Member area login
You don't have or don't remember the password!
Click Here
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 M.S. Graziani

Guida completa allo studio delle emoglobinopatie
Biochimica Clinica ; 46(2) 092-093
Editoriale -
Il ruolo della Bioetica nella Medicina di Laboratorio
Biochimica Clinica ; 45(4) 337
Editoriale - Editorial
Diagnosi, monitoraggio e prevenzione delle patologie renali
Biochimica Clinica ; 45(3) s005-s007
Editoriale - Editorial
Glossario di epidemiologia
Glossary of epidemiology
<p>The COVID-19 pandemic faces the reader of scientific papers with a variety of epidemiologic terms, often not familiar to the reader. A further problem is due to the incomplete standardization of those terms, that can assume partly different meaning in different settings. These problems can hamper the correct comprehension and interpretation of the data presented. These considerations represented the spur to formulate a glossary of the more common epidemiological terms, mainly using the COVID-19 epidemics as example, but taking into account also other infectious diseases and chronic non-infectious diseases as well. To facilitate the reading of the vast majority of papers, which are written in English, the corresponding English terms are reported.</p>
Biochimica Clinica ; 45(2) 180-195
Documenti - Documents
Il percorso comune europeo per la formazione degli specialisti in Medicina di Laboratorio: un traguardo sempre più vicino
Biochimica Clinica ; 45(2) 107-108
Editoriale - Editorial
Temi etici in Medicina di Laboratorio
Biochimica Clinica ; 45(2) 105-106
Editoriale - Editorial
Revisione e aggiornamento del documento di consenso SIBioC per la ricerca e quantificazione della proteina di Bence Jones
Update of the Italian Society of Clinical Biochemistry (SIBioC) Consensus document on the detection and quantification of the Bence Jones protein
<p>Bence Jones protein (BJP) refers to urine monoclonal free immunoglobulin light chains produced by the clonal expansion of a plasma cell in the bone marrow. BJP is strongly associated with systemic amyloidosis AL, light chain deposition disease, and multiple myeloma; less frequently, BJP may be recognized either in patients with monoclonal gammopathies of uncertain significance (MGUS) and with other plasma cell dyscrasias or in patients with malignant non-Hodgkin&#39;s lymphomas and chronic lymphocytic leukemia. This paper contains updated recommendations for the detection and the measurement of BJP in clinical practice from the Working Group &ldquo;Proteins&rdquo; of the Italian Society of Clinical Biochemistry (SIBioC), with specific indications for improving all the steps of the preanalytical, analytical, and postanalytical phases. The first morning void is the urine sample recommended for BJP detection, while 24-hours urine collection is preferred for BJP quantification. Native urine cannot be used for samples with low or very low content in urine total protein; in these cases, samples should be concentrated by using specific disposables, such as ultrafiltration membranes retaining proteins with molecular weight around 10 kDa. The required degree of concentration may vary according to sensitivity of the electrophoretic method utilized and the protein content of the sample. The detection of BJP may be performed directly by the recommended method agarose gel immunofixation (IFE) with specific polyvalent immunoglobulin antisera IgG-IgA-IgM, total  and  light chains; alternatively, an electrophoretic screening may be acceptable to rule out negative test results. However, positive test results should be confirmed by IFE. Tests based on immunometric methods can be used neither as screening test, nor for the BJP quantification; however, it could be useful for monitoring purposes, provided that the renal function of the patient is preserved. BJP measurement should be performed by the densitometric scanning of the electrophoretic peak corresponding to BJP, and results should be expressed as ratio of the BJP peak percentage to the urine total protein. Test results should be always integrated by standardized interpretative comments included in the laboratory reports.</p>
Biochimica Clinica ; 45(1) 075-086
Documenti SIBioC - SIBioC Documents
Al “cuore” del quadro clinico di COVID-19
To the “heart” of the clinical picture of COVID-19
<p>Several studies document cardiac involvement in COVID-19 patients, as evidenced by cardiac biomarkers elevation. Hospitalized patients with cardiac involvement have a poorer prognosis, in terms of need for intensive care unit, or mortality. This paper provides a review of the wealth of literature on heart involvement in COVID 19. The majority of the available papers reports data from the Chinese experience and it is not clear at the moment whether the observations are related to really different populations of patients. The mechanism of the cardiac injury is likely multifactorial. There could be direct myocardial damage by the virus, but the few heart histologic specimens available do not evidence the presence of virus RNA in myocytes. The infection in the lungs may produce a cytokine storm which in turn could damage myocytes. Coagulation system is also affected by COVID-19: D-dimer is increased, while platelets are reduced in most studies, and both parameters relate directly with the risk of death. These alterations are probably the cause of the many cases of pulmonary embolism, venous thromboembolisms, and arterial embolism reported. Hypertension and previous cardiovascular diseases are also likely involved in the severity of the observed cardiac injury. Although all these mechanisms may play a role in cardiac involvement, the severe lung infection alone could justify cardiac damage, due to the simultaneous reduced supply and increased demand of myocardial oxygen. We still know very little about this new viral disease, but as knowledge is accumulating, the medical community will pinpoint the mechanism of cardiac involvement and find the optimal strategy to prevent its severe consequences.</p>
