Analytical and pre-analytical performance characteristics of a novel cartridge-type blood gas analyzer for point-of-care and laboratory testing

作者：Oyaert Matthijs^*; Van Maerken Tom; Bridts Silke; Van Loon Silvi; Laverge Heleen; Stove Veronique

来源：Clinical Biochemistry, 2018, 53: 116-126.

DOI：10.1016/j.clinbiochem.2018.01.007

• Analytical quality specifications
• Blood gas analyses
• Imprecision
• Method comparison
• Point-of-care

Background: Point-of-care blood gas test results may benefit therapeutic decision making by their immediate impact on patient care. We evaluated the (pre-) analytical performance of a novel cartridge-type blood gas analyzer, the GEM Premier 5000 (Werfen), for the determination of pH, partial carbon dioxide pressure (pCO(2)), partial oxygen pressure (pO(2)), sodium (Na+), potassium (K+), chloride (Cl-), ionized calcium (iCa(2+)), glucose, lactate, and total hemoglobin (tHb).
Methods: Total imprecision was estimated according to the CLSI EP5-A2 protocol. The estimated total error was calculated based on the mean of the range claimed by the manufacturer. Based on the CLSI EP9-A2 evaluation protocol, a method comparison with the Siemens RapidPoint 500 and Abbott i-STAT CG8 + was performed. Obtained data were compared against preset quality specifications. Interference of potential pre-analytical confounders on co-oximetry and electrolyte concentrations were studied.
Results: The analytical performance was acceptable for all parameters tested. Method comparison demonstrated good agreement to the RapidPoint 500 and i-STAT CG8 +, except for some parameters (RapidPoint 500: pCO(2), K+, lactate and tHb; i-STAT CG8 +: pO(2), Na+, iCa(2+) and tHb) for which significant differences between analyzers were recorded. No interference of lipemia or methylene blue on CO-oximetry results was found. On the contrary, significant interference for benzalkonium and hemolysis on electrolyte measurements were found, for which the user is notified by an interferent specific flag.
Conclusion: Identification of sample errors from pre-analytical sources, such as interferences and automatic corrective actions, along with the analytical performance, ease of use and low maintenance time of the instrument, makes the evaluated instrument a suitable blood gas analyzer for both POCT and laboratory use.

• 出版日期2018-3