Prakash Shivesh, Bihari Shailesh, Lim Zhan Y, Verghese Santosh, Kulkarni Hemant, Bersten Andrew D
Department of Intensive care, Flinders Medical Centre, Bedford Park, SA, Australia.
Flinders University, Bedford Park, SA, Australia.
J Clin Lab Anal. 2018 Jul;32(6):e22425. doi: 10.1002/jcla.22425. Epub 2018 Mar 3.
We tested the hypothesis that the results of the same test performed on point-of-care blood gas analysis (BGA) machine and automatic analyzer (AA) machine in central laboratory have high degree of concordance in critical care patients and that the two test methods could be used interchangeably.
We analyzed 9398 matched pairs of BGA and AA results, obtained from 1765 patients. Concentration pairs of the following analytes were assessed: hemoglobin, glucose, sodium, potassium, chloride, and bicarbonate. We determined the agreement using concordance correlation coefficient (CCC) and Bland-Altman analysis. The difference in results was also assessed against the United States Clinical Laboratory Improvement Amendments (US-CLIA) 88 rules. The test results were considered to be interchangeable if they were within the US-CLIA variability criteria and would not alter the clinical management when compared to each other.
The median time interval between sampling for BGA and AA in each result pair was 5 minutes. The CCC values ranged from 0.89(95% CI 0.89-0.90) for chloride to 0.98(95% CI 0.98-0.99) for hemoglobin. The largest bias was for hemoglobin. The limits of agreement relative to bias were largest for sodium, with 3.4% of readings outside the US-CLIA variation rule. The number of readings outside the US-CLIA acceptable variation was highest for glucose (7.1%) followed by hemoglobin (5.9%) and chloride (5.2%).
We conclude that there is moderate to substantial concordance between AA and BGA machines on tests performed in critically ill patients. However, the two tests methods cannot be used interchangeably, except for potassium.
我们检验了这样一个假设,即在重症监护患者中,即时检验血气分析仪(BGA)和中心实验室自动分析仪(AA)所进行的相同检测结果具有高度一致性,且这两种检测方法可以互换使用。
我们分析了从1765例患者中获得的9398对匹配的BGA和AA检测结果。评估了以下分析物的浓度对:血红蛋白、葡萄糖、钠、钾、氯和碳酸氢盐。我们使用一致性相关系数(CCC)和Bland-Altman分析来确定一致性。还根据美国临床实验室改进修正案(US-CLIA)88规则评估了结果差异。如果检测结果在美国临床实验室改进修正案的变异标准范围内,并且相互比较时不会改变临床管理,则认为这两种检测结果可以互换使用。
每对结果中BGA和AA采样的中位时间间隔为5分钟。CCC值范围从氯的0.89(95%CI 0.89-0.90)到血红蛋白的0.98(95%CI 0.98-0.99)。最大偏差出现在血红蛋白上。相对于偏差的一致性界限在钠方面最大,有3.4%的读数超出美国临床实验室改进修正案变异规则。超出美国临床实验室改进修正案可接受变异范围的读数数量在葡萄糖方面最高(7.1%),其次是血红蛋白(5.9%)和氯(5.2%)。
我们得出结论,在重症患者中进行的检测,AA和BGA机器之间存在中度至高度一致性。然而,除了钾之外,这两种检测方法不能互换使用。