| Abstract (croatian) | Uvod: Cilj ovog istraživanja bio je usporediti analizator za pretrage uz bolesnika (engl. point-of-care testing, POCT) Gem® Premier™ 4000 s referentnim analizatorima. Posebna je pažnja posvećena metodi mjerenja koncentracije tHb/HCT na analizatorima za POCT.
Materijali i metode: Usporedili smo analitički učinak analizatora Gem® Premier™ 4000 s učincima analizatora Ciba Corning 865, Gem® Premier™ 4000 i Dimension RxL, kod određivanja koncentracije parametara acido-bazičnog statusa (pH, pCO2, pO2), elektrolita, metabolita, hemoglobina i hematokrita. Za analizator Gem® Premier™ 4000 izračunate su nepreciznosti unutar serije i iz dana u dan. 200 uzoraka pune krvi je analizirano u razdoblju od 30 dana.
Rezultati: Dobiveni su zadovoljavajući rezultati ispitivanja nepreciznosti unutar serije za sve analite (CV ≤ 4,89%), osim za pO2 (CV = 14,66%) te nepreciznosti iz dana u dan za sve parametre (CV ≤ 4,41%) osim za laktat (1. razina: CV = 8%, 2. razina: CV = 6,59%). Korelacija s usporednim metodama bila je zadovoljavajuća, koeficijenti korelacija za većinu parametara nalazili su se između vrijednosti 0,9458-0,9948, osim za natrij čiji je koeficijent korelacije bio r = 0,86350. Koeficijenti korelacije za hemoglobin bili su izvrsni, r = 0,9923 (Gem® Premier™ 4000 u usporedbi s Ciba Corning 865) i r = 0,9759 (Gem® Premier™ 4000 u usporedbi s Gem® Premier™ 3000). Regresijska analiza po Passing-Babloku pokazala je dobru podudarnost rezultata koncentracija analita, osim kod natrija (Gem® PremierTM 4000 u usporedbi s Ciba Corning 865; y = 34,7500 + 0,7500x) i hemoglobina (Gem® Premier™ 4000 u usporedbi s Gem® Premier™ 3000; y = 23,6923 + 0,8308x).
Zaključak: Rezultati analiza dobiveni usporednim mjerenjima analita između ispitivanog analizatora i referentnih analizatora bili su sukladni. Metoda za određivanje hemoglobina na analizatoru Gem® Premier™ 4000 u potpunosti je sukladna sa metodom na analizatoru Ciba Corning 865, na kojemu se također tHb određuje kooksimetrijom. |
| Abstract (english) | Objective: The aim of this study was to compare a new point-of-care testing (POCT) Gem® Premier™ 4000 analyzer with reference analyzers. Special attention was given to the technology of measuring the concentration of hemoglobin and hematocrit on POCT analyzers.
Materials and methods: Analytical performance of the Gem® Premier™ 4000 was compared with Ciba Corning 865, Gem® Premier™ 3000 and Dimension RxL analyzers for pH, pCO2, pO2, electrolytes, metabolites and for hemoglobin/hematocrit. Within-run and between-run imprecisions have been determined for the Gem® Gem® Premier™ 4000 analyzer. In the period of 30 days, 200 whole blood samples were analyzed.
Results: Satisfactory results were obtained for within-run imprecision for all study analytes (CV ≤ 4.89%), except for pO2 (CV = 14.66%) and for between-run imprecision for all parameters (CV ≤ 4.41%) except for lactate (Level I: CV = 8%, Level II: CV = 6.59%). The correlation with the comparative methods was satisfactory, correlation coefficients were between 0.9458-0.9948 for most parameters, except for sodium r = 0.8635. For hemoglobin, correlation coefficients were excellent, r = 0.9923 (Gem® Premier™ 4000 vs. Ciba Corning 865) and r = 0.9759 (Gem® Premier™ 4000 vs. Gem® PremierTM 3000). Passing Bablok regression analysis of analyte concentrations showed good compatibility except for sodium (Gem® Premier™ 4000 vs. Ciba Corning 865; y = 34.7500 + 0.7500x) and hemoglobin (Gem® Premier™ 4000 vs. Gem® Premier™ 3000;y = 23.6923 + 0.8308x).
Conclusions: Results of analyses obtained by the comparative measurement of analytes on Gem® Premier™ 4000 and reference analyzers were compatible. In determining hemoglobin concentration, Gem® Premier™ 4000 is completely comparable with Ciba Corning 865 analyzer, both analyzers using the same co-oximetry method. |
