journal: Clinical Chemistry and Laboratory Medicine (CCLM)

Impact Factor: 6.8

Published since January 1, 1963

Clinical Chemistry and Laboratory Medicine (CCLM)

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

ISSN: 1437-4331

Editor-in-chief: Mario Plebani

Edited by: Philippe Gillery, Ronda Greaves, Karl J. Lackner, Giuseppe Lippi, Bohuslav Melichar, Deborah A. Payne, Peter Schlattmann

About this journal

Objective
Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. It is focused on basic and applied research and cutting-edge clinical laboratory medicine. CCLM is one of the leading journals in the field, with an impact factor over 8. All contributions submitted for publication in CCLM are single-blind peer reviewed by at least two experts in the field. CCLM is led by a multi-institutional editorial board. It is issued monthly, both in print and electronically. Letters to the Editor and Congress Abstracts are published online only.

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Topics

clinical biochemistry
clinical genomics and molecular biology
clinical haematology and coagulation
clinical immunology and autoimmunity
clinical microbiology
drug monitoring and analysis
evaluation of diagnostic biomarkers
disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes)
new reagents, instrumentation and technologies
new methodologies
reference materials and methods
reference values and decision limits
quality and safety in laboratory medicine
translational laboratory medicine
clinical metrology

Article formats
Research Articles, Reviews, Mini Reviews and Opinion Papers on all aspects of clinical chemistry and laboratory medicine, Guidelines and Recommendations, Point/Counterpoint Articles, Letters to the Editor, Editorials

For EFLM Academy Members

To take advantage of all the opportunities offered to members of the EFLM Academy, please access your personal area in the EFLM Academy at the link https://academy.eflm.eu/secretariat/login (if you do not remember your login details, you can use the option FORGOT PASSWORD). Click on the section “International Journals” on the left-hand side where you find CCLM as the first listed journal.

Your Benefits

Latest developments in the clinical laboratory sciences
Fundamental and applied approach
Novel teaching and training methods
High quality peer-review
Follow @cclm_degruyter on Twitter!

CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and affiliated to the National Societies that are members of the EFLM Academy. It publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); Slovenia (SZKK); and Spain (SEQC-ML) and it is affiliated to AACB (Australia).

Previous Titles

Vol. 1 - Vol. 4, 1963-1966
Zeitschrift für Klinische Chemie
Vol. 5 - Vol. 9, 1967-1971
Zeitschrift für Klinische Chemie und Klinische Biochemie
Vol. 10 - Vol. 13, 1972-1975
Zeitschrift für Klinische Chemie und Klinische Biochemie Journal of Clinical Chemistry and Clinical Biochemistry
Vol. 14 - Vol. 26, 1976-1988
Journal of Clinical Chemistry and Clinical Biochemistry Zeitschrift für Klinische Chemie und Klinische Biochemie
Vol. 27 - Vol. 28, 1989-1990
Journal of Clinical Chemistry and Clinical Biochemistry
Vol. 29 - Vol. 35, 1991-1997
European Journal of Clinical Chemistry and Clinical Biochemistry

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Volume 62 Issue 1

January 2024

Publicly Available November 28, 2023

Frontmatter

Page range: i-vi

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Editorial

Publicly Available September 11, 2023

Biological management of diabetes mellitus, the laboratory medicine specialist and the patient

Philippe Gillery

Page range: 1-2

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Reviews

Publicly Available July 10, 2023

Remote HbA_1c testing via microsampling: fit for purpose?

Nick Verougstraete, Veronique Stove, Christophe P. Stove

Page range: 3-17

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Abstract

The collection of capillary blood microsamples via finger-prick has several advantages over traditional blood collection. It is considered convenient and more patient-centric, enabling collection of the sample by the patient at her/his home with subsequent analysis in the lab following postal shipment. Determination of the diabetes biomarker HbA 1c in self-collected microsamples to remotely monitor diabetes patients seems to be a very promising option which could eventually lead to better treatment adaptations and disease control. This is especially convenient/relevant for patients living in areas where venipuncture is impractical, or to support virtual consultations using telemedicine. Over the years, a substantial numbers of reports on HbA 1c and microsampling have been published. However, the heterogeneity of the applied study designs and data evaluation is remarkable. This review provides a general and critical overview of these papers, along with specific points of attention that should be dealt with when aiming at implementing microsampling for reliable HbA 1c determination. We focus on the used (dried) blood microsampling techniques, collection conditions, stability of the microsamples, sample extraction, analytical methods, method validation, correlation studies with conventional venous blood samples and patient satisfaction. Lastly, the possibility of using liquid instead of dried blood microsamples is discussed. Liquid blood microsampling is expected to have similar advantages as dried blood microsampling and several studies suggest it to be a suitable approach to collect samples remotely for subsequent HbA 1c analysis in the lab.

Open Access July 10, 2023

The effect of hormonal contraceptive therapy on clinical laboratory parameters: a literature review

Ömer Özcan, Wendy P.J. den Elzen, Jacquelien J. Hillebrand, Martin den Heijer, Laura L. van Loendersloot, Johan Fischer, Henrike Hamer, Robert de Jonge, Annemieke C. Heijboer

Page range: 18-40

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Abstract

Hormonal contraceptives (HC) are widely used among women in reproductive ages. In this review, the effects of HCs on 91 routine chemistry tests, metabolic tests, and tests for liver function, hemostatic system, renal function, hormones, vitamins and minerals were evaluated. Test parameters were differently affected by the dosage, duration, composition of HCs and route of administration. Most studies concerned the effects of combined oral contraceptives (COC) on the metabolic, hemostatic and (sex) steroids test results. Although the majority of the effects were minor, a major increase was seen in angiotensinogen levels (90–375 %) and the concentrations of the binding proteins (SHBG [∼200 %], CBG [∼100 %], TBG [∼90 %], VDBP [∼30 %], and IGFBPs [∼40 %]). Also, there were significant changes in levels of their bound molecules (testosterone, T3, T4, cortisol, vitamin D, IGF1 and GH). Data about the effects of all kinds of HCs on all test results are limited and sometimes inconclusive due to the large variety in HC, administration routes and dosages. Still, it can be concluded that HC use in women mainly stimulates the liver production of binding proteins. All biochemical test results of women using HC should be assessed carefully and unexpected test results should be further evaluated for both methodological and pre-analytical reasons. As HCs change over time, future studies are needed to learn more about the effects of other types, routes and combinations of HCs on clinical chemistry tests.

