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Title: Preanalytical management: serum vacuum tubes validation for routine clinical chemistry. Author: Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Picheth G, Guidi GC. Journal: Biochem Med (Zagreb); 2012; 22(2):180-6. PubMed ID: 22838184. Abstract: INTRODUCTION: The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing. MATERIALS AND METHODS: Blood specimens from 100 volunteers in five different serum vacuum tubes (Tube I: VACUETTE, Tube II: LABOR IMPORT, Tube III: S-Monovette, Tube IV: SST and Tube V: SST II) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas 6000 <c501> module. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation. RESULTS AND CONCLUSIONS: Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices. UVOD:: Proces validacije ključan je u akreditiranim kliničkim laboratorijima. Cilj ovog istraživanja bio je validirati pet vrsta vakumskih serumskih epruveta koje se koriste pri rutinskim biokemijskim pretragama u laboratoriju. MATERIJALI I METODE:: Iskusni laboratorijski tehničar sakupio je uzorke krvi od 100 dobrovoljaca u pet različitih vakumskih serumskih epruveta (epruveta I: VACUETTE®, epruveta II: LABOR IMPORT®, epruveta III: S-Monovette®, epruveta IV: SST® i epruveta V: SST II®). U uzorcima su provedene rutinske biokemijske pretrage na analizatoru cobas® 6000 modul c501. Statistička značajnost razlika između rezultata svakog uzorka procijenjena je Studentovim t-testom nakon provjere normalnosti raspodjele. Razina statističke značajnosti postavljena je na P < 0,005. Naposljetku su sustavne pogreške dobivene rezultatima iz epruvete I, epruvete II, epruvete III, epruvete IV i epruvete V uspoređene s preporučenim vrijednostima odstupanja (engl. desirable quality specifications for bias, B) koja su izvedena iz biološke varijacije. REZULTATI I ZAKLJUČAK:: Naša će validacija omogućiti voditeljima laboratorija ili bolnice odabrati vakumske epruvete određenog proizvođača validirane prema vlastitim tehničkim ili ekonomskim zahtjevima, za sljedeće pretrage: glukozu, ukupni kolesterol, HDL-kolesterol, trigliceride, ukupne proteine, albumin, ureju, mokraćnu kiselinu, alkalnu fosfatazu, aspartat-aminotransferazu, gama-glutamiltransferazu, laktat-dehidrogenazu, kreatinin-kinazu, ukupni bilirubin, direktni bilirubin, kalcij, željezo, natrij i kalij. Posebna se pažnja treba obratiti ukoliko laboratorij već vrši pretrage za određivanje koncentracije kreatinina, fosfora i magnezija te aktivnosti amilaze, ukoliko voditelj upravljanja kvalitetom laboratorija želi promijeniti serumske epruvete. Predlažemo da voditelj laboratorija standardizira postupke i redovito procjenjuje kvalitetu in vitro dijagnostičkih uređaja.[Abstract] [Full Text] [Related] [New Search]