Maria Stella Graziani

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Bruna Lo Sasso
Giampaolo Merlini
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Biochimica Clinica: VOL.37 N.4

Il passaporto biologico dell’atleta: certezze e limiti
The athlete biological passport: facts and drawbacks
G. Lippi  | 
Biochimica Clinica 2013; 37(4) 265-267
Editoriale - Editorial
Emoglobinuria parossistica notturna
Paroxysmal nocturnal hemoglobinuria

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired hematological disease of the hematopoietic stem cell. PNH arises as a consequence of non-malignant clonal expansion of hematopoietic stem cells and progeny mature blood cells of both myeloid and monocyte lineage, which are deficient in some surface proteins, including the two complement regulators CD55 and CD59. As a result, PNH erythrocytes are incapable to modulate on their surface physiologic complement activation, leading to complement-mediated intravascular hemolysis, which is the central clinical feature of PNH. Diagnosis and monitoring of PNH clones currently rely on the analysis of CD59 expression on red blood cells and FLAER (fluorescent aerolysin) and some glycophosphatidylinositol-anchored proteins on granulocyte and monocyte lineages by flow cytometry. Despite the availability of safe and effective targeted therapy that controls intravascular hemolysis, the management of PNH remains difficult because of disease heterogeneity and close association with bone marrow failure syndromes.

Biochimica Clinica 2013; 37(4) 268-274
Rassegne - Reviews
Evaluation of Sysmex XE-2100 for enumeration and differentiation of cellular elements in peritoneal and pleural fluids

The aim of this study was to evaluate the performance of Sysmex XE-2100 for automated flow cytometric analysis of
biological fluids. The results of 106 consecutive peritoneal samples and 20 pleural samples were compared with optical microscopy. A good agreement was found in total nucleated cells (TNC) count between Sysmex XE-2100 and manual microscopy (y=0.98x+3.2, r=0.99; mean bias, -9.5 TNC/μL). The percentage of cells with high fluorescence in XE-2100 correlated with that of macrophages and mesothelial cells at microscopy (r=0.67; P <0.001). The CV of TNC determination on XE-2100 ranged between 1.6% and 11.7%. At the 20% CV, the analytical sensitivity of XE-2100 was 29/μL for TNC, 50/μL for polymorphonuclear leukocytes (PMN) and 66/μL for mononuclear elements. The linearity between 30 and 944 TNC/μL was excellent (r=0.998, P <0.001), whereas the carry-over was <1%. At thresholds of ≥250 PMN/μL in peritoneal fluid and ≥50% PMN or ≥50% lymphocytes in pleural fluid, the diagnostic accuracy of XE-2100 was 96.8%, with Cohen's kappa of 0.90 (P <0.001). We conclude that automated flow cytometric analysis on Sysmex XE-2100 may be a viable options for screening of peritoneal and pleural fluids.

Biochimica Clinica 2013; 37(4) 275-278
Contributi Scientifici - Scientific Papers
Valutazione preliminare del sistema Alere NS-Plus per la determinazione della transferrina fecale
Preliminary evaluation of the Alere NS-Plus system for the determination of faecal transferrin
L. Bressan  |  N. Corcione  |  D. Dama  |  P. Luraschi  | 

Transferrin (Tf) appears in stools after gastro-intestinal tract bleeding. Compared to hemoglobin, Tf is more stable and resistant to degradation; consequently, its determination in stools has been proposed because it could reveal bleeding that may skip with the hemoglobin research. In this study, faecal Tf was determined with the Otsuka Electronics NS-Plus analytical system, using reagents, control materials and disposable devices from Alfresa Pharma (distributed by Alere). Samples were collected by using a disposable device that allows the draw of a standardized amount of faeces and its dilution in a predetermined volume of buffer. Tf measurements were performed immunochemically with a method based on colloidal gold agglutination. We evaluated imprecision (within-run and total CV) at different concentration levels, linearity, method alignment and limit of blank (LOB). The within-run CV was between 0.9% and 23.6% for Tf concentration of 209 and 6 μg/L, respectively. The total CV was 7.4 % and 6.4% for concentrations of 46 and 154 μg/L, respectively. The method showed good linearity and agreement between expected and found values (r=0.999) for a concentration interval 5÷500 μg/L. The value of the LOB was 1.52 μg/L. In conclusion, in this preliminary evaluation the NS-Plus system showed good analytical performance, possibly permitting its use in the clinical setting.

