Marija Kocijancic, Bernhard Kraus Frank, Beatrice Ludwig-Kraus
Central Laboratory, Department for Laboratory Medicine, University Hospital Halle, Halle (Saale), Germany.
Department of Biology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Heliyon. 2021 Oct 30;7(11):e08302. doi: 10.1016/j.heliyon.2021.e08302. eCollection 2021 Nov.
Blood-Gas Analyzers (BGAs) are commonly used in parallel with central laboratory analyzers (CLAs). Given the often-divergent results between BGAs and CLAs this study aims to: 1. Determine whether the measurements of potassium (K), sodium (Na), glucose (Glu), lactate (Lact) and total hemoglobin (ctHb) on BGAs and CLAs are interchangeable; 2. Establish reference intervals (RIs) for both analyzer systems using an indirect statistical approach.
During a one-year study period K, Na, Glu, Lact and ctHb measurements from 500 arterial blood samples, measured on ABL 90 FLEX BGAs were compared with corresponding venous samples measured on Roche c8000 and Sysmex XN-9000 analyzers. Interchangeability of methods was tested based on the Acceptable Change Limit, Total Change Limit and the guidelines published by the German Medical Association for quality assurance in medical laboratories criteria. Indirect RIs were estimated based on all routine analysis data using the software Reference Limit Estimator (RLE).
With the exception of Na, the BGAs differed significantly from the CLAs for the tested analytes (P < 0.001) but, with the exception of ctHb, did meet the interchangeability criteria. For K, Na, Gluc and ctHb the reference intervals obtained with RLE did not differ statistically between the analyzer systems.
The interchangeability criteria were met for Na, K and Gluc and Lact. The indirect RIs obtained with RLE, are comparable between two systems for Na, K, Gluc an ctHb. Lact differed significantly in the lower reference limit between the BGAs and CLAs. The simultaneous use of both analyzing systems is thus only advisable for Na, K and Gluc.
血气分析仪（BGA）通常与中心实验室分析仪（CLA）并行使用。鉴于BGA和CLA的结果常常存在差异，本研究旨在：1. 确定BGA和CLA对钾（K）、钠（Na）、葡萄糖（Glu）、乳酸（Lact）和总血红蛋白（ctHb）的测量结果是否可互换；2. 使用间接统计方法为两种分析仪系统建立参考区间（RI）。
在为期一年的研究期间，将在ABL 90 FLEX血气分析仪上测量的500份动脉血样本中的K、Na、Glu、Lact和ctHb测量值与在罗氏c8000和Sysmex XN - 9000分析仪上测量的相应静脉样本进行比较。基于可接受变化限度、总变化限度以及德国医学协会发布的医学实验室质量保证标准指南来测试方法的互换性。使用参考限度估计器（RLE）软件根据所有常规分析数据估计间接参考区间。
除Na外，所测试分析物的BGA结果与CLA结果存在显著差异（P < 0.001），但除ctHb外，均符合互换性标准。对于K、Na、葡萄糖（Gluc）和ctHb，RLE获得的参考区间在分析仪系统之间无统计学差异。
Na、K、Gluc和Lact符合互换性标准。RLE获得的间接参考区间在Na、K、Gluc和ctHb的两个系统之间具有可比性。BGA和CLA之间Lact的较低参考限存在显著差异。因此，仅在Na、K和Gluc的检测中建议同时使用这两种分析系统。