Biochimica Clinica ; 44(4) 019-020
Presentazione del Supplemento
Biochimica Clinica ; 44(4) 000-000
Il contributo del laboratorio alla corretta gestione del paziente in terapia ipolipemizzante: le raccomandazioni di EFLM e della Società Europea di Aterosclerosi (EAS)
Biochimica Clinica ; 44(3) 287-289
Documenti SIBioC - SIBioC Documents
IFCC Task Force on COVID-19
Biochimica Clinica ; 44(2) 209
Notizie SIBioC - SIBioC News
La Medicina di Laboratorio nella pandemia da SARS-CoV-2
Biochimica Clinica ; 44(2) 115
Editoriale - Editorial
Troponine cardiache: attualità analitiche e prospettive di applicazioni cliniche
Biochimica Clinica ; 44(2) S005-S007
Editoriale - Editorial
Gammopatie monoclonali: quadri clinici principali e ruolo del laboratorio
Monoclonal gammopathies: main clinical pictures and role of the clinical laboratory
F. Adami  |  T. Berno  |  M. Riva  |  F. Lessi  |  M.S. Graziani  | 
<p>The finding of a monoclonal gammopathy both by chance and upon clinical suspicion is becoming more and more frequent and requires in-depth clinical, laboratory and instrumental analyses in order to establish the underlying disease, if any. In the last two decades the improvement of the diagnostic tools has led to the identification and precise definition of several clinical entities pathogenetically linked to the monoclonal gammopathy, thus shrinking the field of the &quot;monoclonal gammopathy of undetermined significance&quot;. Such a striking improvement relies on the increasing sensitivity and accuracy of old analyses and availability of new ones (such as the serum Free Light Chain assay). Currently, data from the clinical biochemistry laboratory provide important clues to the diagnosis and prognosis, and are also crucial for monitoring the therapy. These new achievements, along with the availability of new therapeutic options, allowed a significant, sometimes dramatic improvement of the prognosis of many of the gammopathy-related diseases. In this review the main clinical pictures are described along with the contribution of the clinical biochemistry laboratory to the definition of the diagnosis, the risk profile and the monitoring of the specific diseases.</p>
Biochimica Clinica ; 43(4) 366-383
Rassegne - Reviews
Il consolidamento dei Servizi di Medicina di Laboratorio
Biochimica Clinica ; 43(2) 123-124
Editoriale - Editorial
In memoria del Professor Howard A. Morris
Biochimica Clinica ; 43(2) 248
Notizie SIBioC - SIBioC News
In ricordo di Jillian (Jill) Tate
In memory of Jillian (Jill) Tate
Biochimica Clinica ; 43(1) 115-117
Notizia SiBioC - News SIBioC
Nota all'Editoriale sul Documento della Organizzazione Mondiale della Sanità
Biochimica Clinica ; 43(1) 013
Editoriale - Editorial
Il documento dell’Organizzazione Mondiale della Sanità sulla diagnostica in vitro: una riflessione critica è necessaria
<p>Nello scorso mese di maggio, l&rsquo;Organizzazione Mondiale della Sanit&agrave; (OMS) ha reso disponibile un documento denominato &ldquo;Model List of Essential in Vitro Diagnostics&rdquo; che costituisce un catalogo degli esami di laboratorio che dovrebbero essere universalmente disponibili per la diagnosi e la cura delle pi&ugrave; comuni condizioni cliniche. La pubblicazione di questo documento deve senza dubbio essere salutata come un importante contributo al processo che impegna i governi alla costruzione del repertorio degli esami di laboratorio di base (essenziali), che dovrebbero essere disponibili in ogni tipologia di servizio sanitario e affianca il &ldquo;WHO Model List of Essential Medicines&rdquo; che &egrave; il corrispondente catalogo dedicato ai farmaci.&nbsp;Il documento ha il pregio di riconoscere alla diagnostica di laboratorio un ruolo essenziale per le tre priorit&agrave; strategiche del WHO: migliorare la copertura sanitaria universale, affrontare le emergenze sanitare e promuovere popolazioni pi&ugrave; sane. Una attenta lettura del documento rivela tuttavia alcune criticit&agrave; che ci sembra necessario portare alla attenzione dei laboratoristi Italiani, dopo essere stato oggetto di riflessioni analoghe a livello internazionale.</p>
Biochimica Clinica ; 42(4) 283-284
Editoriale - Editorial
Specifiche di qualità, terminologia e definizione dei metodi di misura delle troponine cardiache Ie T
Quality specifications, terminology and definition of the methods for the measurement of cardiac troponins
<p>All guidelines recommend that cardiac troponin I (cTnI) and T (cTnT) should be considered the preferred biomarkers for the differential diagnosis of acute coronary syndrome (ACS), and also that the 99th upper reference population limit value for cardiac troponins should be measured with an imprecision &le;10 CV%. However, only after the year 2006, some cTn methods showed analytical performances in accordance with the quality specifications required by guidelines. The cTn methods with the best analytical performances (currently named &ldquo;high-sensitivity&rdquo; methods) should be preferred for the early diagnosis of ACS and also for risk stratification of cardiovascular disease both in general population and cardiac patients. The most recent international guidelines recommend that two basic criteria are needed to define the characteristics required for cTn immunoassays in order to be defined as &ldquo;high-sensitivity&rdquo; methods. The first criterion is that the total imprecision (CV) at the 99th percentile value should be &le;10%. The second criterion is that these methods should measure cTn concentrations at least in 50% (and ideally &gt;95%) of both healthy adult men and women with value above the assay&rsquo;s limit of detection. The aim of this SIBioC document is to discuss some critical aspects related to definition of &ldquo;high-sensitivity&rdquo; cTn methods, including: analytical performance, pathophysiological interpretations, and clinical relevance of &ldquo;high-sensitivity&rdquo; cTn assays with particular attention to routine practice of clinical laboratories in Italy, recommending the use of an accurate terminology to avoid the usage of potentially misleading terms.</p>
