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The aim of INSTAND as a medical-scientific professional society is to make contributions on current issues of quality assurance in medical laboratories accessible to a broad professional public. For this reason, we publish the findings from research projects and interlaboratory tests in selected peer-review journals.

We deal with topics of daily laboratory routine in our high-quality series of publications, which summarise the most important findings on methodology and diagnostics in the various fields of laboratory medicine.

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Buchta C., Zeichhardt H., Griesmacher A., Schellenberg I., Kammel M. (2023)
Ignoring SARS-CoV-2 testing performance during COVID-19

Lancet Microbe. 2023 Feb 3:S2666-5247(23)00030-7. doi: 10.1016/S2666-5247(23)00030-7

Buchta C, Zeichhardt H, Aberle SW, Camp JV, Görzer I, Weseslindtner L, Puchhammer-Stöckl E, Huf W, Benka B, Allerberger F, Mielke M, Griesmacher A, Müller MM, Schellenberg I, Kammel M (2023)
Design of external quality assessment schemes and definition of the roles of their providers in future epidemics

Lancet Microbe. 2023 May 5:S2666-5247(23)00072-1. doi: 10.1016/S2666-5247(23)00072-1

Christoph Buchta, Heinz Zeichhardt, Tony Badrick, Wim Coucke, Nathalie Wojtalewicz, Andrea Griesmacher, Stephan W. Aberle, Ingo Schellenberg, Ellis Jacobs, Gunnar Nordin, Christian Schweiger, Karin Schwenoha, Peter B. Luppa, Ulrich M. Gassner, Thomas Wagner, Martin Kammel (2023)
Classification of “Near-patient” and “Point-of-Care” SARS-CoV-2 Nucleic Acid Amplification Test Systems and a first approach to evaluate their analytical independence of operator activities
Klaus-Peter Hunfeld, Peter Kraiczy, Douglas E. Norris and Benedikt Lohr (2023)
The In Vitro Antimicrobial Susceptibility of Borrelia burgdorferi sensu lato: Shedding Light on the Known Unknowns

MDPI, Pathogens 2023, 12(10), 1204; https://doi.org/10.3390/pathogens12101204

Laura Vierbaum, Nathalie Wojtalewicz , Anne Kaufmann, Sabine Goseberg, Patricia Kaiser, Hans-Peter Grunert, Ulf Dühring, Anika Zimmermann, Annemarie Scholz, Janine Michel, Andreas Nitsche, Holger F. Rabenau, Martin Obermeier, Ingo Schellenberg, Heinz Zeichhardt, Martin Kammel (2023)
Results of the first German external quality assessment scheme for the detection of monkeypox virus DNA
Nathalie Wojtalewicz, Laura Vierbaum, Anne Kaufmann, Ingo Schellenberg, Stefan Holdenrieder (2023)
Longitudinal Evaluation of AFP and CEA External Proficiency Testing Reveals Need for Method Harmonization
Valiente E, Falak S, Kummrow A, Kammel M, Corman VM, Macdonald R, Zeichhardt H. (2023 (2023)
Correlation of SARS-CoV-2 RNA and nucleocapsid concentrations in samples used in INSTAND external quality assessment schemes

BMC Res Notes. 2023 Sep 11;16(1):210. doi: 10.1186/s13104-023-06497-7. PMID: 37697348

Vierbaum L., Wojtalewicz N., Grunert H.P., Zimmermann A., Scholz A. , Goseberg S., Kaiser P., Duehring U., Drosten C., Corman V., Niemeyer D., Rabenau H.F., Obermeier M., Nitsche A., Michel J., Puyskens A., Huggett J.F., O'Sullivan D.M., Busby E., Cowen S., Vallone P.M., Cleveland M.H., Falak S., Kummrow A., Schellenberg I., Zeichhardt H., Kammel M. (2023)
Results of German external quality assessment schemes for SARS-CoV-2 antigen detection

Scientific Reports volume 13, Article number: 13206 (2023)

Guido Freckmann , Lutz Heinemann , Stefan Pleus , Astrid Petersmann , Patricia Kaiser , Matthias Nauck (2022)
Messqualität bei der Glukosemessung im Rahmen der Diabetesdiagnose und -therapie in Deutschland

Dtsch Med Wochenschr. 2022 Apr;147(7):407-413.doi: 10.1055/a-1741-2594. Epub 2022 Mar 28.

Guillain Mikaty, Séverine Matheus, Oliver Donoso Mantke, Elaine McCulloch, Heinz Zeichhardt , Jean-Claude Manuguerra, MediLabSecure (2022)
Evaluation of the diagnostic capacities for emerging arboviral diseases in the international network MediLabSecure from 2014 to 2018 - Importance of external quality assessments

J Infect Public Health. 2022 Feb;15(2):203-209. doi: 10.1016/j.jiph.2021.12.005. Epub 2021 Dec 9.

Lisa M.Johnson, Michael Spannagl, Nathalie Wojtalewicz, Jürgen Durner (2022)
Comparison of fecal calprotectin and pancreatic elastase assays based on proficiency testing results

Clin Biochem. 2022 May 14; S0009-9120(22)00131-X. doi: 10.1016/j.clinbiochem.2022.05.002.

Mojca Milavec, Jernej Pavšič, Alexandra Bogožalec Košir, Gerwyn M Jones, Denise M O'Sullivan, Alison S Devonshire, Fran Van Heuverswyn, Maria Karczmarczyk, Jannika Neeb, Annabell Plauth, Philippe Corbisier, Heinz Schimmel, Andreas Kummrow, Jörg Neukammer, Carole A Foy, Martin Kammel, Hans-Peter Grunert, Heinz Zeichhardt, Jim F Huggett (2022)
The performance of human cytomegalovirus digital PCR reference measurement procedure in seven external quality assessment schemes over four years

Methods. 2022 May;201:65-73.doi: 10.1016/j.ymeth.2021.03.016. Epub 2021 Apr 1.

