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doctoral thesis
Commutability evaluation of control samples within external quality assessment programs of medical biochemical laboratories
Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry, 2019. urn:nbn:hr:163:865511
Vlašić Tanasković, Jelena
University of Zagreb
Faculty of Pharmacy and Biochemistry
Department of pharmaceutical analysis

Institutional repository: Repository of Faculty of Pharmacy and Biochemistry University of Zagreb

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Vlašić Tanasković, J. (2019). Commutability evaluation of control samples within external quality assessment programs of medical biochemical laboratories (Doctoral thesis). Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry. Retrieved from https://urn.nsk.hr/urn:nbn:hr:163:865511

Vlašić Tanasković, Jelena. "Commutability evaluation of control samples within external quality assessment programs of medical biochemical laboratories." Doctoral thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2019. https://urn.nsk.hr/urn:nbn:hr:163:865511

Vlašić Tanasković, Jelena. "Commutability evaluation of control samples within external quality assessment programs of medical biochemical laboratories." Doctoral thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2019. https://urn.nsk.hr/urn:nbn:hr:163:865511

Vlašić Tanasković, J. (2019). 'Commutability evaluation of control samples within external quality assessment programs of medical biochemical laboratories', Doctoral thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, accessed 29 March 2025, https://urn.nsk.hr/urn:nbn:hr:163:865511

Vlašić Tanasković J. Commutability evaluation of control samples within external quality assessment programs of medical biochemical laboratories [Doctoral thesis]. Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry; 2019 [cited 2025 March 29] Available at: https://urn.nsk.hr/urn:nbn:hr:163:865511

J. Vlašić Tanasković, "Commutability evaluation of control samples within external quality assessment programs of medical biochemical laboratories", Doctoral thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, 2019. Available at: https://urn.nsk.hr/urn:nbn:hr:163:865511

