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Editor-in-chief
Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

EIC Assistant
Francesco Busardò

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


Publisher
Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282
email: biochimica.clinica@sibioc.it

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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091



Articoli in pubblicazione

EDITORIALI
Equazioni per la stima della velocità di filtrazione glomerulare: siamo a un punto di arrivo?
Biochimica Clinica
DOI: 10.19186/BC_2023.001
Editoriale - Editorial
 
Clinical laboratories and pandemics: new and emerging challenges
Clinical laboratories and pandemics: new and emerging challenges
M. Plebani  | 
Biochimica Clinica
DOI: 10.19186/BC_2023.004
Pubblicato online il: 12.01.2023
Editoriale - Editorial
 
RASSEGNE
Saliva: Challenges, possibilities, and limits of the diagnostic use Part 2 – Pre-analytical and analytical aspects

Part I of this review was dedicated to the biological complexity of saliva and its relationship with the pathophysiology of many organs. In Part II, issues related to the pre-analytical and analytical phases are illustrated, focusing first the attention on the main sources of variability, starting from the few data available on biological variation to the different approaches for sample collection under basal or stimulated conditions. Up to now, published data, obtained on small groups of healthy or diseased individuals, seem to be indicative of wide pre-analytical errors and/or individual variability. The established clinical use of salivary tests is then reviewed and a series of possible new applications are presented. Methodologies employed in saliva are presented, ranging from commonly applied techniques, such as colorimetric enzymatic methods and ELISA, to more sophisticated technologies (gas chromatography–mass spectrometry, liquid chromatography-mass spectrometry and 1H NMR spectroscopy) to investigate proteomics and metabolomics. The aim of this review is to present the pre-analytical issues related to its collection and storage and to illustrate the knowledge gaps and the numerous opportunities that the analysis of this interesting biological fluid may offer.

TAG: saliva   pre-analytical phase   analytical methods  
Biochimica Clinica
DOI: 10.19186/BC_2022.078
Pubblicato online il: 15.12.2022
Rassegne - Reviews
 
CONTRIBUTI SCIENTIFICI
Biochemical profile of children with autism spectrum disorders associated with genetic deficiency of the folate cycle
Biochemical profile of children with autism spectrum disorders associated with genetic deficiency of the folate cycle

Introduction: the results of 5 randomized controlled meta-analysis studies showed the association between genetic  deficiency of folate cycle and autistic spectrum disorders in children. The purpose of the present study is to investigate  the biochemical alterations in children with autism spectrum disorders associated with genetic deficiency of the folate  cycle.  Methods: the experimental group involved 225 children diagnosed with autism spectrum disorders (Diagnostic and  Statistical Manual of Mental Disorders IV-TR, International Statistical Classification of Diseases and Related Health  Problems 10), who suffered from a genetic deficiency of the folate cycle (methylenetetrahydrofolate reductase C677T  + methylenetetrahydrofolate reductase A1298C and/or methionine synthase A2756G and/or methionine synthase 
reductase A66G; polymerase chain reaction). The control group included 51 healthy children who followed the same  age and gender distribution pattern of the patients group.  Results: the study revealed that the patients had a specific pattern of biochemical alterations in serum (p˂0.05; Z˂Z0.05).  Mean value and (SD) are reported. Hyperhomocysteinemia: 9.63 (5.36) μmol/L, r.v. ˂5.2); deficiencies of vitamins: B6  [6.32 (3.58) μg/L, r.i. 8.7-27.2], folic acid [2.97 (6.85) pg/mL, r.i. 3.89-26.8], B12 [112.64 (374.2) pg/mL, r.i. 197-771],  and D3 [13.98 (20.41) ng/mL, r.i. 30-60]; hypercreatininemia [69.13 (64.21) μmol/L, r.i. 3 years: 21-36, 3-5 years: 27-42, 5-8 years: 28-50], increased creatine kinase [314.12 (443.42) U/L, r.i. 39-308 U/L]; and lactate dehydrohenase  [378.47 (443.72) U/L, r.i.135-225]. At the time of examination, an increase in the serum concentration of homocysteine  was registered in 88% of the patients. The associations between different folate cycle genes polymorphisms with  certain biochemical abnormalities were shown Discussion: autism spectrum disorders associated with genetic deficiency of the folate cycle in children are  characterized by a specific pattern of biochemical changes that is not found in healthy children and may be involved in  the pathogenesis of immunodeficiency and encephalopathy. These data can be used in clinical practice for diagnostic  purposes to identify a subgroup of children with autism spectrum disorders associated with genetic folate cycle  deficiency and for the selection of biochemical correction during treatment.

