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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

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


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

BC: Articoli scritti da D. Giavarina

Big Data e Intelligenza Artificiale in Medicina di Laboratorio
Artificial intelligence and big data in laboratory medicine
<p><span style="color:rgb(33, 29, 30); font-family:calibri,sans-serif; font-size:9pt">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&rsquo; 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</span></p>
Biochimica Clinica ; 47(1) 074-081
Documenti - Documents
Il laboratorio nello screening del diabete gestazionale
Laboratory screening of gestational diabetes
M. Carta  |  D. Giavarina  |  G. Bonetti  | 
<p>Gestational diabetes mellitus (GDM) is defined by glucose intolerance first documented during pregnancy. The oral glucose tolerance test (OGTT) is currently the gold standard for the diagnosis of gestational diabetes mellitus, but many variables can affect its reproducibility and accuracy. An important source of pre-analytical variation affecting the glucose values is the type of tube employed for blood collection. Experts recommend immediately separation of the plasma from the cells by centrifugation, or to place the sample tube in an ice-water slurry and separate the plasma from the cells within 30 minutes from blood drawing. Being this approach impractical in daily practice, the use of a blood collection tube containing effective glycolysis inhibitors is a good alternative to avoid the decrease of plasma glucose concentration after blood drawing. Considering that the GDM diagnosis is based on cut off values, the use of tubes for blood collection that limit the in vitro glycolysis, could lead to an increase of the GDM prevalence. The impact of the increase is potentially of clinical significance: it is therefore fundamental that clinicians are aware of the main causes of preanalytical variability and how these variables can affect the patients&rsquo; outcome. A strict collaboration between the clinical laboratories and clinicians should therefore be started and maintained.</p>
Biochimica Clinica ; 46(3) S076-S081
Opinioni - Opinions
Un utile riscontro occasionale di variante emoglobinica
Useful occasional report of a haemoglobin variant.
<p>HbA1c is a marker used for diagnosis and management of diabetes. The clinical case described here describes a patient with Impaired Fasting Glucose who requires the measurement of HbA1c in order to define his metabolic status. The capillary electrophoresis (CE) method used for the HbA1c measurement was unable to return a result for HbA1c because of an atypical pattern which required further investigations. The presence of haemoglobin variants can interfere analytically with HbA1c measurements; also abnormalities in erythrocyte turnover can affect the clinical interpretation of HbA1c values. Therefore, it is important to recognize the presence of a haemoglobin variant, to evaluate whether the result returned from the CE instrument is compatible with the patient&rsquo;s situation.<br />This case demonstrates the importance of implementing safety barriers to prevent errors arising from situations that, although already described and well known, may go unnoticed by the laboratory staff.</p>
Biochimica Clinica ; 46(2) e8-e10
Caso Clinico - Case Report
Adesione alle raccomandazioni dei gruppi di studio SIBioC-SIPMeL (Società Italiana di Patologia Clinica e Medicina di Laboratorio) e SID (Società Italiana di Diabetologia) sulla fase preanalitica per la determinazione della glicemia: ancora margini di miglioramento. Risultati di una indagine conoscitiva nazionale
Adherence to the recommendations of the SIBioC-SIPMeL (Società Italiana di Patologia Clinica e Medicina di Laboratorio) and SID (Società Italiana di Diabetologia) study groups on the preanalytical phase for blood glucose measurement: still room for improvement. A National Survey on the state of art.
A. Terreni  |  M. Carta  |  D. Giavarina  |  V. Miconi  |  A. Mosca  |  G. Bonetti  | 
<p>Introduction: glucose measurement is pivotal in the management of subjects with diabetes mellitus. Laboratories should provide the most useful information to the clinician in order to ensure the best patient outcome.<br />Methods: in October 2019 a survey has been conducted by SIBioC and SIPMeL Study Groups on &ldquo;Diabetes Mellitus&rdquo; and by the Italian Diabetes Society to verify if their recommendations on preanalytical phase have had an impact on Italian laboratory procedures. Fifteen questions were submitted to all SIBioC and SIPMeL members and 190 complete responses were collected, corresponding to around 5% of all Italian laboratories.<br />Results: 74% of the laboratories (n=46) are aware of the recommendations of the &ldquo;Diabetes Mellitus&rdquo; Study Groups, but only 24% apply them. 61% of the first group centrifuges the collection tubes immediately, providing a rapid plasma separation; 9% place the tubes immediately in an ice-water slurry and separate the plasma within 30 minutes. Only 14 of the responders use citrate buffer/sodium EDTA/sodium fluoride (NaF) tube in lyophilic formulation.<br />The survey allowed to determine also which kind of tube is commonly used: for outpatients, 52 (30%) laboratories use serum or heparinized tubes with separator gel, 46 (24%) of the remaining of laboratories use NaF plasma and heparinized plasma tubes. For hospitalized patients, 99 (52%) laboratories utilizes tubes with separator gel or coagulation activator, while 19 (10%) and 15 (8%) respectively use NaF plasma and heparinized plasma. To perform the Oral Glucose Tolerance Test (OGTT), 84 (43%) laboratories uses tubes without glycolysis inhibitors or separator gel, and only 12 laboratories uses tubes with acidified ternary mixture.<br />Conclusion: considering these non-completely satisfactory findings, the educational activity of SIBioC working groups on &ldquo;Diabetes Mellitus&rdquo; and &ldquo;Variability of Extra-analytical phase&rdquo; should be continued, since they appear to be essential for the improvement of the laboratory procedures.</p>
Biochimica Clinica ; 45(3) 248-257
Contributi Scientifici - Scientific Papers
Diagnosi, monitoraggio e prevenzione delle patologie renali
Biochimica Clinica ; 45(3) s005-s007
Editoriale - Editorial
Una nuova equazione dell’European Kidney Function Consortium per la stima della filtrazione glomerulare: implicazioni cliniche delle scelte del laboratorio
Biochimica Clinica ; 45(3) s100-s103
Lettere all'editore - Letters to the editor
Effetti della restrizione calorica sullo stress ossidativo nell'obesità: sono miglioramenti transitori?
Effect of caloric restriction on oxidative stress in obesity: are these transient improvements?