Biochimica Clinica ; 42(4) 335-342
Documenti SIBioC - SIBioC Documents
Il Syllabus di EFLM per la formazione post-laurea dei professionisti Europei: una preziosa opportunità per la definizione a livello europeo dello Specialista in Medicina di Laboratorio
<p>Biochimica Clinica propone in questo numero la traduzione della versione 5 del Syllabus (4), il cui testo originale &egrave; accessibile come materiale supplementare sul sito delle rivista (1S). La versione corrente, rispetto alla precedente, dettaglia maggiormente i requisiti all&rsquo;interno delle singole discipline e vi aggiunge le tecniche analitiche innovative e la conoscenza delle tecniche statistiche. Viene anche proposta una struttura per il percorso di formazione nonch&eacute; le rispettive responsabilit&agrave; del discente e dei docenti. Questo &ldquo;log book&rdquo; &egrave; pure disponibile come materiale supplementare sia nella versione originale (2S) che nella traduzione Italiana (3S). Questa posizione ufficiale di EFLM intende essere di supporto per il CTF, e agli obiettivi della direttiva, nella salvaguardia della mobilit&agrave; professionale all&rsquo;interno dei Paesi europei, in un momento storico nel quale si assiste ad un aumento della domanda di professionisti qualificati accompagnata peraltro da una diseguale distribuzione degli stessi (5). La traduzione del Syllabus &egrave; preceduta da una presentazione di Gilbert Wieringa, Chair del Profession Committee di EFLM.</p>
Biochimica Clinica ; 42(3) 189-190
Editoriale - Editorial
Procalcitonina: una palestra metodologica
Procalcitonin: a methodology training ground
Biochimica Clinica ; 42(2) 095-096
Editoriale - Editorial
Saluto del Direttore
Biochimica Clinica ; 42(1) 14
Editoriale - Editorial
Linee guida per la valutazione del rischio cardiovascolare: siamo a rischio di confusione?
Guidelines for cardiovascular risk assessment: do we risk an overcrowding?
<p>Cardiovascular diseases are highly prevalent in Western countries. Among modifiable risk factors for cardiovascular events, dyslipidaemias have a predominant role, being conveniently controlled either by a healthy lifestyle or by drugs, when necessary. A number of guidelines have been issued to guide both clinicians and laboratorians to assess the cardiovascular risk and to provide the best patient management. Guidelines accumulated and evolved with time, incorporating new available evidence; however, differences among them could generate disorientation among health professionals. The recent recommendations by the American College of Cardiologists and the American Heart Association are a breaking point in the guideline history, mainly because of the suggestion of abandoning the therapeutic LDL cholesterol targets. In this paper, we illustrate available guidelines, emphasizing the different approaches to risk prediction. The possible adoption of the recent American guideline will pose problems to both clinicians and clinical laboratories. The number of subjects to be treated would markedly increase and the lack of therapeutic targets could hamper the possibility to share with patients the targets to fulfil, jeopardising their compliance. For laboratories, the major issue would be the difficulty to report lipid results according to targets adjusted to risk levels. In an opposite direction, a recent national consensus document suggests adopting in reporting lipid results the desirable lipid levels as established by European recommendations.</p>
Biochimica Clinica ; 41(1) 085-095
Opinioni - Opinions
La diagnostica di laboratorio delle dislipidemie
The laboratory diagnosis of dyslipidemia
<p>Dyslipidemias represent a major contributor to cardiovascular risk in Western countries, including Italy, that can be modified. After examining familial dyslipidemias and describing the essential issues for clinical and laboratory diagnostics, the paper considers the laboratory testing in detail. The preanalytical sources of variability (biological, sample collection and handling) are reviewed and essential indications to reduce them are given. About the analytical variability, the paper examines the methods routinely used for measuring the basic lipid parameters (total, LDL and HDL cholesterol, triglycerides and apolipoproteins A-I and B) and describes the state of art of the standardization of these analytes. The last section of the document deals with the reporting of laboratory results. The main indications of the document are the following: a) report the desirable values established by the European guidelines besides the measured concentrations; b) make always clear that the reported values are decisional cut points and not reference limits; c) add a note stating that the reported desirable values refer to individuals at low risk; d) report as critical values lipid concentrations deserving rapid clinical attention, i.e., total cholesterol, &ge;8,00 mmol/L (310 mg/dL); LDL cholesterol, &ge;4,90 mmol/L (190 mg/dL); triglycerides, &ge;10,0 mmol/L (880 mg/dL).</p>
Biochimica Clinica ; 40(4) 338-346
Documenti SIBioC - SIBioC Documents
Come interpretare correttamente il valore di P?
