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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 B. Morelli

Principi per l’implementazione e la gestione del point-of-care-testing (POCT): indicazioni essenziali
Implementation and management of the point-of-care testing (POCT): essential indications
E. Rampoldi \| G. Patrucco \| M. Casati \| B. Morelli \| P. Carraro \|
<p>In recent years, the field of medicine has considerably changed; an important, widespread trend is the reorganization of medical laboratories. These facilities made an effort to improve their efficiency through a process of consolidation and decentralization. In this context, Point-of-Care Testing (POCT) devices offer numerous advantages, but also pose a clinical risk, particularly in Italy, which is limited by its varied, often inadequate, regional regulations. Some examples are reported, representing scenarios of frequent or bothersome POCT use. This document outlines the SIBioC Working Group recommendations for the safe use of POCT instruments. It defines how these have been updated to the state of technologies and medical requirements. Particular attention has been paid to clinical governance, connectivity, the role of the laboratory director and staff, quality control, education, risk management and the role of the in vitro diagnostic companies. Most of the Italian medical practice is based on hospital experience, but the recent pandemic outbreak of SARS-CoV-2 forces us to re-think about the use of POCT in settings that are outside of the hospital such as local clinics, nursing homes and primary care facilities. These facilities will be the next important field of application for those indispensable tools. Networks of instruments, professionals and competence should be carefully tailored to meet local needs and specific clinical settings.</p>
Biochimica Clinica ; 45(3) 312-326 Documenti SIBioC - SIBioC Documents

Alterazioni dei meccanismi dell’emostasi in corso di infezione da SARS-CoV-2 (COVID-19)
Alterations of hemostasis during SARS-CoV-2 infection (COVID-19)
B. Morelli \| B. Montaruli \| M. Bazzan \| P. Calzoni \| P. Fassina \| P. Pradella \|
<p>The corona virus infection (named COVID-19), first identified in December 2019 in Wuhan, China, has contributed to significant mortality in several countries with the number of infected cases increasing exponentially worldwide, in particular in Italy and in the USA. The majority of the most severely ill patients initially presents with single organ failure (i.e. severe respiratory syndrome), but some of them progress to more systemic disease and multiple organ failure (MOF). One of the most significant poor prognostic features in these patients is the development of coagulopathy, similarly to patients who develop sepsis from various infectious agents. Coagulopathy in patients with COVID-19 may be asymptomatic but, in some cases, the septic state may evolve into Sepsis-Induced Coagulopathy (SIC) and overt Disseminated Intravascular Coagulopathy (DIC). In patients with severe clinical manifestations, a cytokine storm occurs that contributes to triggering a greater imbalance of the hemostatic mechanisms by promoting the development of microthrombosis at the level of the pulmonary endothelium. The effectiveness of anticoagulant therapies, performed primarily with low-molecular weight heparin, is greater the earlier the diagnosis is made. This is possible through the adoption of diagnostic protocols that include laboratory tests and clinical scores. The laboratory tests suggested for this purpose by the available Guidelines are prothrombin time, platelet count, D-dimer and fibrinogen. D-dimer appears to be the parameter with the greatest prognostic significance since it also allows a stratification of the thrombotic risk.</p>
Biochimica Clinica ; 44(4) 015-016 COVID-19 - COVID-19

