction of nucleic acid amplification technique screening in Germany: a comparative study with various assays.
Vox Sang 92: 297-301.
Online-Abstract
Seitz R, von Auer F, Blümel J, Burger R, Buschmann A, Dietz K, Heiden M, Hitzler WE, Klamm H, Kreil T, Kretzschmar H, Nübling M, Offergeld R, Pauli G, Schottstedt V, Volkers P, Zerr I (2007): Impact of vCJD on blood supply.
Biologicals 35: 79-97.
Online-Abstract
Pfleiderer C, König C, Chudy M, Schmidt M, Roth WK, Nübling CM (2006): Molecular Epidemiology of West Nile Virus in Humans.
Dev Biol 126: 197-201.
Seitz R, von Auer F, Blümel J, Burger R, Buschmann A, Dietz K, Heiden M, Hitzler WE, Klamm H, Kreil T, Kretzschmar H, Nübling M, Offergeld R, Pauli G, Schottstedt V, Volkers P, Zerr I (2006): Overall Blood Supply Strategy with Regard to Variant Creutzfeldt-Jakob Disease (vCJD).
Transfus Med Hemother 33: Sonderheft.
Online-Abstract
Volkers P, Poley-Ochmann S, Nübling CM (2005): Regulatorische Aspekte klinischer Prüfungen unter besonderer Berücksichtigung biologischer Arzneimittel.
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz 48: 408-414.
Online-Abstract
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Chudy M, Amberg I, Hanker-Dusel C, Nübling CM (2004): Procleix Ultrio Assay performance trial.
Vox Sang 87: 59.
Nübling CM, Chudy M, Löwer J (2003): Neopterin determination during the diagnostic window phase of HIV-1, HBV and HCV infections.
Pteridines 14: 53.
Nübling CM, Daas A, Buchheit KH (2003): Collaborative Study for Establishment of a European Pharmacopoeia Biological Reference Preparation (BRP) for B19 Virus DNA Testing of Plasma Pools by Nucleic Acid Amplification Technique.
Pharmeuropa Bio 2003: 27-34.
Online-Abstract
Chudy M, Stahl-Hennig C, Berger A, Nübling M, Hunsmann G, Rabenau HF, Löwer J (2002): Hepatitis A virus infection in tamarins: experimental transmission via contaminated factor VIII concentrates.
J Infect Dis 185: 1170-1173.
Online-Abstract
Lelie PN, van Drimmelen AAJ, Cuypers HTM, Best S, Dax EM, Stramer S, Hyland CAllain JP, Moncharmont P, Defer C, Nübling CM, Glauser A, da Silva Cardoso M, Viret JF, Lankinen M, Grillner L, Wirthmüller U, Coste J, Schottstedt V, Masecar B (2002): Sensitivity of HCV-RNA and HIV-RNA blood screening assays.
Transfusion 42: 527-536.
Online-Abstract
Nübling CM, Unger G, Chudy M, Raia S, Löwer J (2002): Sensitivity of HCV core antigen and HVC RNA detection in the early infection phase.
Transfusion 42: 1037-1045.
Nübling M (2001): Geplante Einführung der HIV-1 NAT für die Untersuchung von Blutspenden.
Retrovirus Bulletin: 5-6.
Nübling CM, Seifried E, Weichert W, Löwer J (2001): Human T-cell lymphocytotrophic virus prevalence in German blood donors and "at risk" groups.
Vox Sang 81: 204-206.
Schosser R, Keller-Stanislawski B, Nübling CM, Löwer J (2001): Causality assessment of suspected virus transmission by human plasma products.
Transfusion 41: 1020-1029.
Online-Abstract
Humpe A, Legler TJ, Nübling CM, Riggert J, Unger G, Wolf C, Heermann KH, Köhler M (2000): Hepatitis C virus transmission through quarantine fresh-frozen plasma.
Thromb Haemost 84: 784-788.
Online-Abstract
Saldanha J, Heath A, Lelie N, Pisani G, Nübling CM, Yu M (2000): Calibration of HCV working reagents against the HCV international standard. The Collaborative Study Group.
Vox Sang 78: 217-224.
Online-Abstract
Chudy M, Budek I, Keller-Stanislawski B, McCaustland KA, Neidhold S, Robertson BH, Nübling CM, Seitz R, Löwer J (1999): A new cluster of hepatitis A infection in hemophiliacs traced to a contaminated plasma pool.
J Med Virol 57: 91-99.
Online-Abstract
Chudy M, Nübling CM, Löwer J (1999): Implementation of HCV NAT screening in German blood banks: a regulator’s view. (Abstract 35, European Meeting on Molecular Diagnostics, Scheveningen, The Hague, The Netherlands, 13.-16.10.1999).
J Microbiol Meth 27: 291-294.
