The Esr Test: An Old Test With New ContentsThe erythrocyte sedimentation rate (ESR) remains one o... more The Esr Test: An Old Test With New ContentsThe erythrocyte sedimentation rate (ESR) remains one of the most widely used laboratory tests. Its clinical usefulness and interpretation are in the monitoring of inflammatory diseases, in particular rheumatoid arthritis, temporal arteritis and polymyalgia rheumatica. At present, the reference method for measuring the ESR proposed by the International Committee for Standardization in Haematology (ICSH) utilizes EDTA-anticoagulated-undiluted blood to perform the test using the method described by Westergren in 1921. Current interest in the methodology focuses on the development of an automated closed system that allows the determination of the sedimentation rate with selected working methods, using a single sample for more than one haematological test, improving the bio-hazardous aspects of the testing procedures. As a consequence, standardization becomes necessary. ESR results should be reliable, despite the increased number of different me...
To identify the best management strategy for improving the appropriateness of vitamin D, vitamin ... more To identify the best management strategy for improving the appropriateness of vitamin D, vitamin B12 and folate retesting. The study was conducted between 3 November 2012 and 8 June 2015, with inpatients and outpatients being considered separately. After an observational reference period (3 November 2012 to 14 September 2013), an information technology (IT)-based permissive strategy (16 September 2013 to 27 July 2014) followed by a limiting strategy was used to manage the demand for inpatient retesting. For outpatients, an educational strategy period (28 July 2014 to 16 December 2014) with direct contact between medical personnel and general practitioners (GPs) was followed by a post-educational period without any restriction. Data from a total of 66 496 patients for vitamin D, 14 618 for vitamin B12 and 14 445 for folate were retrieved from the laboratory IT system. The main outcomes measures were inappropriate vitamin D, vitamin B12 and folate retesting. The minimal retesting inte...
Coronary-artery disease is the leading cause of death in western countries. Unstable angina and m... more Coronary-artery disease is the leading cause of death in western countries. Unstable angina and myocardial infarction without ST-segment elevation are now recognized as among the most frequent and important clinical manifestations of coronary-artery disease. The European and American professional societies have released guidelines on diagnosis, risk stratification and treatment of these disorders. These guidelines summarise current evidences and translate them in clinical practice. Most important changes relate to the inclusion of troponins into the risk stratification algorithm. In addition, some guidelines released by scientific committees of the laboratory area further define the quality specifications for cardiac troponin assays. Powerful tests, such as cardiac troponins, on which critical decisions will rest need highly reliable methods, quality control and external quality assurance schemes.
World journal of gastroenterology : WJG, Jan 28, 2005
To explore the potential prognostic role of preoperative tumor grade and blood AFP mRNA in a coho... more To explore the potential prognostic role of preoperative tumor grade and blood AFP mRNA in a cohort of patients with hepatocellular carcinoma (HCC) eligible for radical therapies according to a well-defined treatment algorithm not including nodule size and number as absolute selection criteria. Fifty patients with a diagnosis of HCC were prospectively enrolled in the study. Inclusion criteria were: (1) histological assessment of tumor grade by means of percutaneous biopsies; (2) determination of AFP mRNA status in the blood; (3) patient's eligibility for radical therapies. At preoperative evaluation, 54% of the study group had a well-differentiated HCC, 42% had AFP mRNA in the blood, 40% had a tumor larger than 5 cm and 56% had more than one nodule. Surgery (resection or liver transplantation) was performed in 29 patients, while 21 had percutaneous ablation procedures. After a median follow-up of 28 mo, 12-, 24-, and 36-mo survival rates were 78%, 58%, and 51%, respectively. Sur...
Clinical Chemistry and Laboratory Medicine (CCLM), 2015
The lack of interchangeable laboratory results and consensus in current practices has underpinned... more The lack of interchangeable laboratory results and consensus in current practices has underpinned greater attention to standardization and harmonization projects. In the area of method standardization and harmonization, there is considerable debate about how best to achieve comparability of measurement for immunoassays, and in particular heterogeneous proteins. The term standardization should be used only when comparable results among measurement procedures are based on calibration traceability to the International System of Units (SI unit) using a reference measurement procedure (RMP). Recently, it has been promoted the harmonization of methods for many immunoassays, and in particular for thyreotropin (TSH), as accepted RMPs are not available. In a recent paper published in this journal, a group of well-recognized authors used a complex statistical approach in order to reduce variability between the results observed with the 14 TSH immunoassay methods tested in their study. Here we...
