CLINICAL

CHEMISTRY AND
LABORATORY
MEDICINE
Published in Association with the European Federation of Clinical Chemistry and
Laboratory Medicine (EFLM)

CCLM is the official journal of the Association of Clinical Biochemists in Ireland (ACBI), the Austrian Society of Laboratory Medicine and Clinical Chemistry
(ÖGLMKC), the German Society for Clinical Chemistry and Laboratory Medicine (DGKL), the Hungarian Society of Laboratory Medicine (MLDT), the
Royal Belgian Society of Laboratory Medicine (RBSLM), the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC), the
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Medicine (SZKKLM) and the Spanish Society of Laboratory Medicine (SEQC). CCLM is affiliated with the Australasian Association of Clinical Biochemists
(AACB) and Société Francaise de Biologie Clinique (SFBC).

EDITOR-IN-CHIEF Janne Cadamuro Brandon M. Henry, Tze Ping Lo

Mario Plebani Salzburg, Austria Cincinnati, OH, USA Singapore
Padova, Italy Etienne Cavalier Markus Herrmann David Meyre
Liege, Belgium Graz, Italy Hamilton, Canada
ASSOCIATE EDITORS Sail Chun Martin Hersberger Yesim Ozarda
Seoul, Korea Zurich, Switzerland Bursa, Turkey
Giuseppe Lippi
Pradeep Kumar Dabla Johannes J.M.L. Hoffmann Tomris Özben
Reviews Editor Antalya, Turkey
New Delhi, India Nuenen, Netherlands
Verona, Italy Vladimir Palicka
Vincent De Guire Zhi-De Hu
Philippe Gillery Hohhot, P.R. China Hradec Králové,
Montreal, Canada
Reims, France Berend Isermann Czech Republic
Vincent Delatour
Ronda Greaves Magdeburg, Germany Mauro Panteghini
Paris, France
Bundoora, Australia Eleftherios P. Diamandis Joannes F.M. Jacobs, Milan, Italy
Karl J. Lackner Nijmegen, Netherlands Geraldo Picheth
Toronto, Canada
Mainz, Germany Petr Jarolim Curitiba, Brazil
Rajiv T. Erasmus Ted E. Schutzbank,
Bohuslav Melichar Stellenbosch, South Africa Boston, MA, USA
Olomouc, Czech Republic Graham Jones San Diego, CA, USA
Emmanuel Favaloro Ana-Maria Simundic
Deborah A. Payne Darlinghurst, NSW, Australia
Westmead, Australia Zagreb, Croatia
Denver, CO, USA János Kappelmayer
Julien Favresse, Grazyna Sypniewska
Peter Schlattmann Debrecen, Hungary
Brussels, Belgium Bydgoszcz, Poland
Peter Kavsak
Jena, Germany Juan M. Guerrero Michael Vogeser
Toronto, Canada
Seville, Spain Christos Kroupis Munich, Germany
EDITORIAL BOARD João Tiago Guimarães Maria Alice V. Willrich
Athens, Greece
Ivan Brandslund Porto, Portugal Leslie Charles Lai Rochester, MN, USA
Odense, Denmark Liam Heaney Kuala Lumpur, Malaysia
Loughborough, UK Michael Laposata MANAGING EDITOR
Galveston, TX, USA Heike Jahnke
Berlin, Germany
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CCLM is the official journal of the Association of Clinical Biochemists in Ireland (ACBI), the Austrian Society of Laboratory Medicine and Clinical
Chemistry (ÖGLMKC), the German Society for Clinical Chemistry and Laboratory Medicine (DGKL), the Hungarian Society of Laboratory Medicine
(MLDT), the Royal Belgian Society of Laboratory Medicine (RBSLM), the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC),
the Portuguese Society of Clinical Chemistry, Genetics and Laboratory Medicine (SPML), the Slovenian Association for Clinical Chemistry and Laboratory
Medicine (SZKKLM) and the Spanish Society of Laboratory Medicine (SEQC). CCLM is affiliated with the Australasian Association of Clinical Biochemists
(AACB) and Société Francaise de Biologie Clinique (SFBC).

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are exempt from laws and regulations protecting trademarks etc. and therefore free for general use.

