SEKK Pardubice

Czech Republic

SEKK Pardubice

Czech Republic
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Ambrozova J.,OKB H Nemocnice Prachatice A.s | Kratochvila J.,SEKK Pardubice
Klinicka Biochemie a Metabolismus | Year: 2016

EP15-A3 document [1] deals with the procedures designed to determine the quantitative measurement procedures analytical performance, namely the user precision verification and the bias estimations that CLSI presents in the form of the recommendations for user as to achieve both goals within a single experiment, which at a minimum allowable range (design) 5x5 takes five days. The paper topic is concerned on the practical user experience with the procedures according to [1], demonstrated here on the albumin example in Annex [11] and identifying the key differences as to the practices described in the previous the EP15-A2 (version A2). A special part of the study presents a comparison of some calculations according to [1] conducted by the means of common Excel software spreadsheets compared with the calculations generated by the special Excel software supplement, namely by the MSA of Analyse-it version 4.51. Two summary tables demonstrate the bias estimates of twenty basic biochemical analytes and eleven specific proteins based on the seven different reference materials measurements.

Haeckel R.,Bremer Zentrum For Laboratoriumsmedizin | Wosniok W.,University of Bremen | Kratochvila J.,SEKK Pardubice | Carobene A.,Universitario ffaele
Clinical Chemistry and Laboratory Medicine | Year: 2012

Permissible limits for internal and external quality assurance are either based on biological variation or on the state of the art (technical feasibility). The former approach has a scien-tific basis, but, in some cases, leads to limits which are either not achievable under the present technology, or which are not stringent enough. If proficiency testing is mandatory, stringent limits which cannot be fulfilled by the majority of laboratories could lead to juristic consequences. Therefore, most national guidelines were based on the state of the art, however, without providing the underlying reasoning. A simple algorithm for permissible limits in external quality assessment schemes (EQAS) is proposed based on biological variation, technical feasibility and correlated to the rate of false positive results. The proposed limits are compared with some limits from several EQAS (RiliBÄK, SEKK, RCPA, CLIA, PROLARIT). The suggested limits are slightly more stringent than the German RiliBÄK, less stringent than the Australasian guidelines and agreed best with the Czech SEKK and the Italian PROLARIT scheme. The graphical presentation of permissible limits strictly derived of biological variation with the proposed limits led to straight lines with different slopes and a cross-over at the limits for quantities with a medium biological variation (e.g., trijodthyronine). The greatest discordance between the various recommendations was observed for calcium, chloride, hemoglobin A1c and sodium. © 2012 by Walter de Gruyter • Berlin • Boston.

Results obtained in external quality assessment programs show low level of harmonization and comparability in ALP measurement. Dependency of results on the used method/reagent kits are enormous in cases of all types matrices of control samples (individual donor samples, native pool sera, lyophilised sera). Reason of this situation is usual - small number of methods with traceability to IFCC reference method 2011 [3]. Documentation of many methods from many manufacturers systematically confuses real and approved IFCC method 2011 with so called and not valid "reference" method from 1983, developed originally for incubation temperature 30°C [1]. Problems with the lack of harmonization are very strongly deteriorated by use of non-standardized and fully obsolete methods with DEA buffer. These methods give very different results from methods with AMP buffer and are still on the marketplace. Mentioned problems lead us to interim interruption of certificate process in external quality assessment program SEKK for ALP. Nevertheless standardization process for ALP slowly continues and our communication comments and documents this process. We dealed with calibration problems of routine methods for ALP based on the reference method 2011 [1]. We propose some tools for achievement of necessary level oh harmonization of ALP measurement results.

Friedecky B.,UKBD LF UK a FN | Kratochvila J.,SEKK Pardubice
Klinicka Biochemie a Metabolismus | Year: 2010

In near future we can expect some significant changes in performance of external quality assessment programs. These changes are conditioned namely by two factors. Firstly, by introducing the new standard ISO 17043 into practice use, and secondly by the change of quality control from classical control to tool of patients risk management. What does it all means for performance of EQA? Introducing the preanalytical and postanalytical as part of EQA programs. Intensification of their educational potential is expected. Much larger application of two essential parts of metrology-traceability and uncertainty is involved in EQA programs. Expected changes in EQA should begin by auditing respectively corrections of target values and particularly by control limits values.

Fredecy B.,Ustav Klinicke Biochemie a Diagnostiky | Kratochvila J.,SEKK Pardubice | Spirkova J.,Ustav Klinicke Biochemie a Diagnostiky | Budina M.,SEKK Pardubice | Palicka V.,Ustav Klinicke Biochemie a Diagnostiky
Prakticky Lekar | Year: 2011

Four POCT systems designed for HbA1c measurement in blood were compared with a high quality laboratory method based on the HPLC principle and successfully controlled by a proficiency testing program provided by the European reference laboratory for HbA1c (in The Netherlands). The accuracy of all the systems tested was good and covers interval CV %=2.8-5.3. Systematic errors, calculated as differences of individual POCT systems from laboratory HPLC method are high and range in intervals from-6.7 to-9.7%. These systematic differences cause different classifications of diabetes compensation in patients (cut off 53 mmol/mol=5,3 % IFCC). The laboratory method classified 51 (74 %) of the patients analysed to be decompensated, while POCT systems only classified between 41(57 %) to 32 (44 %) patients as decompensated from the total number of 72 assessed patients. Our conclusion is that where well-standardised laboratory methods are available, this is sufficient for patients' needs and POCT measurement has no additive benefits. In fact with the possible differences in the therapeutic classification, it is more likely that use of POCT could increase the risk of insufficient treatment.

Friedecky B.,Ustav Klinicke Biochemie A Diagnostiky LF UK A FN Hradec Kralove | Kratochvila J.,SEKK Pardubice
Prakticky Lekar | Year: 2012

The increase in possibilities offered by the POCT system to physicians, clinical units of intensive care and patient self-monitoring is continuing apace. Is this trend positive for patients and their care Do the manufacturers provide all the qualitatively and quantitatively necessary information needed for risk management It is very important for users to obtain objective, independent information concerning the quality of POCT, and how results compare to the results of clinical laboratories. We show how this information can be obtained in Scandinavian countries. We demonstrate unsolved problems in the Czech Republic by means of examples of glucometers, HbA1c, and C-reactive protein.

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