Oyaert Matthijs, Van Maerken Tom, Bridts Silke, Van Loon Silvi, Laverge Heleen, Stove Veronique
Department of Laboratory Medicine, Ghent University Hospital, Ghent, Belgium.
Department of Laboratory Medicine, Ghent University Hospital, Ghent, Belgium.
Clin Biochem. 2018 Mar;53:116-126. doi: 10.1016/j.clinbiochem.2018.01.007. Epub 2018 Jan 12.
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), partial oxygen pressure (pO), sodium (Na), potassium (K), chloride (Cl), ionized calcium (Ca), glucose, lactate, and total hemoglobin (tHb).
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.
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, K, lactate and tHb; i-STAT CG8+: pO, Na, Ca 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.
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.
即时检测血气分析结果因其对患者护理的直接影响，可能有助于治疗决策。我们评估了一种新型 cartridge 式血气分析仪 GEM Premier 5000（Werfen）在测定 pH、二氧化碳分压（pCO）、氧分压（pO）、钠（Na）、钾（K）、氯（Cl）、离子钙（Ca）、葡萄糖、乳酸和总血红蛋白（tHb）方面的（预）分析性能。
根据 CLSI EP5 - A2 协议估算总不精密度。基于制造商声称的范围均值计算估计总误差。根据 CLSI EP9 - A2 评估协议，与西门子 RapidPoint 500 和雅培 i - STAT CG8 + 进行方法比较。将获得的数据与预设质量规格进行比较。研究了潜在的预分析混杂因素对血氧定量法和电解质浓度的干扰。
所有测试参数的分析性能均可接受。方法比较表明，除了某些参数（RapidPoint 500：pCO、K、乳酸和 tHb；i - STAT CG8 +：pO、Na、Ca 和 tHb）在分析仪之间记录到显著差异外，与 RapidPoint 500 和 i - STAT CG8 + 的一致性良好。未发现脂血或亚甲蓝对血氧定量法结果有干扰。相反，发现苯扎氯铵和溶血对电解质测量有显著干扰，仪器会通过特定的干扰标记向用户发出通知。
识别来自预分析来源的样本误差，如干扰和自动校正措施，以及仪器的分析性能、易用性和低维护时间，使得所评估的仪器成为适用于即时检测和实验室使用的血气分析仪。
