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Article ; Online: Comparison and commutability study among four faecal immunochemical tests (FIT) systems.

Deprez, Liesbet / Piggott, Carolyn / van der Hagen, Eline A E / Frasa, Marieke / Benton, Sally C

Clinical chemistry and laboratory medicine

2023 Volume 62, Issue 1, Page(s) 50–59

Abstract: Objectives: Faecal immunochemical tests for haemoglobin (FIT) are used in colorectal cancer screening programs around the world and increasingly for triage of symptomatic patients. FIT results are currently not traceable to a common reference standard ... ...

Abstract	Objectives: Faecal immunochemical tests for haemoglobin (FIT) are used in colorectal cancer screening programs around the world and increasingly for triage of symptomatic patients. FIT results are currently not traceable to a common reference standard and results obtained on various FIT systems may not be equivalent. The size of the bias between the systems is difficult to quantify due to the complex pre-analytical aspects of FIT. Methods: This study aimed to quantify the bias and the correlation between four FIT systems by measuring a panel of 38 faecal samples while limiting the effect of the pre-analytical aspects. In addition, the commutability of seven candidate reference materials (RM) was assessed. Results: Pairwise method comparisons based on faecal samples demonstrated Pearson correlation coefficients ranging between 0.944 and 0.970 and an average proportional bias of -30 to -35 % for one FIT system compared to the other three. The relative standard deviation among biases of the individual samples was around 20 %. Due to these sample specific differences, no decisive conclusions could be drawn in the commutability study. However, two candidate RMs, prepared in the FIT system-specific storage/extraction buffers, had a better commutable profile than the other five. Conclusions: The use of a common threshold for all FIT systems is currently not possible due to the presence of a proportional bias. We have identified potential commutable RMs to take to further studies on the production of a common calibrator, with the aim being to reduce the analytical bias observed on different FIT systems.
MeSH term(s)	Humans ; Occult Blood ; Reference Standards ; Colorectal Neoplasms/diagnosis ; Bias ; Calibration ; Hemoglobins
Chemical Substances	Hemoglobins
Language	English
Publishing date	2023-06-19
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2023-0278
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Article ; Online: Faecal immunochemical tests for haemoglobin: Analytical challenges and potential solutions.

Benton, Sally C / Symonds, Erin / Djedovic, Natasha / Jones, Samantha / Deprez, Liesbet / Kocna, Petr / Maria Auge, Josep

Clinica chimica acta; international journal of clinical chemistry

2021 Volume 517, Page(s) 60–65

Abstract: Quantitative faecal immunochemical tests for haemoglobin (FIT) are being used increasingly around the world in colorectal cancer screening programmes, and in patients presenting with lower bowel symptoms to determine who should proceed to further bowel ... ...

Abstract	Quantitative faecal immunochemical tests for haemoglobin (FIT) are being used increasingly around the world in colorectal cancer screening programmes, and in patients presenting with lower bowel symptoms to determine who should proceed to further bowel visualisation investigations, usually colonoscopy. The clinical utility of FIT is well reported. There are a number of analytical challenges including pre-analytical variation, difficulty setting up external quality assessment schemes, access to third party internal quality control material and a lack of standardisation or harmonisation of FIT methods. Here we report the work of the International Federation of Clinical Chemistry FIT Working Group. We provide an overview of the main pre-analytical variables; discuss different approaches to external quality assurance of FIT; propose a solution to third party internal quality assurance materials and summarise the challenges of standardisation and harmonisation of FIT.
MeSH term(s)	Colonoscopy ; Colorectal Neoplasms/diagnosis ; Early Detection of Cancer ; Feces/chemistry ; Hemoglobins/analysis ; Humans ; Mass Screening ; Occult Blood
Chemical Substances	Hemoglobins
Language	English
Publishing date	2021-02-09
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	80228-1
ISSN	1873-3492 ; 0009-8981
ISSN (online)	1873-3492
ISSN	0009-8981
DOI	10.1016/j.cca.2021.01.024
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Article ; Online: Recommendations for Setting a Criterion for Assessing Commutability of Secondary Calibrator Certified Reference Materials.

