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Editor-in-chief
Maria Stella Graziani

Deputy Director
Martina Zaninotto

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

EIC Assistant
Francesco Busardò

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


Publisher
Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

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

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



BC: Articoli scritti da P. Natali

Diagnosi di crioproteinemia: preziosa collaborazione tra laboratorio e clinica per la corretta gestione di una patologia rara
Diagnosis of cryoproteinemia: important collaboration between the laboratory and clinicians for the proper management of a rare disease.
P. Natali  |  D. Debbia  |  J. Sheldon  |  A. Bari  |  U. Basile  |  F. Lavatelli  |  D. Patel  |  M. Galli  |  E. Villa  |  C. Salvarani  |  G. Palladini  |  M.T. Mascia  |  G. Sandri  | 
<p>Cryoglobulinemia is a rare pathologic condition that can be difficult to diagnose both clinically and in the laboratory, which is why close collaboration between the clinic and laboratory is essential. The laboratory needs the skills and experience to interpret the laboratory tests and the clinician should not hesitate to contact the laboratory when the result is not supported by the clinical signs. To strengthen this collaboration, the Protein Study Group of the Italian Society of Clinical Biochemistry (SIBioC) in collaboration with the Italian Association for the Fight against Cryglobulinemia (ALCRI) under the patronage of the University of Modena and Reggio Emilia, organised a conference in Modena on September 2021 entitled &quot;Cryoglobulinemia: laboratory and clinic, a virtuous collaboration for the correct management of a rare pathology&quot;. This collective paper is aimed to summarize the topics discussed during the meeting. The conference consisted of two parts: the first aimed at highlighting the critical components of the pre-, intra- and post-analytical phases of cryoglobulin investigation. Cryoprotein testing remains totally manual and operator dependent so it was important to identify areas where best practice guidance or even harmonisation of the laboratory investigation would be beneficial. The second part of the conference focused on clinical aspects and the effects of therapies, including antiviral drugs with direct action against HCV. These drugs are able to eradicate the virus, but the elimination of HCV-related cryoglobulins is seen in only about half of cases. Finally, the clinical consequences of the diagnosis of cryoglobulinemia and the multidisciplinary implications that this entails were highlighted, underlining how the continuous dialogue between the laboratory and clinic is crucial for the correct management of the patient.</p>
Biochimica Clinica ; 46(2) 166-175
Documenti - Documents
 
Le criticità della fase post-analitica della determinazione delle crioglobuline: risultati di uno studio pilota condotto in Emilia-Romagna
Critical issues of the post-analytical phase for cryoglobulin determination: results of a pilot study carried out in Emilia-Romagna, Italy
<p>Introduction: cryoglobulins (CRG) are immunoglobulins that precipitate at low temperature and dissolve at 37 &deg;C. The difficulties associated to the analisys of cryoproteins, are related to the pre-analytical phase, including the collection of the sample and the maintenance of the heat chain; to the analytical phase, because of the many manual steps involved and, to the post-analytical phase as well, due to the operator-depending interpretation of immunofissation (IFE). The Department of Laboratory Medicine of Modena promoted a pilot study to verify the incidence of the post-analytical phase in the accuracy of the CRG analisys.<br />Methods: 30 images of CRG-IFE plates were selected and sent to 8 centers of the Emilia Romagna region that agreed to join the project; 13 different laboratory professionals have been involved in the IFE interpretation.<br />Results: out of 30 IFE, only 3 (10%) were interpreted with the excellent concordance of 100% by all the participants; 10 of them (33%) showed a good concordance, 75-99%; 14 (47%) sufficient concordance, 50-74%; 3 (10%) a poor concordance &lt;50%. Out of 8 centers involved, 4 participated with more than one operator. Arbitrarily assuming that the analysis can be considered acceptable when at least 75% of the participants agree on the interpretation of the gels, the results show that only in 43% of cases the acceptability was reached.<br />Discussion: this pilot study highlights the need to harmonize the CRG determination, not only the pre-analytical and analytical procedures, but also the post-analytical phase. To this end, it could be highly recommended that the clinical laboratories participate to external quality assessment control programs, as the one promoted by UK-NEQAS. Moreover, scientific societies and their Study Groups, can play an important role by promoting the harmonization of CGR evaluation.</p>
Biochimica Clinica ; 45(4) 388-394
Contributi Scientifici - Scientific Papers
 
Proteinuria nel COVID-19: l’importanza di un esame consolidato in una patologia complessa
P. Natali  |  T. Trenti  | 
Biochimica Clinica ; 45(3) s097-s099
Lettere all'editore - Letters to the editor
 