A. Bolner  |  A. Vanzo  |  D. Giavarina  |  G. Nordera  |  O. Bosello  | 
<p>Background: the effects of caloric restriction (CR) on oxidative stress in obesity has been previously studied using markers that not always were able to describe all the components of the oxidative-inflammatory picture.<br />Methods: in this study, the redox state of 20 obese was evaluated at baseline and after 30 and 60 days of CR using a complete panel of markers: the majority of them were determined using HPLC methods.<br />Results: before CR (V0), serum peroxides (dROMs) were very high, total antioxidant barrier (BAP) was at the lower limit of the reference interval and C-reactive protein (hsCRP) was increased; on the opposite, glutathione was well within the reference intervals in both total and reduced form. Despite the imbalance of the dROMs/BAP equilibrium, the markers of oxidative damage, such 3-nitrotyrosine (3NT) and 8-hydroxy-deoxyguanosine (8OHdG), index of a mild oxidative-inflammatory imbalance, were not particularly relevant.<br />After 30 days of CR (V30), in addition to the slight improvements of glucose, fructosamine and HOMA-IR, hsCRP was decreased, while BAP and total glutathione were increased, with consequent improvement of the oxidative stress-inflammatory balance (oxidative-inflammation). After 60 days of CR (V60) the improvements observed at V30 appeared to be slowing down for glucose and fructosamine, in slight inverse tendency for HOMA-IR and hsCRP, and decreasing for BAP and glutathione. The slight increase of inter-quartile range (IQR) of 3NT showed a lower counter-regulatory antioxidant response capacity, as if the ameliorative effects of CR in the first period had turned off.<br />Conclusion: the improvements of the oxidative-inflammatory equilibrium appear to be transient in the course of CR. The rearrangements of the gut microbiota during CR and the consequent epigenetic modulations could be responsible for this peculiar trend.</p>
Biochimica Clinica ; 44(3) 232-238
Contributi Scientifici - Scientific Papers
Gestire, integrare e comunicare l’informazione di laboratorio: il futuro della medicina di laboratorio
Biochimica Clinica ; 44(3) 217-218
Editoriale - Editorial
Una variante emoglobinica rara
A rare hemoglobin variant
<p>When arrived to our observation, BS was an African origin newborn of a few days. His hemoglobin concentration and complete blood count were within normal ranges, and he had no jaundice; however, his parents are heterozygous carriers of hemoglobin variant: HbC trait the mother and HbS trait the father. Screening was therefore required for hemoglobin variants. The request is appropriate since the evidence of a double heterozygosis S/C (SCD) would allow timely treatment of these patients. Screening was performed in capillary electrophoresis but was not conclusive because the presence of a small concentration of HbS and of another variant did us not allow to make a diagnosis, although the presence of HbA allowed to exclude the state of SCD. Hemoglobin electrophoresis was then performed, but it was not conclusive. It was necessary resorting to the molecular analysis, that highlights the presence of HbS trait and a mutation in heterozygosis at the charge of the gamma-globin chain consistent with HbF Granada. The recognition of HbF Granada was meaningless from a clinical point of view, but allowed to exclude the presence of a hemoglobin compound, the main clinical question of this clinical case.</p>
Biochimica Clinica ; 44(3) e020-e022
Casi Clinici - Case Report
Il tipo di campione per la curva da carico orale di glucosio è fondamentale per una corretta identificazione del diabete mellito gestazionale
An appropriate sample for oral glucose tolerance test is fundamental for a correct identification of gestational diabetes mellitus
<p>Background: Gestational Diabetes Mellitus (GDM) is diagnosed by the oral glucose tolerance test (OGTT) using Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study-derived definite cut-off values, where reference glucose is determined in sodium fluoride (NaF) containing tubes immediately centrifuged. The aim of the present study is to evaluate the effect of the use of the recommended citrate containing tubes, as immediate glycolisis inhibitor, for OGTT as screening for GDM, comparing them with NaF containing tubes, used in routine laboratory conditions.<br />Methods: a total of 83 pregnant women were enrolled in the study; OGTT (75 g) was carried out in the Clinical Laboratories of Brescia and Vicenza in all the subjects for screening of GDM. All subjects signed written informed consent to participate in the study. Glucose determination was performed using three different types of glycolysis inhibitor: [sodium fluoride (NaF, in both laboratories), a lyophilized acidified mixture (FC-MIX, in Vicenza), and a liquid acidified mixture (GlucoEXACT, in Brescia)]. The glucose concentration was measured by an hexochinase method on Dimension Vista systems from Siemens Healtheers. The International Association of Diabetes and Pregnancy Study Groups (IAPDGS) criteria, derived from the HAPO study, were used for the diagnosis of GDM.<br />Results: Using NaF and FC-mix tubes, 6/51 (11.8%) and 12/51 (23.5%) women respectively, were diagnosed having GDM in Vicenza. Using NaF and GlucoEXACT tubes 2/31 (6.5%) and 6/31 (18.8%) women respectively, were diagnosed having GDM in Brescia. There was a statistically significant difference (p&lt;0.05) between NaF and citrate acidified mixture in the glucose measurements at all time points.<br />Conclusions: The use of the tubes containing a mixture of NaF, EDTA and citrate is a useful and necessary pre-analytical tool for an accurate OGTT, when utilized for the screening of GDM. Tubes containing NaF alone should no longer be used for screening of GDM because their use results in underdiagnosis of GDM.</p>
Biochimica Clinica ; 44(2) 143-148
Contributi Scientifici - Scientific Papers
Impatto delle variabili preanalitiche e analitiche sulla diagnosi di diabete melito gestazionale
M. Carta  |  D. Giavarina  |  G. Bonetti  | 
Biochimica Clinica ; 44(2) 206-208
Lettere all'Editore - Letters to the Editor
Indagine conoscitiva sulla qualità del referto dell’esame emocromocitometrico
A survey on the quality of the hematological reporting among the Italian laboratories
<p>Introduction: the Working Groups &ldquo;Hematology&rdquo; and &ldquo;Extra-Analytical Variability&rdquo; of the Italian Society of Clinical Biochemistry (SIBioC) promoted a survey investigating the quality of the complete blood count reporting among Italian Laboratories.<br />Methods: the survey included 36 questions and was sent to all the SIBioC members. 251 laboratories participated in the survey.<br />Results: there is a full concordance in reporting the traditional parameters (leukocytes, erythrocytes and platelet count, hemoglobin, hematocrit and the calculated indices, plus the leukocytes differential count), while other relatively new parameters, like the mean platelet volume (MPV) and the platelet distribution width (PDW) are reported by 70% of the laboratories. A low percentage of laboratories (20-30%) do not report the presence of abnormal cell populations, if detected (blasts, immature granulocytes, plasma cells, prolymphocytes and erythroblasts). 70% of laboratories do not report the erythrocyte and leukocyte related parameters available on the new analyzers. Specific reference intervals for gender and age are adopted by 68% of the laboratories, but only 50% have instrument-specific intervals. 83% of the laboratories include interpretative comments in the report, but only in less than half of them these are harmonized according to the recent available recommendations. 83% of the laboratories have a shared document to manage critical values, that are communicated to the requesting physician by 90% of the laboratories.<br />Discussion: activities promoted by the SIBioC Hematology working group to harmonize the hematological report have been effective on traditional parameters reporting with a substantial improvement compared to the 2014 survey. Two issues remain however unresolved: the inclusion of interpretative comments and of the recent available parameters in the report.</p>