TAG: homocysteine   B vitamins   folic acid  
Biochimica Clinica
DOI: 10.19186/BC_2022.082
Pubblicato online il: 27.01.2023
Contributi Scientifici - Scientific Paper
 
Big data e intelligenza artificiale in medicina di laboratorio: una indagine SiBioC nei i laboratori clinici italiani
A survey on Artificial Intelligence and Big Data utilisation in Italian Clinical Laboratories

Objectives: the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) Big Data and Artificial Intelligence (BAI) Working Group promoted a survey to frame the knowledge, skills, and technological predisposition in Clinical Laboratories. Methods: questionnaire, focusing on digitization, IT infrastructures, data accessibility, and BAI projects underway was sent to 1351 SIBioC participants. The responses were evaluated using SurveyMonkey software and Google Sheets. Results: the 227 respondents (17%) from all over Italy (47% of 484 labs), mainly biologists, laboratory physicians and managers, mostly from laboratories of public hospitals, revealed lack of hardware, software and corporate Wi-Fi, and dearth of PCs. Only 25% work daily on clouds, while 65%-including Laboratory Directors-cannot acquire health data from sources other than laboratories. Only 50% of those with access can review a clinical patient’s health record, while the other access only to laboratory information. The integration of laboratory data with other health data is mostly incomplete, which limits BAI-type analysis. Many are unaware of integration platforms. Over 90% report pulling data from the LIS, with varying degrees of autonomy. Very few have already undertaken BAI projects, frequently relying on IT partnerships. The majority consider BAI as crucial in helping professional judgments, indicating a growing interest. Conclusions: the questionnaire received relevant feedback from SIBioC participants. It highlighted the level of expertise and interest in BAI applications. None of the obstacles stands out more than the others, emphasising the need to allaround work: IT infrastructures, data warehouses, BAI analysis software acquisition, data accessibility and training.

TAG: intelligenza artificiale   Big Data   digitalizzazione  
Biochimica Clinica
DOI: 10.19186/BC_2022.079
Pubblicato online il: 13.12.2022
Contributi Scientifici - Scientific Papers
 
Vantaggi dei marcatori di ox-infiammazione nella valutazione dello stato di allenamento negli sport ad alta intensità: dati preliminari
Utility of ox-inflammation markers in assessing training status in high-intensity sports: preliminar results

Introduction: the increase in high-intensity fraction of training shifts the ox-inflammation balance towards a more oxidizing environment, overcoming the antioxidant barrier and causing molecular oxidative damage, impaired performance and greater risk of injury for athletes. Methods: a team of male cyclists and one of female basketball players were evaluated during a competitive season. A number of serum parameters usually employed in sports medicine together with some ox-inflammation biomarkers most recently suggested, were measured at definite intervals of time. Results: significant variations related to the extent of workload were observed for several biomarkers; glutathione (GSH), 3-nitrotyrosine (3NT) and 8-hydroxy-deoxy-guanosine (8OHdG) showed the greatest (exceeding the limits of the referenge ranges) and most significant changes (exceeding the reference change values, RCV). Discussion: the measurements of ox-inflammation biomarkers allowed to evaluate the extent of oxidative imbalance determined by training. In cyclists, which were subjected to the highest workloads and for a longer time, the increasing of 3NT levels suggested that the antioxidant systems was not completely able to neutralize the imbalance, causing a progressive oxidative damage on proteins. The lower levels of 3NT and 8OHdG in basketball players showed that minor workloads have lower impact on the imbalance. Since ox-inflammation biomarkers vary with training load with greater amplitude and significance compared to other parameters, their measurements are proposed for the evaluation of the effects of training programs in athletes.