Utilità della tecnica denaturing high performance liquid chromatography (DHPLC) per la diagnosi d... more Utilità della tecnica denaturing high performance liquid chromatography (DHPLC) per la diagnosi di deficit di mevalonato chinasi nelle febbri periodiche di sospetta natura autoinfiammatoria * Utility of denaturing high performance liquid chromatography (DHPLC) for the diagnosis of mevalonate kinase deficiency in periodic fevers of autoinflammatory nature suspicion
Welcome to the latest issue of Seminars in Thrombosis & Hemostasis, the fourth devoted to the con... more Welcome to the latest issue of Seminars in Thrombosis & Hemostasis, the fourth devoted to the concept of "quality" within the field of thrombosis and hemostasis. 1-3 The foremost goal of health care is to provide medical resources of high quality to all who need them. As such, the notion of quality in medicine is rather broad and entails the concepts of doing the right thing, at the right time, in the right way, for the right person and, last but not the least, for generating the best possible outcomes for patients/consumers/payers, clinicians, national and supranational agencies, local communities, provider organizations, and employers. 4
The effect of an acid-protected pancreatic enzyme preparation was evaluated in 10 patients with c... more The effect of an acid-protected pancreatic enzyme preparation was evaluated in 10 patients with chronic pancreatitis and steatorrhea. (Twelve patients were enrolled but two withdrew because of poor compliance.) Fecal fat excretion and stool weight were measured, a p-aminobenzoic acid (PABA) test was performed, and gastrointestinal symptoms were assessed before and after 4 weeks of treatment with a standardized dose
Remarkable advances in understanding human biology in health and disease, propelled by technologi... more Remarkable advances in understanding human biology in health and disease, propelled by technological innovations, have contributed to an increase in the number and quality of diagnostic tests. This evolving scenario has been accompanied by the proliferation of false myths and legends in laboratory diagnostics, consuming valuable human and economic resources and jeopardizing the clinical reasoning. The aim of this article is to provide a synthetic overview about some paradigmatic examples of false beliefs in laboratory diagnostics involving activated partial thromboplastin time (APTT), cardiospecific troponins, ischemia modified albumin (IMA), D-dimer, prostate specific antigen (PSA), dibucaine number, Bence Jones protein (BJP), lipoprotein(a), neutrophil gelatinaseassociated lipocalin (NGAL), potassium and reference ranges. Although the suggestive cases described in this article are not intended to be comprehensive, we hope that their description may help remove some mysticisms in laboratory diagnostics.
In order to demonstrate the relationship between performance characteristics of laboratory tests ... more In order to demonstrate the relationship between performance characteristics of laboratory tests and clinical outcomes, diabetes seems to represent a paradigmatic disease: diagnosis, monitoring of therapeutic efficacy and prognosis are adequately achieved by means of laboratory testing. Starting from a simple molecule, glucose, used for the diagnosis of diabetes, continuing with creatinine, used for monitoring renal function in diabetic patients and concluding with cardiac troponins, a recognised gold standard for the diagnosis and risk stratification of cardiovascular diseases, several criticisms may be stressed considering the current methodological state-of-the art. Finally, an often overlooked aspect of performance, the analytical interferences, being responsible of unexpected results, that in turn depend from unknown or undisclosed factors will be discussed, concerning in particular, in our paper, the macroprolactin and the heterophilic antibodies aspects.
Data on quality indicators (QIs) should be collected over time in order to identify and continuou... more Data on quality indicators (QIs) should be collected over time in order to identify and continuously monitor clinical laboratory performance and to improve patient safety by identifying and implementing effective interventions. The aim of the present study was to ascertain whether the utilization of a set of quality indicators over a 3-year period resulted in an improvement in the efficiency and effectiveness of an individual laboratory. Over a 3-year time interval (2009-2011), a series of 38 QIs covering all stages of the total testing process (21 in the pre-analytic, nine in the analytic and eight in the post-analytic phase) was monitored. On the basis of their patterns, QIs have been grouped into the following categories: [1] seven QIs of the pre-analytical phase and three of the intra-analytical phase with a significant trend and a significant linearity demonstrating an improvement over time; [2] 10 QIs of the pre-analytical and two of the intra-analytical phase with a significa...