Opinion Paper

Open Access June 23, 2023

Continuous glucose monitoring has an increasing role in pre-symptomatic type 1 diabetes: advantages, limitations, and comparisons with laboratory-based testing

Kriti Joshi, Mark Harris, Andrew Cotterill, John M. Wentworth, Jennifer J. Couper, Aveni Haynes, Elizabeth A. Davis, Kate E. Lomax, Tony Huynh

Page range: 41-49

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Abstract

Type 1 diabetes (T1D) is well-recognised as a continuum heralded by the development of islet autoantibodies, progression to islet autoimmunity causing beta cell destruction, culminating in insulin deficiency and clinical disease. Abnormalities of glucose homeostasis are known to exist well before the onset of typical symptoms. Laboratory-based tests such as the oral glucose tolerance test (OGTT) and glycated haemoglobin (HbA 1c ) have been used to stage T1D and assess the risk of progression to clinical T1D. Continuous glucose monitoring (CGM) can detect early glycaemic abnormalities and can therefore be used to monitor for metabolic deterioration in pre-symptomatic, islet autoantibody positive, at-risk individuals. Early identification of these children can not only reduce the risk of presentation with diabetic ketoacidosis (DKA), but also determine eligibility for prevention trials, which aim to prevent or delay progression to clinical T1D. Here, we describe the current state with regard to the use of the OGTT, HbA 1c , fructosamine and glycated albumin in pre-symptomatic T1D. Using illustrative cases, we present our clinical experience with the use of CGM, and advocate for an increased role of this diabetes technology, for monitoring metabolic deterioration and disease progression in children with pre-symptomatic T1D.

IFCC Paper

Open Access June 19, 2023

Comparison and commutability study among four faecal immunochemical tests (FIT) systems

Liesbet Deprez, Carolyn Piggott, Eline A.E. van der Hagen, Marieke Frasa, Sally C. Benton, on behalf of the IFCC Working Group on Fecal Immunochemical Testing (WG FIT)

Page range: 50-59

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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.

Guidelines and Recommendations

May 3, 2023

Evidence-based procedures to improve the reliability of circulating miRNA biomarker assays

Sarah R. Greytak, Kelly B. Engel, Dave S.B. Hoon, Kevin M. Elias, Christina M. Lockwood, Ping Guan, Helen M. Moore

Page range: 60-66

Abstract

Circulating cell-free microRNAs (cfmiRNA) are an emerging class of biomarkers that have shown great promise in the clinical diagnosis, treatment, and monitoring of several pathological conditions, including cancer. However, validation and clinical implementation of cfmiRNA biomarkers has been hindered by the variability introduced during different or suboptimal specimen collection and handling practices. To address the need for standardization and evidence-based guidance, the National Cancer Institute (NCI) developed a new Biospecimen Evidenced-Based Practices (BEBP) document, entitled “Cell-free miRNA (cfmiRNA): Blood Collection and Processing”. The BEBP, the fourth in the document series, contains step-by-step procedural guidelines on blood collection, processing, storage, extraction, and quality assessment that are tailored specifically for cfmiRNA analysis of plasma and serum. The workflow outlined in the BEBP is based on the available literature and recommendations of an expert panel. The BEBP contains the level of detail required for development of evidence-based standard operating procedures (SOPs) as well as the flexibility needed to accomodate (i) discovery- and inquiry-based studies and (ii) the different constraints faced by research labs, industry, clinical and academic institutions to foster widespread implementation. Guidance from the expert panel also included recommendations on study design, validating changes in workflow, and suggested quality thresholds to delineate meaningful changes in cfmiRNA levels. The NCI cfmiRNA: Blood Collection and Processing BEBP is available here as supplementary information as well as through the NCI Biorepositories and Biospecimen Research Branch (BBRB) (https://biospecimens.cancer.gov/resources/bebp.asp).

General Clinical Chemistry and Laboratory Medicine

July 21, 2023

Commutability assessment of candidate reference materials for plasma renin activity measurement: current challenges

Zhenni Liu, Lizi Jin, Zijia Ma, Xiaerbanu Nizhamuding, Jie Zeng, Tianjiao Zhang, Jiangtao Zhang, Weiyan Zhou, Chuanbao Zhang

Page range: 67-76

Abstract

Objectives This study aims to evaluate the commutability of external quality assessment (EQA) materials and candidate reference materials (RMs) for plasma renin activity (PRA) assay. Methods Commutabilities of 16 candidate RMs were measured along with 40 clinical samples by the four different routine PRA assays, including three LC‒MS/MS assays and one chemiluminescence immunoassay. Sixteen candidate RMs included native/spiked human plasma pools (small-scale pools with <50 individuals) and current EQA materials (large-scale pools with >1,000 individuals). Difference in bias approach and linear regression with prediction interval approach were adopted to determine the commutability. Two-way variance analysis was used to estimate the effects of spiked and pool size on the commutability. Stability and homogeneity studies were performed. Results Precision and correlation performance of all assays was acceptable. In the difference in bias approach, the commutability results were not satisfactory (noncommutability: 14/16) and significant sample-specific effects were detected in assay pairs using different incubation buffers. For the prediction interval approach, no commutability was observed in the spiked small-scale pools; EQA materials (4/9) had more satisfactory commutability among all assays than the small-scale pools (2/7); RMs of large-scale pools tend to have better commutability no matter spiked or not. Conclusions Commutable RMs were obtainable but challenging. Current EQA materials with relatively good commutability, stability, and homogeneity were appropriate RMs. Large-scale pools are tending to be commutable. Spiking in small-scale pools was not suggested to prepare RMs. MPs adopting a uniform incubation buffer would be preferable for further commutability research.

