Biochemia Medica, Vol. 19 No. 2, 2009.
Professional paper
Analytical performance of the Gem® Premier™ 4000 - a comparison study
Snježana Hrabrić Vlah
orcid.org/0000-0003-4436-7552
; Department of Clinical Laboratory Diagnostics, Rijeka Clinical Hospital Center, Rijeka, Croatia
Štefica Dvornik
; Department of Clinical Laboratory Diagnostics, Rijeka Clinical Hospital Center, Rijeka, Croatia
Dino Grdović
; Department of Clinical Laboratory Diagnostics, Rijeka Clinical Hospital Center, Rijeka, Croatia
Abstract
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.
Keywords
point of care testing; Gem® Premier™ 4000; hemoglobin
Hrčak ID:
37621
URI
Publication date:
3.6.2009.
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