ISSN 1434-6621 ∙ e-ISSN1437-4331 ∙ CODEN CCLMFW

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 Clin Chem Lab Med 2022 | Volume 60 | Issue 7

Contents

Editorial Estibaliz Alegre, Nerea Varo, Pilar Fernández-Calle,

Mario Plebani and Claudio Galli
The never-ending quest for antibody assays
standardization and appropriate measurement
units 959
Refers to article on p e151
Review
Fernando C. Chume, Priscila A. C. Freitas,
Luisa G. Schiavenin, Ana L. Pimentel
and Joíza Lins Camargo
Glycated albumin in diabetes mellitus: a meta-analysis of
diagnostic test accuracy 961
Opinion Paper
Giuseppe Lippi, Julien Favresse, Michael M. Gromiha,
Jeffrey A. SoRelle, Mario Plebani and Brandon M. Henry
Ad interim recommendations for diagnosing SARS-CoV-2
infection by the IFCC SARS-CoV-2 variants working
group 975
Guidelines and Recommendations
Hanneke W.M. van Deutekom and Saskia Haitjema
Recommendations for IVDR compliant in-house software
development in clinical practice: a how-to paper with
three use cases 982
General Clinical Chemistry and Laboratory
Medicine
Tae-Dong Jeong, Soo-Kyung Kim, Sollip Kim, Chi-Yeon Lim
and Jae-Woo Chung
Comparison between polynomial regression and weighted
least squares regression analysis for verification of
analytical measurement range 989
Lars Willems, Michael Paal and Michael Vogeser
Transport stability profiling – a proposed generic
protocol 995
Sofía Calleja and Álvaro González
Impact of ultra-low temperature long-term storage on the
preanalytical variability of twenty-one common
biochemical analytes 1003
Andreas Meinitzer, Dietmar Enko, Sieglinde Zelzer,
Florian Prüller, Nerea Alonso, Eva Fritz-Petrin
and Markus Herrmann
Development of a liquid chromatography mass
spectrometry method for the determination of vitamin K1,
menaquinone-4, menaquinone-7 and vitamin K1-2,3
epoxide in serum of individuals without vitamin K
supplements 1011
Mariella Giannone, Miriam Dalla Costa, Chiara Sabbadin,
Silvia Garelli, Monica Salvà, Stefano Masiero,
Mario Plebani, Diego Faggian, Nicoletta Gallo,
Fabio Presotto, Loris Bertazza, Davide Nacamulli,
Simona Censi, Caterina Mian and Corrado Betterle
TSH-receptor autoantibodies in patients with chronic
thyroiditis and hypothyroidism 1020
Sascha Dierks, Reiner Andag, Friederike Gauss,
Kathrin Budde, Paul Francke, Manuela Peschka,
Andreas Fischer, Julie Schanz and Astrid Petersmann
Evaluation of the AFIAS-1 thyroid-stimulating hormone
point of care test and comparison with laboratory-based
devices 1031
Tanja K. Eggersmann, Albert Wolthuis,
Peter H. van Amsterdam and Georg Griesinger
Lack of analytical interference of dydrogesterone in
progesterone immunoassays 1039
Anouk C.M. Platteel, Pieter van der Pol, Jean-Luc Murk,
Ingrid Verbrugge-Bakker, Marian Hack-Steemers,
Theo H.W.M. Roovers and Michiel Heron
A comprehensive comparison between ISAC and ALEX2
multiplex test systems 1046
Marcus Clarin, Annika Petersson, Henrik Zetterberg
and Kim Ekblom
Detection of subarachnoid haemorrhage with
spectrophotometry of cerebrospinal fluid – a comparison
of two methods 1053
Clin Chem Lab Med 2022 | Volume 60 | Issue 7
Rosa Ferrer, Nuole Zhu, Javier Arranz, Inmaculada Porcel,
Shaimaa El Bounasri, Oriol Sánchez, Soraya Torres,
Josep Julve, Alberto Lleó, Francisco Blanco-Vaca,
Daniel Alcolea and Mireia Tondo
Importance of cerebrospinal fluid storage conditions for
the Alzheimer’s disease diagnostics on an automated
platform 1058
Guillaume Résimont, Laura Vranken, Hans Pottel,
François Jouret, Jean-Marie Krzesinski, Etienne Cavalier
and Pierre Delanaye
Estimating urine albumin to creatinine ratio from protein