Biochimica Clinica ; 44(2) 129-142
Contributi Scientifici - Scientific Papers
Raccomandazioni per la rilevazione e la gestione dei campioni non idonei nei laboratori clinici
Recommendations for the detection and management of unsuitable samples in clinical laboratories
<p>A large body of evidence supports that quality improvement efforts tailored to the analytical phase only, are less likely to generate further clinical and economical progresses. Actually, most diagnostic errors made within the laboratory diagnostics emerge in the extra-analytical domains of testing, especially within the preanalytical phase. It is now clear that the underlying causes are most frequently due to system errors or to the implementation of poorly standardized procedures for collection, handling, transportation, preparation and storage of biospecimens. Some of these problems could generate a number of issues related to the quality of clinical samples, ending up with the reception by the laboratory of unsuitable samples. The identification and the management of unsuitable samples represent thus unavoidable practices in clinical laboratories to guarantee the quality of test results throughout the total testing process. Due to the ongoing evolution of the in vitro diagnostic market and the availability of new evidence, this paper provides a revision of the national recommendations issued by the Italian Society of Clinical Biochemistry and Clinical Molecular Biology in 2007 for detection and practical management of unsuitable specimens in clinical laboratories.</p>
Biochimica Clinica ; 44(2) 180-193
Documenti SIBioC - SIBioC Documents
Interferenza da biotina negli immunodosaggi: raccomandazioni del Gruppo di Studio SIBioC sulla Variabilità Extra-Analitica (SIBioC-VEA)
Biotin interference in immunoassays: recommendations of the SIBioC Working Group on Extra-AnalyticalVariability (WG-VEA).
<p><span style="background-color:rgb(255, 255, 255); color:rgb(51, 51, 51); font-family:sans-serif,arial,verdana,trebuchet ms; font-size:13px">Biotin is a water-soluble vitamin, which participates to a vast array of metabolic pathwaysinvolving fatty acids, carbohydrates and amino acids metabolism. This vitamin is also capable to form high-affinitybonds with various molecules, including streptavidin and avidin, which are essential components of manyimmunoassays based on the principle of biotin-streptavidin or biotin-avidin binding. In patients assuming high dosesof biotin, therefore, some competitive and non-competitive immunoassays may exhibit falsely increased and falselydecreased test results, respectively, with magnitude of interference depending on biotin concentration in the testsample and on specific vulnerability of the immunoassay. With the aim to provide some expert guidance foridentifying, preventing and managing biotin interference in clinical laboratory practice, this document contains a seriesof consensus recommendations endorsed by the Working Group on Extra-Analytical Variability of the Italian Societyof Clinical Chemistry and Clinical Molecular Biology (SIBioC). Briefly, the most important recommendationsencompass local evaluation of possible biotin interference, routine history taking on biotin intake for both inpatientsand outpatients, informing clinicians on potentially biotin-sensitive immunoassays, sample retesting 24-48 hours afterthe last biotin administration, along with possible consideration to add a note in the laboratory report highlighting themethods more vulnerable to biotin interference. Routine biotin measurement in all samples is currently discouraged.</span></p>
Biochimica Clinica ; 43(3) 327-331
Medicina di Laboratorio e Medicina d’Urgenza: il connubio continua
Laboratory medicine and emergency medicine: a perpetual relationship.
<p>The essential goals that laboratorymedicine shall pursue to adequately fulfill clinical needs can be summarized in delivering high quality information,availability of clinically usable tests and turnaround time. The governance of urgent laboratory testing encompassesa harmonious integration of clinical needs and laboratory organization. Clinical laboratories shall hence be morefocused on the pre-preanalytical phase, be involved in proactive efforts for standardizing pre-analytical and analyticalprocedures, optimize the post-analytical and post-post-analytical phases, thus providing a complete information andallowing the achievement of favorable outcomes. Throughout this ample and multifaceted process, the strictcooperation between laboratory professionals and emergency physicians is pivotal. As rationale follow-up of thecollective article published concomitantly with the first joint Academy of Emergency Medicine and Care (AcEMC) -Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) meeting, this new collective paperaims to summarize the topics discussed during the second joint event &ldquo;Laboratory Medicine and EmergencyMedicine: a resumed link&rdquo;, specifically including the governance of urgent tests, acid-base disorders, venousthromboembolism, acute heart failure, trauma, acute intoxications, viral diseases and other emerging infections.</p>
Biochimica Clinica ; 43(3) 296-304
Documenti - DOCUMENTS
Il consolidamento dei Servizi di Medicina di Laboratorio
Biochimica Clinica ; 43(2) 123-124
Editoriale - Editorial
La tele-ematologia nel consolidamento dei laboratori clinici
Tele-haematology in the consolidation of clinical laboratories
D. Giavarina  |  M. Carta  | 
<p>Haematological laboratory diagnostics couldbenefit widely from telematics, but some critical issues need to be addressed for a successful organization. Imagetransmission is probably the most critical item. In fact, specific competences are required for the selection of thesamples to be reviewed, preparing of the slides, choosing fields and cells to be examined, and so on. Thetransmission of the entire blood film could be a good solution, but it is not yet available for laboratory haematology,while expert automated systems are nowadays ready for high performance processes without the need of specificskills.<br />Digitization of laboratory haematology can harmonize the activities utilizing the same rules of selection of thepreparations to be reviewed, and for the control, verification and validation of the analysed samples and finally forreporting. It offers support for consultancy and training. When these needs involve different sites far from each other,the transmission of data and images effectively requires automation technologies for preparing and reading thepreparations, information technologies for an integrated management of all the necessary data helpful for thediagnosis and a suitable network to make communications travel in suitable quantities and speeds.<br />The new frontiers of artificial intelligence will probably have a greater role both in the management of process, in theverification of automatic validations, and finally in the recognition of pathological morphological patterns. All this toolscannot replace the specialized expertise in the final supervision of haematological diagnoses, but will allow simpler,faster and safer management of haematological analyses and revisions, meeting the changing needs of modernlaboratory medicine.</p>