Miller, W Greg / Keller, Thomas / Budd, Jeffrey / Johansen, Jesper V / Panteghini, Mauro / Greenberg, Neil / Delatour, Vincent / Ceriotti, Ferruccio / Deprez, Liesbet / Rej, Robert / Camara, Johanna E / MacKenzie, Finlay / Lyle, Alicia N / van der Hagen, Eline / Burns, Chris / Fauskanger, Pernille / Sandberg, Sverre

Clinical chemistry

2023 Volume 69, Issue 9, Page(s) 966–975

Abstract: A secondary higher-order calibrator is required to be commutable with clinical samples to be suitable for use in the calibration hierarchy of an end-user clinical laboratory in vitro diagnostic medical device (IVD-MD). Commutability is a property of a ... ...

Abstract	A secondary higher-order calibrator is required to be commutable with clinical samples to be suitable for use in the calibration hierarchy of an end-user clinical laboratory in vitro diagnostic medical device (IVD-MD). Commutability is a property of a reference material that means results for a reference material and for clinical samples have the same numeric relationship, within specified limits, across the measurement procedures for which the reference material is intended to be used. Procedures for assessing commutability have been described in the literature. This report provides recommendations for establishing a quantitative criterion to assess the commutability of a certified reference material (CRM). The criterion is the maximum allowable noncommutability bias (MANCB) that allows a CRM to be used as a calibrator in a calibration hierarchy for an IVD-MD without exceeding the maximum allowable combined standard uncertainty for a clinical sample result (umaxCS). Consequently, the MANCB is derived as a fraction of the umaxCS for the measurand. The suitability of an MANCB for practical use in a commutability assessment is determined by estimating the number of measurements of clinical samples and CRMs required based on the precision performance and nonselectivity for the measurand of the measurement procedures in the assessment. Guidance is also provided for evaluating indeterminate commutability conclusions and how to report results of a commutability assessment.
Language	English
Publishing date	2023-08-11
Publishing country	England
Document type	Journal Article
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1093/clinchem/hvad104
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Article ; Online: Recommendations for Setting a Criterion and Assessing Commutability of Sample Materials Used in External Quality Assessment/Proficiency Testing Schemes.

Sandberg, Sverre / Fauskanger, Pernille / Johansen, Jesper V / Keller, Thomas / Budd, Jeffrey / Greenberg, Neil / Rej, Robert / Panteghini, Mauro / Delatour, Vincent / Ceriotti, Ferruccio / Deprez, Liesbet / Camara, Johanna E / MacKenzie, Finlay / Lyle, Alicia N / van der Hagen, Eline / Burns, Chris / Greg Miller, W

Clinical chemistry

2023 Volume 69, Issue 11, Page(s) 1227–1237

Abstract: It is important for external quality assessment materials (EQAMs) to be commutable with clinical samples; i.e., they should behave like clinical samples when measured using end-user clinical laboratory in vitro diagnostic medical devices (IVD-MDs). Using ...

Abstract	It is important for external quality assessment materials (EQAMs) to be commutable with clinical samples; i.e., they should behave like clinical samples when measured using end-user clinical laboratory in vitro diagnostic medical devices (IVD-MDs). Using commutable EQAMs makes it possible to evaluate metrological traceability and/or equivalence of results between IVD-MDs. The criterion for assessing commutability of an EQAM between 2 IVD-MDs is that its result should be within the prediction interval limits based on the statistical distribution of the clinical sample results from the 2 IVD-MDs being compared. The width of the prediction interval is, among other things, dependent on the analytical performance characteristics of the IVD-MDs. A presupposition for using this criterion is that the differences in nonselectivity between the 2 IVD-MDs being compared are acceptable. An acceptable difference in nonselectivity should be small relative to the analytical performance specifications used in the external quality assessment scheme. The acceptable difference in nonselectivity is used to modify the prediction interval criterion for commutability assessment. The present report provides recommendations on how to establish a criterion for acceptable commutability for EQAMS, establish the difference in nonselectivity that can be accepted between IVD-MDs, and perform a commutability assessment. The report also contains examples for performing a commutability assessment of EQAMs.
MeSH term(s)	Humans ; Reference Standards ; Laboratory Proficiency Testing ; Clinical Laboratory Services ; Reagent Kits, Diagnostic
Chemical Substances	Reagent Kits, Diagnostic
Language	English
Publishing date	2023-09-19
Publishing country	England
Document type	Journal Article
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1093/clinchem/hvad135
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Article ; Online: Development of an LC-MRM-MS-Based Candidate Reference Measurement Procedure for Standardization of Serum Apolipoprotein (a) Tests.