International journal of clinical & laboratory research, 1996
Tumor spread may be favored by a reduced production and/or an enhanced degradation of extracellul... more Tumor spread may be favored by a reduced production and/or an enhanced degradation of extracellular matrix components (collagen, fibronectin, laminin). Most tumor cell behavior, from growth to spread, may be regulated by cytokines, the exact roles of which, however, are not yet fully understood. We here evaluate the effects of some cytokines (epidermal growth factor, transforming growth factor-beta 1, interleukin-1 alpha, and interleukin-1 beta) on both cell growth and the production of the aminoterminal peptide of type III procollagen, the urokinase plasminogen activator, and the plasminogen activator inhibitor-1 in neoplastic cell lines originating in the pancreas and colon. Cells were stimulated daily with the above cytokines and the aminoterminal peptide of type III procollagen, urokinase plasminogen activator, and plasminogen activator inhibitor-1 were measured in the conditioned media. Epidermal growth factor stimulated cell growth of both cell lines. Transforming growth facto...
Aim: An experimental approach to the use of point-of-care testing for cardiac markers in the Emer... more Aim: An experimental approach to the use of point-of-care testing for cardiac markers in the Emergency Department Ž .
Detection of AFP mRNA in peripheral blood is considered a useful predictor of HCC recurrence afte... more Detection of AFP mRNA in peripheral blood is considered a useful predictor of HCC recurrence after resection. However, its interpretation and clinical significance remains to be determined. This study was designed to evaluate the clinical significance of detecting AFP mRNA positive cells in peripheral blood. A total of 153 patients without macroscopic vascular invasion, who underwent liver resection, were prospectively enrolled in this study. The pattern of HCC recurrence was confirmed by image studies and divided into four types: (1) no recurrence (control group, n = 68); (2) intrahepatic single recurrence (SR group, n = 28); (3) intrahepatic multiple recurrences (MR group, n = 38); and (4) extrahepatic HCC recurrence (EX group, n = 19). HCC recurrence was identified in 85 (55.6%) patients during a follow-up of 8.6 ± 6.7 (range, 0.7-36) months. Multivariate analysis identified preoperative AFP mRNA (HR = 2.54; P = 0.006) as an independent risk factor for HCC recurrence. Preoperative AFP mRNA expression was a significant predictor of HCC recurrence in the MR/EX group (P = 0.029) but not in the SR group (P = 0.467). Detection of AFP mRNA expression in peripheral blood before surgery for HCC is a useful predictor of multiple or extrahepatic HCC recurrences.
The Esr Test: An Old Test With New ContentsThe erythrocyte sedimentation rate (ESR) remains one o... more The Esr Test: An Old Test With New ContentsThe erythrocyte sedimentation rate (ESR) remains one of the most widely used laboratory tests. Its clinical usefulness and interpretation are in the monitoring of inflammatory diseases, in particular rheumatoid arthritis, temporal arteritis and polymyalgia rheumatica. At present, the reference method for measuring the ESR proposed by the International Committee for Standardization in Haematology (ICSH) utilizes EDTA-anticoagulated-undiluted blood to perform the test using the method described by Westergren in 1921. Current interest in the methodology focuses on the development of an automated closed system that allows the determination of the sedimentation rate with selected working methods, using a single sample for more than one haematological test, improving the bio-hazardous aspects of the testing procedures. As a consequence, standardization becomes necessary. ESR results should be reliable, despite the increased number of different me...
To identify the best management strategy for improving the appropriateness of vitamin D, vitamin ... more To identify the best management strategy for improving the appropriateness of vitamin D, vitamin B12 and folate retesting. The study was conducted between 3 November 2012 and 8 June 2015, with inpatients and outpatients being considered separately. After an observational reference period (3 November 2012 to 14 September 2013), an information technology (IT)-based permissive strategy (16 September 2013 to 27 July 2014) followed by a limiting strategy was used to manage the demand for inpatient retesting. For outpatients, an educational strategy period (28 July 2014 to 16 December 2014) with direct contact between medical personnel and general practitioners (GPs) was followed by a post-educational period without any restriction. Data from a total of 66 496 patients for vitamin D, 14 618 for vitamin B12 and 14 445 for folate were retrieved from the laboratory IT system. The main outcomes measures were inappropriate vitamin D, vitamin B12 and folate retesting. The minimal retesting inte...
Coronary-artery disease is the leading cause of death in western countries. Unstable angina and m... more Coronary-artery disease is the leading cause of death in western countries. Unstable angina and myocardial infarction without ST-segment elevation are now recognized as among the most frequent and important clinical manifestations of coronary-artery disease. The European and American professional societies have released guidelines on diagnosis, risk stratification and treatment of these disorders. These guidelines summarise current evidences and translate them in clinical practice. Most important changes relate to the inclusion of troponins into the risk stratification algorithm. In addition, some guidelines released by scientific committees of the laboratory area further define the quality specifications for cardiac troponin assays. Powerful tests, such as cardiac troponins, on which critical decisions will rest need highly reliable methods, quality control and external quality assurance schemes.