P. Kaiser, G. Freckmann, A. Petersmann, M. Nauck, L. Heinemann (2022)
[HbA1c-Messungen im Ringversuch: Anpassung der Akzeptanzgrenzen in der Rili-BÄK][German only]
Renata Šmit, Nathalie Wojtalewicz, Laura Vierbaum, Farzin Nourbakhsh, Ingo Schellenberg, Klaus-Peter Hunfeld, Benedikt Lohr (2022)
Epidemiology, Management, Quality of Testing and Cost of Syphilis in Germany: A Retrospective Model Analysis

Front Public Health. 2022 Apr 26;10:883564. doi: 10.3389/fpubh.2022.883564. eCollection 2022.

Samreen Falak, Rainer Macdonald, Eloise J Busby, Denise M O'Sullivan, Mojca Milavec, Annabell Plauth, Martin Kammel, Heinz Zeichhardt, Hans-Peter Grunert, Andreas Kummrow, Jim F Huggett (2022)
An assessment of the reproducibility of reverse transcription digital PCR quantification of HIV-1

Methods. 2022 May;201:34-40.doi: 10.1016/j.ymeth.2021.03.006. Epub 2021 Mar 12.

Tim Mercer, Neil Almond, Michael A Crone, Patrick S G Chain , Alina Deshpande, Deepa Eveleigh, Paul Freemont, Sebastien Fuchs, Russell Garlick, Jim Huggett, Martin Kammel, Po-E Li, Mojca Milavec, Elizabeth M Marlowe, Denise M O'Sullivan, Mark Page, Gary A Pestano, Sara Suliman, Birgitte Simen, John J Sninsky, Lynne Sopchak, Cristina M Tato, Peter M Vallone, Jo Vandesompele, Thomas J White, Heinz Zeichhardt, Marc Salit (2022)
The Coronavirus Standards Working Group's roadmap for improved population testing

Nat Biotechnol. 2022 Nov;40(11):1563-1568.doi: 10.1038/s41587-022-01538-1.

Tony Badrick, Graham Jones, W Greg Miller, Mauro Panteghini, Andrew Quintenz, Sverre Sandberg, Michael Spannagl (2022)
Differences between Educational and Regulatory External Quality Assurance/Proficiency Testing Schemes

Clin Chem Lab Med. 2022 Aug 23. doi: 10.1515/cclm-2022-0683

Vierbaum L, Wojtalewicz N, Grunert H-P, Lindig V, Duehring U, Drosten C, Corman V, Niemeyer D, Ciesek S, Rabenau HF, Berger A, Obermeier M, Nitsche A, Michel J, Mielke M, Huggett J, O'Sullivan D, Busby E, Cowen S, Vallone PM, Cleveland MH, Falak S, Kummrow A, Keller T, Schellenberg I, Zeichhardt H, Kammel M (2022) (2022)
RNA reference materials with defined viral RNA loads of SARS-CoV-2—A useful tool towards a better PCR assay harmonization

PLoS One, 2022. 17(1): p. e0262656

William Jonathan Windsor, Yannik Roell, Heidi Tucker, Chi-An Cheng, Sara Suliman, Laura J Peek, Gary A Pestano, William T Lee, Heinz Zeichhardt, Molly M Lamb, Martin Kammel, Hui Wang, Ross Kedl, Cody Rester, Thomas E Morrison, Bennet J Davenport, Kyle Carson, Jennifer Yates, Kelly Howard, Karen Kulas, David R Walt, Aner Dafni, Daniel Taylor, May Chu (2022)
Harmonization of Multiple SARS-CoV-2 Reference Materials Using the WHO IS (NIBSC 20/136): Results and Implications

Front Microbiol. 2022 May 30;13:893801.doi: 10.3389/fmicb.2022.893801. eCollection 2022.

Daniel Evans, Simon Cowen, Martin Kammel, Denise M O'Sullivan, Graham Stewart, Hans-Peter Grunert, Jacob Moran-Gilad, Jasper Verwilt, Jiwon In, Jo Vandesompele, Kathryn Harris, Ki Ho Hong, Nathaniel Storey, Suzie Hingley-Wilson, Ulf Dühring, Young-Kyung Bae , Carole A Foy, Julian Braybrook, Heinz Zeichhardt, Jim F Huggett (2021)
The Dangers of Using Cq to Quantify Nucleic Acid in Biological Samples: A Lesson From COVID-19

Clin Chem. 2021 Dec 30;68(1):153-162.doi: 10.1093/clinchem/hvab219.

Hildebrandt A, Zintl A, Montero E, Hunfeld KP, Gray J. (2021)
Human Babesiosis in Europe
Hoffmüller P, Brüggemann M, Eggermann T, Ghoreschi K, Haase D, Hofmann J, Hunfeld KP, Koch K, Meisel C, Michl P, Müller J, Müller C, Rabenau HF, Reinhardt D, Riemenschneider MJ, Sachs UJ, Sack U, Stenzinger A, Streichert T, von Neuhoff N, et al. (2021)
Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR).

AWMF Ad hoc Commision In-vitro Diagnostic Medical Devices.

Ger Med Sci. 2021 Jun 1;19:Doc08. doi: 10.3205/000295.

Huynh HH, Bœuf A, Pfannkuche J, Schuetz P, Thelen M, Nordin G, van der Hagen E, Kaiser P, Kesseler D, Badrick T, Poggi B, Tiikkainen U, Davies GJ, Kessler A, Plebani M, Vinh J, Delatour V; The IFCC WG-PCT members. (2021)
Harmonization status of procalcitonin measurements: what do comparison studies and EQA schemes tell us?

Clin Chem Lab Med. 2021 Jun 21. doi: 10.1515/cclm-2021-0566.

