Department of Laboratory Medicine, University-Hospital of Padova, Italy.
Department of Laboratory Medicine, University-Hospital of Padova, Italy.
Clin Chim Acta. 2018 Nov;486:313-319. doi: 10.1016/j.cca.2018.08.019. Epub 2018 Aug 15.
Blood gas analysis (BGA) is essential for the diagnosis and management of acid-base imbalances. We evaluated and compared the analytical characteristics of the new GEM Premier™ 5000 (GP5000) (Instrumentation Laboratory, Bedford, MA, United States) BGA point-of-care (POC) device with those of the GEM Premier™ 4000 (GP4000) (Instrumentation Laboratory, Bedford, MA, United States) and RapidPoint 405 (RP405) (Siemens Healthcare, Milan, Italy) POC analyzers. The effect of sample mixing on patient results was also studied.
Quantitative measurement of pH, pCO, pO, Na, K, Cl, Ca, glucose, lactate, tHb, COHb, MetHb, OHb, HHb and Hct were carried out. The imprecision study (IS) and method comparison study (MS) were performed according to CLSI EP guidelines, using respectively internal as well as external quality controls (IS) and whole blood samples collected from the routine analysis (MS).
GP5000 demonstrated satisfactory characteristics in the IS showing comparable (GM4000) or even better (RP405) imprecision results than the routine POC devices. Good performance was observed in the MS both using GP4000 and RP405 as reference instruments. Pre-analytical sample management can heavily affect the accuracy of BGA results. In the specimen mixing evaluation, a significant improvement in results accuracy was observed when mixing procedures were more meticulous.
Considering the overall analytical performance observed, the ease of use of the system, the rapid time-to-results and the innovative Intelligent Quality Management technology (iQM2), GP5000 seems suitable to be used in clinical care for safe patient management. Additionally, effective sample mixing upon draw and before analysis is strongly advisable in order to ensure the most clinically reliable BGA results.
血气分析（BGA）对于酸碱失衡的诊断和管理至关重要。我们评估并比较了新型 GEM Premier™ 5000（GP5000）（美国马萨诸塞州贝德福德的Instrumentation Laboratory）即时检测（POC）血气分析仪与 GEM Premier™ 4000（GP4000）（美国马萨诸塞州贝德福德的Instrumentation Laboratory）和 RapidPoint 405（RP405）（意大利米兰的Siemens Healthcare）POC 分析仪的分析特性。还研究了样品混合对患者结果的影响。
进行了 pH、pCO、pO、Na、K、Cl、Ca、葡萄糖、乳酸、tHb、COHb、MetHb、OHb、HHb 和 Hct 的定量测量。根据 CLSI EP 指南进行不精密度研究（IS）和方法比较研究（MS），分别使用内部和外部质量控制（IS）以及从常规分析中收集的全血样本（MS）。
GP5000 在 IS 中表现出令人满意的特性，显示出与常规 POC 设备相当（GM4000）甚至更好（RP405）的不精密度结果。在 MS 中，使用 GP4000 和 RP405 作为参考仪器均观察到良好的性能。在样本前处理管理中，样本混合会严重影响 BGA 结果的准确性。在标本混合评估中，当混合程序更加细致时，观察到结果准确性的显著提高。
考虑到观察到的整体分析性能、系统的易用性、快速的结果时间和创新的智能质量管理技术（iQM2），GP5000 似乎适合用于临床护理，以安全管理患者。此外，建议在采集和分析前进行有效的样品混合，以确保获得最可靠的临床 BGA 结果。