World journal of gastroenterology : WJG, Jan 28, 2005
To explore the potential prognostic role of preoperative tumor grade and blood AFP mRNA in a coho... more To explore the potential prognostic role of preoperative tumor grade and blood AFP mRNA in a cohort of patients with hepatocellular carcinoma (HCC) eligible for radical therapies according to a well-defined treatment algorithm not including nodule size and number as absolute selection criteria. Fifty patients with a diagnosis of HCC were prospectively enrolled in the study. Inclusion criteria were: (1) histological assessment of tumor grade by means of percutaneous biopsies; (2) determination of AFP mRNA status in the blood; (3) patient's eligibility for radical therapies. At preoperative evaluation, 54% of the study group had a well-differentiated HCC, 42% had AFP mRNA in the blood, 40% had a tumor larger than 5 cm and 56% had more than one nodule. Surgery (resection or liver transplantation) was performed in 29 patients, while 21 had percutaneous ablation procedures. After a median follow-up of 28 mo, 12-, 24-, and 36-mo survival rates were 78%, 58%, and 51%, respectively. Sur...
Clinical Chemistry and Laboratory Medicine (CCLM), 2015
The lack of interchangeable laboratory results and consensus in current practices has underpinned... more The lack of interchangeable laboratory results and consensus in current practices has underpinned greater attention to standardization and harmonization projects. In the area of method standardization and harmonization, there is considerable debate about how best to achieve comparability of measurement for immunoassays, and in particular heterogeneous proteins. The term standardization should be used only when comparable results among measurement procedures are based on calibration traceability to the International System of Units (SI unit) using a reference measurement procedure (RMP). Recently, it has been promoted the harmonization of methods for many immunoassays, and in particular for thyreotropin (TSH), as accepted RMPs are not available. In a recent paper published in this journal, a group of well-recognized authors used a complex statistical approach in order to reduce variability between the results observed with the 14 TSH immunoassay methods tested in their study. Here we...
Utilità della tecnica denaturing high performance liquid chromatography (DHPLC) per la diagnosi d... more Utilità della tecnica denaturing high performance liquid chromatography (DHPLC) per la diagnosi di deficit di mevalonato chinasi nelle febbri periodiche di sospetta natura autoinfiammatoria * Utility of denaturing high performance liquid chromatography (DHPLC) for the diagnosis of mevalonate kinase deficiency in periodic fevers of autoinflammatory nature suspicion
Welcome to the latest issue of Seminars in Thrombosis & Hemostasis, the fourth devoted to the con... more Welcome to the latest issue of Seminars in Thrombosis & Hemostasis, the fourth devoted to the concept of "quality" within the field of thrombosis and hemostasis. 1-3 The foremost goal of health care is to provide medical resources of high quality to all who need them. As such, the notion of quality in medicine is rather broad and entails the concepts of doing the right thing, at the right time, in the right way, for the right person and, last but not the least, for generating the best possible outcomes for patients/consumers/payers, clinicians, national and supranational agencies, local communities, provider organizations, and employers. 4
The effect of an acid-protected pancreatic enzyme preparation was evaluated in 10 patients with c... more The effect of an acid-protected pancreatic enzyme preparation was evaluated in 10 patients with chronic pancreatitis and steatorrhea. (Twelve patients were enrolled but two withdrew because of poor compliance.) Fecal fat excretion and stool weight were measured, a p-aminobenzoic acid (PABA) test was performed, and gastrointestinal symptoms were assessed before and after 4 weeks of treatment with a standardized dose
Remarkable advances in understanding human biology in health and disease, propelled by technologi... more Remarkable advances in understanding human biology in health and disease, propelled by technological innovations, have contributed to an increase in the number and quality of diagnostic tests. This evolving scenario has been accompanied by the proliferation of false myths and legends in laboratory diagnostics, consuming valuable human and economic resources and jeopardizing the clinical reasoning. The aim of this article is to provide a synthetic overview about some paradigmatic examples of false beliefs in laboratory diagnostics involving activated partial thromboplastin time (APTT), cardiospecific troponins, ischemia modified albumin (IMA), D-dimer, prostate specific antigen (PSA), dibucaine number, Bence Jones protein (BJP), lipoprotein(a), neutrophil gelatinaseassociated lipocalin (NGAL), potassium and reference ranges. Although the suggestive cases described in this article are not intended to be comprehensive, we hope that their description may help remove some mysticisms in laboratory diagnostics.