Schneider H, Hess C, Kessler A, Steimer W. (2021)
Quantification of antibiotics in patient samples: state of the art in standardization and proficiency testing

Ther Drug Monit. 2021 Dec 17. doi: 10.1097/FTD.0000000000000953. PMID: 34923543

Sebastian Hörber , Patricia Kaiser, Peter Achenbach, Erwin Schleicher, Andreas Peter (2021)
New classification of diabetes mellitus - requirements for laboratory measurements

Diabetologie 2021; 16: 1–7

Stefan Pleus  , Lutz Heinemann , Guido Freckmann , Matthias Nauck , Andrea Tytko , Patricia Kaiser , Astrid Petersmann (2021)
[Glukosemessung in der Diabetesdiagnostik und -therapie: Laboratoriumsmedizinische Untersuchung inkl. patientennaher Sofortdiagnostik, Blutglukoseselbstmessung und kontinuierliches Glukosemonitoring] (German)

Diabetologie und Stoffwechsel, DOI: 10.1055/a-1528-8248

Wojtalewicz N, Vierbaum L, Schellenberg I, Hunfeld KP (2021)
Evaluation of INSTAND e.V.'s External Proficiency Testing Program for Tetanus and Diphtheria Antitoxin Detection: Lessons for Assessing Levels of Immunoprotection

Int J Infect Dis. 2020 Dec 21;S1201-9712(20)32570-4.

doi: 10.1016/j.ijid.2020.12.046

Alexandra Bogožalec Košir, Tašja Cvelbar, Martin Kammel, Hans-PeterGrunert, Heinz Zeichhardt, Mojca Milavec (2020)
Digital PCR method for detection and quantification of specific antimicrobial drug-resistance mutations in human cytomegalovirus

Journal of Virological Methods, Volume 281, July 2020, 113864 DOI: doi.org/10.1016/j.jviromet.2020.113864

Delatour V, Clouet-Foraison N, Jaisson S, Kaiser P, Gillery P (2020)
Beware of Noncommutability of External Quality Assessment Materials for Hemoglobin A 1c

Clin Chem 2020;66(2):390-391 DOI: doi.org/10.1093/clinchem/hvz024

Denis Grote-Koska*, Rainer Klauke, Patricia Kaiser, Udo Kramer, Rainer Macdonald, Dietmar Lerche, Antje Staaden, Korbinian Brand and Gerhard Schumann (2020)
Total haemoglobin – a reference measuring system for improvement of standardisation

Clinical Chem Lab Med 2020;aop. DOI: doi.org/1 0.1515/cclm-2019-1177

Huggett JF, Benes V, Bustin SA, Garson JA, Harris K, Kammel M , Kubista M , McHugh TD , Moran-Gilad J , Nolan T, Pfaffl MW, Salit M, Shipley G,Vallone PM,Vandesompele J,Wittwer C, Zeichhardt H (2020)
Cautionary Note on Contamination of Reagents Used for Molecular Detection of SARS-CoV-2

Clin Chem. 2020 Nov 1;66(11):1369-1372.

doi: 10.1093/clinchem/hvaa214.

INSTAND Publication Series (2020)
Selected methods of CSF diagnostics and clinical neurochemistry

Deutsche Gesellschaft für Liquordiagnostik und Klinische Neurochemie e.V., ISBN 978-3-98217-810-3

Michael Schmidt, Sebastian Hoehl, Annemarie Berger, Heinz Zeichhardt, Kai Hourfar, Sandra Ciesek, Erhard Seifried (2020)
Novel multiple swab method enables high efficiency in SARS-CoV -2 screenings without loss of sensitivity for screening of a complete population

Transfusion. 2020 Jul 6;10.1111/trf.15973. doi: 10.1111/trf.15973 DOI: onlinelibrary.wiley.com/doi/full/10.1111/trf.15973

P. Kaiser, M. Spannagl (2020)
Effects of the new acceptance limits according to Rili-BÄK on the pass rates in the HbA1c interlaboratory test

Diabetes, Stoffwechsel und Herz, Band 29, 3/2020

Rauer S, Kastenbauer S, Hofmann H, Fingerle V, Huppertz HI, Hunfeld KP, Krause A, Ruf B, Dersch R; Consensus group. (2020)
Guidelines for diagnosis and treatment in neurology - Lyme neuroborreliosis.

Ger Med Sci. 2020 Feb 27;18:Doc03. doi: 10.3205/000279. eCollection 2020.

PMID: 32341686

Bress K, Madlener K, Hunfeld KP (2019)
Improved guideline adherence in endocarditis therapy: The Endocarditis Conference as an important steering tool

GMS Z Forder Qualitatssich Med Lab 2019; 10:Doc03 (20191128)

Kupsch C, Gräser Y (2019)
Genome detection of dermatophytes: Current findings from the external quality assessment test

Hautarzt. 2019 Aug;70(8):627-637. doi: 10.1007/s00105-019-4435-3.

Nathalie Wojtalewicz, Ingo Schellenberg, Klaus-Peter Hunfeld (2019)
Evaluation of INSTAND e.V.'s external quality assessment for C-reactive protein and procalcitonin

PLoS One. 2019 Aug 16;14(8):e0221426. doi: 10.1371/journal.pone.0221426

Patricia Kaiser, Michael Spannagl (2019)
Quality assurance in laboratory diagnostics

Management & Krankenhaus 9/2019, S.37

www.management-krankenhaus.de/restricted-files/136436

Patscheke H, Hallbach J, Hunfeld KP (2019)
Position of in vitro diagnostic medical devices in medical device law - role of interlaboratory comparisons and reference institutions for patient safety

GMS Z Forder Qualitatssich Med Lab 2019; 10:Doc04 (20191203)

Reischl U, Ehrenschwender M, Hiergeist A, Maaß M, Baier M, Frangoulidis D, Grass G, von Buttlar H, Scholz H, Fingerle V, Sing A, Dumke R, Reiter-Owona I, Anders A (2019)
Bacterial and fungal genome detection PCR/NAT: Evaluation of the November 2018 INSTAND e.V. EQA scheme for external quality control of molecular biological detection methods in bacteriological diagnostics

GMS Z Forder Qualitatssich Med Lab 2019; 10:Doc02 (20191007)

Reischl U, Ehrenschwender M, Hiergeist A, Maaß M, Baier M, Frangoulidis D, Grass G, von Buttlar H, Scholz H, Fingerle V, Sing A, Dumke R, Reiter-Owona I, Anders A (2019)
Bacterial and fungal genome detection PCR/NAT: Evaluation of the EQA scheme June 2018 by INSTAND e.V. for external quality control of molecular biological detection methods in bacteriological diagnostics

GMS Z Forder Qualitatssich Med Lab 2019; 10:Doc01 (20190215)

Vincent Delatour, Noemie Clouet-Foraisona, Stephane Jaisson, Patricia Kaiser and Philippe Gillery (2019)
Trueness assessment of HbA1c routine assays: are processed EQA materials up to the job?

