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

Matthijs Oyaert (UGent) , Tom Van Maerken (UGent) , SILKE BRIDTS (UGent) , Silvi Van Loon (UGent) , Heleen Laverge (UGent) and Veronique Stove (UGent)
(2018) CLINICAL BIOCHEMISTRY. 53. p.116-126
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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 (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.
Keywords
Analytical quality specifications, Blood gas analyses, Imprecision, Method comparison, Point-of-care, ELECTROLYTE ANALYZER, SPECIMENS, ARTERIAL, METHEMOGLOBINEMIA, INTERFERENCE, HEMOGLOBIN, POTASSIUM, CHEMISTRY, HEMOLYSIS, ACCURACY

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Chicago
Oyaert, Matthijs, Tom Van Maerken, SILKE BRIDTS, Silvi Van Loon, Heleen Laverge, and Veronique Stove. 2018. “Analytical and Pre-analytical Performance Characteristics of a Novel Cartridge-type Blood Gas Analyzer for Point-of-care and Laboratory Testing.” Clinical Biochemistry 53: 116–126.
APA
Oyaert, Matthijs, Van Maerken, T., BRIDTS, S., Van Loon, S., Laverge, H., & Stove, V. (2018). Analytical and pre-analytical performance characteristics of a novel cartridge-type blood gas analyzer for point-of-care and laboratory testing. CLINICAL BIOCHEMISTRY, 53, 116–126.
Vancouver
1.
Oyaert M, Van Maerken T, BRIDTS S, Van Loon S, Laverge H, Stove V. Analytical and pre-analytical performance characteristics of a novel cartridge-type blood gas analyzer for point-of-care and laboratory testing. CLINICAL BIOCHEMISTRY. 2018;53:116–26.
MLA
Oyaert, Matthijs, Tom Van Maerken, SILKE BRIDTS, et al. “Analytical and Pre-analytical Performance Characteristics of a Novel Cartridge-type Blood Gas Analyzer for Point-of-care and Laboratory Testing.” CLINICAL BIOCHEMISTRY 53 (2018): 116–126. Print.
@article{8556901,
  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 (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.},
  author       = {Oyaert, Matthijs and Van Maerken, Tom and BRIDTS, SILKE and Van Loon, Silvi and Laverge, Heleen and Stove, Veronique},
  issn         = {0009-9120},
  journal      = {CLINICAL BIOCHEMISTRY},
  keyword      = {Analytical quality specifications,Blood gas analyses,Imprecision,Method comparison,Point-of-care,ELECTROLYTE ANALYZER,SPECIMENS,ARTERIAL,METHEMOGLOBINEMIA,INTERFERENCE,HEMOGLOBIN,POTASSIUM,CHEMISTRY,HEMOLYSIS,ACCURACY},
  language     = {eng},
  pages        = {116--126},
  title        = {Analytical and pre-analytical performance characteristics of a novel cartridge-type blood gas analyzer for point-of-care and laboratory testing},
  url          = {http://dx.doi.org/10.1016/j.clinbiochem.2018.01.007},
  volume       = {53},
  year         = {2018},
}

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