to creatinine ratio using same day measurement:
validation of equations 1064
Jun Zhang, Lin Chen, Qin Xu, Yue Tao, Jie Pan, Jianmin Guo,
Jing Su, Hui Xie and Yuxin Chen
An automated, rapid fluorescent immunoassay to quantify
serum soluble programmed death-1 (PD-1) protein using
testing-on-a-probe biosensors 1073
Hematology and Coagulation
Elisa Piva, Alice Stoppa, Michela Pelloso and Mario Plebani
The VES-Matic 5 system: performance of a novel
instrument for measuring erythrocyte sedimentation
rate 1081
Cancer Diagnostics
Luca Giovanella, Luca Ceriani and Maria Luisa Garo
Is thyroglobulin a reliable biomarker of differentiated
thyroid cancer in patients treated by lobectomy?
A systematic review and meta-analysis 1091
Cardiovascular Diseases
Gus Koerbin, Julia M. Potter, Marcela Pinto do Nascimento,
Louise Cullen, Samuel L. Scanlan, Catherine Woods
and Peter E. Hickman
The intra-individual variation of cardiac troponin I: the
effects of sex, age, climatic season, and time between
samples 1101
Infectious Diseases
Andrea Padoan, Chiara Cosma, Foscarina della Rocca,
Francesco Barbaro, Claudia Santarossa, Luigi Dall’Olmo,
Luisa Galla, Annamaria Cattelan, Vito Cianci,
Daniela Basso and Mario Plebani
A cohort analysis of SARS-CoV-2 anti-spike protein
receptor binding domain (RBD) IgG levels and neutralizing
antibodies in fully vaccinated healthcare workers 1110
Antigona Ulndreaj, Mingyue Wang, Salvia Misaghian,
Louis Paone, George B. Sigal, Martin Stengelin,
Christopher Campbell, Logan R. Van Nynatten,
Antoninus Soosaipillai, Atefeh Ghorbani, Anu Mathew,
Douglas D. Fraser, Eleftherios P. Diamandis
and Ioannis Prassas
Patients with severe COVID-19 do not have elevated
autoantibodies against common diagnostic
autoantigens 1116
Ivar Tjernberg, Paula Gyllemark, Henrik Zetterberg,
Kaj Blennow, Jan Ernerudh, Pia Forsberg, Johanna Sjöwall
and Anna J. Henningsson
Cerebrospinal fluid markers of inflammation and brain
injury in Lyme neuroborreliosis – a prospective follow-up
study 1124
Online Only Content
https://www.degruyter.com/view/j/cclm.2022.60.issue-7/
issue-files/cclm.2022.60.issue-7.xml
Letters to the Editors
Young Bae Lee Hansen, Koh Furuta, Sridevi Devaraj,
Fatma Meric Yilmaz and Gunnar Nordin
Misleading nomenclature of units of WHO materials used
for standardization of SARS COv-2 serology e151
Julien Favresse, Jean-Michel Dogné and Jonathan Douxfils
Assessment of the humoral response in Omicron
breakthrough cases in healthcare workers who received
the BNT162b2 booster e153
 Clin Chem Lab Med 2022 | Volume 60 | Issue 7

Joris R. Delanghe, Marijn M. Speeckaert Jenny E. Kootstra-Ros, Eline A.E. van der Hagen,
and Marc L. De Buyzere Marith van Schrojenstein Lantman and Marc Thelen and
COVID-19 related mortality and religious denomination vs. Miranda van Berkel, on behalf of the SKML General Clinical
genetics e157 Chemistry Group
(In)direct chloride ISE measurements, room for
Erik Ames and Raffick A.R. Bowen improvement e168
Unexpectedly low tacrolimus concentrations attributed to
inappropriately labeled water container from the Guillaume Grzych, Fanny Lemonnier, Jean David Pekar,
instrument manufacturer e159 Manon Deschildt and Joan Bitan
New concept of interactive academic poster used in
Shui Fu, Qi-Lei Hu, Liang Zhang and Zuo-Jie Li medical scientific congress presented in the EuroMedLab
Effects of different pepsinogen cut offs in the screening of 2021 Munich Session e172
apparently healthy people e161

Francesco Di Mario, Lorella Franzoni, Marilisa Franceschi,

Kryssia Isabel Rodriguez-Castro, Michele Russo
and Pellegrino Crafa
Low levels of G17 and Barrett esophagus: a clinical
relationship e165