Open Access July 21, 2023

Aggregated data from the same laboratories participating in two glucose external quality assessment schemes show that commutability and transfers of values to control materials are decisive for the biases found

Gro Gidske, Sverre Sandberg, Pernille Fauskanger, Jonna Pelanti, Mette C. Tollånes, Anne E. Solsvik, Una Ø. Sølvik, Wenche S. Vie, Anne Stavelin

Page range: 77-84

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Abstract

Objectives We report the results of glucose measurements performed during one year by the same measurement procedures (MPs) in 58 Norwegian hospital laboratories using control materials provided by external quality assessment (EQA) schemes from two different providers. The providers used materials with presumed vs. verified commutability and transfers of values using reference material vs. using a highest-order reference MP. Methods Data from six Labquality and three Noklus glucose EQA surveys were aggregated for each MP (Abbott Alinity, Abbott Architect, Roche Cobas, and Siemens Advia) in each scheme. For each EQA result, percent difference from target value (% bias) was calculated. Median percent bias for each MP per scheme was then calculated. Results The median % biases observed for each MP in the Labquality scheme were significantly larger than those in the Noklus scheme, which uses verified commutable control materials and highest-order reference MP target values. The difference ranged from 1.2 (Roche Cobas, 2.9 vs. 1.7 %) to 4.4 percentage points (Siemens Advia, 3.2 % vs. −1.2 %). The order of bias size for the various MPs was different in the two schemes. In contrast to the Labquality scheme, the median % biases observed in the Noklus scheme for Abbott Alinity (−0.1 %), Abbott Architect (−0.5 %), and Siemens Advia (−1.2 %) were not significantly different from target value (p>0.756). Conclusions This study underlines the importance of using verified commutable EQA materials and target values traceable to reference MPs in EQA schemes designed for assessment of metrological traceability of laboratory results.

Open Access August 7, 2023

Methodological considerations in determining sex steroids in children: comparison of conventional immunoassays with liquid chromatography-tandem mass spectrometry

Carina Ankarberg-Lindgren, Charlotte Becker, Emilia Svala, Henrik Ryberg

Page range: 85-96

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Abstract

Objectives In laboratory medicine, external quality assessment (EQA) schemes have become versatile tools for detecting analytical flaws. However, EQA schemes are lacking for pediatric sex steroid levels. We aimed to investigate the suitability of different estradiol and testosterone immunoassays in a pediatric setting in comparison with clinical liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays. Methods The study was conducted by staff and the advisory group on endocrinology at Equalis, the Swedish provider of EQA schemes for laboratory medicine. The test material consisted of five pooled serum samples from children who were either prepubertal or in puberty. Clinical laboratories enrolled in Equalis EQA schemes for estradiol and testosterone were invited to participate, as were clinical laboratories using LC-MS/MS-assays. Samples were analyzed by either routine immunoassays (n=18) or in-house LC-MS/MS assays (n=3). Results For estradiol, LC-MS/MS assays showed a high degree of conformity with interlaboratory coefficients of variation (CV) below 24.2 %. Reported levels were between 4.9 ± 1.2 and 33.9 ± 1.6 pmol/L (group mean ± standard deviation). The direct immunoassays had lower precision; their CVs were up to 81.4 %. Reported concentrations were between 25.3 ± 18.1 and 45.7 ± 19.4 pmol/L, an overestimation compared to LC-MS/MS. Testosterone LC-MS/MS also showed a high degree of conformity, CVs were below 13.4 %, and reported concentrations were from 0.06 ± 0.00 to 1.00 ± 0.11 nmol/L. The direct immunoassays had a larger discrepancy between results; CVs were up to 95.8 %. Concentrations were between 0.12 ± 0.11 and 0.85 ± 0.23 nmol/L. Conclusions For the safe diagnosis and determination of sex steroids in children, analysis with mass spectrometry-based methods is recommended.

July 13, 2023

From “wet” matrices to “dry” blood spot sampling strategy: a versatile LC-MS/MS assay for simultaneous monitoring caffeine and its three primary metabolites in preterm infants

Hao-Ran Dai, Hong-Li Guo, Wei-Jun Wang, Xian Shen, Rui Cheng, Jing Xu, Ya-Hui Hu, Xuan-Sheng Ding, Feng Chen

Page range: 97-110

Abstract

Objectives To update traditional “wet” matrices to dried blood spot (DBS) sampling, based on the liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) technique, and develop a method for simultaneous analyzing caffeine and its three primary metabolites (theobromine, paraxanthine, and theophylline), supporting routine therapeutic drug monitoring (TDM) for preterm infants. Methods DBS samples were prepared by a two-step quantitative sampling method, i.e., volumetric sampling of a quantitative 10 μL volume of peripheral blood and an 8 mm diameter whole punch extraction by a methanol/water (80/20, v/v) mixture containing 125 mM formic acid. Four paired stable isotope labeled internal standards and a collision energy defect strategy were applied for the method optimization. The method was fully validated following international guidelines and industrial recommendations on DBS analysis. Cross validation with previously developed plasma method was also proceeded. The validated method was then implemented on the TDM for preterm infants. Results The two-step quantitative sampling strategy and a high recovery extraction method were developed and optimized. The method validation results were all within the acceptable criteria. Satisfactory parallelism, concordance, and correlation were observed between DBS and plasma concentrations of the four analytes. The method was applied to provide routine TDM services to 20 preterm infants. Conclusions A versatile LC-MS/MS platform for simultaneous monitoring caffeine and its three primary metabolites was developed, fully validated, and successfully applied into the routine clinical TDM practices. Sampling method switching from “wet” matrices to “dry” DBS will facilitate and support the precision dosing of caffeine for preterm infants.