Clin Chem Lab Med 2019; aop

DOI: https://doi.org/10.1515/cclm-2019-0219

Andreas Bietenbeck, Wolf J Geilenkeuser, Frank Klawonn, Michael Spannagl, Matthias Nauck, Astrid Petersmann, Markus A Thale, Christof Winter, Peter B Luppa (2018)
External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact

Clin Chem Lab Med. 2018 Jul 26;56(8):1238-1250.doi: 10.1515/cclm-2017-1142.

Cristian Gabriel Arsene, Patricia Kaiser, Renata Paleari, Ande Henrion, Michael Spannagl, Andrea Mosca, on behalf of the IFCC Working Group on Standardisation of Hemoglobin A2 (WG-HbA2) (2018)
Determination of HbA2 by quantitative bottom-up proteomics and isotope dilution mass spectrometry

Clinica Chimica Acta 2018; 487:318-24

Garry John, Emma English, Rajiv T Erasmus, David Barry Sacks, Cas Weykamp, Christoph Buchta, Mathias M. Mueller, Yolande Lenga, Marek Budina, Josef Kratochvila, Bedrich Friedecky, Jean-Pascal Siest, Patricia Kaiser et al. (2018)
EurA1c: the European HbA1c Trial to Investigate the Performance of HbA1c Assays in 2166 Laboratories across 17 Countries and 24 Manufacturers by Use of the IFCC Model For Quality Targets

Clinical Chemistry Jun 2018, clinchem.2018; DOI: 10. 1373/clinchem.2018.288795

Lutz Heinemann, Patricia Kaiser, Guido Freckmann, Denis Grote-Koska, Wolfgang Kerner, Rüdiger Landgraf, Ludwig Merker, Ulrich Alfons Müller, Dirk Müller-Wieland, Johannes Roth, Michael Spannagl, Henri Wallaschofski, Matthias Nauck (2018)
HbA1c measurements in Germany: Is the quality sufficient for follow-up and diagnosis?

Diabetologie 2018; 13 46-53

Lutz Heinemann, Patricia Kaiser; Guido Freckmann; Denis Grote-Koska; Wolfgang Kerner, Rüdiger Landgraf; Ludwig Merker; Ulrich A. Müller; Dirk Müller-Wieland; Johannes Roth; Michael Spannagl; Henri Wallaschofski; Matthias Nauck (2018)
Higher HbA1c measurement quality standards are needed for follow-up and diagnosis: Experience and Analyses from Germany

Horm Metab Res 2018; 50(10): 728-734

Manfred Uhr, Patricia Kaiser (2018)
Instand ring test for destruction and dementia markers - ways to standardised CSF signostics [German]

Trillium Diagnostik 2018;16(1):60

Ralf-Rüdiger Flörke, Günther Kappert (2018)
Proficiency testing for hereditary coagulation disorders - External quality control [German]

Trillium Diagnostik 2018;16(4):286

Rauer S, Kastenbauer S, Hofmann H, Fingerle V, Huppertz HI, Hunfeld KP et al. (2018)
Neuroborreliosis, S3 guideline [German]

Deutsche Gesellschaft für Neurologie (Hrsg.), Leitlinien für Diagnostik und Therapie in der Neurologie.

Rauer, S; Kastenbauer, S; Fingerle, V; Hunfeld, K; Huppertz, H; Dersch, R (2018)
Clinical practice guideline: Lyme neuroborreliosis

Dtsch Arztebl Int 2018; 115(45): 751-6; DOI: 10.3238/arztebl.2018.0751

Rüttger S, Müller I, Hunfeld KP. (2018)
On the quality of bacteriological infection serological methods in Germany:Evaluation of the infection serological ring tests 2015 - Contribution of the Quality Assurance Commission of the DGHM [German]

GMS Z Forder Qualitatssich Med Lab; 9: Doc03.DOI: 10.3205/lab000031, URN: urn:nbn:de:0183-lab0000315

Wayne Dimech, Liza M Cabuang, Hans-Peter Grunert, Vanessa Lindig, Vivienne James, Brigitte Senechal, Giuseppe A Vincini, Heinz Zeichhardt (2018)
Results of cytomegalovirus DNA viral loads expressed in copies per millilitre and international units per millilitre are equivalent

J Virol Methods. 2018 Feb;252:15-23.doi: 10.1016/j.jviromet.2017.11.001. Epub 2017 Nov 7.

Wellinghausen N, Abele-Horn M, Donoso Mantke O, Enders M, Fingerle V, Gärtner B, Hagedorn J, Rabenau H F, Reiter-Owona I, Tintelnot K, Weig M, Zeichhardt H, Hunfeld KP (2018)
MiQ, Immunological Methods for the Detection of Infectious Diseases

INSTAND e.V., Düsseldorf iin cooperation with Dustri-Verlag Dr. Karl Feistle, Oberhaching, ISBN 978-3-87185-518-4.