Understanding the P value
<p>A number of recent contributions about the P value in statistics gave the spur to&nbsp;consider different aspects of its use in scientific papers. There is indeed a need of correct information on how and&nbsp;when to apply the P value to evaluate results of a scientific experiment and how to appropriately interpret the&nbsp;numerical value as well, considering that the P statistic is rather frequently reported in the medical literature. In this&nbsp;paper we first described the origin of the P value and its correct significance, using examples where the statistical&nbsp;significance of the P value does not necessarily mean a clinical significance. Then, we defined which kind of&nbsp;assumptions cannot be drawn from the a P value. The most common misuse is when a non-statistically significant P&nbsp;value is used to establish that two laboratory techniques are equivalent. Finally, some alternatives are given, the most&nbsp;common being the use of the confidence intervals. In spite of the interpretation mistakes commonly observed in&nbsp;scientific articles, the P value remains a useful statistic tool to be utilized and interpreted with better consciousness.</p>
Biochimica Clinica ; 40(1) 40-44
Opinioni - Opinions
La diagnostica di laboratorio della malattia renale cronica in Italia: armonizzare è d’obbligo
The laboratory role in chronic kidney disease (CKD) in Italy: need of harmonization
<p>The diagnosis and&nbsp;classification of CKD are based on laboratory tests. Aim of this paper is to examine different aspects of the laboratory&nbsp;contribution to verify their harmonization at national level. We review relationships between laboratory and clinical&nbsp;organizations, the role of 2012 Kidney Disease Improving Global Outcomes (KDIGO) guidelines, the quality of&nbsp;creatinine and urine albumin measurements, the status of estimated glomerular filtration rate (eGFR) reporting, the use&nbsp;of cystatin C and testing plans. Questionnaires examining different aspects of the CKD diagnostics were sent out and&nbsp;EQAS for creatinine and urine albumin measurements were carried out. For creatinine measurement, enzymatic&nbsp;assays show the best performance, while for urine albumin a bias still exists between different methods. The eGFR is&nbsp;routinely reported by 75% of surveyed laboratories, but only 15% of them use the equation derived by the CKDEpidemiology&nbsp;Collaboration (CKD-EPI) study. For urine albumin, the recommended first morning void sample is used&nbsp;by ~60% of laboratories, but the wrong terminology of &ldquo;microalbuminuria&rdquo; is still used by &gt;40% of them. Cystatin C is&nbsp;offered by a minority of laboratories. In conclusion, even if an improvement can be observed during the recent years,&nbsp;efforts for a better alignment to international recommendations are needed. Often they just require cultural and&nbsp;organizational changes, without the availability of additional economic resources.</p>
Biochimica Clinica ; 39(6) 617-626
Opinioni - Opinions
Valutazione dell’impatto delle raccomandazioni del Gruppo di Studio SIBioC Proteine sull’operatività dei laboratori italiani
Evaluation of the impact of recommendations by the SIBioC Proteins Study Group on Italian laboratory procedures
<p>Protein diagnostics is central in the management of subjects with monoclonal gammopathy. Laboratory&nbsp;should provide the most useful information to ensure the best patient outcome. To assess if recommendations issued&nbsp;after the 2007 survey have impacted on Italian laboratories contributing to a better harmonization of the post-analytical&nbsp;phase, the SIBioC Proteins Study Group has repeated a similar survey in February 2015. Twenty questions were&nbsp;electronically submitted to all SIBioC members using the software &quot;Survey monkey&quot;. 103 responses were collected,&nbsp;corresponding to ~6% of Italian laboratories. 47% of laboratories add an appropriate comment to the serum protein&nbsp;electrophoresis report when no monoclonal component (MC) is detected (36% in 2007). MC are correctly defined by&nbsp;63% of the laboratories; however, 11% reports MC as &ldquo;thickening&rdquo; or &ldquo;asymmetry&rdquo; or &ldquo;homogeneous peak&rdquo;. These&nbsp;ambiguous terms were used by roughly the same percentage (14%) in 2007. In 2015, the number of laboratories&nbsp;performing a MC typing only when requested by the clinician is reduced by 10% when compared to 2007. In both&nbsp;surveys, the percentage of laboratories performing and reporting the MC quantification is 77%. The worse results were&nbsp;obtained for Bence Jones protein (BJP) determination (not investigated in 2007): only 66% of laboratories utilize the&nbsp;immunofixation to detect the BJP and 57% do not quantify the protein. Although some progresses in harmonization of&nbsp;reporting are observed in CM testing over years, there is still room for significant improvement.</p>
Biochimica Clinica ; 39(6) 585-590
Contributi scientifici - Scientific Papers
L’aggiornamento dei criteri per la diagnosi di mieloma multiplo da parte dell’“International Myeloma Working Group”
The update of the criteria for the diagnosis of multiple myeloma by the International Myeloma Working Group (IMWG)