Ruhaak, L Renee / Romijn, Fred P H T M / Begcevic Brkovic, Ilijana / Kuklenyik, Zsusanna / Dittrich, Julia / Ceglarek, Uta / Hoofnagle, Andrew N / Althaus, Harald / Angles-Cano, Eduardo / Coassin, Stefan / Delatour, Vincent / Deprez, Liesbet / Dikaios, Ioannis / Kostner, Gerhard M / Kronenberg, Florian / Lyle, Alicia / Prinzing, Urban / Vesper, Hubert W / Cobbaert, Christa M

Clinical chemistry

2023 Volume 69, Issue 3, Page(s) 251–261

Abstract: Background: Medical results generated by European CE Marking for In Vitro Diagnostic or in-house tests should be traceable to higher order reference measurement systems (RMS), such as International Federation of Clinical Chemistry and Laboratory ... ...

Abstract	Background: Medical results generated by European CE Marking for In Vitro Diagnostic or in-house tests should be traceable to higher order reference measurement systems (RMS), such as International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)-endorsed reference measurement procedures (RMPs) and reference materials. Currently, serum apolipoprotein (a) [apo(a)] is recognized as a novel risk factor for cardiovascular risk assessment and patient management. The former RMS for serum apo(a) is no longer available; consequently, an International System of Units (SI)-traceable, ideally multiplexed, and sustainable RMS for apo(a) is needed. Methods: A mass spectrometry (MS)-based candidate RMP (cRMP) for apo(a) was developed using quantitative bottom-up proteomics targeting 3 proteotypic peptides. The method was provisionally validated according to ISO 15193 using a single human serum based calibrator traceable to the former WHO-IFCC RMS. Results: The quantitation of serum apo(a) was by design independent of its size polymorphism, was linear from 3.8 to 456 nmol/L, and had a lower limit of quantitation for apo(a) of 3.8 nmol/L using peptide LFLEPTQADIALLK. Interpeptide agreement showed Pearson Rs of 0.987 and 0.984 for peptides GISSTVTGR and TPENYPNAGLTR, and method comparison indicated good correspondence (slopes 0.977, 1.033, and 1.085 for LFLEPTQADIALLK, GISSTVTGR, and TPENYPNAGLTR). Average within-laboratory imprecision of the cRMP was 8.9%, 11.9%, and 12.8% for the 3 peptides. Conclusions: A robust, antibody-independent, MS-based cRMP was developed as higher order RMP and an essential part of the apo(a) traceability chain and future RMS. The cRMP fulfils predefined analytical performance specifications, making it a promising RMP candidate in an SI-traceable MS-based RMS for apo(a).
MeSH term(s)	Humans ; Apoprotein(a) ; Mass Spectrometry ; Reference Standards ; Serum ; Calibration ; Peptides
Chemical Substances	Apoprotein(a) (EC 3.4.21.-) ; Peptides
Language	English
Publishing date	2023-01-16
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1093/clinchem/hvac204
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Article ; Online: External quality assessment of SARS-CoV-2 serology in European expert laboratories, April 2021.