Wojtalewicz N, Goseberg S, Kabrodt K, Schellenberg I. (2018)
Evaluation of the manufacturer-dependent differences in specific immunoglobulin E results for indoor allergens

Ann Allergy Asthma Immunol. 2018 Oct;121(4):490-495. doi: 10.1016/j.anai.2018.07.016

Zoltán Prohászka, Michael Kirschfink, Ashley Frazer-Abel (2018)
Complement analysis in the era of targeted therapeutics

Molecular Immunology 102 (2018) 84–88

Durner J, Spannagl M. (2017)
New perspectives on existing data in comparative measurements: A simple extension of the regression analysis
Hofmann H, Fingerle V, Hunfeld KP, Huppertz HI, Krause A, Rauer S, Ruf B; Consensus group. (2018) (2017)
Cutaneous Lyme borreliosis: Guideline of the German Dermatology Society

Ger Med Sci. Doc14. doi: 10.3205/000255. eCollection 2017

Lohr B, Hildebrandt A, Hunfeld KP (2017)
Human babesiosis: a brief clinical-microbiological profile [German]
Renata Paleari, Donatella Caruso, Patricia Kaiser, Cristian Gabriel Arsene, Christine Schaeffer-Reiss, Alain Van Dorsselaer, Emmanuel Bissé, Maria Ospina, Víctor R. De Jesús, Barbara Wild, Andrea Mosca on behalf of the IFCC Working Group on Standardisatio (2017)
Developing a reference system for the IFCC standardization of HbA2

Clin Chim Acta 467 (2017) 21–26

S Santibanez, J M Hübschen, M C Ben Mamou, M Muscat, K E Brown, R Myers, O Donoso Mantke, H Zeichhardt, D Brockmann, S V Shulga, C P Muller, P M O'Connor, M N Mulders, A Mankertz (2017)
Molecular surveillance of measles and rubella in the WHO European Region: new challenges in the elimination phase

Clin Microbiol Infect. 2017 Aug;23(8):516-523. doi: 10.1016/j.cmi.2017.06.030.

Schürer-Maly CC, Guder WG, Wolf E, Bauer D, Fried R (2017)
Preanalytics: Online Continuing Education for Medical Assistants - International Study on Need, Benefit and Sustainability [German]
Wojtalewicz N, Goseberg S, Kabrodt K, Schellenberg I (2017)
Discrepant results in allergy diagnostics [German]
Wojtalewicz N, Goseberg S, Kabrodt K, Schellenberg I (2017)
Six years of INSTAND e.V. sIgE proficiency testing: An evaluation of in vitro allergy diagnostics

Allergy J. Int. 2017; 26 (2): 43-52

Wojtalewicz N. (2017)
Externe Qualitätskontrolle in der Labormedizin - Mehr als nur ein notwendiges Übel [only German]
C. Brauckmann,   C. Frank,   D. Schulze,   P. Kaiser,   R. Stoscha and   C. Swarta (2016)
Preparation and characterisation of an 57Fe enriched haemoglobin spike material for species-specific isotope dilution mass spectrometry

J. Anal. At. Spectrom., 2016,31, 1846-1857

Deutsche Dermatologische Gesellschaft e.V. (DDG) (2016)
S2k Guideline Cutaneous Lyme Borreliosis

AWMF

www.awmf.org/leitlinien/detail/ll/013-044.html

Kaiser P, Peetz D, Spannagl M (2016)
Quality assurance in diabetology

Der Diabetologe 2016;12:1-4

Kragh T, Giebl A, Dick A, Kutsch M, Spannagl M (2016)
Thrombelastometry - internal and external quality assurance
Magiera R, Abholz H-H, Schürer-Maly CC, Pentzek M (2016)
Una dieta a ridotto contenuto di lattosio è adatta ai pazienti con un disturbo intestinale organicamente inspiegabile?

Z Allg Med 2016; 92 (10): 390-396.

Mai M, Müller I, Walch D, Hunfeld K.-P (2016)
On the Quality of Bacteriological Infection Serological Methods in Germany: Evaluation of the Infection Serological Interlaboratory Tests 2012 - Contribution of the Quality Assurance Commission of the DGHM

Der Mikrobiologe 26/1, S. 32-50

Mai M, Müller I, Walch D, Hunfeld KP (2016)
On the Quality of Bacteriological Infection Serological Methods in Germany: Evaluation of the Infection Serological Interlaboratory Tests 2012 - Contribution of the Quality Assurance Commission of the DGHM
Patricia Kaiser, Michael Spannagl, Christel van Campenhout, Yolande Lenga, Carla Siebelder, Cas Weykamp (2016)
HbA1c: EQA in Germany, Belgium and the Netherlands using fresh whole blood samples with target values assigned with the IFCC reference system

Clin Chem Lab Med 2016;54:1769-75

Wellinghausen N, Abele-Horn M, Donoso Mantke O, Enders M, Fingerle V, Gärtner B, Hagedorn J, Rabenau H F, Reiter-Owona I, Tintelnot K, Weig M, Zeichhardt H, Hunfeld KP (2016)
MiQ Quality standards in microbiological-infectiological diagnostics: Infection immunological methods

Urban & Fischer München, Jena

Zoltán Prohászka, Bo Nilsson, Ashley Frazer-Abel, Michael Kirschfink (2016)
Complement analysis 2016: Clinical indications, laboratorydiagnostics and quality control

Immunobiology 221 (2016) 1247–1258

Bundesärztekammer (German Medical Association), Instand e.V. (2015)
Guidelines of the German Medical Association on quality assurance in medical laboratory testing

GMS Z Forder Qualitatssich Med Lab 2015;6:Doc03 (20150408)

www.egms.de/static/pdf/journals/lab/2015-6/lab000018.pdf

Lohr B, Mueller I, Mai M, Norris DE, Schoeffski O, Hunfeld KP (2015)
Epidemiology and cost of hospital care for Lyme borreliosis in Germany: Lessons from a health care utilization database analysis

Ticks Tick Borne Dis., 6: 56-62

Reischl U, Schneider W, Ehrenschwender M, Hiergeist A et al. (2015)
Bacterial and fungal genome detection PCR/NAT: Evaluation of the round robin test May 2015 by INSTAND e.V. for external quality control of molecular biological detection methods in bacteriological diagnostics

GMS Z Forder Qualitatssich Med Lab 2015;6:Doc04 (20150630)

www.egms.de/static/pdf/journals/lab/2015-6/lab000019.pdf

Reischl U, Schneider W, Ehrenschwender M, Hiergeist A et al. (2015)
Bacterial and fungal genome detection PCR/NAT: Evaluation of the November 2015 INSTAND e.V. EQA scheme for external quality control of molecular biological detection methods in bacteriological diagnostics