August 4, 2023

A sensitive LC-MS/MS methotrexate assay capable of assessing adherence to methotrexate therapy in rheumatoid arthritis

Malcolm P. McTaggart, James Bluett, Brian G. Keevil

Page range: 111-117

Abstract

Objectives To develop a sensitive liquid chromatography-tandem mass spectrometry method capable of measuring serum methotrexate in patients with rheumatoid arthritis to assess adherence to drug treatment. Methods Isotopically labelled internal standard and deionised water were added to sample prior to solid phase extraction using a Waters Oasis Max ion-exchange 96-well plate. Following extraction, samples were analysed by LC-MS/MS on a TQS-micro mass spectrometer. Results Mean recovery was 107 % for four different concentrations of methotrexate spiked into seven patient samples, whilst post extraction spiking gave a mean recovery of 100 %. Between-batch and within-batch CVs were ≤6 % at three different concentrations of methotrexate in fresh frozen plasma. Mean bias was <5 % for between-batch and within batch analysis at three different weighed in concentrations of methotrexate certified reference material. The lower limit of quantification of the assay was 0.1 nmol/L with linearity up to approximately 100 nmol/L. Dilution linearity studies were used to validate the dilution of patient samples prior to analysis. There was no significant interference in the method from lipaemia, haemolysis or icterus. Conclusions A sensitive LC-MS/MS assay for methotrexate has been developed and validated. The method has been used to measure methotrexate adherence in patient samples from clinical trials and could be used in future research to assess the ability of the assay as a biofeedback intervention to improve adherence to methotrexate therapy.

Open Access July 25, 2023

Determination of cortisone and cortisol in human scalp hair using an improved LC-MS/MS-based method

Mina Mirzaian, Sofie K.M. van Zundert, Wim F. Schilleman, Mostafa Mohseni, Susanne Kuckuck, Elisabeth F.C. van Rossum, Ron H.N. van Schaik, Sjoerd A.A. van den Berg

Page range: 118-127

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Abstract

Objectives Human scalp hair is an easily available but complex matrix for determination of cortisone and cortisol, and has been shown to reflect long-term glucocorticoid exposure. Hair glucocorticoid analysis has been used to detect hypo- and hypercortisolism. In this study, we describe the development and validation of a LC-MS/MS method for quantification of cortisone and cortisol in human scalp hair, and provide a novel approach for analysis and interpretation of the results. Methods Improved sample preparation using pulverization and solid phase extraction allowed for low sample volumes (10 mg). Baseline chromatographic separation without matrix interference was achieved by reversed phase chromatography and MRM measurement in negative ion mode. Run-to-run time was 8 min. Mixed model analyses were performed to create individual patterns of cortisone and cortisol concentrations. Results Matrix matched calibration curves showed excellent linearity up to 100 pg (analyte)/mg (hair) for both cortisone and cortisol (R 2 >0.995). LLOQ was 1.5 and 1.0 pg/mg for cortisone and cortisol, respectively. Matrix effect was negligible for hair color (recoveries 95–105 %). Cortisone and cortisol concentrations decreased from proximal to distal hair segments, following a predictable, but subject-specific pattern, with less individual variation for cortisone than for cortisol. Conclusions This improved LC-MS/MS method is able to accurately quantify cortisone and cortisol in human hair with minimum matrix interference. This new way of data analysis and interpretation including individual patterns of cortisone and cortisol will be of help with detection of pathological concentrations in both the high – and the low ranges of glucocorticoids.

Open Access July 14, 2023

Mild hypophosphatasia may be twice as prevalent as previously estimated: an effective clinical algorithm to detect undiagnosed cases

Trinidad González-Cejudo, Juan Miguel Villa-Suárez, María Ferrer-Millán, Francisco Andújar-Vera, Victoria Contreras-Bolívar, María Carmen Andreo-López, José María Gómez-Vida, Luis Martínez-Heredia, Sheila González-Salvatierra, Tomás de Haro Muñoz, Cristina García-Fontana, Manuel Muñoz-Torres, Beatriz García-Fontana

Page range: 128-137

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Abstract

Objectives Since the prevalence of hypophosphatasia (HPP), a rare genetic disease, seems to be underestimated in clinical practice, in this study, a new diagnostic algorithm to identify missed cases of HPP was developed and implemented. Methods Analytical determinations recorded in the Clinical Analysis Unit of the Hospital Universitario Clínico San Cecilio in the period June 2018 – December 2020 were reviewed. A new clinical algorithm to detect HPP-misdiagnosed cases was used including the following steps: confirmation of persistent hypophosphatasemia, exclusion of secondary causes of hypophosphatasemia, determination of serum pyridoxal-5′-phosphate (PLP) and genetic study of ALPL gene. Results Twenty-four subjects were selected to participate in the study and genetic testing was carried out in 20 of them following clinical algorithm criteria. Eighty percent of patients was misdiagnosed with HPP following the current standard clinical practice. Extrapolating these results to the current Spanish population means that there could be up to 27,177 cases of undiagnosed HPP in Spain. In addition, we found a substantial proportion of HPP patients affected by other comorbidities, such as autoimmune diseases (∼40 %). Conclusions This new algorithm was effective in detecting previously undiagnosed cases of HPP, which appears to be twice as prevalent as previously estimated for the European population. In the near future, our algorithm could be globally applied routinely in clinical practice to minimize the underdiagnosis of HPP. Additionally, some relevant findings, such as the high prevalence of autoimmune diseases in HPP-affected patients, should be investigated to better characterize this disorder.