Biochimica Clinica ; 43(2) 125-134
Rassegne - Reviews
Raccomandazione congiunta EFLM-COLABIOCLI per il prelievo di sangue venoso
Joint EFLM-COLABIOCLI Recommendation for venous blood sampling
<p>This document provides a joint recommendation for venous blood sampling of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) and Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI). It offers guidance on the requirements for ensuring that blood collection is a safe and patient-centered procedure and provides practical guidance on how to successfully overcome potential barriers and obstacles to its widespread implementation. The target audience for this recommendation are healthcare staff&nbsp;members directly involved in blood collection. This recommendation applies to the use of a closed blood collection system and does not provide guidance for the blood collection with an open needle and syringe and catheter collections. Moreover, this document neither addresses patient consent, test ordering, sample handling and transport nor collection from children and unconscious patients. The recommended procedure is based on the best available evidence. Each step was graded using a system that scores the quality of the evidence and the strength of the recommendation. The process of grading was done at several face-to-face meetings involving the same mixture of stakeholders stated previously. The main parts of this recommendation are: 1) Pre-sampling procedures, 2) Sampling procedure, 3) Postsampling procedures and 4) Implementation. A first draft of the recommendation was circulated to EFLM members for public consultation. WG-PRE-LATAM was also invited to comment the document. A revised version has been sent for voting on to all EFLM and COLABIOCLI members and has been officially endorsed by 33/40 EFLM and 21/21 COLABIOCLI members. We encourage professionals throughout Europe and Latin America to adopt and implement this recommendation to improve the quality of blood collection practices and increase patient and workers safety.</p>
Biochimica Clinica ; 43(2) 200-227
Appropriatezza degli esami di screening oncologici: il caso del antigene prostatico specifico
<p>Al congresso di &ldquo;Whatchamacallit&rdquo;, il moderatore termin&ograve; la presentazione e Tom Dick, professore ordinario di tutte le chirurgie possibili e immaginabili nella pi&ugrave; blasonata universit&agrave; europea sal&igrave; sul podio. Con forza espositiva senza pari e con una chiarezza di termini da rendere semplice anche il pi&ugrave; complicato e astruso degli argomenti al pi&ugrave; inetto degli esseri umani spieg&ograve;, in poche e taglienti diapositive, come il 70% degli interventi che tutti i chirurghi fanno quotidianamente in ogni regione e ospedale d&rsquo;Italia, d&rsquo;Europa, per non dire del mondo, fossero inutili; mostr&ograve; quanti esami istologici e autoptici gridavano all&rsquo;umanit&agrave; l&rsquo;inappropriatezza degli interventi condotti e delle scelte operative, e quante cistifellee, tonsille, linfonodi, appendici, noduli avrebbero potuto rimanere al loro posto senza alcun nocumento al paziente, anzi, e con grande risparmio di risorse per il sistema sanitario.&nbsp;</p>
Biochimica Clinica ; 42(4) 281-282
Editoriale - Editorial
Raccomandazioni per l’identificazione e la gestione dei risultati critici nei laboratori clinici
Recommendations for the detection and management of critical results in clinical laboratories
<p>Critical results, (also known as panic or alarm results) identify a laboratory test result associated with a serious risk for the patient&rsquo;s health, requiring immediate communication to the physician to establish appropriate therapeutic interventions. The adoption of an efficient procedure for the communication of critical values/results is crucial for clinical, ethical, organizational reasons, because it is a requirement for laboratory accreditiation and because of potential legal consequences related to the lack of notification of harmful laboratory results. In 2008, the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) published its first consensus-based recommendation for the detection and management of critical values in clinical laboratories, with the aim to improve the implementation of standardized and universally accepted procedures, promoting an essential policy toward rational and efficient solutions to this issue. These new recommendations represent a complete review of the first document. Using the same consensus conference method between experts of scientific societies, the main aspects of clinical risk, patient safety and legal liability of health care workers were re-considered. The SIBioC and the Italian Society of Laboratory Medicine (SIPMeL), Intersociety Study Group on Standardization of extra-analytical variability of laboratory results, together with the Italian Society of Ergonomics and Human Factors (SIE) collaboration, issued the present join document.</p>
Biochimica Clinica ; 42(2) 167-179
Documenti SIBioC - SIBioC Documents
Documento di consenso SIBioC-Medicina di Laboratorio e Academy of Emergency Medicine and Care (AcEMC) sull’utilizzo in Pronto Soccorso dei biomarcatori per la diagnosi di sepsi batterica
Biomarkers for diagnosing sepsis in the emergency department: a consensus document by SIBioCMedicina di Laboratorio and the Academy of Emergency Medicine and Care
<p>This article is drafted as a consensus document involving eight members of the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) and eight members of the Academy of Emergency Medicine and Care (AcEMC), to whom a questionnaire was submitted for obtaining opinions on some recommendations about the use of biomarkers for diagnosing sepsis and managing antibiotic therapy in the emergency department. These recommendations were drafted following the National Guidelines Program (PNLG). According to the cumulative consent, three &quot;A&quot; recommendations (strongly recommended indication) emerged, which include biomarker availability (always available on prescription), clinical use (always interpreted in according to clinical data) and timing of the request based on half-life of the analyte. Recommendations of type &quot;B&quot; (indications carefully considered) included a general agreement about the clinical usefulness of sepsis biomarkers, the combination of procalcitonin (PCT) and Creactive protein (CRP), the possibility to be free on prescription to the laboratory, the use of cut-offs favoring a high negative predictive value, the use of more analytically sensitive assays and the possibility of using PCT for monitoring antibiotic therapy, with timing of ordering defined according to the metabolism of the analyte. As regards the specific biomarkers, a similar &ldquo;B&rdquo; consensus has been reached for measuring both PCT and CRP, and for measuring lactic acid. The measurement of other biomarkers is discouraged except for presepsin, for which there is still substantial uncertainty in favor or against.</p>