GMS Z Forder Qualitatssich Med Lab 2015;6:Doc05 (20151222)

www.egms.de/static/pdf/journals/lab/2015-6/lab000020.pdf

Kress M, Meissner D, Kramer U, Spannagl M, Kaiser P (2014)
Measurement procedure for glucose in serum using liquid chromatography isotope dilution – tandem mass spectrometry

Clin Lab 2014;60:1509-1515

Magiera R, Schürer-Maly C.-C., Mortsiefer A., Abholz H.-H., Maly F. E. Pentzek M (2014)
Are there Differences between Patients with and without the Homozygous -13910CC Genetic Variant in the MCM-6 Gene Upstream from the Lactase Gene? - A Non-Randomised, Two Armed Intervention Study without Control Group

Clin. Lab. 2014;60:1617-1625

Mai M, Müller I, Hunfeld KP (2014)
Quality of bacteriological-infection serological methods in Germany: Evaluation of the infection serological proficiency tests 2011 - Contribution of the Quality Assurance Commission of the German Society for Hygiene and Microbiology (DGHM)

GMS Z Forder Qualitatssich Med Lab 2014;5:Doc04 (20141007)

www.egms.de/static/pdf/journals/lab/2014-5/lab000014.pdf

Maly FE, Fried R, Spannagl M. (2014)
Participation and Performance in INSTAND Multi-Analyte Molecular Genetics External Quality Assessment Schemes from 2006 to 2012

Clin. Lab. 2014;60:333-338

Maneg D, Müller I, Hunfeld KP (2014)
Results of the bacteriological-infection serological INSTAND EQA scheme 2010: A summary analysis - Contribution of the Quality Assurance Commission of the German Society for Hygiene and Microbiology (DGHM)

GMS Z Forder Qualitatssich Med Lab 2014;5:Doc02 (20140127)

www.egms.de/static/pdf/journals/lab/2014-5/lab000012.pdf

Reischl U, Schneider W, Holzmann T, Ehrenschwender M et al. (2014)
Bacterial and fungal genome detection PCR/NAT: Evaluation of the round robin test May 2014 by INSTAND e.V. for external quality control of molecular biological detection methods in bacteriological diagnostics

GMS Z Forder Qualitatssich Med Lab 2014;5:Doc03 (20140701)

www.egms.de/static/pdf/journals/lab/2014-5/lab000013.pdf

Reischl U, Schneider W, Holzmann T, Ehrenschwender M et al. (2014)
Bacterial and fungal genome detection PCR/NAT: Evaluation of the November 2014 INSTAND e.V. round robin test for external quality control of molecular biological detection methods in bacteriological diagnostics

GMS Z Forder Qualitatssich Med Lab 2014;5:Doc05 (20141216)

www.egms.de/static/pdf/journals/lab/2014-5/lab000015.pdf

Reischl U, Schneider W, Holzmann T, Ehrenschwender M. et al. (2014)
Bacterial and fungal genome detection PCR/NAT: Evaluation of the November 2013 INSTAND e.V. round robin test for external quality control of molecular biological detection methods in bacteriological diagnostics

GMS Z Forder Qualitatssich Med Lab 2014;5:Doc01 (20140108)

www.egms.de/static/pdf/journals/lab/2014-5/lab000011.pdf

Flegel A, Chiosea I, Sachs U, Bein G (2013)
External quality assessment in molecular immunohematology: the INSTAND proficiency test program

Transfusion 2013;53:2850-2858

Kramer U, Kress M, Reinauer H, Spannagl M, Kaiser P (2013)
Candidate Reference Measurement Procedures for Chloride, Potassium, Sodium, Calcium, Magnesium, and Lithium by Inductively Coupled Plasma (Isotope Dilution) Sector Field Mass Spectrometry (ICP-(ID) SFMS) in Serum

Clin Lab 2013;59:1017-1029

Reischl U, Straube E, Maaß M, Jacobs E, Schneider W, Fingerle V, Busch U, Frangoulidis D, Splettstösser W, Grass G, Reiter-Owona I (2013)
Bacterial and fungal genome detection PCR/NAT: Evaluation of the round robin test May 2013 by INSTAND e.V. for external quality control of molecular biological detection methods in bacteriological diagnostics

GMS Z Forder Qualitatssich Med Lab 2013;4:Doc03 (20130722)

www.egms.de/static/pdf/journals/lab/2013-4/lab000010.pdf

Riffelmann M, Hunfeld KP, Müller I, Xing D, Kennerknecht N, Wirsing von König CH. (2013)
External quality assessment of pertussis serology in Germany

Eur. J. Clin. Microbiol. Infect. Dis., 32:421-3.

Rüsch-Gerdes S, Janitschke K, Homorodean D (2013)
Second Conference of National Tuberculosis Reference Laboratories from Central and East European Countries

GMS Z Forder Qualitatssich Med Lab 2013;4:Doc01 (20130606)

www.egms.de/static/pdf/journals/lab/2013-4/lab000008.pdf

Schürer-Maly C, Wood WG, Falbo R, Brambilla P, Heller C, Schwarz P, Illigen D, Adler M, Heitzmann N, Bauer D, Fischer M, Spannagl M (2013)
An Educational Web-Based External Quality Assessment Outcome and Evaluation: First Experiences with Urinary Sediment and Hemostaseology

Clin. Lab. 2013;59:1061-1069

Wittek M, Müller I, Hunfeld KP (2013)
Results of the bacteriological-infection serological INSTAND ring test 2009: A summary analysis - Contribution of the Quality Assurance Commission of the German Society for Hygiene and Microbiology (DGHM)

GMS Z. Forder. Qualitätssich. Med. Lab. (4):: Doc02, DOI: 10.3205/lab000000, URN: urn:nbn:de:0183-lab0000094

Wittek M, Müller I, Hunfeld KP (2013)
Results of the bacteriological-infection serological INSTAND ring test 2009: A summary analysis - Contribution of the Quality Assurance Commission of the German Society for Hygiene and Microbiology (DGHM)