September 21, 2023

Combined deficient response to polysaccharide-based and protein-based vaccines predicts a severe clinical phenotype

Maaike Cockx, Filomeen Haerynck, Levi Hoste, Rik Schrijvers, Jutte Van der Werff ten Bosch, Doreen Dillaerts, Debby Thomas, Heidi Schaballie, Giorgia Bucciol, Wiert Robberechts, Dina Patel, Guy Berbers, Isabelle Desombere, Nick Geukens, Isabelle Meyts, Xavier Bossuyt

Page range: 138-149

Abstract

Objectives Antibody response on polysaccharide- and protein-based vaccines is useful to test B cell functionality. As only few studies have explored the value of studying immune response to both vaccines, we evaluated the clinical value of anti-polysaccharide and anti-protein Luminex-based multiplex assays in context of primary immunodeficiency (PID) diagnosis. Methods A 10-plex Luminex-based assay detecting antibodies to ten pneumococcal polysaccharide (PnPS) serotypes [present in unconjugated Pneumovax, not in 13-valent pneumococcal conjugated vaccine (PCV)] and a 5-plex assay detecting antibodies to five protein antigens (present in DTap/Tdap) were clinically validated in healthy individuals (n=99) and in retrospective (n=399) and prospective (n=108) patient cohorts. Clinical features of individuals with impaired response to PnPS and/or proteins were compared to those with normal response. Results Antigen-specific antibody thresholds were determined in healthy individuals. Individuals with impaired anti-PnPS responses and deficient immunoglobulin levels suffered more from autoimmune diseases and had lower B cell levels compared to individuals with impaired anti-PnPS response with normal immunoglobulin levels. Individuals with combined impaired response to PnPS and proteins showed more severe clinical manifestations compared to individuals with isolated impaired response to PnPS or proteins. Eight of the 11 individuals with severely impaired responses to both PnPS and proteins had common variable immunodeficiency. Evaluation of the anti-PnPS response to four serotypes not contained in 20-valent PCV was comparable to evaluation to ten serotypes not contained in 13-valent PCV. Conclusions Multiplexed assessment of anti-PnPS and anti-protein responses combined with immunoglobulin quantification provides useful clinical information to support PID diagnosis.

Reference Values and Biological Variations

September 20, 2023

A sex-specific association of leukocyte telomere length with thigh muscle mass

Eva Maria Hassler, Gunter Almer, Gernot Reishofer, Hannes Deutschmann, Harald Mangge, Markus Herrmann, Stefan L. Leber, Felix Gunzer, Tanja Langsenlehner, Wilfried Renner

Page range: 150-156

Abstract

Objectives Telomeres are DNA–protein complexes at the ends of linear chromosomes that protect against DNA degradation. Telomeres shorten during normal cell divisions and therefore, telomere length is an indicator of mitotic-cell age. In humans, telomere shortening is a potential biomarker for disease risk, progression and premature death. Physical activity has been associated with longer leukocyte telomere length (LTL) in some studies. In the current study the relationship between LTL, thigh muscle mass and adipose tissue distribution was explored. Methods We performed anthropometric measurements and magnetic resonance imaging (MRI) measurements of the thigh in 149 healthy subjects (77 male, 72 female). LTL was measured using qPCR. Additionally, the subjects answered a questionnaire concerning their training behaviour. Results In male subjects, LTL was significantly associated with thigh muscle mass, independent of age and body mass index (p=0.006). In addition, a slight association of LTL with weekly endurance units in the male group was found. These relations could not be observed in females. Conclusions In conclusion, we observed a sex-specific association of LTL and thigh muscle mass in healthy males. The reason of this sex-specific association is currently unclear, but could be related to different training effects and/or hormonal pathways in men and women.

Cancer Diagnostics

Open Access July 31, 2023

Optimized procedure for high-throughput transcriptome profiling of small extracellular vesicles isolated from low volume serum samples

Petra Vychytilova-Faltejskova, Sara Vilmanova, Lucie Pifkova, Tina Catela Ivković, Marie Mᶏdrzyk, Robin Jugas, Tana Machackova, Jan Kotoucek, Milana Sachlova, Lucia Bohovicova, Teodor Stanek, Jana Halamkova, Igor Kiss, Ondrej Slaby

Page range: 157-167

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Abstract

Objectives Small extracellular vesicles (EVs) contain various signaling molecules, thus playing a crucial role in cell-to-cell communication and emerging as a promising source of biomarkers. However, the lack of standardized procedures impedes their translation to clinical practice. Thus, we compared different approaches for high-throughput analysis of small EVs transcriptome. Methods Small EVs were isolated from 150 μL of serum. Quality and quantity were assessed by dynamic light scattering, transmission electron microscopy, and Western blot. Comparison of RNA extraction efficiency was performed, and expression of selected genes was analyzed by RT-qPCR. Whole transcriptome analysis was done using microarrays. Results Obtained data confirmed the suitability of size exclusion chromatography for isolation of small EVs. Analyses of gene expression showed the best results in case of samples isolated by Monarch Total RNA Miniprep Kit. Totally, 7,182 transcripts were identified to be deregulated between colorectal cancer patients and healthy controls. The majority of them were non-coding RNAs with more than 70 % being lncRNAs, while protein-coding genes represented the second most common gene biotype. Conclusions We have optimized the protocol for isolation of small EVs and their RNA from low volume of sera and confirmed the suitability of Clariom D Pico Assays for transcriptome profiling.