Biochimica Clinica ; 42(1) 62-73
Documenti SIBioC - SIBioC Documents
Il laboratorio clinico nelle indagini tossicologiche
The role of clinical laboratory in toxicological investigations
<p>Clinical toxicology laboratory activities are carried out both for clinical purposes, providing support to the diagnosis and treatment of intoxicated patients, and for medico-legal aspects, providing data with value of judicial proof. The new Italian law (no. 41, March 23, 2016) considers vehicular homicide and road traffic injuries criminal offences to be severely punished, especially if the driver is under the influence of alcohol or psychotropic substances. Since toxicology results have an impact on administrative and legal decisions, analytical reliability and traceability of data, including the implementation of a chain of custody of samples, are crucial. Forensic toxicological analyses use conventional matrices (blood and urine) and alternative matrices (hair, saliva, sweat). To assess the current use of illicit drugs, blood is the matrix of choice because substance concentrations correlate with subject&rsquo;s physical and mental status at the time of collection. On the other hand, urine testing is simple, rapid and non-invasive. A positive result indicates that the substance assumption was from several hours to a few days prior to sampling. The hair matrix is suitable to identify past use or abuse and segmental hair analysis allows the reconstruction of the history of abuse. Analytical methods for alcohol and drugs of abuse include qualitative screening tests and quantitative confirmatory tests. A negative result of the screening test does not require further investigation, while a positive result cannot assume forensic value without confirmatory analysis. The use of mass spectrometry in combination with chromatographic or electrophoretic separation techniques for confirmatory tests has found the consensus of the international scientific community.</p>
Biochimica Clinica ; 41(3) 216-227
Rassegne - Reviews
Esami di laboratorio in Pronto Soccorso: una proposta di consenso SIBioC - Medicina di Laboratorio e Academy of Emergency Medicine and Care
Laboratory tests in the Emergency Department: a consensus document by SIBioC-Medicina di Laboratorio and the Academy of Emergency Medicine and Care
<p>Laboratory diagnostics in the emergency setting encompasses the identification of appropriate testing according to specific acute conditions. Since the pathway of ordering tests in the Italian Emergency Departments (EDs) is rather heterogeneous, SIBioC-Medicina di Laboratorio and the Academy of Emergency Medicine and Care designed a survey aimed to generate consensus pertaining to appropriate laboratory tests in most frequent acute conditions. A questionnaire including a panel of laboratory tests was administered to 8 representative members of each of the two societies, who were asked to provide a score between 1 and 3 for the various tests, where a score of 1 entailed &ldquo;highly recommended&rdquo;, 2 &ldquo;recommended in specific conditions&rdquo; and 3 identified &ldquo;highly discouraged&rdquo; tests. The results of the questionnaire are shown as mean (&plusmn;SD) of individual responses, thus allowing to define a scale of priority comprised between &ldquo;highly recommended&rdquo; and &ldquo;highly discouraged&rdquo;. Overall, 24 tests were classified as &ldquo;highly recommended&rdquo;, whereas 6 were &ldquo;highly discouraged&rdquo;. The remaining 16 tests were classified as &ldquo;somehow recommended&rdquo; or &ldquo;somehow discouraged&rdquo;. In the expectations of the two societies, this document may represent a first step towards harmonizing the laboratory test ordering in Italian EDs.</p>
Biochimica Clinica ; 41(2) 183-188
Documenti SIBioC - SIBioC Documents
Indagine conoscitiva su matrice biologica e gestione della fase preanalitica nei laboratori clinici
Indagine conoscitiva su matrice biologica e gestione della fase preanalitica nei laboratori clinici
<p>The vast majority of biochemistry tests is traditionally performed using either serum or heparinized plasma. Since little information is available on organization of clinical chemistry areas and type of biological samples used for this type of testing, the SIBioC Study Group on Extra-analytical variability planned a survey to be delivered to the members of the society. The questionnaire, consisting of 10 questions, was delivered by two newsletters and published on the SIBioC website for one month. Overall, 229 replies were collected from ~3000 society members. The most relevant aspect emerged from the survey was that serum not only was the most common biological matrix used for clinical chemistry tests (82% of responders), but it was also regarded as the ideal biological matrix (76% of responders). In 80% of cases, clinical chemistry testing was performed using blood collected in tubes containing a separator. Unlike ordinary testing, urgent analyses were performed using serum only in 58% of cases. The use of blood tubes with separator was also more frequent for urgent chemistry testing (64% of responders). A physical integration between clinical chemistry instruments was reported in approximately half of cases, whereas integration with preanalytical modules was reported to be slightly lower (45% of responders). The availability to change the biological matrix by the majority of responders demonstrates a substantial awareness that a major degree of harmonization should be pursued in the preanalytical phase.</p>
Biochimica Clinica ; 41(2) 142-147
Contributi scientifici - Scientific papers
Verifica locale dei sistemi di prelievo nei laboratori clinici: adattamento delle linee guida EFLM
Blood collection systems in clinical laboratories: local adaptation of the EFLM guidelines
<p>The importance of the process of purchasing or changing blood collection devices is often overlooked. This is likely attributable to many factors such as the limited knowledge that policymakers, healthcare administrators and also laboratory managers have on the significance of preanalytical quality, but also to the lack of validated criteria for analyzing the quality of blood collection devices. Since a gap remains to be filled between companies&rsquo; and laboratory&rsquo;s validation, the EFLM Working Group on Preanalytical Phase (WG-PRE) has published a comprehensive document, which contains essential prerequisites and technical issues (e.g., physical imperfections, defects of functioning, safety deficiencies) to support local clinical laboratories for the development of tenders for blood tubes and for the validation of new materials ahead of local routine use. This consensus document is a national adaptation of these guidelines.</p>
Biochimica Clinica ; 40(4) 347-352
Documenti SIBioC - SIBioC Documents