TAG: ox-infiammazione   allenamento   biomarcatori  
Biochimica Clinica
DOI: 10.19186/BC_2022.074
Pubblicato online il: 23.11.2022
Contributi Scientifici - Scientific Paper
 
OPINIONI
Impact on laboratory medicine of transitioning from COVID-19 pandemic to “tripledemic”
Impact on laboratory medicine of transitioning from COVID-19 pandemic to “tripledemic”
G. Lippi  | 

It has now become clear that SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) will remain among us for long time, becoming a “harmingly” endemic infectious disease. Although virulence and pathogenicity have gradually decreased over time, the infectivity has instead increased after the emergence of new sublineages belonging to Omicron family, so that the volume of tests that need to be performed for diagnosing and monitoring coronavirus disease 2019 (COVID-19) remains paramount. The situation has become even more complicated after resurgence of other infectious respiratory diseases, namely Influenza and Respiratory Syncytial Virus (RSV), which are now responsible for an unprecedented “tripledemic”. In this catastrophic scenario, laboratory medicine needs to be proactive and timely adapt to the new challenge. Further development and implementation of SARS-CoV-2 antigen rapid diagnostic testing (Ag-RDT) will play a crucial role in the future, especially encompassing devices that will enable to confirm (or rule out) more infectious diseases at the same time (i.e., COVID-19, Influenza and RSV). Considering that the clinical phenotypes of the three viruses is overlapping, new diagnostic tests designed for simultaneous assessment of multiple viruses within a single Ag-RDT device represent a valuable option for achieving a rapid differential diagnosis between different respiratory infections, or even for diagnosing multiple concomitant infections. A novel strategy could hence be profiled, entailing the screening by means of combined Ag-RDT of all subjects whose infective status may jeopardize their own health as well as the health of other people.

TAG: SARS-CoV-2   influenza   Respiratory Syncytial Virus  
Biochimica Clinica
DOI: 10.19186/BC_2023.002
Pubblicato online il: 12.01.2022
Opinioni - Opinions
 
A “special dose” of ethics in forensic toxicology

Forensic toxicology is the branch of toxicology that applies the principles and knowledge of the latter to issues and problems related to the field of law enforcement officers, lawyers, judges, and juries. There is a need to establish specific codes, currently lacking, for forensic toxicologists, to guide them in situations where ethical issues are linked to the job the toxicologists carry out. To fill this gap, two international scientific societies: The International Association of Forensic Toxicologists (TIAFT) and the Society of Forensic Toxicologists (SOFT) decreed the same Code of Ethics indicating personal and professional behaviours to be followed by societies' members. The code details what it is intended for: professionalism, competency, proficiency, and clear communication of forensic toxicologists, trying to answer the ethical dilemmas, not yet encoded in official norms. Concerning toxicological and forensic analyses, necessary to support medical evidences, the knowledge of laboratory data uncertainty is mandatory to ensure the reliability of analytical results to be used in medico-legal contexts. Gathered together, all the discussed recommendations constitute the authors’ vision of “special dose” of ethics in forensic toxicolog

TAG: ethics   forensic toxicology   ethical code  
Biochimica Clinica
DOI: 10.19186/BC_2022.075
Pubblicato online il: 28.11.2022
Opinioni - Opinions
 
DOCUMENTI
Indicazioni per l’armonizzazione degli intervalli di riferimento nel monitoraggio terapeutico di farmaci antiepilettici
Recommendations for the harmonization of reference intervals in the therapeutic monitoring of antiepileptic drugs

Therapeutic monitoring (TDM) of antiepileptic drugs (AEDs), or antiseizure medicines (ASMs) represents a pragmatic approach to the management of patients with epilepsy to assess either compliance, efficacy and toxicity. Dose adjustments based on drug concentrations detected in biological fluids allow physicians to optimize and personalize the pharmacologic regimens for the single patient. TDM of AEDs has become increasingly popular since the 1970s because it is difficult to identify the optimal drug dose for each patient and because AEDs concentrations correlate better than dose with clinical effects. This document aims to suggest reference intervals to harmonize the pharmacokinetic activity among Italian Laboratories in the monitoring of AEDs plasma exposures according to recent international literature and guidelines. 

