| Sažetak | Uvod Svaku novu ili izmijenjenu epruvetu, koja se uvodi u rutinski rad laboratorija, potrebno je verificirati, odnosno procijeniti odgovara li specifikacijama proizvođača. Cilj verifikacije je ispitati jesu li rezultati dobiveni iz uzorka u novim ispitivanim epruvetama usporedivi s rezultatima iz kontrolnih epruveta. Cilj istraživanja Cilj istraživanja bio je verificirati epruvete BD Barricor za dvadeset četiri biokemijska analita iz hitnog programa pretraga. Ispitanici i metode Uzorci (N=47) pacijenata prosječne dobi 65 godina (22-87) uzorkovani su u dvije različite epruvete (Becton, Dickinson and Company): RST (referentna) i Barricor LH (testna) epruvete. Uzorci u RST epruvetama centrifugirani su unutar trideset minuta od uzorkovanja, deset minuta pri 1300 g, a uzorci iz Barricor LH epruvetama, tri minute pri 4000g. CRP je izmjeren imunoturbidimetrijskom metodom (ROCHE Diagnostics GmbH), GUK, CK, CK-MB, AST, ALT, ALP, LDH, GGT, urea, kreatinin, amilaza, urati enzimatskom metodom (ROCHE Diagnostics GmbH), Ca, proteini i albumini fotometrijskom metodom, te elektroliti Na, K i Cl indirektnom potenciometrijom. Za sve navedene analite korišten je analizator Olympus AU680 (BeckmanCoulter, Inc., USA). cTnI i Mgb su izmjereni imunokemijskom metodom na analizatoru Dimension EXL s LM (Siemens Healthcare Diagnostics Inc., Newark, USA). Hormoni štitnjače: FT3,FT4 te TSH izmjereni su na Arhitect i2000SR instrumentu (Abbott Laboratories, Lake Forest, USA) kemiluminiscentnom, mikročestičnom imunoanalizom. Rezultati su obrađeni statističkim programom MedCalc, verzija12.4.0.0.0. (MedCalc Software, Mariakerke, Belgium). Rezultati Srednje razlike u mjerenjima bile su u okviru klinički prihvatljivih odstupanja za sve testirane analite,osim za K i proteine: K -4,95% i proteini 4,15%. Ispitivanjem stabilnosti analita u uzorcima plazme u inicijalnom vremenu te nakon dvadeset četiri sata utvrđene su klinički značajne razlike za GUK -3,81%i CK-MB -23,68%. Zaključak Za sve pretrage, osim za K i proteine, dobiveno je prihvatljivo odstupanje rezultata u ispitivanim Barricor epruvetama u odnosu na kontrolne RST epruvete prema biološkim kriterijima prihvatljivosti. Postojeći sustav RST epruveta može se zamijeniti novim Barricor LH epruvetama, ali uz korekciju referentnih intervala za K i proteine. |
| Sažetak (engleski) | Introduction Each and every new or modified test tube introduced into the routine work of the laboratory needs to be verified, i.e. to assessed whether the manufacturer's specifications are correct. The aim of the verification is to examine whether the results obtained from the sample in the new test tubes are comparable with the results from the test tubes already in use. Objective The aim of the research was to verify BD Barricor tubes for 24 biochemical analytes from the emergency examination program. Participants and Methods Samples (N=47) from patients of average 65 years of age (22–87) were sampled in two different tubes (Becton, Dickinson and Company): RST (reference) and Barricor LH (test) tubes. Samples in RST tubes were centrifuged within 30 minutes from sampling, for 10 minutes at 1300 g, and samples from Barricor LH tubes, for 3 minutes at 4000 g. CRP was measured by the immunoturbidimetric method (ROCHE Diagnostics GmbH); GUK, CK, CK MB, AST, ALT, ALP, LDH, GGT, urea, creatinine, amylase and urates were measured by enzymatic method (ROCHE Diagnostics GmbH); Ca, protein and albumins were measured by photometric method, while Na, K and Cl electrolytes were measured by indirect potentiometry. For all the analyses mentioned, the Olympus AU680 (Beckman Coulter, Inc., USA) analyzer was used. Mgb and cTnI were measured by the immunochemical method on the Dimension EXL analyzer with LM (Siemens Healthcare Diagnostics Inc., Newark, USA). Thyroid hormones FT3, FT4, and TSH were measured on the Arhitect i2000SR instrument (Abbott Laboratories, Lake Forest, USA) by chemiluminescent microparticle immunoassay. The results were processed by statistical program MedCalc, version 12.4.0.0.0. (MedCalc Software, Mariakerke, Belgium). Results The mean differences in the measurements were within the range of clinically acceptable deviations for all the tested analytes, except K and proteins: K -4.95% and proteins 4.15%. Analyzing the stability of analytes in plasma samples in initial time and after 24 hours, there were clinically significant differences found for GUK -3.81% and CK-MB -23.68%. Conclusion Acceptable deviation of the results in the analyzed Barricor tube with respect to the control RST tubes was obtained for all the tested analytes except for K and proteins. The existing RST tubes could be replaced with new Barricor LH tubes, but with the correction of reference intervals for K and proteins. |