Mögling, Ramona / Colavita, Francesca / Reimerink, Johan / Melidou, Angeliki / Leitmeyer, Katrin / Keramarou, Maria / Lapa, Daniele / Francalancia, Massimo / Murk, Jean-Luc / Vossen, Ann / Carletti, Fabrizio / Hogema, Boris / Meijer, Adam / Deprez, Liesbet / di Caro, Antonino / Castilletti, Concetta / Reusken, Chantal Bem

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin

2022 Volume 27, Issue 42

Abstract: BackgroundCountries worldwide are focusing to mitigate the ongoing SARS-CoV-2 pandemic by employing public health measures. Laboratories have a key role in the control of SARS-CoV-2 transmission. Serology for SARS-CoV-2 is of critical importance to ... ...

Abstract	BackgroundCountries worldwide are focusing to mitigate the ongoing SARS-CoV-2 pandemic by employing public health measures. Laboratories have a key role in the control of SARS-CoV-2 transmission. Serology for SARS-CoV-2 is of critical importance to support diagnosis, define the epidemiological framework and evaluate immune responses to natural infection and vaccine administration.AimThe aim of this study was the assessment of the actual capability among laboratories involved in sero-epidemiological studies on COVID-19 in EU/EEA and EU enlargement countries to detect SARS-CoV-2 antibodies through an external quality assessment (EQA) based on proficiency testing.MethodsThe EQA panels were composed of eight different, pooled human serum samples (all collected in 2020 before the vaccine roll-out), addressing sensitivity and specificity of detection. The panels and two EU human SARS-CoV-2 serological standards were sent to 56 laboratories in 30 countries.ResultsThe overall performance of laboratories within this EQA indicated a robust ability to establish past SARS-CoV-2 infections via detection of anti-SARS-CoV-2 antibodies, with 53 of 55 laboratories using at least one test that characterised all EQA samples correctly. IgM-specific test methods provided most incorrect sample characterisations (24/208), while test methods detecting total immunoglobulin (0/119) and neutralising antibodies (2/230) performed the best. The semiquantitative assays used by the EQA participants also showed a robust performance in relation to the standards.ConclusionOur EQA showed a high capability across European reference laboratories for reliable diagnostics for SARS-CoV-2 antibody responses. Serological tests that provide robust and reliable detection of anti-SARS-CoV-2 antibodies are available.
MeSH term(s)	Humans ; SARS-CoV-2 ; Laboratories ; COVID-19 ; Antibodies, Viral ; Sensitivity and Specificity ; Immunoglobulin M ; Antibodies, Neutralizing
Chemical Substances	Antibodies, Viral ; Immunoglobulin M ; Antibodies, Neutralizing
Language	English
Publishing date	2022-10-21
Publishing country	Sweden
Document type	Journal Article
ZDB-ID	1338803-4
ISSN	1560-7917 ; 1025-496X
ISSN (online)	1560-7917
ISSN	1025-496X
DOI	10.2807/1560-7917.ES.2022.27.42.2101057
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Article ; Online: Commutability Assessment of Candidate Reference Materials for Lipoprotein(a) by Comparison of a MS-based Candidate Reference Measurement Procedure with Immunoassays.

Dikaios, Ioannis / Althaus, Harald / Angles-Cano, Eduardo / Ceglarek, Uta / Coassin, Stefan / Cobbaert, Christa M / Delatour, Vincent / Dieplinger, Benjamin / Grimmler, Matthias / Hoofnagle, Andrew N / Kostner, Gerhard M / Kronenberg, Florian / Kuklenyik, Zsusanna / Lyle, Alicia N / Prinzing, Urban / Ruhaak, L Renee / Scharnagl, Hubert / Vesper, Hubert W / Deprez, Liesbet

Clinical chemistry

2023 Volume 69, Issue 3, Page(s) 262–272

Abstract: Background: Elevated concentrations of lipoprotein(a) [Lp(a)] are directly related to an increased risk of cardiovascular diseases, making it a relevant biomarker for clinical risk assessment. However, the lack of global standardization of current Lp(a) ...