L’iniziativa dei laboratori della Regione Veneto “Passaggio al Litro”
"Switching to the Liter": the initiative of laboratories in Veneto Region
Biochimica Clinica ; 40(2) 166-167
Lettere all'Editore - Letters to the Editor
Il laboratorio nella terapia anticoagulante orale
The role of laboratory medicine in monitoring oral anticoagulant therapy
A. Tosetto  |  S. Testa  |  W Ageno  |  C. Legnani  |  O. Paoletti  |  M. Plebani  |  D. Poli  |  D. Giavarina  | 
<p>The oral anticoagulant therapy is used&nbsp;in the prevention and treatment of venous and arterial thromboembolism in many different clinical settings. For this&nbsp;purpose, vitamin K antagonists (VKA), which indirectly reduce the activity of factors II, VII, IX and X preventing the&nbsp;vitamin K-mediated carboxylation of specific glutamic acid residues, and direct oral anticoagulants (DOAC), providing&nbsp;direct inhibition of thrombin (factor IIa) or factor Xa, are available. The VKA monitoring represents a daily challenge for&nbsp;clinical laboratories, due to the increasing number of patients, frequency of needed controls and the management&nbsp;complexity. Several solutions have been proposed to improve the management of patients treated by VKA, such as&nbsp;surveillance in dedicated clinics and use of portable monitors to allow patient self-testing and self-management.&nbsp;Although DOAC have been declared not requiring a standard laboratory monitoring, laboratory testing for measuring&nbsp;drug anticoagulant activity is however needed in many situations, such as in case of bleeding or thromboembolic&nbsp;complications, surgery or invasive procedures, suspected overdose and drug interactions, noncompliance or presence&nbsp;of renal or liver disease.</p>
Biochimica Clinica ; 40(1) 13-20
Rassegne - Reviews
A multicentre observational study evaluating the effectiveness of a phlebotomy check-list in reducing preanalytical errors
<p>Several preanalytical errors are attributable to inappropriate or poorly standardized activities during the venous blood&nbsp;collection. We designed a multicenter observational study to establish whether the implementation of a phlebotomy&nbsp;check-list in 7 phlebotomy centers and 4 emergency departments is effective in reducing the rate of preanalytical&nbsp;errors related to the blood drawing. The investigation was divided in two 3-month periods during which 5 common&nbsp;preanalytical errors were systematically recorded. After the introduction of the phlebotomy check-list, the rate of&nbsp;preanalytical errors was significantly decreased in phlebotomy centers (0.04% vs. 0.05%, P=0.001), but remained&nbsp;unchanged in emergency departments (0.83% vs. 0.82%, P=0.84). A significant decrease was achieved for sample&nbsp;identification errors and clotted specimens in phlebotomy centers and emergency departments, whereas a significant<br />reduction in hemolysis was noticed only in phlebotomy centers. The rate of inappropriate filling and wrong containers&nbsp;remained unchanged. The results obtained in this study show that the introduction of a phlebotomy check-list may&nbsp;help in reducing preanalytical errors related to misidentification and undue clotting.</p>
Biochimica Clinica ; 39(6) 559-562
Contributi scientifici - Scientific Papers
Armonizzazione in Medicina di Laboratorio
Harmonization in Laboratory Medicine
F. Ceriotti  |  M. Panteghini  |  A. Tosetto  |  V. Valentini  |  L. Politi  |  R. Rolla  |  T. Guastafierro  |  T. Köken  |  E. Capoluongo  |  C. Mazzaccara  |  V. D'Argenio  |  V. D'Argenio  |  G. Lippi  |  M. Plebani  |  D. Giavarina  |  M. Berardi  |   A survey on sample matrix and preanalytical management in clinical laboratories  |  D. Bozzato  |  G. Messeri  |  M. Zaninotto  |  M. Vidali  |  A. Padoan  |  G. Parigi  |  A. Clerico  |  L. Sciacovelli  |  M. Ciaccio  |  G.L. Salvagno  |  G. Barberio  |  G. Barberio  |  G.L. Salvagno  |  M. Pepe  |  M. Panteghini  |  F. Braga  |  G. Gessoni  |  M. Montagnana  |  N. Doğan  |  M. Barberis  |  M. Barberis  |  A. Marchetti  |  F. Borrillo  |  L. Bonfanti  |  P.M. Ness  |  G. Messeri  |  S. Nannini  |  J. Queraltò  |  M. Zaninotto  |  A. Mosca  |  BM. Henry  |  G. Santini  |  A. Coglianese  |  V. D'Argenio  |  E. Fiorio  |  L. Crinò  |  M. A. V. Willrich  |  A. Modenese  |  M. Berardi  |  G. Nordera  |  M. Girelli  |  R. Tomaiuolo  |  D. Giavarina  |  R. Dittadi  |  L. Pighi  |  V. Guaraldo  |  G. Bambagiotti  |  E. Franceschini  |  R. Danesi  |  M. Locatelli  |  F. Balboni  |  D. Cosseddu  |  M. Savoia  |  S. Bernardini  |  C. Domenichini  |  M. Lamonaca  |  M. Perrone  |  M. Perrone  |   per il Gruppo di Studio Intersocietario SIBioC-SIPMeL Diabete Mellito  |  P. Pradella  |  A. Padoan  |  M.T. Sandri  |  L. Belloni  |  A. D'Avolio  |  T. Trenti  |  A. Fortunato  |  T. Trenti  | 
Biochimica Clinica ; 39(6) 546-547
Editoriale - Editorial
Armonizzazione in Medicina di Laboratorio
Harmonization in Laboratory Medicine
F. Ceriotti  |  M. Panteghini  |  A. Tosetto  |  V. Valentini  |  L. Politi  |  R. Rolla  |  T. Guastafierro  |  T. Köken  |  E. Capoluongo  |  C. Mazzaccara  |  V. D'Argenio  |  V. D'Argenio  |  G. Lippi  |  M. Plebani  |  D. Giavarina  |  M. Berardi  |   A survey on sample matrix and preanalytical management in clinical laboratories  |  D. Bozzato  |  G. Messeri  |  M. Zaninotto  |  M. Vidali  |  A. Padoan  |  G. Parigi  |  A. Clerico  |  L. Sciacovelli  |  M. Ciaccio  |  G.L. Salvagno  |  G. Barberio  |  G. Barberio  |  G.L. Salvagno  |  M. Pepe  |  M. Panteghini  |  F. Braga  |  G. Gessoni  |  M. Montagnana  |  N. Doğan  |  M. Barberis  |  M. Barberis  |  A. Marchetti  |  F. Borrillo  |  L. Bonfanti  |  P.M. Ness  |  G. Messeri  |  S. Nannini  |  J. Queraltò  |  M. Zaninotto  |  A. Mosca  |  BM. Henry  |  G. Santini  |  A. Coglianese  |  V. D'Argenio  |  E. Fiorio  |  L. Crinò  |  M. A. V. Willrich  |  A. Modenese  |  M. Berardi  |  G. Nordera  |  M. Girelli  |  R. Tomaiuolo  |  D. Giavarina  |  R. Dittadi  |  L. Pighi  |  V. Guaraldo  |  G. Bambagiotti  |  E. Franceschini  |  R. Danesi  |  M. Locatelli  |  F. Balboni  |  D. Cosseddu  |  M. Savoia  |  S. Bernardini  |  C. Domenichini  |  M. Lamonaca  |  M. Perrone  |  M. Perrone  |   per il Gruppo di Studio Intersocietario SIBioC-SIPMeL Diabete Mellito  |  P. Pradella  |  A. Padoan  |  M.T. Sandri  |  L. Belloni  |  A. D'Avolio  |  T. Trenti  |  A. Fortunato  |  T. Trenti  | 
Biochimica Clinica ; 39(6) 546-547
Editoriale - Editorial
L’appropriatezza in Medicina di Laboratorio
Appropriateness of test request