Open Access September 8, 2023

Ultra-short cell-free DNA fragments enhance cancer early detection in a multi-analyte blood test combining mutation, protein and fragmentomics

Fenfen Wang, Xinxing Li, Mengxing Li, Wendi Liu, Lingjia Lu, Yang Li, Xiaojing Chen, Siqi Yang, Tao Liu, Wen Cheng, Li Weng, Hongyan Wang, Dongsheng Lu, Qianqian Yao, Yingyu Wang, Johnny Wu, Tobias Wittkop, Malek Faham, Huabang Zhou, Heping Hu, Hai Jin, Zhiqian Hu, Ding Ma, Xiaodong Cheng

Page range: 168-177

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Abstract

Objectives Cancer morbidity and mortality can be reduced if the cancer is detected early. Cell-free DNA (cfDNA) fragmentomics emerged as a novel epigenetic biomarker for early cancer detection, however, it is still at its infancy and requires technical improvement. We sought to apply a single-strand DNA sequencing technology, for measuring genetic and fragmentomic features of cfDNA and evaluate the performance in detecting multiple cancers. Methods Blood samples of 364 patients from six cancer types (colorectal, esophageal, gastric, liver, lung, and ovarian cancers) and 675 healthy individuals were included in this study. Circulating tumor DNA mutations, cfDNA fragmentomic features and a set of protein biomarkers were assayed. Sensitivity and specificity were reported by cancer types and stages. Results Circular Ligation Amplification and sequencing (CLAmp-seq), a single-strand DNA sequencing technology, yielded a population of ultra-short fragments (<100 bp) than double-strand DNA preparation protocols and reveals a more significant size difference between cancer and healthy cfDNA fragments (25.84 bp vs. 16.05 bp). Analysis of the subnucleosomal peaks in ultra-short cfDNA fragments indicates that these peaks are regulatory element “footprints” and correlates with gene expression and cancer stages. At 98 % specificity, a prediction model using ctDNA mutations alone showed an overall sensitivity of 46 %; sensitivity reaches 60 % when protein is added, sensitivity further increases to 66 % when fragmentomics is also integrated. More improvements observed for samples representing earlier cancer stages than later ones. Conclusions These results suggest synergistic properties of protein, genetic and fragmentomics features in the identification of early-stage cancers.

July 13, 2023

Clinical relevance of clonal hematopoiesis and its interference in cell-free DNA profiling of patients with gastric cancer

Kwang Seob Lee, Choong-Kun Lee, Soon Sung Kwon, Woo Sun Kwon, Sejung Park, Seung-Tae Lee, Jong Rak Choi, Sun Young Rha, Saeam Shin

Page range: 178-186

Abstract

Objectives Clonal hematopoiesis (CH) is a condition in which healthy individuals have somatic mutations in hematopoietic stem cells. It has been reported with increased risk of hematologic malignancy and cardiovascular disease in the general population, but studies of Korean populations with comorbid disease entities are scarce. Methods White blood cells (WBCs) from patients with gastric cancer (GC) (n=121) were analyzed using a DNA-based targeted (531 genes) panel with customized pipeline designed to detect single nucleotide variants and small indels with low-allele-frequency of ≥0.2 %. We defined significant CH variants as having variant allele frequency (VAF) ≥2 % among variants found in WBCs. Matched cell-free DNA (cfDNA) samples were also analyzed with the same pipeline to investigate the false-positive results caused by WBC variants in cfDNA profiling. Results Significant CH variants were detected in 29.8 % of patients and were associated with age and male sex. The number of CH variants was associated with a history of anti-cancer therapy and age. DNMT3A and TET2 were recurrently mutated. Overall survival rate of treatment-naïve patients with stage IV GC was higher in those with CH, but Cox regression showed no significant association after adjustment for age, sex, anti-cancer therapy, and smoking history. In addition, we analyzed the potential interference of WBC variants in plasma cell-free DNA testing, which has attracted interest as a complementary method for tissue biopsy. Results showed that 37.0 % (47/127) of plasma specimens harbored at least one WBC variant. VAFs of interfering WBC variants in the plasma and WBC were correlated, and WBC variants with VAF ≥4 % in WBC were frequently detected in plasma with the same VAF. Conclusions This study revealed the clinical impact of CH in Korean patients and suggests the potential for its interference in cfDNA tests.

August 4, 2023

Development and analytical validation of a novel nasopharynx swab-based Epstein-Barr virus C promoter methylation quantitative assay for nasopharyngeal carcinoma detection

Zhi-Cong Wu, Ke-Na Lin, Xue-Qi Li, Xin Ye, Hua Chen, Jun Tao, Hang-Ning Zhou, Wen-Jie Chen, Dong-Feng Lin, Shang-Hang Xie, Su-Mei Cao

