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Ricos C.,Spanish Society of Clinical Biochemistry and Molecular Pathology SEQC | Alvarez V.,Spanish Society of Clinical Biochemistry and Molecular Pathology SEQC | Alvarez V.,Laboratori Clinic LHospitalet | Perich C.,Spanish Society of Clinical Biochemistry and Molecular Pathology SEQC | And 19 more authors.
Clinical Chemistry and Laboratory Medicine

The aims of this study are: 1) to use the data included in the biological variation (BV) database to address the usability of BV estimates; and 2) to use different examples from the authors' laboratories to illustrate the use and the usefulness of BV data in laboratory medicine. The BV database is an essential tool for laboratory management. Examples of application of data derived from BV are given in this paper, such as analytical performance specifications that have been included in various quality control software designed to optimize operative rules; also they have been incorporated as acceptability limits in external quality assurance reports. BV data from pathological status are of utmost interest for monitoring patients and differences between the intra-individual coefficients of variation (CVI) estimated from healthy and patients are shown. However, for a number of analytes there are limited data available and for many there are no data, consequently new studies should be encouraged at an international level. In addition, developing international criteria to evaluate publications dealing with the estimation of BV components would be of the utmost interest. We are ready and willing to collaborate with such worthy initiatives. The first EFLM strategic conference on analytical performance specifications is an excellent opportunity for debating these ideas. © 2015 by De Gruyter. Source

Ruiz R.,Laboratori Clinic LHospitalet | Llopis M.A.,Laboratori Clinic Barcelones Nord i Valles Oriental | Biosca C.,Servei de Bioquimica Clinica Hospital Germans Trias i Pujol | Trujillo G.,Laboratori Clinic Bages | And 14 more authors.
Clinical Chemistry and Laboratory Medicine

Background: Quality specifications for indicators of the key analytic processes have been defined by international consensus. However, only preliminary specifications for laboratory-related strategic and support processes have been developed. The present study attempts to increase the robustness of the preliminary proposed specifications. Methods: Recovering records and incidences occurred over a 4-year follow-up period, for 12 indicators, used in all laboratories from this group regarding strategic and support processes. Results and conclusions: The results obtained indicate that it is better to establish an interval rather than a fixed value for the majority of indicators. Longer studies are needed to properly assess some quality specifications, and data recording system must be standardized in others. Additional, multicenter studies are needed to establish more robust specifications and determine the state of the art of laboratories in other settings. © 2010 by Walter de Gruyter, Berlin, New York. Source

Perich C.,SEQC Analytical Quality Commission | Perich C.,Laboratori Clinic Bon Pastor | Ricos C.,SEQC Analytical Quality Commission | Alvarez V.,SEQC Analytical Quality Commission | And 18 more authors.
Clinica Chimica Acta

Introduction: Current external quality assurance schemes have been classified into six categories, according to their ability to verify the degree of standardization of the participating measurement procedures. SKML (Netherlands) is a Category 1 EQA scheme (commutable EQA materials with values assigned by reference methods), whereas SEQC (Spain) is a Category 5 scheme (replicate analyses of non-commutable materials with no values assigned by reference methods). Aim: The results obtained by a group of Spanish laboratories participating in a pilot study organized by SKML are examined, with the aim of pointing out the improvements over our current scheme that a Category 1 program could provide. Method: Imprecision and bias are calculated for each analyte and laboratory, and compared with quality specifications derived from biological variation. Results: Of the 26 analytes studied, 9 had results comparable with those from reference methods, and 10 analytes did not have comparable results. The remaining 7 analytes measured did not have available reference method values, and in these cases, comparison with the peer group showed comparable results. The reasons for disagreement in the second group can be summarized as: use of non-standard methods (IFCC without exogenous pyridoxal phosphate for AST and ALT, Jaffé kinetic at low-normal creatinine concentrations and with eGFR); non-commutability of the reference material used to assign values to the routine calibrator (calcium, magnesium and sodium); use of reference materials without established commutability instead of reference methods for AST and GGT, and lack of a systematic effort by manufacturers to harmonize results. Conclusions: Results obtained in this work demonstrate the important role of external quality assurance programs using commutable materials with values assigned by reference methods to correctly monitor the standardization of laboratory tests with consequent minimization of risk to patients. © 2013 Elsevier B.V. Source

Aakre K.M.,University of Bergen | Thue G.,University of Bergen | Subramaniam-Haavik S.,University of Bergen | Cooper J.,University of Bergen | And 17 more authors.
Diabetes Research and Clinical Practice

Aims: To assess general practitioners (GPs) knowledge of guideline recommendations on diagnosing microalbuminuria (MA) and to evaluate how this diagnosis influences drug treatment of diabetes patients. Methods: A postal case-history based questionnaire describing a male patient (previously not tested for MA) with type 2 diabetes who had several risk markers for cardiovascular disease. Results: 2078. GPs from nine European countries were included, with response rates varying from 7% to 43%. Almost all GPs recommended annual testing for MA. Forty-five to 77% (depending on country) of GPs required more than one positive test to diagnose MA. The absolute increase in the percentages of GPs who would supplement the patient's drug treatment if MA developed was: for anginotensin converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) 23-50% (depending on country), for statins 0-19%, for acetylsalicylic acid 2-13%, and for hypoglycemic agents (tablets and insulin) 0-33%. The proportion of GPs recommending all four possible treatment modalities was low. Conclusions: Guidelines for diagnosing MA were partly followed. ACEIs and ARBs were recommended when MA was present, but the recommended multifactorial treatment of cardiovascular risk markers was not implemented. © 2010 Elsevier Ireland Ltd. Source

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