GMS Z Forder Qualitatssich Med Lab 2013;4:Doc02 (20130715)

www.egms.de/static/pdf/journals/lab/2013-4/lab000009.pdf

Hagedorn, HJ, Brockmeyer, NH, Hunfeld, KP, Münstermann, D, Potthof, A, Schöfer, D (2012)
Syphilis. MiQ 16. microbiological-infectiological quality standards (MIQ)

Hrs. Podbielski A., Kniehl, E., Mauch H. und Rüssmann H., Uraban und Fischer, München

Müller, I., Freitag, M., Scharnetzky, E., Schoerner, Ch., Hlobil, H., Hagedorn, H.-J., Stanek G., Schubert-Unkmaeir, A., Norris, D., Gensichen, J., and Hunfeld, K.-P. (2012)
Evaluating frequency, diagnostic quality and cost of Lyme borreliosis testing in Germany: A retrospective model analysis

Clin. Develop. Immunol., Volume 2012, Article ID 595427, 13 pages doi: 10.1155/2012/595427

Janitschke K, Rüsch-Gerdes S, Homorodean D (2011)
Report on the Conference of National Tuberculosis Reference Laboratories from Central and East European Countries

GMS Z Forder Qualitatssich Med Lab 2011;3:Doc01 (20110919)

www.egms.de/static/pdf/journals/lab/2011-3/lab000006.pdf

Kaiser P, Reinauer H (2011)
Diabetes mellitus: The long way of standardization of Hba1c to the level of highest metrological order
Molnar PM, Dux L, Reinauer H, Kress M, Akerboom T, Szederkenyi E, Kaiser P (2011)
Procedure for determination of immunosuppressive drugs in whole blood with liquid chromatography-isotope dilution mass spectrometry

Clin Lab 2011;57:983-992

Stanek G, Fingerle V, Hunfeld KP, Jaulhac B, Kaiser R, Krause A, Kristoferitsch W, O'Connell S, Ornstein K, Strle F, Gray J (2011)
Lyme borreliosis: Clinical case definitions for diagnosis and management in Europe

Clin. Microbiol. Infect. 17(1):69-79, (online)

Walch D, Müller I, Coste O, and Hunfeld KP (2011)
Results of the bacteriological-infection serological INSTANS ring trials 2008: A summary report - Contribution of the Quality Assurance Commission of the German Society for Hygiene and Microbiology (DGHM)

GMS Zeitschr. Förd. Qualitätssich. Med. Lab., Vol. 3, ISSN 1869-4241. (online)

Walch D, Müller I, Coste O, Hunfeld KP (2011)
Results of the bacteriological-infection serological INSTAND ring trials 2008: A summary report - Contribution of the Quality Assurance Commission of the German Society for Hygiene and Microbiology (DGHM)

GMS Z Forder Qualitatssich Med Lab 2011;3:Doc02 (20111228)

www.egms.de/static/pdf/journals/lab/2011-3/lab000007.pdf

Böttcher, M, Straube, E., Hunfeld, KP, Arndt, KH,  Maaß, M (2010)
EXTENDED CHLAMYDIA PNEUMONIAE SEROLOGY WITH A MIF-CALIBRATED THRESHOLD VALUE. In: Chlamydia Infections, Proceedings of the 12th International Symposium of Human Chlamydia Infections

ISBN 0-9664383-3-7

Coste O, Müller I, Brade V, Hunfeld KP (2010)
Results of the INSTAND Bacteriological Infection Serology Ring Trial 2007: A Summary Report - Contribution of the Quality Assurance Commission of the German Society for Hygiene and Microbiology (DGHM), Bacteriologic Infection Serology S

GMS Z Forder Qualitatssich Med Lab 2010;2:Doc01 (20100913)

www.egms.de/static/pdf/journals/lab/2010-2/lab000005.pdf

Kaiser P, Akerboom T, Rüdiger Ohlendorf R, Reinauer H (2010)
Liquid Chromatography-Isotope Dilution-Mass Spectrometry as a New Basis for the Reference Measurement Procedure for Hemoglobin A1c Determination

Clinical Chemistry 2010;56:5:750-754

Hunfeld, K.P., Kraiczy, P. (2009)
When is the best time to order a Western blot and how should it be interpreted?

Curr. Probl. Dermatol. 37:167-77

Müller I, Besier S, Hintereder G, Brade V, Hunfeld KP (2009)
On the quality of bacteriological infection serology in Germany: a meta-analysis of the infection serology proficiency tests of 2006 - contribution of the Quality Assurance Commission of the DGHM

GMS Z Forder Qualitatssich Med Lab 2009;1:Doc04 (20091020)

www.egms.de/static/pdf/journals/lab/2009-1/lab000004.pdf

Reinauer H. (2009)
International standardisation at ISO and CEN and interlaboratory tests

GMS Z Forder Qualitatssich Med Lab 2009;1:Doc03 (20091020)

www.egms.de/static/pdf/journals/lab/2009-1/lab000003.pdf

Kaiser P, Akerboom T, Molnar P, Reinauer H. (2008)
Modified HPLC-Electrospray Ionization/Mass Spectrometry Method for HbA1c Based on IFCC Reference measurement Procedure

Clinical Chemistry 2008;54:6:1018-1022

Muller, I., Brade, V., Hagedorn, H.J., Straube, E., Schoerner, C., Frosch, M., Hlobil, H., Stanek, G., Hunfeld, K.-P (2008)
Is serological testing a reliable tool in laboratory diagnosis of syphilis? Meta-analysis of eight external quality control surveys performed by the German infection serology proficiency testing program

J. Clin. Microbiol. 44:1335-1341.

Bewarder N, Abmeier F, Bergmann S, Drohla S et al. Multicentre evaluation of performance of C-reactive protein analysis over a one-year period. Clin Lab. 2006;52(11-12):639-654

Poggensee, G. Fingerle, V. Hunfeld, KP et al., (2008)
Lyme borreliosis: research needs and research approaches. Results of an interdisciplinary expert meeting at the Robert Koch Institute