Metadata
TitleCommutability evaluation of control samples within external quality assessment programs of medical biochemical laboratories
Title (croatian)Prosudba komutabilnosti kontrolnih uzoraka u programima vanjske procjene kvalitete medicinskobiokemijskih laboratorija
AuthorJelena Vlašić Tanasković
MentorJadranka Vuković Rodriguez (mentor)
Committee memberDunja Rogić (predsjednik povjerenstva)
Committee memberJozsef Petrik (član povjerenstva)
Committee memberAna-Maria Šimundić (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Pharmacy and Biochemistry
(Department of pharmaceutical analysis)
Zagreb
Defense date and country2019-07-03, Croatia
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Pharmacy
Medical Biochemistry
Universal decimal classification
(UDC)		615 - Pharmacology. Therapeutics. Toxicology
Abstract
Introduction and aim: External quality assessment (EQA) is an integral part of quality management systems in medical biochemical laboratories enabling monitoring of individual results as well as harmonisation and standardisation of measurement procedures (MPs) used in the clinical setting. Commutability of control samples is a major prerequisite for assessing laboratory and MP performance according to the unique target value. Commutable samples show the same properties in different MPs as... More well as patient samples. Commutability is usually evaluated using regression analysis and statistically determined criteria of acceptance without taking into consideration analytical performance specifications for the analyte. The aim of this research is to propose a new model for the evaluation of commutability criteria using analytical performance specifications for each analyte within the EQA program for medical biochemical laboratories. Materials and methods: Lyophilised control samples were distributed together with native and spiked serum samples to all participants of Croatian EQA (CROQALM). The participants analysed both samples using routine MPs. Commutability of control samples was evaluated using the results of two kinds of samples and newly proposed false flagging method. The results for commutability were compared to statistically determined commutability criteria obtained by recommended regression analysis for commutability evaluation of EQA control samples. Results: Three lyophilised EQA control samples were evaluated for commutability for 22 biochemistry analytes and related MPs used in medical biochemical laboratories. The controls were found commutable for 13 analytes: AMY, AST, CK, glucose, iron, LDH, phosphate, potassium, sodium, proteins, triglycerides, urate and urea. High noncommutability of control materials was found for chloride in all three control samples and HDL-cholesterol, AP, creatinine and calcium in two out of three control samples. Unequal criteria in statistically defined commutability limits resulted in commutability conclusions that are dependent on measurement results of patient serum samples by evaluated MPs. Conclusions: The false flagging method, proposed in this thesis, can be used for evaluating commutability of control samples within the EQA program of medical biochemical laboratories. The commutability limits are equally designed for all MP combinations and connected to established analytical performance specifications of the analytes. Less
Abstract (english)
Uvod i cilj: Vanjska procjena kvalitete sastavni je dio sustava za upravljanje kvalitetom medicinskobiokemijskih laboratorija. Osim prosudbe mjernih rezultata, vanjska procjena kvalitete ima za svrhu praćenje globalnih ciljeva harmonizacije i standardizacije mjernih postupaka (MP) koji se koriste u laboratorijima. Komutabilnost kontrolnih uzoraka nužan je preduvjet za valjanu prosudbu kvalitete prema jedinstvenoj ciljnoj vrijednosti. Komutabilni uzorci pokazuju jednaka svojstva kao i... More uzorci pacijenata u različitim MP. Komutabilnost se uobičajeno procjenjuje korištenjem regresijske analize i statističkih kriterija za prosudbu, ne uzimajući u obzir analitičke ciljeve kvalitete ispitivanog analita. Stoga je cilj ovog doktorskog rada postavljanje i validacija nove metode za prosudbu komutabilnosti kontrolnih uzoraka uzimajući u obzir postavljene analitičke ciljeve kvalitete u sklopu vanjske procjene kvalitete medicinsko-biokemijskih laboratorija . Materijali i metode. Medicinsko-biokemijskim laboratorijima koji sudjeluju u vanjskoj procjeni kvalitete CROQALM poslani su liofilizirani komercijalni kontrolni uzorci zajedno sa svježim uzorcima seruma, te svježim uzorcima seruma uz dodatak glukoze, ureje, natrija, kalija, klorida i bilirubina. Uzorci su analizirani upotrebom standardnih MP, a komutabilnost komercijalnih kontrolnih uzoraka ispitana je korištenjem dvije vrste uzoraka i novom predloženom ‘metodom lažnog odstupanja’ (engl. false flagging method). Dobiveni rezultati uspoređivani su sa statističkim kriterijima prosudbe komutabilnosti kontrolnih uzoraka u okviru vanjske procjene kvalitete medicinsko-biokemijskih laboratorija. Rezultati: Metodom lažnog odstupanja ispitana je komutabilnost kontrolnih uzoraka za 22 analita i 331-426 parova MP koji se koriste u rutinskom radu laboratorija. Sva tri kontrolna uzorka pokazuju komutabilnost za većinu kombinacija MP za mjerenje amilaza, AST, CK, glukoze, željeza, LDH, fosfata, kalija, natrija, proteina, triglicerida, urata i ureje. Nekomutabilnost sva tri kontrolna uzorka dokazana je za kloride, te HDL-kolesterol, AP, kreatinin i kalcij u dvije kontrole. Neujednačenost statistički postavljenih kriterija za prosudbu komutabilnosti rezultira zaključcima koja uvelike zavise o rezultatima mjerenja uzoraka seruma pacijenata na ispitivanim MP. Zaključci: Metoda lažnog odstupanja predložena u ovom radu predstavlja novi pristup u prosudbi komutabilnosti i može se primijeniti za veliki broj analita i MP u okviru vanjske procjene kvalitete medicinsko-biokemijskih laboratorija. Pri tome su kriteriji prosudbe jednoznačni za sve parove MP, omogućavajući prosudbu kliničke i/ili analitičke jednakovrijednosti kontrolnih uzoraka prema dijagnostičkim značajkama samog analita. Less
Keywords
Keywords (english)
Languageenglish
URN:NBNurn:nbn:hr:163:865511
Study programmeTitle: Pharmacy and biochemistry
Study programme type: university
Study level: postgraduate
Academic / professional title: doktor znanosti (doktor znanosti)
Type of resourceText
File originBorn digital
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2019-10-11 13:53:44
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