<p>Current pressures on the laboratory testing appropriateness are due to two main&nbsp;reasons: the difficulties in the sustainability of healthcare systems and the concerns about the harms of unnecessary&nbsp;treatments. There is growing evidence that many people are over-diagnosed and over-treated for a wide range of&nbsp;conditions and, consequently, a concern is growing about escalating healthcare spending; at the same time, there is&nbsp;an increasing effort to avoid harm when a patient is cared. However, large uncertainties remain about where and how&nbsp;the line between appropriate and inappropriate care should be drawn in individual cases. For laboratory tests, to&nbsp;distinguish between appropriate and inappropriate requests is even more difficult. In fact, the outcome deriving from&nbsp;performing or not a specific test depends non only on the quality of the test itself (right test, right patient, right time,&nbsp;right result, right decision levels, etc.), but also on the actions taken after the availability of results. An unnecessary test&nbsp;could be harmful for a false positive result, but even simply unhelpful or redundant. A lacking test is always dangerous,&nbsp;due to a possible delay in diagnosis or a misdiagnosis. Basic tests help physicians in formulating their clinical questions&nbsp;and represent a kind of &ldquo;biochemical&rdquo; patient examination. To evaluate the appropriateness of a test request, one can&nbsp;consider the pre-test probability of disease (avoiding to test if it is low) or we can apply an evidence-based medicine&nbsp;methodology to define the clinical question, searching and evaluating the available evidence, applying and finally&nbsp;auditing the effectiveness of the considered test.</p>
Biochimica Clinica ; 39(6) 609-616
Opinioni - Opinions
Casi clinici: un approccio nuovo per Biochimica Clinica, uno strumento utile per i professionisti di laboratorio
Case reports: a new approach by Biochimica Clinica, a useful tool for laboratory professionals
Biochimica Clinica ; 39(1) 015-016
Editoriale - Editorial
L’esame liquorale nella diagnosi di emorragia subaracnoidea
Cerebrospinal fluid (CSF) examination for subarachnoid hemorrhage (SAH) diagnosis
<p>SAH denotes a bleeding&#160;between the arachnoid membrane and the pia mater. In the first days following the event, the computed tomography&#160;(CT) recognises &gt;95% of SAH; however, this high sensitivity decreases with time. In two-three weeks, the CSF&#160;examination for the presence of hemoglobin (or its catabolite, bilirubin) becomes the most sensitive test for SAH&#160;diagnosis. Since the presence of hemoglobin in the CSF can be caused by traumatic collection, special attention should&#160;be paid to preanalytical conditions. Bilirubin gives a yellow colouring to CSF that can be detected by visual inspection.&#160;However, this colouring, also named xantochromia, could not be accurately perceived by the human eye. The 2008&#160;United Kingdom guidelines for SAH diagnosis are based on the spectrophotometric analysis of the CSF that represents&#160;at present the reference method. However, this procedure is complex, requires skilled specialists and a sufficient number&#160;of cases to maintain the competence. Furthermore, its availability as emergency test can be difficult. This is probably&#160;the reason why the vast majority of laboratories continue to evaluate the presence of xantochromia by visual inspection.<br />The automation of the bilirubin measurement on clinical chemistry analysers has been proposed. This method is&#160;certainly less accurate than spectrophotometric analysis; however, it can be performed on common analysers and made&#160;results available for emergency situations, with a short turnaround time.</p>
Biochimica Clinica ; 38(3) 191-197
Rassegne - Reviews
Malattie del sistema nervoso e laboratorio: molto più che un settore di nicchia
Neurological disease and laboratory: much more than a niche
Biochimica Clinica ; 38(3) 172-174
Editoriale - Editorial
La riduzione della pressione di aspirazione diminuisce l’emolisi nei prelievi da catetere intravenoso
Reducing stress shear may decrease hemolysis associated to intravenous catheter blood collection
<p>Blood&nbsp;collection through intravenous (IV) catheter is one of the most frequent causes of hemolysis and stress shear is&nbsp;reported to have an important role in that. Aim of this work was to determine whether the hemolysis rate of blood&nbsp;samples drawn through IV catheter may decrease by using 2.5 mL vacuum collection tubes instead of 5 mL tubes,&nbsp;currently in use. Consecutive samples collected at the emergency department to measure potassium using a 18&nbsp;gauge IV catheter were evaluated for the presence of hemolysis in the 5 mL lithium heparin with separator gel tubes.&nbsp;The same samples were retested in a similar tube with 2.5 mL aspiration volume, collected at the same time.&nbsp;Hemolysis was evaluated spectrophotometrically on Siemens Advia 2400 analyzer as hemolysis index (HI) in the&nbsp;same run on the two types of tubes for the potassium array. Using a 150 HI cut-off, 48 (6%) of the 798 5 mL&nbsp;specimens were hemolysed, with median HI of 278 (95% confidence interval: 228&divide;362, range 153&divide;1146). Using the&nbsp;2.5 mL tubes, only 6 samples of these 48 had an HI &gt;150 (P &lt;0.0001). On average, the percentage of reduction of&nbsp;HI values was 86% (range, 44&divide;98). These data confirm that shear stress due to the strength of aspiration is an&nbsp;important cofactor of the hemolysis induced by IV catheter. Last generation analyzers require few microliters of&nbsp;sample to perform a lot of tests. The use of tubes with lower filling volume and consequently lower negative pressure&nbsp;could reduce the rate of samples to be rejected for hemolysis that can delay patient care in overcrowded emergency&nbsp;departments.</p>
Biochimica Clinica ; 37(4) 283-286
Contributi Scientifici - Scientific Papers
Note metodologiche sull’acquisizione e sull’uso dei sistemi chiusi sottovuoto per il prelievo, il trattamento e la conservazione dei campioni ematici venosi destinati alla diagnostica di laboratorio
Methodological notes on acquisition and use of close evacuated systems for collection, handling and storage of venous blood samples for laboratory diagnostics
M. Plebani  |  M. Caputo  |  D. Giavarina  |  G. Lippi  | 
<p>Evacuated systems for collection of venous blood&nbsp;are integrated systems of medical and in vitro diagnostic medical devices regulated under European Directives and&nbsp;Italian Legislative Decrees. Both Directives and Decrees endorse the requirement that the whole combination of&nbsp;devices, representing an integrated apparatus, must be safe and not impair the specific performance of each single&nbsp;device. According to mandatory requirements, manufacturers must ensure full compatibility between each component&nbsp;of the system, while the users are responsible for verifying the compatibility of different devices in order to avoid&nbsp;potential quality and safety problems. The acquisition of various devices from different manufacturers may lead to&nbsp;combinations that are not validated by manufacturers themselves and are thus expected to be validated and verified&nbsp;by the users to demonstrate that the system remains safe and will not impair the performance of the individual&nbsp;elements. Therefore, the possibility of purchasing different devices separately should be carefully weighted in terms&nbsp;of risk-benefit, taking into consideration the additional costs of the validation/verification process that should be&nbsp;carried out by the potential user. Since preanalytical problems are the major source of errors in the total testing&nbsp;process, the selection and acquisition of close evacuated systems for blood collection should be considered a critical&nbsp;issue for assuring quality, safety and efficiency of the preanalytical phase of laboratory diagnostics and, therefore, of&nbsp;the total testing process.</p>
Biochimica Clinica ; 37(4) 303-311
Documenti SIBioC - SIBioC Documents
Proposta di una “checklist” per il prelievo di sangue venoso