<p>The IMWG has recently updated the disease definition of multiple myeloma, by adding validated biomarkers&nbsp;to the existing requirements of organ damage (hypercalcemia, renal insufficiency, anemia, bone lesions). These&nbsp;changes are based on the identification of biomarkers able to detect the subset of patients with smouldering multiple&nbsp;myeloma at imminent risk of developing organ damage and should, therefore, be considered for therapy. Considering&nbsp;that the clinical laboratory is involved in the measurement of these new markers, this paper is aimed to illustrate the&nbsp;proposed changes giving at the same time some indications for their accurate measurements. As for the organ&nbsp;damage, the major change is related to the evaluation of renal function: the new criteria include the estimation of the&nbsp;glomerular filtration rate using established formulas (eGFR) rather than the use of serum creatinine concentrations&nbsp;alone, as previously indicated. The diagnosis of renal insufficiency requires an eGFR &lt;40 mL/min/1.73 m<sup>2</sup>. The&nbsp;criteria for anemia and hypercalcemia remain unchanged. As biomarker of malignancy, a ratio &gt;100 of involved to&nbsp;uninvolved serum free light chains is recognized. Another relevant modification is the elimination of the monoclonal&nbsp;protein quantification; it is based on the consideration that an important percentage of patients with multiple myeloma&nbsp;does not show a serum or urine monoclonal protein. Other changes based on imaging techniques or bone marrow&nbsp;examination do not involve the clinical laboratory and are not discussed in this paper. Additional biomarkers will&nbsp;probably be indentified in the near future, but they need to be validated by more independent studies.</p>
Biochimica Clinica ; 39(4) 275-280
Opinioni - Opinions
1st EFLM Strategic Conference ‘Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine’
Biochimica Clinica ; 39(1) 078-079
Notizie SIBioC - SIBioC News
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
Glossario per il lettore di un articolo scientifico. Parte III: la meta-analisi
Glossary for the reader of a scientific paper. Part III: the meta-analysis
<p>This document represents the third part&nbsp;of the project related to a glossary for statistics. The meta-analysis is the technique used to integrate the results from&nbsp;a number of different studies in only one quantitative evaluation to obtain conclusions that are stronger than those&nbsp;obtained from single studies. The meta-analysis is actually useful when the available studies are inadequately&nbsp;powerful because performed in a limited number of patients or when the results from single studies are discordant.&nbsp;The document includes statistical terms of more common use. To facilitate the reading of the vast majority of articles,&nbsp;which are written in English, corresponding English terms are also reported.</p>
Biochimica Clinica ; 38(6) 630-638
Documenti - Documents
Glossario per il lettore di un articolo scientifico. Parte II: la statistica inferenziale
Glossary for the reader of a scientific paper. Part II: inferential statistics
<p>This document represents the second&nbsp;part of the project related to a glossary for statistics. The inferential statistics is the part of the statistic used to&nbsp;formulate statements about the characteristics of a population from a sample of it, selected randomly. The document&nbsp;includes statistical terms of more common use. To facilitate the reading of the vast majority of articles, which are&nbsp;written in English, corresponding English terms are also reported.</p>
Biochimica Clinica ; 38(4) 314-325
Documenti - Documents
Valutazione delle caratteristiche analitiche di un nuovo strumento per l’elettroforesi capillare delle proteine sieriche
Evaluation of the analytical performance of a new capillary electrophoresis system for serum protein analysis
<p>Electrophoresis techniques are used in clinical laboratories to detect, type and quantify monoclonal&nbsp;components (MC), and are therefore of pivotal importance in the management of patients with monoclonal&nbsp;gammopathies. Capillary electrophoresis (CE) is an attractive alternative to agarose gel electrophoresis (AGE)&nbsp;because it offers a higher degree of automation without requiring the use of toxic reagents. Aim of this study was to&nbsp;evaluate analytical characteristics of a recently marketed instrument for CE, comparing it with both a well established&nbsp;CE and with AGE. The new system (V8, Helena Biosciences) was compared for MC detection with Capillarys (Sebia)&nbsp;and for typing with both the AGE Hydrasys system (Sebia) and the immunosubtraction technique on Capillarys. All&nbsp;the evaluated analytical characteristics were related to MC investigations, i.e. detection, typing and quantification. The&nbsp;interference effect of some substances and the carryover were also investigated. For MC detection, an agreement of&nbsp;98.5% has been demonstrated between the two CE systems; the discordant samples show a MC &lt;1 g/L. The limit of&nbsp;detection for a MC was 0.5 g/L. A total agreement in the typing of MC &gt;5 g/L between the two CE systems was&nbsp;observed. V8 was able to correctly characterize 18 MC with concentration &lt;5 g/L out of 20 samples typed by AGE&nbsp;immunofixation. V8 can quantify MC with elevated precision (CV 3,5% and 1,2% for <span style="font-family:symbol">b</span>- and <span style="font-family:symbol">g</span>-zone MC, respectively)&nbsp;and the measurement is linear till &lt;1 g/L. Fibrinogen and contrast media appear in the CE patterns as homogeneous&nbsp;bands MC like. From these results, we conclude that the V8 analytical characteristics are fully adequate for the&nbsp;system use in clinical laboratories for managing patients with monoclonal gammopathies.</p>
Biochimica Clinica ; 38(4) 295-301
Contributi scientifici - Scientific Papers
Documento di consenso SIBioC e Società Italiana di Radiologia Medica (SIRM) sulla richiesta di esami di laboratorio per la valutazione del danno renale da mezzi di contrasto
SIBioC-SIRM consensus document on the request of laboratory tests for evaluation of contrast media nephrotoxicity
