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. 2018 Mar:53:116-126.
doi: 10.1016/j.clinbiochem.2018.01.007. Epub 2018 Jan 12.

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

Matthijs Oyaert  1 , Tom Van Maerken  2 , Silke Bridts  2 , Silvi Van Loon  2 , Heleen Laverge  2 , Veronique Stove  2
Affiliations
Free article

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

Matthijs Oyaert et al. Clin Biochem. 2018 Mar.
Free article

Abstract

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 (pCO2), partial oxygen pressure (pO2), sodium (Na+), potassium (K+), chloride (Cl-), ionized calcium (iCa2+), 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: pCO2, K+, lactate and tHb; i-STAT CG8+: pO2, Na+, iCa2+ 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.

Keywords: Analytical quality specifications; Blood gas analyses; Imprecision; Method comparison; Point-of-care.

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