Il ruolo del laboratorio di coagulazione nel monitoraggio del trattamento eparinico dei pazienti con COVID-19
The role of laboratory monitoring in heparin treatment of COVID-19 patients
B. Montaruli \| B. Morelli \| M. Marchetti \| M. Bazzan \|
<p>Coronavirus disease 2019 (COVID-19) can be associated with serious clinical complications such as acute respiratory distress syndrome (ARDS), sepsis and multiple organ failure (MOF). A key event in the pathophysiology of ARDS is immunothrombosis, a process initiated by the innate immune system that provides a first line of defense for local control of infection. In its physiological form, immunothrombosis is intended to facilitate the recognition, containment and destruction of pathogens, thus protecting the integrity of the host without inducing significant collateral damage. The cytokine storm that occurs during COVID-19 induces often venous and arterial thrombotic events affecting different organs, not limited to the respiratory system. It is therefore necessary to introduce an anticoagulant treatment in patients with COVID-19 to prevent the onset and the extension of thrombotic events. The low molecular weight heparin (LMWH) is the first-choice drug recommended by the main international scientific societies; alternatively, unfractionated heparin (UFH) or fondaparinux can be used. The dosage of these drugs in patients with COVID-19 is still under discussion. The coagulation testing plays an important role in monitoring the efficacy and safety of UFH treatment; in the case of LMWHs, these usually do not require monitoring but, if alterations of renal function occur, it is important to perform the chromogenic determinations of the anti-Xa activity, paying a particular attention to the timing of sampling, the pre-analytical variables, calibration of the test and reference ranges.</p>
Biochimica Clinica ; 44(4) 017-018 COVID-19 - COVID-19

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
D. Farci Santarcangeli \| M. Careno \| M. L. Frassanito \| D. Giavarina \| G. Lippi \| A. Modenese \| B. Morelli \| E. Trabuio \| R. Vettori \| B. Bonetti \|
<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

Raccomandazioni per la diagnosi di laboratorio della malattia di von Willebrand
Recommendations for the laboratory diagnosis of von Willebrand disease
B. Morelli \| F. Stufano \|
<p>Von Willebrand disease (VWD) is the most common inherited bleeding disorder. Clinically, VWD induces mucosal bleeding caused by a decreased quantity or quality of von Willebrand factor (VWF). Diagnosis of VWD requires careful consideration of patient specific factors, bleeding symptoms, and laboratory results. There is no single diagnostic test for VWD; laboratory diagnosis requires a number of assays of VWF amount and function, and factor VIII activity, with no single straightforward diagnostic test available up to know to either confirm or exclude the diagnosis. The currently available laboratory testing for VWD is imperfect, but if accompanied by an attentive and careful interpretation provides significant clinical utility by categorizing affected patients by type of VWD. As the diagnosis of VWD variants has implications fort reatment, laboratory testing is therefore critical for optimising patient care. Newer assays of VWF function are becoming available and will be of great help in establishing the laboratory diagnosis of VWD.</p>
Biochimica Clinica ; 44(1) 073-085 Documenti - Documents

La variabilità preanalitica in coagulazione
Pre-analytical issues in coagulation testing
B. Morelli \| B. Montaruli \| D. Cabodi \| A. Appiani \| F. Bertone \| V. Conterio \| M.S. Demicheli \| E. Muccini \| C. Novelli \| M. R. Portalupi \| P. Pradella \| S. Prestigio \|
<p>Poor standardization of preanalytic variables influences greatly thereliability of coagulation testing, consuming health care resources and compromising patient outcomes. Thesevariables include patient preparation, sample collection, handling, transportation, processing, and storage until timeof analysis: lack of standardized procedures for sample collection accounts for most of the errors encountered withinthe total testing process. Most pre-analytical problems may arise from system faults and insufficient audit of theoperators involved in specimen collection and handling, leading to unsuitable specimens due to misidentification,hemolysis, clotting, inappropriate volume, wrong container, contamination from the infusive route. Detection,acknowledgement and management of pre-analytical variables, is mandatory for delivering accurate laboratoryresults. The present document, issued by the Study Group on Haemostasis of the Italian Society of LaboratoryMedicine, is a summary of the recommendations for standardisation of the pre-analytical phase of the coagulationtesting, related to sample collection, transportation, and storage and provides guidance to reduce the effects of pre-analytical issues that can have a significant impact on patient care.</p>
Biochimica Clinica ; 43(3) 313-326 Documenti SIBioC - SIBioC Documents