<p>The contrast media, widely used in imaging diagnostics, show a favorable safety profile. As the&#160;presence of pre-existing disease is considered a risk factor for adverse events, patients should be carefully evaluated&#160;prior to the procedure. The aim of this consensus document is to recommend appropriate biochemical tests to be&#160;performed for an early recognition of individuals at higher risk of contrast media nephrotoxicity. This condition is defined&#160;by an increase of serum creatinine concentrations of at least 0.50 mg/dL and/or 25% within 3-4 days from contrast media&#160;exposure. The most important risk factor is renal insufficiency [estimated glomerular filtration rate (eGFR) &lt;60&#160;mL/min/1.73 m<sup>2</sup> or serum creatinine &gt;1.50 mg/dL]. Other risk factors are age &gt;75 years, dehydration, diabetes, heart&#160;failure and anemia. Monoclonal gammopathies, multiple myeloma, Waldenstr&#246;m macroglobulinemia and amyloidosis&#160;are not considered risk factors per se. On the basis of available guidelines, it is recommended: a) prior to the&#160;examination, to measure serum creatinine baseline with a method traceable to the international reference measurement&#160;system and report its concentration together with the eGFR using the Chronic Kidney Disease &#8211; Epidemiology&#160;Collaboration (CKD-EPI) equation; b) for monitoring, to measure serum creatinine more than once calculating the delta&#160;from the baseline value: if serum creatinine increases &gt;5%, repeat the test within 48-72 h. Performing of laboratory tests&#160;to exclude the presence of monoclonal gammopathies (i.e., serum protein electrophoresis, Bence Jones protein&#160;determination, serum free light chain measurements) is not required.</p>
Biochimica Clinica ; 38(2) 139-142
Documenti SIBioC - SIBioC Documents
Glossario per il lettore di un articolo scientifico. Parte I: la statistica descrittiva
Glossary for the reader of a scientific paper. Part I: descriptive statistics
<p>Glossary for the reader of a scientific paper. Part I: descriptive statistics. The medical literature uses statistics<br />to describe results of observational studies, clinical trials and experimental studies and to test the underlying scientific&nbsp;hypothesis. The statistic language could, however, not be familiar to any reader; this can hamper the correct&nbsp;comprehension of the paper and the appropriate interpretation of results. These considerations represented the spur&nbsp;to formulate a glossary of the more common statistical terms. To facilitate the reading of the vast majority of articles,&nbsp;which are written in English, corresponding English terms are also reported. The present document represents the&nbsp;first part of the project, related to descriptive statistics.</p>
Biochimica Clinica ; 38(2) 129-135
Documenti - Documents
Rispondono gli Autori dell’articolo in questione
In reply
Biochimica Clinica ; 38(2) 157-158
Lettere all'Editore - Letters to the Editor
Il contributo della diagnostica proteica nella gestione delle gammopatie monoclonali
Protein diagnostics in the management of monoclonal gammopathies
<p>This document examines laboratory tests&nbsp;to be used for the management of monoclonal gammopathies in different clinical scenarios, from screening to&nbsp;monitoring and assessment of the response to therapy. The content is based on international recommendations and&nbsp;guidelines currently available. It includes sections on the analytical aspects of different tests&nbsp;(serum&nbsp;protein&nbsp;electrophoresis, typing and quantification of monoclonal components, Bence Jones protein determination and free&nbsp;light chain measurement) and on their clinical significance as well. Different clinical settings are examined: screening,&nbsp;diagnosis, risk stratification, monitoring and response assessment. For each of those, laboratory tests to be used are&nbsp;indicated. Aim of the document is to help clinical laboratories avoiding unnecessary tests, ensuring in the meantime&nbsp;that all the investigations required for a optimal patient management are carried out.</p>
Biochimica Clinica ; 38(1) 47-53
Documenti SIBioC - SIBioC Documents
Un aggiornamento delle linee guida internazionali per la valutazione e la gestione della malattia renale cronica
An update of international guidelines for the evaluation and management of chronic kidney disease
<p>An&nbsp;update of the 2002 guidelines for the evaluation and management of chronic kidney disease (CKD) has recently been&nbsp;published by the Kidney Disease Improving Global Outcomes (KDIGO) initiative. This report intends to summarize&nbsp;and comment the topics of interest for the clinical laboratory, emphasizing differences with the previous guideline.&nbsp;Clinical biochemists are explicitly mentioned among the target audience of new guidelines, because of the&nbsp;fundamental role that laboratory tests have in the detection and follow up of CKD; this is certainly something new in&nbsp;the history of clinical guidelines. The most important differences between 2002 and new guidelines are: a new risk&nbsp;prediction model including cause, glomerular filtration rate (GFR) and urine albumin results; a higher role assigned&nbsp;to urine albumin considered both as a component of risk prediction and as the primary test to detect proteinuria; the&nbsp;suggestion to use the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (considered more&nbsp;accurate than the Modification of Diet in Renal Disease (MDRD) formula) to calculate GFR; the utility of using cystatin&nbsp;C and the GFR formulas based on this protein to confirm the renal impairment in certain categories of patients.&nbsp;Laboratorians can find in the guidelines a number of detailed indications on how to report and interpret laboratory&nbsp;tests for CKD, ranging from the type of sample to be used for urine albumin measurement (i.e., the first morning void)&nbsp;to the way of estimated GFR reporting (rounded to the nearest whole number) and to creatinine and cystatin C&nbsp;calibration approaches that should be traceable to the international reference materials.</p>