Biochimica Clinica 2013; 37(4) 279-282
Contributi Scientifici - Scientific Papers
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

Blood collection through intravenous (IV) catheter is one of the most frequent causes of hemolysis and stress shear is reported to have an important role in that. Aim of this work was to determine whether the hemolysis rate of blood samples drawn through IV catheter may decrease by using 2.5 mL vacuum collection tubes instead of 5 mL tubes, currently in use. Consecutive samples collected at the emergency department to measure potassium using a 18 gauge IV catheter were evaluated for the presence of hemolysis in the 5 mL lithium heparin with separator gel tubes. The same samples were retested in a similar tube with 2.5 mL aspiration volume, collected at the same time. Hemolysis was evaluated spectrophotometrically on Siemens Advia 2400 analyzer as hemolysis index (HI) in the 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 specimens were hemolysed, with median HI of 278 (95% confidence interval: 228÷362, range 153÷1146). Using the 2.5 mL tubes, only 6 samples of these 48 had an HI >150 (P <0.0001). On average, the percentage of reduction of HI values was 86% (range, 44÷98). These data confirm that shear stress due to the strength of aspiration is an important cofactor of the hemolysis induced by IV catheter. Last generation analyzers require few microliters of sample to perform a lot of tests. The use of tubes with lower filling volume and consequently lower negative pressure could reduce the rate of samples to be rejected for hemolysis that can delay patient care in overcrowded emergency departments.

Biochimica Clinica 2013; 37(4) 283-286
Contributi Scientifici - Scientific Papers
Il controllo della spesa nel laboratorio clinico: dall’emergenza dei tagli alla creazione di modelli di risparmio basati sul miglioramento delle cure
Expenditure control in clinical laboratories: from urgent cuts to creation of models to save costs based on the improvement of patient outcome
M. Mussap  | 

The pressure for expenditure containment and the progressive reduction in available healthcare resources has led to abrupt cuts in hospital budgets, generating, in turn, downsized operations in the provision of medical services, including laboratory ones. These short term strategies are oriented by policy maker and health care manager purposes often neglecting appropriateness, effectiveness, quality improvement and, ultimately, impact on patient outcome. With the objective to reduce costs, diagnostic products are evaluated by the key criterion of ‘cost-per-test’, like buying household consumables, e.g. soaps, towels, etc. In this way, healthcare managers aim to downsize expenditures very quickly, with the assumption of no apparent negative impact on patient outcome. There is a need to introduce new rules, criteria and indicators to favor a quality-oriented selection. Industry competitors on the market should present not only a project specifically tailored to the laboratory organization, but also a well-structured strategic plan. This would facilitate laboratory professionals in evaluating the industry ability to share goals, responsibilities and management with a clinical laboratory organization, ensuring the best efficiency, effectiveness and cost savings. Of course, this should happen with a contemporaneous improvement in the expertise of clinical laboratory professionals.

Biochimica Clinica 2013; 37(4) 287-291
Opinioni - Opinions
Il laboratorio e i nuovi anticoagulanti orali
Laboratory and new oral anticoagulants
B. Morelli  |  E. Ascari  | 

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.

Biochimica Clinica 2013; 37(4) 292-300
Documenti - Documents
Documento di consenso di Federazione dei Centri per la Diagnosi della Trombosi e la Sorveglianza delle Terapie Antitrombotiche (FCSA), Società Italiana di Medicina di Laboratorio (SIMeL), SIBioC e Comitato Italiano per la Standardizzazione dei Metodi Emat
Consensus document of Italian Federation of Thrombosis Services (FCSA), Italian Society of Laboratory Medicine (SIMeL), SIBioC e Italian Committee for Standardization of Laboratory Tests (CISMEL) on laboratory monitoring of the therapy with novel oral ant
G. Lippi  |  G. Di Iorio  |  S. Testa  |  C. Manotti  |  A. Tripodi  | 

Oral anticoagulant therapy is used to prevent and treat thromboembolic disease. The new oral anticoagulants (NOAs) can be prescribed at fixed dosage without adjustment by laboratory testing. However, this does not necessarily mean that the laboratory does not play a role for their management. This position paper reports the consensus of Italian scientific societies dealing with laboratory issues in thrombosis and hemostasis. It is aimed at reviewing: a) which test(s) should be used to evaluate the anticoagulant effect of each of the NOAs presently available (i.e., dabigatran, rivaroxaban and apixaban), b) the patients to be investigated and c) the timing of investigation.