Bundesgesundheitsblatt, 51: 1329-1339

Vacata V, Jahns-Streubel G, Baldus M, Wood WG (2008)
Practical solution for the control of the pre-analytical phase in decentralized clinical laboratories for meeting requirements of the medical laboratory accreditation standard ISO 15189

Clin Lab. 2007;53(3-4):211-215

Walch D, Müller I, Coste O, Hunfeld KP (2008)
Results of the bacteriological-infection serological INSTAND ring trials 2008

GMS Z Förder Qualitatssich Med Lab 2011;3: ISSN 1869-4241

www.egms.de/static/pdf/journals/lab/2011-3/lab000007.pdf

Kaiser P, Akerboom T, Dux L, Reinauer H. (2006)
Modification of the IFCC reference measurement procedure for determination of HbA1c by HPLC-ESI-MS
Kaiser P, Akerboom T, Wood WG, Reinauer H. (2006)
A new approach for the determination of immunosuppressive drugs using HPLC-MS/MS and Cs+ adducts

GMS Ger Med Sci 2006;4:Doc01 (electronic publishing – January 2006)

www.egms.de/static/pdf/journals/gms/2006-4/000030.pdf

Kaiser P, Akerboom T, Wood WG, Reinauer H. (2006)
A novel LC-IDMS/MS method for the determination of the cardiac glycosides digoxin and digitoxin using caesium adducts

Clin. Lab. 2006;52:37-42

Wood WG. (2006)
Problems with the external quality assessment of accuracy of point of care devices (POCD) for blood glucose are independent of sample composition

Clin Lab 2006; 52(7-8):345-351

Lüdemann J, Schminke U, Berger K (2005)
Alte D et al. Association between alcohol consumption, laboratory markers and subclinical carotid atherosclerosis. The study of health in Pomerania

Clin. Chem. Lab. Med. 2005;43:A 72

Mitusch R, Lüdemann J, Wood W.G, Berger K et al. (2005)
Asymptomatic carotid atherosclerosis is associated with circulating Chlamydia pneumoniae DNA in younger normotensive subjects in a general population survey

Arteriosclerosis, Thrombosis and Vascular Biology 2005;25:386-391

Reinauer H, Wood WG. (2005)
External quality assessment of tumour marker analysis – The state of the art and consequences for estimating diagnostic sensitivity and specificity

GMS Ger Med Sci 2005;3: Doc 02 (electronic publishing – 2005-05-31)

www.egms.de/static/pdf/journals/gms/2005-3/000020.pdf

Schminke U, Lüdemann J, Berger K, Jaschinski A et al. (2005)
The association between alcohol consumption and subclinical carotid atherosclerosis. The Study of Health in Pomerania

Stroke 2005;36:1746-1752

Wood WG (2005)
The preanalytical phase – Can the requirements of the DIN-EN-ISO 15189 be met practically for all laboratories? A view of the "German situation"

Clin. Lab. 2005;51:665-671

Wood WG (2005)
Some practical thoughts on restructuring the current guideline of the Federal Medical Council (Richtlinie der Bundesärztekammer [RiliBÄK]) in Germany for quality control in clinical laboratory analysis based on results from external quality assesment surv

Clin. Lab. 2005;51:547-573

Wood WG, Hanke R, Reinauer H. (2004)
Comparability of method results and performance in a national external quality assessment scheme between 1993 and 2003 using thyroid associated antibodies as examples.

Clin. Lab. 2004;50:209-222

Wood WG, Kramer U. (2004)
Correction to the IFCC primary reference method for the measurement of catalytical activity concentration of enzymes at 37°C – part 2: reference procedure for the measurement of creatine kinase – Letter to the Editor

Clin. Chem. Lab. Med. 2004;342:353

Wood WG, Singer J, Schmidt-Gayk H. (2004)
Establishment of reference intervals for enzyme catalytic activity concentration measurements at 37 °C – a practical approach

Clin. Lab. 2004;50:455-475

Kaiser P, Kramer U, Meißner D, Kress, M et al. (2003)
Determination of the cardiac glycosides digoxin and digitoxin by liquid chromatography combined with isotope dilution mass spectrometry (LCIDMS) – a candidate reference measurement procedure

Clin. Lab. 2003;49:329-343

Wood WG, Hanke R, Meißner D, Reinauer H. (2003)
Experience with an external quality assessment programme for point-of-caretesting (POCT) devices for the determination of blood glucose

Clin. Lab. 2003;49:151-159

Kress M, Meißner D, Kaiser P, Hanke R, Wood WG (2002)
The measurement of theophylline in human serum or plasma using gas chromatography and isotope-dilution mass-spectrometry (GC-IDMS) taking other substituted xanthines into consideration

Clin. Lab. 2002;48:535-540

Kress M, Meißner D, Kaiser P, Hanke R, Wood WG. (2002)
Determination of theophylline by HPLC and GC-IDMS, the effect of chemically similar xanthine derivatives on the specificity of the method and the possibility of paracetamol as an interfering substance

Clin. Lab. 2002;48:541-551

Kress M, Meißner D, Kaiser P, Wood WG (2002)
How to make things work again – troubleshooting using the GC-IDMS determination of triacylglycerols as an example

Clin. Lab. 2002;48:635-646

Wood WG (2002)
Errors in the determination of tumour markers

Dtsch. Med. Wochenschr. 2002;127:577

Wood WG. (2002)
When should ESR or CRP be determined?

Dtsch. Med. Wochenschr. 2002;127:2527-2528

Wood WG, Kress M, Meißner D, Hanke R, Reinauer H. (2001)
The determination of free and protein-bound haemoglobin in plasma using a combination of HPLC and absorption spectrometry

Clin. Lab. 2001;47:279-288

Appel W, Briehl E, Brüggemann M, da Fonseca Wolheim F et al. (1999)
Good Laboratory Diagnostic Practice GLDP - Concept of a "Good Laboratory Diagnostic Practice

Clin. Lab. 1999;45: 569-580