Biochimica Clinica ; 38(1) 32-38
Opinioni - Opinions
Componenti monoclonali piccole ma dannose
Small but harmful monoclonal components
<p>A small B-cell clone can synthesize a toxic monoclonal protein that&nbsp;causes severe organ damage. Diseases caused by these toxic immunoglobulins range from AL amyloidosis, light&nbsp;chain deposition disease and cryoglobulinemia to the POEMS (Polineuropathy, Organomegaly, Endocrinopathy,&nbsp;Monoclonal protein and Skin changes) syndrome. The serum monoclonal components are, in these cases, usually&nbsp;small and difficult to be detected by the commercially available methods. However, an early detection and a correct&nbsp;characterization of the monoclonal component is essential, because misdiagnosis or a delay in diagnosis can prevent&nbsp;the proper treatment of the patient worsening his outcome. Here we present two cases of amyloidosis AL, where the&nbsp;correct diagnosis was facilitated by specific and sensitive techniques. This does not mean that every clinical&nbsp;laboratory should be competent in this field and use these methods routinely, but simply that people should be aware&nbsp;of the problem, so that these clinical conditions can be properly managed.</p>
Biochimica Clinica ; 37(5) 431-434
Casi clinici - Case Report
La determinazione delle catene leggere libere nel siero può sostituire la ricerca e quantificazione della proteinuria di Bence Jones nella pratica clinica?
Can serum free light chain determination replace detection and quantitation of Bence Jones proteinuria in clinical practice?
<p>Serum free light chain (FLC) determination became available for clinical laboratories 12 years ago.&nbsp;Since its introduction, it has been postulated that the urine study (i.e. Bence Jones proteinuria detection and&nbsp;quantitation) could have been abandoned due to the higher sensitivity and better practicability of the serum FLC&nbsp;assay. This paper investigates this hypothesis, presenting the evidence derived from the literature so far. Primary&nbsp;studies show some results in favour of the urine study discontinuation; however, a correct evaluation of this evidence&nbsp;is hampered by the lack of information about the sensitivity of the immunofixation method used as comparison. A&nbsp;number of guidelines and recommendations has been published on plasma cell dyscrasias, examining different&nbsp;clinical settings where the two tests can be used (screening, diagnosis, risk stratification, monitoring and response to&nbsp;treatment). Serum FLC measurements should be preferred in the screening and risk stratification subsets [apart from&nbsp;amyloidosis and POEMS (Polineuropathy, Organomegaly, Endocrinopathy, Monoclonal protein and Skin changes)&nbsp;syndrome]; on the contrary, determination of Bence Jones proteinuria should be used in the assessment of the&nbsp;response to therapy, when disease is quantifiable. At the moment, the FLC determination cannot replace the urine&nbsp;study in any circumstance and the two tests should be considered complementary until other evidences will be&nbsp;provided. Considering the dependence of both tests upon renal function, studies examining this issue could help&nbsp;elucidating their role in the wide scenario of plasma cell dyscrasias.</p>
Biochimica Clinica ; 37(5) 405-418
Opinioni - Opinions
Etica e metodologia di scrittura di un lavoro scientifico
Publication ethics and scientific writing
<p>Ethic issues and the structure of manuscripts are two main aspects when writing a research paper in the biomedical field with the aim to submit it to a scientific journal for publication. Considering publication ethics, the integrity of the scientific writing is under the responsibility of authors, reviewers, and editor of the journal and should be maintained across the entire process of publication. The authors&rsquo; responsibility includes unequivocal transgression (falsification of data, plagiarism, authorship, conflict of interest), which cannot be tolerated, and undesirable practice (self plagiarism, redundant publication) as well. The reviewers&rsquo; responsibility includes conflict of interest and confidentiality. Among the journal editor&rsquo;s responsibilities, there are conflict of interest, publication bias, willingness of publishing complaints, clarifications and apologies. A scientific article should usually have a definite structure, made up of different sections. Here suggestions are given on how to find an appealing &ldquo;Title&rdquo;, how to prepare a comprehensive &ldquo;Abstract&rdquo;, how to cope with the &ldquo;Introduction&rdquo;, how to improve the description of employed &ldquo;Methods&rdquo;, how to present data in the &ldquo;Results&rdquo; section, and how to better organize the results &ldquo;Discussion&rdquo;. Our experience as editors of this journal suggests that our colleagues should be more aware of both ethical aspects and correct procedures to follow before starting to write a scientific paper in order to prevent the rejection of their work.</p>
Biochimica Clinica ; 37(1) 40-47
Opinioni - Opinions
Procalcitonina e sepsi: alcuni aspetti relativi all’appropriatezza della richiesta
Procalcitonin and sepsis: hints on clinical appropriateness