Page range: 187-198

Abstract

Objectives Epstein-Barr virus (EBV) C promoter (Cp) hypermethylation, a crucial factor for EBV latent infection of nasopharyngeal epithelial cells, has been recognized as a promising biomarker for nasopharyngeal carcinoma (NPC) detection. In this study, we develop a novel EBV Cp methylation quantification (E-CpMQ) assay and evaluate its diagnostic performance for NPC detection. Methods A novel qPCR assay for simultaneous quantification of methylated- and unmethylated EBV Cp was developed by the combinational modification of MethyLight and QASM, with an innovative calibrator to improve the detection accuracy and consistency. The NP swab samples and synthetic standards were used for the analytical validation of the E-CpMQ. The diagnostic efficacy of the developed E-CpMQ assay was validated in 137 NPC patients and 137 non-NPC controls. Results The E-CpMQ assay can detect the EBV Cp methylation ratio in one reaction system under 10 copies with 100 % recognition specificity, which is highly correlated to pyrosequencing with a correlation coefficient over 0.99. The calibrated E-CpMQ assay reduces the coefficient of variation by an average of 55.5 % with a total variance of less than 0.06 units standard deviation (SD). Linear methylation ratio detection range from 4.76 to 99.01 %. The sensitivity and specificity of the E-CpMQ respectively are 96.4 % (95 % CI: 91.7–98.8 %), 89.8 % (95 % CI: 83.5–94.3 %). Conclusions The developed E-CpMQ assay with a calibrator enables accurate and reproducible EBV Cp methylation ratio quantification and offers a sensitive, specific, cost-effective method for NPC early detection.

Infectious Diseases

Open Access August 3, 2023

(Pre)analytical considerations concerning the analysis of synovial calprotectin

Mohammed F. Alkadhem, Lucie M.F. Wagenmakers-Huizenga, Marjan Wouthuyzen-Bakker, Anneke C. Muller Kobold

Page range: 199-206

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Abstract

Objectives Several studies have demonstrated that synovial calprotectin is a highly accurate biomarker in diagnosing periprosthetic joint infections (PJI). Assuring reliability is of great importance and coincides with adequate preanalytical handling. This study focuses on potentially interfering factors. Methods To assess the stability of synovial calprotectin, the effect of time, storage temperature, EDTA, freeze-thaw cycles, viscosity, and blood and lipid contamination was investigated. In the blood and lipid contamination experiments, hemolyzed and non-hemolyzed blood, homogenized adipose tissue, intralipid and chylomicrons were added. The effect of viscosity was investigated using freeze-thaw cycles, enzymatic pretreatment and sonification. Results No effect on synovial calprotectin levels was observed in synovial samples kept at room temperature compared to samples kept at 4 °C for up to seven days of storage. Freeze-thaw cycles did not result in significantly different calprotectin levels, although samples without EDTA resulted in higher recoveries after 1 and 2 freeze-thaw cycles. Blood and lipid contamination did not interfere with accurate synovial calprotectin analysis. Sample pretreatment to reduce sample viscosity by pretreating samples with DNAse and/or hyaluronidase did not influence calprotectin analysis. Sonification, however, resulted in increased calprotectin values. Conclusions Synovial calprotectin is a stable biomarker and its analysis is not easily influenced by potential interfering factors.

Corrigendum

Publicly Available November 10, 2023

Thermal and chronological stability of monocyte distribution width (MDW), the new biomarker for sepsis

Jardel Cristiano Bordignon, Rodrigo Galvão Bueno Gardona, Leonardo de Souza Vasconcellos, Joslaine Schuartz Iachinski, Robbson Haugusto Dambros, Gisele Arruda, Beatriz Castro Reis, Edson Abdala

Page range: 207-207

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Acknowledgment

Publicly Available November 10, 2023

Acknowledgment

Page range: 208-211

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Letters to the Editor

Publicly Available July 27, 2023

In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency

Florent J.L.A. Vanstapel, Guilaine Boursier, Christa M. Cobbaert

Page range: e1-e3

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July 27, 2023

Use of thyroid function tests in urine: a position statement of the Belgian Thyroid Club

Damien Gruson, Patrick Petrossians, David Unuane, Annick Van den Bruel, Vincent Vander Poorten, Bruno Lapauw, Aglaia Kyrilli, Rodrigo Moreno-Reyes, Maria-Cristina Burlacu, Brigitte Decallonne

Page range: e4-e5

July 20, 2023

State of the art of measurement uncertainty of serum ferritin

Leila Rovegno, Elisa Civera, Ilenia Infusino, Mauro Panteghini

Page range: e6-e8

July 12, 2023

Analytical performance evaluation and consumable waste reduction strategies using a tube-based quality control material

Erving T. Laryea, Kelsey Mitchell, Julia Hernández, Eric Stanford, Kwaku Twum, Joesph R. Wiencek

Page range: e9-e12

July 20, 2023

Stability of fecal calprotectin extracts using the Diasorin^® kit

Blandine Billet, Luc Choisnard, Patrice Faure, Denis Guicherd, Elodie Cussigh, Eric Peyrin, Corinne Ravelet, Benoit Chovelon

Page range: e13-e15

July 19, 2023

Reverse cascade testing from newborn screening: the opportunity to improve family healthcare outcomes

Simona Ferraro, Elvira Verduci, Gianvincenzo Zuccotti, Camilla Sertori

Page range: e16-e18

July 10, 2023

An indirect data-mining approach to standardise paediatric serum phosphate reference intervals in Wales

Annabel Rodham, Soha Zouwail

Page range: e19-e21

July 27, 2023

Sodium and risk assessment of osmotic demyelination syndrome: the method matters!