TAG: monitoraggio terapeutico   farmaci antiepilettici   intervalli di riferimento  
Biochimica Clinica
DOI: 10.19186/BC_2022.083
Pubblicato online il: 17.01.2023
Documenti - Documents
 
Big Data e Intelligenza Artificiale in Medicina di Laboratorio
Artificial intelligence and big data in laboratory medicine

In the last few years, artificial intelligence (AI) is gaining attention in several medical disciplines, including laboratory medicine (LM). The raised interest on AI has been fueled not only by the huge amounts of information daily generated, but also by the special natural context offered by laboratories, where digitalization have already occupied an important part of the routine workflow of patients’ data. Motivated by these topics and under the auspices of SIBioC, a conference on AI and big data was organized in May 2022 in Bologna, Italy. This conference covered several topics of AI and big data, including but not limited to the current and future perspectives, comprising ethical challenges and the role of laboratory specialists, including young professionals, the productive integration of AI with information technologies and with other digital infrastructure, such as the LOINC and the block chain. Furthermore, some examples of real application of AI in LM were reported, including diagnosis and monitoring of familiar hypercholesterolemia, management of insulin treatments for diabetes, reference intervals identification and verification by indirect methods, COVID-19 diagnosis and the monitoring of outpatients monoclonal gammopathy treatment by digital healthcare

TAG: etica   sistemi esperti   sistemi informatici di laboratorio.  
Biochimica Clinica
DOI: 10.19186/BC_2022.080
Pubblicato online il: 30.11.2022
Documenti - Documents
 
DOCUMENTI SIBioC
Variability of cardiac troponin levels in normal subjects and in patients with cardiovascular diseases: analytical considerations and clinical relevance. A consensus document by the Study Group on Cardiac Biomarkers from Italian Society of Biochemical Chemistry (SIBioC) and European Ligand Assay Society (ELAS)

In accordance with all the most recent international guidelines, the variation of circulating levels of cardiac troponins I and T, measured with high-sensitivity methods (hs-cTnI and hs-cTnT), should be used for the detection of acute myocardial injury. Recent experimental and clinical evidences have demonstrated that the evaluation of hs-cTnI an hs-cTnT variations is particularly relevant: for the differential diagnosis of Acute Coronary Syndromes in patients admitted to the Emergency Department (ED); for the evaluation of cardiovascular risk in patients undergoing major cardiac or non-cardiac surgery, and in asymptomatic subjects of the general population aged >55 years and with comorbidities; for the evaluation of cardiotoxicity caused by administration of some chemotherapy drugs in patients with malignant tumors. The aim of this document is to discuss the fundamental statistical and biological considerations on the intraindividual variability of hs-cTnI and hs-cTnT over time in the same individual. Firstly, it will be discussed in detail as the variations of circulating levels strictly depend not only on the analytical error of the method used but also on the intra-individual variability of the biomarker. Afterwards, the pathophysiological interpretation and the clinical relevance of the determination of the variability of the hs-cTnI and hs-cTnT values in patients with specific clinical conditions are discussed. Finally, the evaluation over time of the variation in circulating levels of hs-cTnI and hs-cTnT is proposed for a more accurate estimation of cardiovascular risk in asymptomatic subjects from the general population.

TAG: cardiovascular risk   biological variation   immunoassay methods  
Biochimica Clinica
DOI: 10.19186/BC_2023.005
Pubblicato online il: 25.01.2023
Documenti SIBioC - SIBioC Documents
 
La nuova equazione Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) senza la correzione per l’etnia per la stima del filtrato glomerulare: è applicabile in Europa? La posizione della European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
The new, race-free, Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equation to estimate glomerular filtration rate: is it applicable in Europe? A position statement by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

The EFLM recommends not to implement the race-free Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equation in European laboratories and to keep the 2009 version of the CKD-EPI equation, without applying a race correction factor. This recommendation is completely in line with a recent Editorial published by the European Renal Association who has also proposed to change to a novel equation only when it has considerably better performance, trying to reach global consensus before implementing such a new glomerular filtration rate (GFR) estimation equation. In Europe, this equation could be for instance the new European Kidney Function Consortium (EKFC) equation, which is population-specific, developed from European cohorts and accurate from in- fants to the older old. Beyond serum creatinine, the estimating equations based on cystatin C will probably gain in popularity, especially because cystatin C seems independent of race. Finally, we must keep in mind that all GFR equations remain an estimation of GFR, especially rough at the individual level. Measuring GFR with a reference method, such as iohexol clearance, remains indicated in specific patients and/or specific situations, and here also, the role of the clinical laboratories is central and should still evolve positively in the future.