Proposal of a checklist for venous blood collection
<p>The collection of venous blood is central in clinical laboratory&nbsp;activity. Although there is widespread perception that this practice is simple and free of complications and side effects,&nbsp;it is undeniable that the vast majority of laboratory errors arises from ignorance, incompetence or negligence during&nbsp;venipuncture. It has hence become advisable to prepare a document in simplified form of checklist, consisting of a&nbsp;concise but comprehensive list of activities to be completed or verified in order to prevent errors during venous blood&nbsp;collection. In the intention of authors, this synthetic checklist is a modular tool, adaptable to different local contexts,&nbsp;it can be easily and gradually implemented, it is supported by scientific evidence and consensus of experts and&nbsp;created with the support of different healthcare professionals and it is adherent to the best practices and requires&nbsp;minimal resources for implementation. It is reasonable to assume that this checklist may be able to withstand system&nbsp;and individual changes, strengthening the standards for safety of both operators and patients, limiting potential failure&nbsp;patterns. We hope that the checklist may be implemented in all healthcare facilities where routine venous blood&nbsp;collection is performed, after adaptation to suit characteristics of local organization.</p>
Biochimica Clinica ; 37(4) 312-317
Documenti SIBioC - SIBioC Documents
Casi clinici e medicina di laboratorio basata sulle prove
Evidence-based medicine (EBM) case reports in laboratory medicine
<p>Case reports are not a source of strong evidence for the EBM. Systematic reviews usually take into account all sources of evidence, but using a hierarchy for scientific publications, putting randomized controlled trials first, followed by nonrandomized trials, cohort and casecontrol studies, while case reports come last. However, the EBM movement soon has had to care not only of evidence theory, but also of the application to clinical practice, integrating the best external available evidence with the individual clinical expertise and patient expectations. To deal with the necessity to apply the research evidence to individual patients, in 1998 the British Medical Journal launched a new type of articles; the evidence-based case reports. These reports should attempt to show how evidence can be applied at all stages of patient care. Basically, case reports can have at least two fields of application in EBM, in addition to learning: in new cases due to the occurrence of unknown disease or use of new technologies and in adverse or rare events (for instance, unusual outcome or condition not considered by recommendations). As an example, the AIDS was first described in a case report on the American Journal of Dermatophatology. We use case reports every day, talking with our clinical colleagues, making a counselling or discussing on a mailbase list. Eventually, the diagnostic process can often be <br />compared to an investigation process, as Sherlock Holmes said (&#8220;There is nothing like firsthand evidence&#8221;). Case reports possibly are part of it.</p>
Biochimica Clinica ; 36(2) 121-125
Opinioni - Opinions
Raccomandazioni di consenso SIBioC-SIMeL per la rilevazione e gestione dei campioni emolisati e utilizzo dell'indice di emolisi
SIBioC-SIMeL consensus recommendations for the identification and management of hemolysed specimens and the implementation of hemolysis index
<p><strong>SIBioC-SIMeL consensus recommendations for the identification and management of hemolysed specimens</strong><br /><strong>and the implementation of hemolysis index.</strong> The presence of hemolysis in a biological blood sample is mainly<br />caused by hemolytic anemia or hemolysis in vitro. The latter is caused by inappropriate collection and processing of biological samples, which may affect the reliability of test results. Hemolysis is assessed by free hemoglobin quantification, whose limit is 0.02 g/L in plasma and 0.05 g/L in serum, and visually observed when the concentration of free hemoglobin exceeds 0.30 g/L. Since hemolysis is the most frequent cause of unsuitable biological samples in clinical laboratories, with a prevalence approaching 3% of all received samples, these recommendations have been drafted specifically to assist laboratory professionals in detection and management of hemolysed specimens. In summary, the recommended approach is based on: (i) systematic detection and quantification of hemolysis, by visual inspection and subsequent quantification of the hemolysis index on all samples with visually detectable hemolysis; (ii) immediate notification to the referring department of the presence of hemolysis in the sample, as locally determined; (iii) suppression of all results affected by the presence and/or degree of hemolysis; and (iv) timely request of a second sample, on which the previously deleted tests can be performed.</p>
Biochimica Clinica ; 35(6) 481-490
Equazioni per la stima della velocità di filtrazione glomerulare: lontani da un punto di arrivo
Equations for estimating glomerular filtration rate: far from an end point
<p>The recent position paper by the European Federation of Laboratory Medicine (EFLM) advises against following<br />the US recommendations on the use of the new race-free version of the Chronic Kidney Disease-Epidemiology<br />Consortium (CKD-EPI 2021) equation to estimate the glomerular filtration rate (eGFR). The main concern derives<br />from a possible poor CKD estimation, causing an underestimation of renal impairment for the Caucasian population,<br />and therefore for all Europeans. Considering the relevance of the EFLM indication, Biochimica Clinica published the<br />Italian translation of the document and an accompanying editorial suggesting that the European position could be an<br />end point for a better eGFR harmonization.<br />However, the use of different equations for eGFR in US and Europe will entail rather a worse harmonisation: the eGFR<br />values are used for patients enrolment in numerous clinical studies, for the admission to diagnostic procedures or<br />therapies and for the evaluation of their complications and adverse effects. As a consequence, many clinical trials will<br />not be comparable, guidelines and recommendations will be less easily transferable from one country to another and<br />the &quot;regionality&quot; of the equations will not slow down the search for new equations, for different groups and different<br />countries. With equally shared responsibility between US and Europe, this situation seems to be a paradigmatic<br />example of how recommendations in laboratory medicine should not be developed.<br />Nevertheless, the EFLM indication not to adopt the CKD-EPI 2021 race-free equation should be accepted for the<br />moment in Europe, since the harmonization between neighbouring and regional sanitary structures is a priority in the<br />patient care. It should be strengthened that the problem has not been solved yet, and that a greater harmonization<br />action must be rapidly sought, with the aim of a homogeneous calculation and reporting of this widely diffused estimate.</p>
Biochimica Clinica ; 17(1)
Opinioni - Opinions