Veronique V. Stove, Matthijs Oyaert, Joris R. Delanghe

Page range: e22-e23

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Editorial

Editor-in-Chief
Mario Plebani, Padova, Italy

Associate Editors
Philippe Gillery, Reims, France
Ronda Greaves, Bundoora, VIC, Australia
Karl Lackner, Mainz, Germany
Giuseppe Lippi, Verona, Italy
Bohuslav Melichar, Olomouc, Czech Republic
Deborah A. Payne, Denver, CO, USA
Peter Schlattmann, Jena, Germany

Editorial Board
Ivan Brandslund, Odense, Denmark
Christoph Buchta, Vienna, Austria
Janne Cadamuro, Salzburg, Austria
Etienne Cavalier, Liège, Belgium
Vincent De Guire, Montreal, Canada
Vincent Delatour, Paris, France
Pilar Fernandez-Calle, Madrid, Spain
Emmanuel Favaloro, Westmead, NSW, Australia
Julien Favresse, Brussels, Belgium
Joao Tiago Guimaraes, Porto, Portugal
Liam Heaney, Loughborough, UK
Brandon M. Henry, Cincinnati, OH, USA
Markus Herrmann, Graz, Austria
Martin Hersberger, Zurich, Switzerland
Johannes J.M.L. Hoffmann, Nuenen, Netherlands
Evgenija Homšak, Lenart, Slovenia
Zhi-De Hu, Hohhot, P.R. China
Berend Isermann, Leipzig, Germany
Joannes F.M. Jacobs, Nijmegen, The Netherlands
Petr Jarolim, Boston, MA, USA
Graham Jones, Darlinghurst, NSW, Australia
János Kappelmayer, Debrecen, Hungary
Peter Kavsak, Toronto, ON, Canada
Magdalena Krintus, Bydgoszcz, Poland
Vathany Kulasingam, Toronto, ON, Canada
Leslie Charles Lai, Kuala Lumpur, Malaysia
Ivana Lapić, Zagreb, Croatia
Michael Laposata, Galveston, TX, USA
Nicholas E. Larkey, Charlottesville, VA, USA
Tze Ping Loh, Singapore
Konstantinos Makris, Makris, Greece
David Meyre, Hamilton, Canada
Yesim Ozarda, Bursa, Turkey
Tomris Özben, Antalya, Turkey
Andrea Padoan, Padova, Italy
Vladimir Palicka, Hradec Králové, Czech Republic
Geraldo Picheth, Curitiba, Brazil
Ted E. Schutzbank, San Diego, CA, USA
Cord Spreckelsen, Jena, Germany
Grazyna Sypniewska, Bydgoszcz, Poland
Michael Vogeser, Munich, Germany
Maria Alice V. Willrich, Rochester, MN, USA
Annalise E. Zemlin, Cape Town, South Africa

Editorial
Heike Jahnke
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(Deutsch)

Online ISSN: 1437-4331
Print ISSN: 1434-6621
Type: Journal
Language: English
Publisher: De Gruyter
First published: January 1, 1963
Publication Frequency: 12 Issues per Year
Audience: basic scientists, translational researchers, clinical researchers, industry scientists and professionals in the field of laboratory medicine

Clinical Chemistry and Laboratory Medicine (CCLM)

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

Frontmatter

Biological management of diabetes mellitus, the laboratory medicine specialist and the patient

Remote HbA1c testing via microsampling: fit for purpose?

Abstract

The effect of hormonal contraceptive therapy on clinical laboratory parameters: a literature review

Abstract

Continuous glucose monitoring has an increasing role in pre-symptomatic type 1 diabetes: advantages, limitations, and comparisons with laboratory-based testing

Abstract

Comparison and commutability study among four faecal immunochemical tests (FIT) systems

Abstract

Evidence-based procedures to improve the reliability of circulating miRNA biomarker assays

Abstract

Commutability assessment of candidate reference materials for plasma renin activity measurement: current challenges

Abstract

Aggregated data from the same laboratories participating in two glucose external quality assessment schemes show that commutability and transfers of values to control materials are decisive for the biases found

Abstract

Methodological considerations in determining sex steroids in children: comparison of conventional immunoassays with liquid chromatography-tandem mass spectrometry

Abstract

From “wet” matrices to “dry” blood spot sampling strategy: a versatile LC-MS/MS assay for simultaneous monitoring caffeine and its three primary metabolites in preterm infants

Abstract

A sensitive LC-MS/MS methotrexate assay capable of assessing adherence to methotrexate therapy in rheumatoid arthritis

Abstract

Determination of cortisone and cortisol in human scalp hair using an improved LC-MS/MS-based method

Abstract

Mild hypophosphatasia may be twice as prevalent as previously estimated: an effective clinical algorithm to detect undiagnosed cases

Abstract

Combined deficient response to polysaccharide-based and protein-based vaccines predicts a severe clinical phenotype

Abstract

A sex-specific association of leukocyte telomere length with thigh muscle mass

Abstract

Optimized procedure for high-throughput transcriptome profiling of small extracellular vesicles isolated from low volume serum samples

Abstract

Ultra-short cell-free DNA fragments enhance cancer early detection in a multi-analyte blood test combining mutation, protein and fragmentomics

Abstract

Clinical relevance of clonal hematopoiesis and its interference in cell-free DNA profiling of patients with gastric cancer

Abstract

Development and analytical validation of a novel nasopharynx swab-based Epstein-Barr virus C promoter methylation quantitative assay for nasopharyngeal carcinoma detection

Abstract

(Pre)analytical considerations concerning the analysis of synovial calprotectin

Abstract

Thermal and chronological stability of monocyte distribution width (MDW), the new biomarker for sepsis

Acknowledgment

In-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency

Use of thyroid function tests in urine: a position statement of the Belgian Thyroid Club

State of the art of measurement uncertainty of serum ferritin

Analytical performance evaluation and consumable waste reduction strategies using a tube-based quality control material

Stability of fecal calprotectin extracts using the Diasorin® kit

Reverse cascade testing from newborn screening: the opportunity to improve family healthcare outcomes

An indirect data-mining approach to standardise paediatric serum phosphate reference intervals in Wales

Sodium and risk assessment of osmotic demyelination syndrome: the method matters!

Remote HbA_1c testing via microsampling: fit for purpose?

Stability of fecal calprotectin extracts using the Diasorin^® kit