Biochimica Clinica 2013; 37(4) 301-302
Documenti SIBioC - SIBioC Documents
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  | 

Evacuated systems for collection of venous blood are integrated systems of medical and in vitro diagnostic medical devices regulated under European Directives and Italian Legislative Decrees. Both Directives and Decrees endorse the requirement that the whole combination of devices, representing an integrated apparatus, must be safe and not impair the specific performance of each single device. According to mandatory requirements, manufacturers must ensure full compatibility between each component of the system, while the users are responsible for verifying the compatibility of different devices in order to avoid potential quality and safety problems. The acquisition of various devices from different manufacturers may lead to combinations that are not validated by manufacturers themselves and are thus expected to be validated and verified by the users to demonstrate that the system remains safe and will not impair the performance of the individual elements. Therefore, the possibility of purchasing different devices separately should be carefully weighted in terms of risk-benefit, taking into consideration the additional costs of the validation/verification process that should be carried out by the potential user. Since preanalytical problems are the major source of errors in the total testing process, the selection and acquisition of close evacuated systems for blood collection should be considered a critical issue for assuring quality, safety and efficiency of the preanalytical phase of laboratory diagnostics and, therefore, of the total testing process.

Biochimica Clinica 2013; 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

The collection of venous blood is central in clinical laboratory activity. Although there is widespread perception that this practice is simple and free of complications and side effects, it is undeniable that the vast majority of laboratory errors arises from ignorance, incompetence or negligence during venipuncture. It has hence become advisable to prepare a document in simplified form of checklist, consisting of a concise but comprehensive list of activities to be completed or verified in order to prevent errors during venous blood collection. In the intention of authors, this synthetic checklist is a modular tool, adaptable to different local contexts, it can be easily and gradually implemented, it is supported by scientific evidence and consensus of experts and created with the support of different healthcare professionals and it is adherent to the best practices and requires minimal resources for implementation. It is reasonable to assume that this checklist may be able to withstand system and individual changes, strengthening the standards for safety of both operators and patients, limiting potential failure patterns. We hope that the checklist may be implemented in all healthcare facilities where routine venous blood collection is performed, after adaptation to suit characteristics of local organization.

Biochimica Clinica 2013; 37(4) 312-317
Documenti SIBioC - SIBioC Documents
Il passaporto biologico dell’atleta
The athlete biological passport
P.-E. Sottas  |  N. Robinson  |  O. Rabin  |  M. Saugy  | 

In elite sports, the growing availability of doping substances identical to those naturally produced by the human body seriously limits the ability of drug-testing regimes to ensure fairness and protection of health. The Athlete Biological Passport (ABP), the new paradigm in testing based on the personalized monitoring of biomarkers of doping, offers the enormous advantage of being independent of this endless pharmaceutical race. Doping triggers physiological changes that provide physiological enhancements. In the same way that disease-related biomarkers are invaluable tools that assist physicians in the diagnosis of pathology, specifically selected biomarkers can be used to detect doping. The ABP is a new testing paradigm with immense potential value in the current climate of rapid advancement in biomarker discovery. In addition to its original aim of providing proof of a doping offense, the ABP can also serve as a platform for a Rule of Sport, with the presentation before competition of the ABP to objectively demonstrate that the athlete will participate in a healthy physiological condition that is unaltered by performance enhancing drugs. Finally, the decision-support system used today for the biological monitoring of world top-level athletes can also be advantageously transferred to other areas of clinical practice to reach the goal of personalized medicine.

Biochimica Clinica 2013; 37(4) 318-325
Il meglio di Clinical Chemistry - Clinical Chemistry highlights
Un caso di emoglobinuria parossistica notturna associata a mielodisplasia
A case of paroxysmal nocturnal hemoglobinuria in a patient with myelodysplasia

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired hematological disease of the hematopoietic stem cell. PNH arises as a consequence of non-malignant clonal expansion of hematopoietic stem cells and progeny mature blood cells of both myeloid and monocyte lineage, which are deficient in some surface proteins, including the two complement regulators CD55 and CD59. As a result, PNH erythrocytes are incapable to modulate on their surface physiologic complement activation, leading to complement-mediated intravascular hemolysis, which is the central clinical feature of PNH. We present a case of a 16 years old Ukrainian boy who presented with a diagnosis of myelodysplastic syndrome and who was found to be affected by PNH.

Biochimica Clinica 2013; 37(4) 326-328
Casi clinici - Case Report
Il congresso IFCC-EFLM EuroMedLab a Milano: un grande successo della Medicina di Laboratorio italiana
IFCC-EFLM EuroMedLab congress in Milano: a big success of Italian Laboratory Medicine
L. Prencipe  | 
Biochimica Clinica 2013; 37(4) 329-331
Notizie SIBioC - SIBioC News
In ricordo di Renzo Galanello
In memory of Renzo Galanello
A. Mosca  | 
Biochimica Clinica 2013; 37(4) 332
Notizie SIBioC - SIBioC News