Online-Abstract
Nübling CM, Chudy M, Löwer J (1999): Validation of HCV-NAT assays and experience with NAT application for blood screening in Germany.
Biologicals 27: 291-294.
Online-Abstract
Nübling CM, Chudy M, Löwer J: The impact of NAT-testing on enhancing viral safety.
In: Manucci PM (Hrsg.), Coagulation Factors: The State of the Art. Frankfurt: Med. Verl.-Ges. Umwelt und Medizin, 1999. 33-38. ISBN 3-921320-41-0
Nübling CM, Chudy M, Löwer J (1999): Höhere Sicherheit durch verkleinertes "diagnostisches Fenster".
Diagnostica Dialog 1/99: 4-6.
Kaul A, Nübling CM, Kempfer M, Schmidt I, Löwer J (1998): Entwicklung von molekularbiologischen Alternativmethoden zur Prüfung von Poliomyelitis-Impfstoffen.
ALTEX 15: 18-20.
Online-Abstract
Nübling CM, Gröner A, Löwer J (1998): GB Virus C / Hepatitis G Virus and intravenous immunoglobulins.
Vox Sanguinis 75: 189-192.
Online-Abstract
Nübling CM (1998): HCV-NAT in der Transfusionsmedizin - Hintergrund, Anforderungen, Validierung.
Hygiene und Mikrobiologie 3: 9-11.
Nübling CM (1998): HCV-NAT in der Transfusionsmedizin - Hintergrund, Anforderungen, Validierung.
Hygiene und Mikrobiologie.
Nübling CM, Löwer J: GB-C / Hepatitis G Virus bei Hämophilen, Dialysepatienten, HIV-Infizierten und sein Nachweis in Blutprodukten.
Scharrer I, Schramm W (Hrsg.), 27. Hämophilie-Symposion Hamburg 1996 Berlin, Heidelberg: Springer, 1998. 47-53 ISBN 3-540-62915-7
Nübling CM, Seitz R, Löwer J (1998): Application of Nucleic Acid Amplification Techniques for Blood Donation Screening.
Infusion Therapy and Transfusion Medicin 25: 86-90.
Online-Abstract
Seitz R, Burger R, Gerlich W, Gürtler L, Heiden M, Kretschmer V, Lefèvre H, Löwer J, Montag-Lessing T, Neumann R, Pauli G, Schlenkrich U, Werner E, Willkommen H, Schreier E, Nübling M (1998): GB-Virus Typ C (GBV-C), Andere Bezeichnung: Hepatitis-G-Virus (HGV).
Bundesgesundheitsbl. 41: 88-90.
Van Buul C, Cuypers H, Lelie P, Chudy M, Nübling CM, Melsert R, Oudshoorn P (1998): The NucliSenstm Extractor.
Infusionstherapie und Transfusionsmedizin 25: 147-151.
Nübling CM, Bialleck H, Fürsch AJ, Scharrer I, Schramm W, Seifried E, Schmidt U, Staszewski S, Löwer J (1997): Frequencies of GB-C / Hepatitis G virus genomes and of specific antibodies in risk and non-risk populations.
Journal of Medical Virology 53: 218-224.
Online-Abstract
Nübling CM, Chudy M, Löwer J (1997): Virus Testing of Plasma Pools and Blood Products by Nucleic Acid Amplification.
Hämostaseologie 16: 274-276.
Nübling CM, Löwer J (1997): The role of nucleic acid amplification technique.
Biotest Bulletin 5: 377-381.
Nübling CM, Seitz R, Löwer J: Bedeutung der PCR für die Sicherheit von Blutprodukten.
In: Scharrer I, Schramm W (Hrsg.), 26. Hämophilie-Symposion: Hamburg 1995 : Verhandlungsberichte. Berlin, Heidelberg: Springer, 1997. 51-57.
Chudy M, Nübling CM, Scheiblauer H, Willkommen H, Löwer J (1996): Virusübertragung durch Blutprodukte: Mögliche Ursachen und Konsequenzen. Antwort auf den Leserbrief von D.L. Tankersley.
Hämostaseologie 16: 52-54.
Nübling CM, Chudy M, Löwer J (1996): Virus testing of plasma pools and blood products by nucleic acid amplification.
Hämostaseologie 16: 274-276.
Nübling CM, Löwer J (1996): Presence of GB-C genomes in a potential high risk group, in plasma pools and in intravenous immunoglobulins ("letter to the editor").
The Lancet 347: 68.
Online-Abstract
Scheiblauer H, Nübling M, Willkommen H, Löwer J (1996): The Prevalence of Hepatitis C Virus in Plasma Pools and the Effectiveness of Cold Ethanol Fractionation.
Clinical Therapeutics 18: 59-70.
Online-Abstract
Nübling CM, Willkommen H, Löwer J (1995): Hepatitis C transmission associated with intravenous immunoglobulins.
The Lancet 345: 1174.
Online-Abstract
