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Primerjava pristopov za vrednotenje medlaboratorijskih razlik pri meritvah biokemičnih parametrov
ID Draščič, Sara (Author), ID Jerin, Aleš (Mentor) More about this mentor... This link opens in a new window, ID Bratož, Saša (Comentor)

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Abstract
Ker 70 % odločitev zdravnikov temelji na rezultatih laboratorijskih analiz, je temeljni cilj laboratorijske medicine pridobiti primerljive rezultate meritev vzorcev pacientov, ne glede na čas, laboratorij in merilni proces. Primerljivost rezultatov ne glede na čas, laboratorij in merilni proces dosežemo z vzpostavitvijo sistema sledljivosti do skupne reference, pri čemer ima pomembno vlogo referenčni sistem, sledljivost pa vzpostavimo s standardizacijo ali harmonizacijo merilnega procesa. Primerljivost med laboratoriji preverjamo s shemami zunanje ocene kakovosti (EQA), ki omogočajo prepoznavanje analitičnih nepravilnosti in spodbujajo izboljšave na področju medlaboratorijskih razlik. Z nalogo smo želeli opredeliti primerljivost rezultatov slovenskih laboratorijev, ki sodelujejo v Slovenski nacionalni shemi za zunanjo oceno kakovosti (SNEQAS). Z obravnavo 8 biokemičnih parametrov (kloridi, glukoza, železo, holesterol, celokupni bilirubin, AST, ALT, ALP) v 15 ciklih SNEQAS, ki so se zvrstili od leta 2014 pa do vključno 3. cikla v letu 2017 smo uporabili metodo sigmametrije in merilne negotovosti. Pri obeh metodah so bili najboljši rezultati dobljeni za železo, najslabši pa za klorid, glukozo, holesterol in ALP. Razlogov za razlike med skupinami metod in med skupinami slovenskih laboratorijev, ki uporabljajo enako metodo, je več: nekomutabilnost kontrolnega materiala sheme SNEQAS za določanje biokemičnih parametrov, izbor statističnih metod, enačb in podatkov (TEa, ciljna vrednost), nevzpostavljen sistem sledljivosti do skupne reference, razlike med reagenti različnih serij, laboratoriji uporabljajo različne analizatorje, metode in reagente, sistemske in naključne napake ter vsesplošno pomanjkanje standardizacije merilnih procesov. Standardizacijo bi bilo smiselno začeti vzpostavljati v posameznih laboratorijih, nato pa še v shemi SNEQAS, z uporabo komutabilnega kontrolnega materiala.

Language:Slovenian
Keywords:EQA, SNEQAS, sledljivost, komutabilnost, sigmametrija, merilna negotovost
Work type:Master's thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2019
PID:20.500.12556/RUL-111914 This link opens in a new window
Publication date in RUL:17.10.2019
Views:2002
Downloads:239
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Secondary language

Language:English
Title:Comparison of approaches for evaluating inter-laboratory differences in biochemical parameter measurements
Abstract:
Since 70 % of medical decisions are based on the results of laboratory analyzes, the basic goal of laboratory medicine is to obtain comparable results of patient sample measurements regardless of time, laboratory and measurement process. Comparability of the results regardless of time, laboratory and measurement process is achieved by establishing a traceability system to a common reference where the reference system plays an important role, and traceability is established by standardization or harmonization of the measurement process. Comparability between laboratories is checked through external quality assessment schemes (EQA), which allow the identification of analytical abnormalities and encourage improvements. We wanted to define the comparability of the results of Slovenian laboratories participating in the Slovenian National External Quality Scheme (SNEQAS). For assessment of 8 biochemical analytes (chlorides, glucose, iron, cholesterol, total bilirubin, AST, ALT, ALP) in 15 SNEQAS cycles, from 2014 to the third cycle in 2017, we used the sigmametric method and measurement uncertainty. The best results were obtained for iron and the worst results were obtained for chloride, glucose, cholesterol and ALP. There are several reasons for the incomparability of the results of Slovenian laboratories: noncommutability of the control samples of the SNEQAS scheme for the determination of biochemical parameters, the choice of statistical methods, equations and data (TEa, target value), traceability system to the common reference in laboratories is not established, the differences between reagents of different series, the laboratories use different analyzers, methods and reagents, systemic and random errors, and overall lack of standardization of measurement processes. Standardization should be started in individual laboratories an then continued in the SNEQAS scheme, using a commutable control material.

Keywords:EQA, SNEQAS, traceabilitiy, commutability, sigmametrics, measurement uncertainty

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