Abstract	Background: Elevated concentrations of lipoprotein(a) [Lp(a)] are directly related to an increased risk of cardiovascular diseases, making it a relevant biomarker for clinical risk assessment. However, the lack of global standardization of current Lp(a) measurement procedures (MPs) leads to inconsistent patient care. The International Federation for Clinical Chemistry and Laboratory Medicine working group on quantitating apolipoproteins by mass spectrometry (MS) aims to develop a next-generation SI (International system of units)-traceable reference measurement system consisting of a MS-based, peptide-calibrated reference measurement procedure (RMP) and secondary serum-based reference materials (RMs) certified for their apolipoprotein(a) [apo(a)] content. To reach measurement standardization through this new measurement system, 2 essential requirements need to be fulfilled: a sufficient correlation among the MPs and appropriate commutability of future serum-based RMs. Methods: The correlation among the candidate RMP (cRMP) and immunoassay-based MPs was assessed by measuring a panel of 39 clinical samples (CS). In addition, the commutability of 14 different candidate RMs was investigated. Results: Results of the immunoassay-based MPs and the cRMPs demonstrated good linear correlations for the CS but some significant sample-specific differences were also observed. The results of the commutability study show that RMs based on unspiked human serum pools can be commutable with CS, whereas human pools spiked with recombinant apo(a) show different behavior compared to CS. Conclusions: The results of this study show that unspiked human serum pools are the preferred candidate secondary RMs in the future SI-traceable Lp(a) Reference Measurement System.
MeSH term(s)	Humans ; Chemistry, Clinical ; Immunoassay ; Lipoprotein(a) ; Mass Spectrometry ; Reference Standards
Chemical Substances	Lipoprotein(a) ; LPA protein, human
Language	English
Publishing date	2023-01-16
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1093/clinchem/hvac203
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Article ; Online: Genetics of epilepsy syndromes starting in the first year of life.

Deprez, Liesbet / Jansen, An / De Jonghe, Peter

Neurology

2009 Volume 72, Issue 3, Page(s) 273–281

Abstract: Background: Incidence rates of epilepsy in children are highest during the first year of life. Most frequently, epilepsy results from a metabolic or structural defect in the brain. However, some infants have clearly delineated epilepsy syndromes for ... ...

Abstract	Background: Incidence rates of epilepsy in children are highest during the first year of life. Most frequently, epilepsy results from a metabolic or structural defect in the brain. However, some infants have clearly delineated epilepsy syndromes for which no underlying etiology can be identified except for a genetic predisposition. Methods: We reviewed the current knowledge on the genetics of epilepsy syndromes starting in the first year of life. We focus on those epilepsy syndromes without a clear structural or metabolic etiology. Results: Recent molecular studies have led to the identification of the responsible gene defects for several of the monogenetic epilepsy syndromes with onset in the first year of life. Discussion: This knowledge has consequences for clinical practice as it opens new perspectives for genetic testing, improving early diagnosis, and facilitating genetic counseling. This overview of epilepsy syndromes and associated gene defects might serve as a basis for the selection of patients in whom genetic testing can be helpful.
MeSH term(s)	Epilepsy/genetics ; Humans ; Infant ; Infant, Newborn ; Syndrome
Language	English
Publishing date	2009-01-20
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	207147-2
ISSN	1526-632X ; 0028-3878
ISSN (online)	1526-632X
ISSN	0028-3878
DOI	10.1212/01.wnl.0000339494.76377.d6
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Article ; Online: Towards an SI-Traceable Reference Measurement System for Seven Serum Apolipoproteins Using Bottom-Up Quantitative Proteomics: Conceptual Approach Enabled by Cross-Disciplinary/Cross-Sector Collaboration.

