20.500.12556/DKUM-18972 VALIDACIJA ANALIZNIH METOD ZA DOLOČANJE NEPROTEINSKIH DUŠIKOVIH SPOJIN V KRVNEM SERUMU VALIDATIUM OF ANALYTICAL METHODS FOR NON-PROTEIN NITROGEN COMPOUNDS DETERMINATION IN BLOOD SAMPLES Predpisi in standardi laboratorije obvezujejo, da se izvajajo analize po kriterijih o zagotavljanju kakovosti (Quality Assurance) in po načelu dobre laboratorijske prakse (Good Laboratory Practice). Namen diplomske naloge je bil preveriti in potrditi zanesljivost rezultatov ter pravilnost analiznih postopkov za določanje neproteinskih dušikovih spojin: sečnine, kreatinina in sečne kisline v krvnem serumu na avtomatskem analizatorju Dimension Xpand Plus. Rezultati so bili statistično ovrednoteni v skladu z zahtevami validacijskih postopkov. Obravnavana je bila pravilnost linearnega modela umeritvene krivulje, meja zaznavnosti, meja določljivosti, točnost in natančnost. Natančnost metod je bila testirana tudi s sodelovanjem v zunanji kontroli kakovosti. Po uspešni validaciji analiznih metod za določanje neproteinskih dušikovih spojin smo v okviru diplomske naloge analizirali krvni serum 62 preiskovancem. Od tega smo obravnavali 33 žensk povprečne starosti 52,7 let (od 25 do 85 let) in 29 moških povprečne starosti 55,7 let (od 18 do 87 let). V serumskih vzorcih populacije ženskega spola je bila povprečna koncentracija sečnine 5,35 ± 2,10 mmol/L. Znotraj referenčne vrednosti je bilo 82 % rezultatov. Povprečna koncentracija kreatinina je bila 75,72 ± 25,24 µmol/L. Znotraj referenčne vrednosti je bilo 79 % rezultatov. Ocena glomerulne filtracije je bila v območju 83,52 ± 25,08 mL/min/1,72 m2. Nad 60 mL/min/1,72 m2 je bilo 85 % rezultatov. Povprečna koncentracija sečne kisline je bila 261,76 ± 65,14 µmol/L. Znotraj referenčne vrednosti je bilo 91 % rezultatov. V serumskih vzorcih populacije moškega spola je bila povprečna koncentracija sečnine 6,57 ± 3,35 mmol/L. Znotraj referenčne vrednosti je bilo 69 % rezultatov. Povprečna koncentracija kreatinina je bila 103 ± 35,99 µmol/L. Znotraj referenčne vrednosti je bilo 76 % rezultatov. Ocena glomerulne filtracije je bila v območju 78 ± 23,94 mL/min/1,72 m2. Nad 60 mL/min/1,72 m2 je bilo 79 % rezultatov. Povprečna koncentracija sečne kisline je bila 356,52 ± 74,63 µmol/L. Znotraj referenčne vrednosti je bilo 83 % rezultatov. Regulations and standards bind us to implementing analysis on the criteria of QA (Quality Assurance), and the principle of GLP (Good Laboratory Practice). The purpose of this study was to validate the reliability of results and their accuracy regarding the analytical procedures for determining non-protein nitrogen compounds: urea, creatinine and uric acid in the blood serum of the automatic analyzer Dimension Xpand Plus. The results were statistically-evaluated in accordance with the requirements of the validation procedures. The subject for discussion was the confirmation of a linear model of the calibration curve, the limit of detection (LOD), the limit of quantification (LOQ), accuracy, and precision. The precision of methods were tested with the cooperation of external quality-control. After successful validation of the analytical methods for determining non-protein nitrogen compounds, we analyzed the blood serums of 62 blood donors, 33 women aged between 25 and 85 years, mean being 52,7, and 29 men aged between 25 and 85 years, mean being 55,7. For the serum samples of the female population mean concentration of urea was 5,35 ± 2,10 mmol/L. 82% of the results were inside the reference value. The mean concentration of creatinine was 75,72 ± 25.24 μmol/L. 79% of the results were inside the reference value. The oGF was 83,52 ± 25.08 mL/min/1,72 m2. 85% of the results were over 60 mL/min/1,72 m2. The mean concentration of uric acid was 261,76 ± 65,14 μmol/L. 91% of the results were inside the reference value. For the serum samples of the male population mean concentration of urea was 6,57 ± 3,35 mmol/L. 69% of the results were inside the reference value. The mean concentration of creatinine was 103 ± 35,99 μmol/L. 76% of the results were inside the reference value. The oGF was 78 ± 23,94 mL/min/1,72 m2. 79% of the results were over 60 mL/min/1,72 m2. The mean concentration of uric acid was 356,52 ± 74,63 μmol/L. 83% of the results were inside the reference value. neproteinske dušikove spojine sečnina kreatinin sečna kislina validacija avtomatski analizator serum. non-protein nitrogen compounds urea creatinine uric acid validation automatic analyzer serum. true true false [D. Mahnič] Slovenski jezik Angleški jezik Diplomsko delo 2011-06-13 20:47:37 2011-06-23 13:30:13 2022-04-13 14:58:33 2023-12-19 03:36:36 2011 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 577.12:577.31(043.2) 15162134 URN:SI:UM:DK:PA6HDC4P UNI_Mahnic_Darja_2011.pdf UNI_Mahnic_Darja_2011.pdf 1 DA2A511E8AA5A2FC5F39C3A63FD56DA0 65d8aa9d5ebdf3697c6cd64bb799370e5fa141c5621bbbb9d0f5108d34400de4 42a4c7af-7c05-11eb-bb7a-00155d0001ca 20.500.12556/dkum/d759dccd-e810-44bb-a827-9fcaeb805057 https://dk.um.si/Dokument.php?lang=slv&id=22742 Fakulteta za kemijo in kemijsko tehnologijo 0 0 0