CLINICAL CHEMISTRY AND LABORATORY MEDICINE

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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
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).

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).

The publisher, together with the authors and editors, has taken great pains to ensure that all information presented in this work (programs, applications,
amounts, dosages, etc.) reflects the standard of knowledge at the time of publication. Despite careful manuscript preparation and proof correction, errors
can nevertheless occur. Authors, editors and publisher disclaim all responsibility for any errors or omissions or liability for the results obtained from use of
the information, or parts thereof, contained in this work.
The citation of registered names, trade names, trademarks, etc. in this work does not imply, even in the absence of a specific statement, that such names
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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RESPONSIBLE EDITOR(S) Prof. Dr. Mario Plebani, Università di Padova, Dipartimento di Medicina di Laboratorio, Azienda Ospedaliera di
Padova, Via Nicolo Giustiniani 2, 35131 Padova, Italy. Tel.: +390 (0)49 821 2792, Fax: +390 (0)49 663 240, e-mail: mario.plebani@unipd.it

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Clin Chem Lab Med       2021 | Volume 59 | Issue 6

Contents

Editorial                                                      Jose C. Jara Aguirre, Andrew P. Norgan, Walter J. Cook and
                                                               Brad S. Karon
Giuseppe Banfi and Giuseppe Lippi                               Error simulation modeling to assess the effects of bias and
COVID-19: which lessons have we learned?         1009          precision on bilirubin measurements used to screen for
Refers to article on p 1035                                    neonatal hyperbilirubinemia       1069

                                                               Paula Lafuente-Ganuza, Fran Carretero, Paloma Lequerica-
Review                                                         Fernández, Ana Fernandez-Bernardo, Ana I. Escudero,
                                                               Jesus M. de la Hera-Galarza, Daniel Garcia-Iglesias,
Juergen Kratzsch, Nikola A. Baumann, Ferruccio Ceriotti,       Rut Alvarez-Velasco and Francisco V. Alvarez
Zhong X. Lu, Matthias Schott, Antonius E. van Herwaarden,      NT-proBNP levels in preeclampsia, intrauterine growth
José Gilberto Henriques Vieira, Dusanka Kasapic and            restriction as well as in the prediction on an imminent
Luca Giovanella                                                delivery     1077
Global FT4 immunoassay standardization: an expert
opinion review      1013                                       Chenjun Huang, Lijuan Liu, Hao Wang, Meng Fang,
                                                               Huijuan Feng, Ya Li, Mengmeng Wang, Lin Tong, Xiao Xiao,
                                                               Ziyi Wang, Xuewen Xu, Yutong He and Chunfang Gao
Mini Review                                                    Serum N-glycan fingerprint nomogram predicts liver
                                                               fibrosis: a multicenter study   1087
Mercy Thomas, Winita Hardikar, Ronda F. Greaves,
David G. Tingay, Tze Ping Loh, Vera Ignjatovic, Fiona Newall
and Anushi E. Rajapaksa                                        Hematology and Coagulation
Mechanism of bilirubin elimination in urine: insights and
prospects for neonatal jaundice       1025                     Sumi Yoon, Mina Hur, Mikyoung Park, Hanah Kim, Seung
                                                               Wan Kim, Tae-Hwan Lee, Minjeong Nam, Hee-Won Moon
                                                               and Yeo-Min Yun
Opinion Paper
                                                               Performance of digital morphology analyzer Vision Pro on
                                                               white blood cell differentials  1099
Mario Plebani
Laboratory medicine in the COVID-19 era: six lessons for
the future    1035                                             Cardiovascular Diseases

                                                               Minseok Song, Taerim Kim, Eun-Jin Kang, Jong Eun Park,
EFLM Paper
                                                               Soo Hyun Park, Won Cul Cha, Hee Yoon, Sung Yeon Hwang,
                                                               Tae Gun Shin, Min Seob Sim, IkJoon Jo, Hyung-Doo Park
Pieter Vermeersch, Glynis Frans, Alexander von Meyer,
                                                               and Jin-Ho Choi
Seán Costelloe, Giuseppe Lippi and Ana-Maria Simundic
                                                               Prognostic implication of elevated cardiac troponin I in
How to meet ISO15189:2012 pre-analytical requirements
                                                               patients visiting emergency department without
in clinical laboratories? A consensus document by the
                                                               diagnosis of coronary artery disease     1107
EFLM WG-PRE         1047

                                                               Denis Monneret, Matteo Fasiolo and
General Clinical Chemistry and Laboratory                      Dominique Bonnefont-Rousselot
                                                               Relationships between renal function variations and
Medicine
                                                               relative changes in cardiac troponin T concentrations
                                                               based on quantile generalized additive models
Corrie M. de Kat Angelino and Joannes F.M. Jacobs
                                                               (qgam)      1115
External quality assessment of M-protein diagnostics: a
realistic impression of the accuracy and precision of
M-protein quantification      1063
Clin Chem Lab Med       2021 | Volume 59 | Issue 6

Diabetes                                                      Online Only Content