Cobbaert, Christa M / Althaus, Harald / Begcevic Brkovic, Ilijana / Ceglarek, Uta / Coassin, Stefan / Delatour, Vincent / Deprez, Liesbet / Dikaios, Ioannis / Dittrich, Julia / Hoofnagle, Andrew N / Kostner, Gerhard M / Kronenberg, Florian / Kuklenyik, Zsusanna / Prinzing, Urban / Vesper, Hubert W / Zegers, Ingrid / Ruhaak, L Renee

Clinical chemistry

2020 Volume 67, Issue 3, Page(s) 478–489

Abstract: Current dyslipidemia management in patients with atherosclerotic cardiovascular disease (ASCVD) is based on traditional serum lipids. Yet, there is some indication from basic research that serum apolipoproteins A-I, (a), B, C-I, C-II, C-III, and E may ... ...

Abstract	Current dyslipidemia management in patients with atherosclerotic cardiovascular disease (ASCVD) is based on traditional serum lipids. Yet, there is some indication from basic research that serum apolipoproteins A-I, (a), B, C-I, C-II, C-III, and E may give better pathophysiological insight into the root causes of dyslipidemia. To facilitate the future adoption of clinical serum apolipoprotein (apo) profiling for precision medicine, strategies for accurate testing should be developed in advance. Recent discoveries in basic science and translational medicine set the stage for the IFCC Working Group on Apolipoproteins by Mass Spectrometry. Main drivers were the convergence of unmet clinical needs in cardiovascular disease (CVD) patients with enabling technology and metrology. First, the residual cardiovascular risk after accounting for established risk factors demonstrates that the current lipid panel is too limited to capture the full complexity of lipid metabolism in patients. Second, there is a need for accurate test results in highly polymorphic and atherogenic apolipoproteins such as apo(a). Third, sufficient robustness of mass spectrometry technology allows reproducible protein quantification at the molecular level. Fourth, several calibration hierarchies in the revised ISO 17511:2020 guideline facilitate metrological traceability of test results, the highest achievable standard being traceability to SI. This article outlines the conceptual approach aimed at achieving a novel, multiplexed Reference Measurement System (RMS) for seven apolipoproteins based on isotope dilution mass spectrometry and peptide-based calibration. This RMS should enable standardization of existing and emerging apolipoprotein assays to SI, within allowable limits of measurement uncertainty, through a sustainable network of Reference Laboratories.
MeSH term(s)	Apolipoproteins/blood ; Apolipoproteins/standards ; Cardiovascular Diseases/complications ; Cardiovascular Diseases/diagnosis ; Cooperative Behavior ; Dyslipidemias/complications ; Dyslipidemias/diagnosis ; Humans ; Mass Spectrometry/methods ; Proteomics/methods ; Reference Standards
Chemical Substances	Apolipoproteins
Language	English
Publishing date	2020-12-16
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1093/clinchem/hvaa239
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Article: Validation of a digital PCR method for quantification of DNA copy number concentrations by using a certified reference material.

Deprez, Liesbet / Corbisier, Philippe / Kortekaas, Anne-Marie / Mazoua, Stéphane / Beaz Hidalgo, Roxana / Trapmann, Stefanie / Emons, Hendrik

Biomolecular detection and quantification

2016 Volume 9, Page(s) 29–39

Abstract: Digital PCR has become the emerging technique for the sequence-specific detection and quantification of nucleic acids for various applications. During the past years, numerous reports on the development of new digital PCR methods have been published. ... ...

Abstract	Digital PCR has become the emerging technique for the sequence-specific detection and quantification of nucleic acids for various applications. During the past years, numerous reports on the development of new digital PCR methods have been published. Maturation of these developments into reliable analytical methods suitable for diagnostic or other routine testing purposes requires their validation for the intended use. Here, the results of an in-house validation of a droplet digital PCR method are presented. This method is intended for the quantification of the absolute copy number concentration of a purified linearized plasmid in solution with a nucleic acid background. It has been investigated which factors within the measurement process have a significant effect on the measurement results, and the contribution to the overall measurement uncertainty has been estimated. A comprehensive overview is provided on all the aspects that should be investigated when performing an in-house method validation of a digital PCR method.
Language	English
Publishing date	2016-08-30
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2821770-6
ISSN	2214-7535
ISSN	2214-7535
DOI	10.1016/j.bdq.2016.08.002
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