Indagine sulla modalità di refertazione dell’esame D-dimero nei laboratori nazionali e indicazioni per una sua armonizzazione
A survey on D-dimer test reporting in Italian laboratories and some suggestions for its harmonization
G. Lippi \| B. Morelli \| A. Tripodi \|
<p>D-dimer assessment represents a cornerstone in the diagnostic approach and therapeutic management of several thrombotic disorders, namely venous thromboembolism and disseminated intravascular coagulation. Nevertheless, this test is still plagued by an insufficient degree of analytical and post-analytical standardization. In particular, despite the existence of national guidelines, result reporting is quite heterogeneous. A specific on-line, 5-item questionnaire was disseminated to the SIBioC members to obtain a picture of the current national situation. As regards to the units, a modest prevalence (53%) of D-dimer unit (DDU) over fibrinogen equivalent unit (FEU) (47%) was found. The most widespread measurement unit was “ng/mL” (60%), followed by “μg/L” (18%), “mg/L” (15%) and “μg/mL” (6%). The vast majority of laboratories (90%) did not use an age-adjusted cut-off. The data distribution did not differ among different types of healthcare settings (i.e., general hospital, university hospital or private facilities). The use of at least 16 different unit approaches for D-dimer emerged from the survey is quite alarming and calls for a standardization, using a single result reporting as .</p>
Biochimica Clinica ; 39(6) 591-594 Contributi scientifici - Scientific Papers

Documento di consenso di “Academy of Emergency Medicine and Care”, Comitato Italiano per la Standardizzazione dei Metodi Ematologici e di Laboratorio, SIBioC - Medicina di Laboratorio e Società Italiana di Medicina di Laboratorio sull’utilizzo del dosaggi
Consensus document of Academy of Emergency Medicine and Care, Italian Committee for Standardization of Hematology and Laboratory Methods, SIBioC-Laboratory Medicine and Italian Society of Laboratory Medicine on D-dimer testing for suspected venous thrombo
G. Lippi \| I. Casagranda \| B. Morelli \| S. Testa \| A. Tripodi \|
<p>The assessment of D-dimer represents the biochemical standard for diagnosing venous thromboembolism (VTE) and it is hence included in all diagnostic algorithms. Despite the unquestionable diagnostic value, there is broad evidence that the clinical usefulness of D-dimer may be biased by preanalytical, analytical and post-analytical issues. This is particularly true in emergency departments, where a large number of patients with suspected VTE is admitted, triaged and managed. Therefore, representatives of societies listed in the title have drafted this consensus document aimed to cover the most important critical areas in D-dimer testing, providing tentative recommendations to improve its clinical effectiveness for diagnosing VTE in the emergency department.</p>
Biochimica Clinica ; 38(2) 136-138 Documenti SIBioC - SIBioC Documents

Il laboratorio e i nuovi anticoagulanti orali
Laboratory and new oral anticoagulants
B. Morelli \| E. Ascari \|
<p>Heparins and vitamin K antagonists are drugs of choice for treatment and prevention of thrombotic pathologies. These drugs have a considerable degree of safety and efficacy, but they may present certain drawbacks, as they require frequent laboratory monitoring (unfractionated heparins and anti-vitamin K) or intravenous or subcutaneous administration (low molecular weight heparins). Due to these reasons, several studies have been performed to identify new anticoagulant drugs with characteristics of safety, efficacy and possibility of oral administration and no need of laboratory monitoring. New direct oral anticoagulants (DOAs) have as direct target thrombin (factor IIa) or factor-Xa inhibition; their safety and efficacy have been investigated in several phase III studies. DOAs in most advanced stage of release are dabigatran, rivaroxaban and apixaban; the first drug is a direct thrombin inhibitor, the others are direct factor-Xa inhibitors. DOAs do not require routine laboratory monitoring due to their high dose-response predictability; there is, however, a necessity to measure their anticoagulant effect in some particular situations. In those situations, it is important for the laboratory to consider: 1) how DOAs can interfere in the measurement of basic and more specialistic coagulation parameters; 2) which tests are the most suitable to detect the presence of the new drug; 3) which tests are the most useful to measure the anticoagulant effect; 4) which tests are the most suitable to monitor the antagonizing effect of some drugs ("reversal") in case of DOA overdose.</p>
Biochimica Clinica ; 37(4) 292-300 Documenti - Documents