<p>Sepsis in know to be a challenge for clinicians, given the poor outcome and high costs. Both diagnosis and management are a matter of concern, as appropriate and early therapy can result in higher survival rate. Various biological parameters have been proposed to establish diagnosis<br />and evaluate risk. Procalcitonin (PCT), the precursor of calcitonin, has gained attention as serological marker of sepsis and several authors have claimed for PCT a role in rapid diagnosis as well as risk stratification and prognosis evaluation. Data from systematic reviews support the use of PCT as an alternative to C-reactive protein in adult intensive care unit patients, although its use as sole diagnostic marker does not appear to be appropriate in critical patients. In the emergency department setting PCT can be used to rule out sepsis in adult febrile patients. Data on risk stratification and prognosis are less clear cut and specific clinical questions need further investigation.</p>
Biochimica Clinica ; 37(1) 15-22
Rassegne - Reviews
Due casi di malaria diagnosticati incidentalmente con un analizzatore ematologico
Two cases of malaria incidentally diagnosed with a hematology analyzer
<p>Although the malaria infection is essentially a problem in tropical countries, it has becoming a health issue even in Western countries due to tourism and immigration. The specific diagnostic tests are ordered if a clinical suspicion is raised, but symptoms of malaria infection can be vague and easily attributed to minor febrile affections, particularly in non-endemic regions. The diagnosis of malaria cannot be dismissed to rapidly establish the appropriate treatment, avoiding harmful complications of the disease. Recently, hematological analyzers have been proposed as potentially useful tools to detect in the blood count of affected patients abnormalities that can guide a timely malaria diagnosis. We present here two cases of malaria infection in which the first diagnostic suspicion was posed on the basis of abnormal scattergrams of a hematological analyzer. The aim is to present this relatively new diagnostic opportunity, increasing the awareness of laboratorians on the possibility to raise a suspicion of malaria infection, even if specific diagnostic tests have not been ordered.</p>
Biochimica Clinica ; 36(3) 204-208
Casi Clinici - Case Report
Esperienza pilota di accreditamento di un centro per la diagnosi della trombosi e la sorveglianza delle terapie antitrombotiche
A pilot accreditation experience of a thrombosis center
<p>This paper describes the process of the accreditation of our Thrombosis Center by the Italian Federation of Thrombosis Centers (FCSA). The experience is reported, describing in details the organizational and clinical standard requirements and emphasizing foreseeable benefits and expectations for patients, operators, hospital, and health service.</p>
Biochimica Clinica ; 36(2) 090-097
Contributi Scientifici - Scientific Papers
Un caso di macrolattatodeidrogenasemia
A case of macrolactatedehydrogenasemia
<p>We present here the detection of a lactate dehydrogenase (LDH) macroenzyme in the blood of an apparently healthy female. The finding of an increased LDH activity during routine biochemical investigations led to a number of further laboratory and imaging examinations. When the diagnostic problem was finally posed to the laboratory consultant, a serum treatment with polyethylene glycol and an isoenzyme electrophoretic separation allowed to demonstrate the presence of a circulating macroenzyme. Macroenzymes have been described from almost 50 years, but despite many efforts it was difficult to recognize a pathogenetic role. Their recognition is, however, important in order to avoid expensive and cumbersome procedures to explain elevated enzyme values.</p>
Biochimica Clinica ; 36(1) 66-68
Casi Clinici - Case Report
Glossario dei principali termini in uso nell'ambito di ricerche bibliografiche
Glossary of terms used for literature search.
<p><strong>Glossary of terms used for literature search.</strong> The challenge for modern Laboratory Medicine is to find and apply the best available evidence. Electronic access to databases and scientific journals makes information easily retrievable and solves the issue of finding current best evidence. On the other hand, searches may yield a huge amount of data and result in information overload difficult to manage. To be useful, searches should be&#160; made using specific techniques that can be taught and learned. The aim of this glossary is to introduce readers in the world of the literature&#8217;s searches by defining the common use terms. It follows to the glossary, published in 2010 (Biochim Clin 2010;34:212-7), related to the terms used to describe and evaluate clinical trials and papers reporting on the diagnostic performance of laboratory tests.</p>
Biochimica Clinica ; 35(6) 474-480
Sei casi di gammopatia monoclonale IgD
Six cases of IgD monoclonal components.
Biochimica Clinica ; 35(5) 417
E' possibile utilizzare la determinazione della lipocalina associata alla gelatinasi dei neutrofili (NGAL) nella valutazione della nefrotossicità da bisfosfonati?
Biochimica Clinica ; 35(4) 331
Indicazioni per la misura dell'albumina nelle urine per l'accertamento e il monitoraggio della nefropatia diabetica
Recommendations on the urine albumin measurement for diagnosis and monitoring of diabetic nephropathy
Biochimica Clinica ; 35(2) 127
Equazioni per la stima della velocità di filtrazione glomerulare: siamo a un punto di arrivo?
Biochimica Clinica ; 17(1)
Editoriale - Editorial
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)
<p>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.</p>
Biochimica Clinica ; 17(1)
Documenti SIBioC - SIBioC Documents