TAG: chronic kidney disease epidemiology consortium (CKD-EPI)   equation   estimated glomerular filtration rate (eGFR)  
Biochimica Clinica
DOI: 10.19186/BC_2022.084
Pubblicato online il: 09.01.2022
Documenti SIBioC - SIBioC Documents
 
LETTERE ALL'EDITORE
Standardizzazione e armonizzazione dell’albuminuria: a che punto siamo?
M. Mussap  |  A. Carobene  | 
Biochimica Clinica
DOI: 10.19186/BC_2022.077
Pubblicato online il: 21.11.2022
Lettere all'Editore - Letters to the Editors
 
CASI CLINICI
Tempo di tromboplastina parziale attivato e carenza di precallicreina
Activated partial thromboplastin time and prekallikrein deficiency
M Gagliardi  |  L. Capone  |  A. Ciampa  | 

Prekallikrein (PK) is a contact factor of the intrinsic pathway of the coagulation cascade. Patients with PK deficiency usually do not show bleeding tendency despite prolonged activated partial thromboplastin time (aPTT). Here we report two cases of male patients in their seventies, both with a prolonged aPTT detected at a pre-operative screening. The aPTT correction after 1:1 mixing with normal pool plasma (NPP) indicated a coagulation factor deficiency; however,
factors XII, XI, IX and VIII activities were normal. The aPTT test was then performed increasing the pre-incubation time of the patient’s plasma. This resulted in a significant shortening of the aPTT. The PK deficiency was ultimately confirmed by direct measurement of PK plasma activity. This experience shows that PK deficiency should be considered for asymptomatic patients with prolonged aPTT and that, whenever a PK deficient plasma is not available, the diagnosis
can be correctly obtained through a simple modification of the procedure of the aPTT test.

TAG: precallicreina   tempo di tromboplastina attivato   fattori della coagulazione  
Biochimica Clinica
DOI: 10.19186/BC_2023.003
Pubblicato online il: 23.01.2023
Casi Clinici - Case Report
 
Due pazienti fragili in Pronto Soccorso: il ruolo del laboratorio nel monitoraggio della terapia con anticoagulanti orali ad azione diretta
Two frail patients in the Emergency Room: the laboratory role in the monitoring of the direct anticoagulants therapy

This case report is about two frail women admitted to the Emergency Room. The first patient, with a history of alcohol dependence, accessed to First Aid because of an accidental fall; she presented anemia, and elevation of the coagulation tests (prothrombin time 3.02; activated partial thromboplastin time 2.45). After the clinicians’ prescription for the measurements of coagulation factors, the FII was found significantly reduced (6%). Suspecting previous assumption of dabigatran (not declared at the admission), the laboratory decided to measure the plasma concentration of dabigatran, which resulted rather elevated (658 ng/mL). The second patient, aged 94, accessed to the first aid for anuria. Laboratory tests revealed severe anemia, kidney impairment and elevated coagulation tests. The patient was on dabitagran and verapamil. The dabitagran plasma concentrations were particularly elevated (1 224 mg/L. The dabitagran was discontinued in both patients and its plasma concentrations decreased rapidly; the coagulation tests returned to normal. Stroke prevention in elderly people with atrial fibrillation is of great importance, as stroke risk rises greatly with age. The elderly and frail patients have more favourable outcomes when on direct oral anticoagulant (DOACs). The use of these drugs in daily clinical practice does not require monitoring of coagulation. However, the measurement of DOACs is advisable in certain situations, as demonstrated in these two case reports, since elevated drug concentrations. pose the patients at an increased bleeding risk. Anticoagulant activity can be measured easily measured in laboratory practice, using specific coagulation assays developed for the quantification of DOACs plasma levels

TAG: DOAC   dabitagran   monitoraggio terapeutico dei farmaci  
Biochimica Clinica
DOI: 10.19186/BC_2022.080
Pubblicato online il: 28.11.2022
Casi Clinici - Case Report