In order to demonstrate the relationship between performance characteristics of laboratory tests ... more In order to demonstrate the relationship between performance characteristics of laboratory tests and clinical outcomes, diabetes seems to represent a paradigmatic disease: diagnosis, monitoring of therapeutic efficacy and prognosis are adequately achieved by means of laboratory testing. Starting from a simple molecule, glucose, used for the diagnosis of diabetes, continuing with creatinine, used for monitoring renal function in diabetic patients and concluding with cardiac troponins, a recognised gold standard for the diagnosis and risk stratification of cardiovascular diseases, several criticisms may be stressed considering the current methodological state-of-the art. Finally, an often overlooked aspect of performance, the analytical interferences, being responsible of unexpected results, that in turn depend from unknown or undisclosed factors will be discussed, concerning in particular, in our paper, the macroprolactin and the heterophilic antibodies aspects.
Data on quality indicators (QIs) should be collected over time in order to identify and continuou... more Data on quality indicators (QIs) should be collected over time in order to identify and continuously monitor clinical laboratory performance and to improve patient safety by identifying and implementing effective interventions. The aim of the present study was to ascertain whether the utilization of a set of quality indicators over a 3-year period resulted in an improvement in the efficiency and effectiveness of an individual laboratory. Over a 3-year time interval (2009-2011), a series of 38 QIs covering all stages of the total testing process (21 in the pre-analytic, nine in the analytic and eight in the post-analytic phase) was monitored. On the basis of their patterns, QIs have been grouped into the following categories: [1] seven QIs of the pre-analytical phase and three of the intra-analytical phase with a significant trend and a significant linearity demonstrating an improvement over time; [2] 10 QIs of the pre-analytical and two of the intra-analytical phase with a significa...
International journal of clinical & laboratory research, 1996
Tumor spread may be favored by a reduced production and/or an enhanced degradation of extracellul... more Tumor spread may be favored by a reduced production and/or an enhanced degradation of extracellular matrix components (collagen, fibronectin, laminin). Most tumor cell behavior, from growth to spread, may be regulated by cytokines, the exact roles of which, however, are not yet fully understood. We here evaluate the effects of some cytokines (epidermal growth factor, transforming growth factor-beta 1, interleukin-1 alpha, and interleukin-1 beta) on both cell growth and the production of the aminoterminal peptide of type III procollagen, the urokinase plasminogen activator, and the plasminogen activator inhibitor-1 in neoplastic cell lines originating in the pancreas and colon. Cells were stimulated daily with the above cytokines and the aminoterminal peptide of type III procollagen, urokinase plasminogen activator, and plasminogen activator inhibitor-1 were measured in the conditioned media. Epidermal growth factor stimulated cell growth of both cell lines. Transforming growth facto...
Aim: An experimental approach to the use of point-of-care testing for cardiac markers in the Emer... more Aim: An experimental approach to the use of point-of-care testing for cardiac markers in the Emergency Department Ž .
Detection of AFP mRNA in peripheral blood is considered a useful predictor of HCC recurrence afte... more Detection of AFP mRNA in peripheral blood is considered a useful predictor of HCC recurrence after resection. However, its interpretation and clinical significance remains to be determined. This study was designed to evaluate the clinical significance of detecting AFP mRNA positive cells in peripheral blood. A total of 153 patients without macroscopic vascular invasion, who underwent liver resection, were prospectively enrolled in this study. The pattern of HCC recurrence was confirmed by image studies and divided into four types: (1) no recurrence (control group, n = 68); (2) intrahepatic single recurrence (SR group, n = 28); (3) intrahepatic multiple recurrences (MR group, n = 38); and (4) extrahepatic HCC recurrence (EX group, n = 19). HCC recurrence was identified in 85 (55.6%) patients during a follow-up of 8.6 ± 6.7 (range, 0.7-36) months. Multivariate analysis identified preoperative AFP mRNA (HR = 2.54; P = 0.006) as an independent risk factor for HCC recurrence. Preoperative AFP mRNA expression was a significant predictor of HCC recurrence in the MR/EX group (P = 0.029) but not in the SR group (P = 0.467). Detection of AFP mRNA expression in peripheral blood before surgery for HCC is a useful predictor of multiple or extrahepatic HCC recurrences.
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Papers by Mario Plebani