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
 
Confronto tra un metodo nefelometrico ed un metodo turbidimetrico per la determinazione delle catene leggere libere sieriche: punti di forza e criticità
Comparison between a turbidimetric and a nephelometric method for the measurement of serum free light chains: strengths and weaknesses
<p>Background: monoclonal gammopathies include a broad spectrum of pathologies, and free light chains (FLC) measurement is recommended by guidelines for the diagnosis, follow up and prognosis of plasma cell dyscrasia. The aim of the study is to compare the measurement of FLC performed with two different analytical platforms, a nephelometer and a turbidimeter, in order to assess the analytical and diagnostic agreement.<br />Methods: 87 consecutive samples received by the laboratory with a request of FLC measurement were analyzed on nephelometer Immage 800 (Beckman Coulter, USA) and turbidimeter Optilite (The Binding Site, UK), using the same antibodies (Freelite, The Binding Site, UK).<br />Results: by applying the Passing-Bablok regression and the Bland-Altman analysis, a proportional and constant systematic error but non-significant bias for FLC ratio (rFLC) has been observed. By applying the Weighted Cohen&rsquo;s Kappa (WK) test to the rFLC values, an excellent diagnostic agreement between the two instruments has been shown, considering both the normal range (0.26 &ndash; 1.65) (WK=0.87) and the diagnostic range for multiple myeloma (&lt;0.01 or &gt;100) (WK=0.84).<br />Conclusions: Although there are statistical differences between the measurements performed by the two instruments, these do not affect the diagnostic agreement, that is excellent. Nevertheless, the turbidimeter is provided with a software that can automatically detect the antigen excess; by diluting further the samples automatically, it performs fewer dilutions than the nephelometer and provides a wider range of measurement, especially for low concentrations. These characteristics assist the operator both during the analysis and the validation phases of the results, saving time and resources. On the basis of the results of the study, it can be concluded that the turbidimeter shows better performances compared to the nephelometer.</p>
Biochimica Clinica ; 44(2) 149-156
Contributi Scientifici - Scientific Papers
 
Una paziente con dolori ossei diffusi: il ruolo del laboratorio nel diagnosticarne la causa
A female patient with diffuse bone pain: the role of the clinical laboratory in the diagnostic process
D. Debbia  |  P. Natali  |  L. Ferrara  |  M. Varani  |  G. Longo  |  T. Trenti  | 
<p>Multiple myeloma (MM) represents 10% of all hematologic malignancies; in 15% of MM the monoclonal component consists of only free light chains. A 53 year-old patient performs at the Corelab laboratory (AOU-AUSL Modena) blood tests for bone pain. Serum electrophoresis shows hypogammaglobulinemia (5,5 g/L). The laboratory professional decides to carry on further studies: a serum immunofixation that highlighted the presence of kappa free light chains not traceable to any heavy chain and the measure of the serum free light chains (sFLC) with the following results: FLC-&kappa; 26 777 mg/L (i.r. 3.3-19.4); FLC-&lambda; 6.15 mg/L (i.r. 5.7-26.3); ratio FLC (rFLC), 435.31 (i.r. 0.26-1.65). The light chain MM is a type of MM difficult to recognize. The laboratory professional&#39;s own initiative defines a procedure of &quot;personalized medicine&quot; oriented to to the patient&#39;s needs. The expertise of the laboratory professional is crucial in assuring the patient the best outcome when carried out on the basis of the available guidelines.</p>
Biochimica Clinica ; 43(4) e35-e36
Casi Clinici - Case Report
 
La riorganizzazione del settore dedicato alla diagnostica proteica: un esempio virtuoso fondato su criteri di Evidence Based Laboratory Medicine e di sostenibilità economica
The organization of the protein unit: a beneficial example founded on evidence based laboratory medicine criteria and on the appropriate use of the available resources
P. Natali  |  T. Trenti  | 
<p>The sustainability of the National Health Service is a current subject of debate&nbsp; due to the pressure that the changes in our societies are having on health systems. Reviewing diagnostic processes is increasingly urgent to contain costs and to maintain the quality of the health services provided.The Evidence Based Laboratory Medicine (EBLM) approach allows to identify and eliminate obsolete methods, replacing them with more adequate ones. The EBLM approach can also provide higher diagnostic accuracy, a rationalisation of diagnostic pathways, a reduction of turnaround-time and a decrease of costs. To reach these objectives, a careful analysis of production processes and assessment of the costs are both necessary. The EBLM approach has been applied to the Protein Unit of Laboratory of Modena. The change in the workflow of the Bence Jones protein determination and the consolidation of the measurement of a number of serum proteins on clinical chemistry analysers allowed a better diagnostic accuracy coupled to important economical savings. The savings made it possible to extend the availability of the free light chains measurements (that before was restricted to patients admitted to the haematology department) to the out-patients of the Province of Modena. The EBLM approach is the most effective way to reach such objectives: really, providing better quality performance does not necessarily correspond to an increase of costs. In addition to developing an adequate level of scientific expertise, the laboratory professional must acquire managerial skills to introduce up-to-date diagnostic methods and to optimize the use of assigned resources, in all areas of laboratory medicine.</p><p>&nbsp;</p>
Biochimica Clinica ; 43(1) 044-051
Contributi Scientifici - Scientific Paper
 
Accuratezza dell’immunonefelometria come metodo di screening per la determinazione della proteinuria di Bence Jones
Accuracy of immunonephelometry as a screening method for Bence Jones proteinuria
<p>The Bence Jones protein (BJP) is an important biomarker for the identification and management of patients with plasma cell dyscrasia. The recommended method for BJP detection is the immunofixation, which is a time consuming and expensive procedure. The aim of the study was to evaluate immunonephelometry (INA) as a screening method for the identification of urine samples negative for BJP and to compare it to a simplified immunofixation method (uIFE-3). First morning urine samples were collected from 1000 consecutive patients and analyzed by INA. Samples with free light chain concentrations &gt;10 mg/L and &gt;5 mg/L were considered positive. All samples were further analyzed by uIFE-3 using 3 antisera (anti-GAM, -&kappa; and -&lambda;). The INA results (at both cut-off levels) were compared with the uIFE-3, showing a poor accuracy due to the high number of false positives and false negatives. Consequently, INA resulted unable to accurately screen BJP.</p>
Biochimica Clinica ; 41(2) 148-153
Contributi scientifici - Scientific papers