Servizio Medicina Of Laboratorio

Rovigo, Italy

Servizio Medicina Of Laboratorio

Rovigo, Italy
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Carobene A.,Servizio Medicina Of Laboratorio | Carobene A.,Biological Variation Working Group | Roraas T.,Haraldsplass Hospital | Solvik U.O.,University of Bergen | And 22 more authors.
Clinical Chemistry | Year: 2017

Background: We sought to develop estimates of biological variation (BV) for 9 enzymes in blood serum as part of the European Biological Variation Study. Methods: Ninety-one healthy study participants (38 male and 53 female, 21-69 years old) were phlebotomized in each of 10 consecutive weeks at 6 European laboratories. The same preanalytical sample-handling protocol was followed at each center before transport to San Raffaele Hospital, Milan, Italy, for analysis. Sera were stored at -80 °C before analysis in duplicate within a single run on an ADVIA 2400 Clinical Chemistry System (Siemens Healthcare) following a protocol designed to minimize analytical imprecision. Assay traceability was established using frozen sera with target values assigned by reference methods. The results were subjected to outlier analysis before CV-ANOVA to deliver valid BV estimates. Results for 9 enzymes were subsequently partitioned for graphical display allowing visual assessment of the effects of country of origin, sex, and age on BV estimates. Results: We found no effect of country upon the observed variation, but overall sex-related differences were evident for alanine amino transferase (ALT), γ-glutamyl transferase (GGT), and creatine kinase (CK). The following estimates for within-subject BV (CVI) and between-subject BV (CVG), respectively, were obtained: ALT: 9.3%, 28.2%; aspartate aminotransferase: 9.5%, 20.3%; GGT: 8.9%, 41.7%; alkaline phosphatase : 5.3%, 24.9%; lactate dehydrogenase: 5.2%, 12.6%; CK: 14.5%, 31.5%; amylase: 6.8%, 30.4%; pancreatic α-amylase: 6.3%, 24.9%; and lipase (LIP): 7.7%, 23.8%. Conclusions: All CVI and some CVG estimates were lower than those reported in the online BV 2014 updated database. Analytical performance specifications derived from BV can be applied internationally. © 2017 American Association for Clinical Chemistry.


Bartlett W.A.,Laboratory Medicine Biological Variation Working Group | Bartlett W.A.,Diagnostics Group Ninewells Hospital and Medical School | Braga F.,Laboratory Medicine Biological Variation Working Group | Braga F.,University of Milan | And 12 more authors.
Clinical Chemistry and Laboratory Medicine | Year: 2015

Data on biological variation are used for many purposes in laboratory medicine but concern exists over the validity of the data reported in some studies. A critical appraisal checklist has been produced by a working group established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) to enable standardised assessment of existing and future publications of biological variation data. The checklist identifies key elements to be reported in studies to enable safe accurate and effective transport of biological variation data sets across healthcare systems. The checklist is mapped to the domains of a minimum data set required to enable this process. © 2015 by De Gruyter.


Carobene A.,Servizio Medicina Of Laboratorio | Carobene A.,Biological Variation Working Group | Strollo M.,Servizio Medicina Of Laboratorio | Jonker N.,Biological Variation Working Group | And 19 more authors.
Clinical Chemistry and Laboratory Medicine | Year: 2016

Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) the reliability and limitations of current BV data were discussed. The EFLM Working Group on Biological Variation is working to increase the quality of BV data by developing a European project to establish a biobank of samples from healthy subjects to be used to produce high quality BV data. The project involved six European laboratories (Milan, Italy; Bergen, Norway; Madrid, Spain; Padua, Italy; Istanbul, Turkey; Assen, The Netherlands). Blood samples were collected from 97 volunteers (44 men, aged 20-60 years; 43 women, aged 20-50 years; 10 women, aged 55-69 years). Initial subject inclusion required that participants completed an enrolment questionnaire to verify their health status. The volunteers provided blood specimens once per week for 10 weeks. A short questionnaire was completed and some laboratory tests were performed at each sampling consisting of blood collected under controlled conditions to provide serum, K2EDTA-plasma and citrated-plasma samples. Samples from six out of the 97 enroled subjects were discarded as a consequence of abnormal laboratory measurements. A biobank of 18,000 aliquots was established consisting of 120 aliquots of serum, 40 of EDTA-plasma, and 40 of citrated-plasma from each subject. The samples were stored at -80 °C. A biobank of well-characterised samples collected under controlled conditions has been established delivering a European resource to enable production of contemporary BV data. © 2016 2016 Walter de Gruyter GmbH, Berlin/Boston.


Camerotto A.,Servizio Medicina Of Laboratorio | Pozzato A.,Struttura Organizzativa Complessa di Ostetricia e Ginecologia | Truppo V.,Servizio Medicina Of Laboratorio | Bedendo S.,Servizio Medicina Of Laboratorio | And 6 more authors.
Biochimica Clinica | Year: 2012

Laboratory tests play a pivotal role in the diagnostic process. Unfortunately, their usefulness is undermined by a substantial proportion of inappropriateness. Up to now the employed strategies appear inadequate to solve the problem. This study presents a structural solution based on health information technology. In 2008 and 2010, an innovative way for prescribing laboratory tests was tested with the help of general practitioners of ULSS 18 Rovigo and ULSS 13 Mirano. It uses a software called GOELM (Guide Order Entry Laboratory Medicine). During the order entry, the software proposes indications about the clinical use of the laboratory test in real time. The general practitioner could accept or not the indication. The number of prescriptions formulated with the use of GOELM was compared with the number of prescriptions formulated by the same doctors without GOELM in the same period of the previous year. Our results demonstrate that the use of GOELM software has achieved a reduction in the total number of prescriptions up to 38% in Rovigo and up to 26% in Mirano. This trial demonstrates that it is possible to make governance in prescription without political and/or administrative measures. GOELM was therefore proved effective in reducing the inappropriateness through knowledge management.

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