Dabao He, Wenbin Kuang, Xiaoling Yang and Miao Xu             https://www.degruyter.com/view/j/cclm.2021.59.issue-6/
Association of hemoglobin H (HbH) disease with                issue-files/cclm.2021.59.issue-6.xml
hemoglobin A1c and glycated albumin in diabetic and
non-diabetic patients   1127
                                                              Letters to the Editors
Ha Nui Kim and Soo-Young Yoon
Comparative study of i-SENS glucometers in neonates           John E. Midgley
using capillary blood samples    1133                         Global FT4 immunoassay standardization. Response to:
                                                              Kratzsch J et al. Global FT4 immunoassay standardization:
                                                              an expert opinion review       e223
Infectious Diseases
                                                              Luca Giovanella
Christian Irsara, Alexander E. Egger, Wolfgang Prokop,        Free-thyroxine standardization: waiting for Godot while
Manfred Nairz, Lorin Loacker, Sabina Sahanic, Alex Pizzini,   well serving our patients today    e225
Thomas Sonnweber, Wolfgang Mayer, Harald Schennach,
Judith Loeffler-Ragg, Rosa Bellmann-Weiler,                    Samuel D. Brown, Kate A. Ottaway, Gary Weaving and
Ivan Tancevski, Günter Weiss, Markus Anliker,                 Kate E. Shipman
Andrea Griesmacher and Gregor Hoermann                        Response to: towards the rational utilization of SARS-CoV-2
Evaluation of four commercial, fully automated                serological tests in clinical practice   e227
SARS-CoV-2 antibody tests suggests a revision of the
Siemens                                                       Margot Egger, Christian Bundschuh, Kurt Wiesinger,
SARS-CoV-2 IgG assay        1143                              Elisabeth Bräutigam, Thomas Berger, Martin Clodi and
                                                              Benjamin Dieplinger
                                                              Prevalence of SARS-CoV-2 antibodies in health care
Laurence Orchard, Matthew Baldry, Myra Nasim-Mohi,
                                                              personnel of two acute care hospitals in Linz,
Chantelle Monck, Kordo Saeed, Michael P. W. Grocott,
                                                              Austria     e231
Dushianthan Ahilanandan and on behalf of the University
Hospital Southampton Critical Care Team and the REACT
                                                              Mary Kathryn Bohn, Alexandra Hall, Siobhan Wilson,
COVID Investigators
                                                              Jennifer Taher, Lusia Sepiashvili and Khosrow Adeli
Vitamin-D levels and intensive care unit outcomes of a
                                                              Pediatric evaluation of clinical specificity and sensitivity
cohort of critically ill COVID-19 patients   1155
                                                              of SARS-CoV-2 IgG and IgM serology assays          e235

Ellen Haag, Claudia Gregoriano, Alexandra Molitor,
                                                              Mirco Capacci, Maria Infantino, Valentina Grossi,
Milena Kloter, Alexander Kutz, Beat Mueller and
                                                              Barbara Lari, Sergio Fabbri, Alessio Bellucci, Patrizia Sani,
Philipp Schuetz
                                                              Alessandro Perri, Maurizio Benucci, Lorenza Cristiano,
Does mid-regional pro-adrenomedullin (MR-proADM)
                                                              Silvia Pancani, Luciana Amendola, Francesca Veneziani,
improve the sequential organ failure assessment-score
                                                              Patrizia Casprini, Sandra Rogialli and Mariangela Manfredi
(SOFA score) for mortality-prediction in patients with
                                                              Prevention and control of COVID-19 in the penitentiary of
acute infections? Results of a prospective observational
                                                              Florence      e239
study     1165
Clin Chem Lab Med       2021 | Volume 59 | Issue 6

Ezgi Cibali, Jürgen J. Wenzel, Rudi Gruber and                the first wave and the second wave of the
Andreas Ambrosch                                              pandemic       e255
Pooling for SARS-CoV-2-testing: comparison of three
commercially available RT-qPCR kits in an experimental        Stephen W. Smith, Ashley M. Strobel, Amy K. Saenger and
approach        e243                                          Fred S. Apple
                                                              Laboratory findings in a child with SARS-CoV-2 (COVID-19)
Nicasio Mancini, Nicola Clementi, Roberto Ferrarese,          multisystem inflammatory syndrome         e259
Alessandro Ambrosi, Marco Tonelli, Alberto Zangrillo,
Giovanni Landoni and Massimo Clementi                         Daniel Fatela-Cantillo, Gustavo A. Cortez Quiroga,
Very high SARS-CoV-2 load at the emergency department         Antonio Fernández-Suárez and Aurora Muñoz-Colmenero
presentation strongly predicts the risk of admission to the   Discrepant cardiac troponin results in a young
intensive care unit and death      e247                       woman       e263

Lingjie Song, Guibao Xiao, Ruixiang Tang, Xianqin Zhang,
Zhan Gao, Shixia Sun, Lin Zhang, Youjun Feng,                 Congress Abstract
Guangxin Luan, Sheng Lin, Miao He and Xu Jia
Next-generation sequencing and RT-PCR to identify a           12th National Scientific Congress SPML, 29–31 October
32-day SARS-CoV-2 carrier       e251                          2020, Online, Portugal      eA1

Antonin Saldmann, Annabelle Stoclin, Sophie Rym
Hamada, Bernard Cholley, Pascal Houillier, Stéphanie
Baron, Caroline Prot-Bertoye, Simon Travers, Gérard
Friedlander, Anne-Sophie Jannot, Jean-Claude
Souberbielle and Marie Courbebaisse
25-Hydroxyvitamin D concentrations in COVID-19
patients hospitalized in intensive care unit during
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