ABG RAW DATA

Validation of the OMNI S b221 Blood Gas Analyser method for point-of-care testing at the largest Academic Hospital in the Southern Hemisphere Ernest Philani Buthelezi1*, Edwin Rampota2, Matumi Mphogo2, Florence Marule2 and Donald M Tanyanyiwa3,4 1. Department of Health, Laboratory and Blood Services, Johannesburg, South Africa. 2. Department of Chemical Pathology National Health Laboratory Service, Johannesburg, South Africa. 3. Department of Chemical Pathology, University of the Witwatersrand, Johannesburg, South Africa. 4. Department of Chemical Pathology, Sefako Magkatho Health Sciences University, Pretoria, South Africa. *Correspondence: Ernest Philani Buthelezi1, Department of Health, Laboratory and Blood Services, Johannesburg, South Africa. Telephone: [phone]; Mobile phone: [phone]. Email: [e-mail] Abstract Introduction: The introduction of a new method or new analyser is a common occurrence in laboratory practice. Since Astrup developed the first analyser in the 1950s, blood gas analysers have evolved from the measurement of basic pH, partial pressures of oxygen (pO2) and carbon dioxide (pCO2) to the measurement of various forms of haemoglobin, serum electrolytes, and other metabolites. These analysers offer the best form of point-of-care testing (POCT). When a new POCT analyser is obtained, the performance of the analyser should be evaluated by comparison to the central laboratory or outgoing analysers in cases of replacements. Objectives: Evaluation of method performance of pH, pCO2, pO2, glucose, lactate and electrolytes on Roche Cobas OMNI S b221 (Arterial blood gas) ABG analyser. Materials and Methods: To analyse the method performance of the pH, pO2, pCO2, glucose, lactate and electrolytes (Na+, K+ Ca++) on Cobas b221 arterial blood gas (ABG) analyser by comparing 40 samples run on Cobas b221 with the results obtained from Radiometer ABL700, GEM PREMIER for all the parameters and the Roche Hitachi 917 analyser to compare two electrolytes (Na+ and K+). The correlation coefficient was calculated for the results obtained from each paired set of instruments (ABL 700 vs GEM PREMIER and ABL 700 vs OMNI S b221). Comparability between analyser methods performance was determined using Scatter plots. Results: The correlation coefficient between the paired analytical platforms were all between 0.81 and 0.99, demonstrating a good correlation. The coefficient of variation (CV) for all the parameters were less than 2 also demonstrating good precision. Conclusion: ABG b221 analyser correlated well with the outgoing ABG ABL 700 analyser, GEM PREMIER ABG and the central laboratory analyser, Roche Hitachi 917 and therefore, verified as a good platform to run arterial blood gas samples.

南半球最大学术医院OMNI S b221血气分析仪床旁检测方法验证
作者：Ernest Philani Buthelezi¹*，Edwin Rampota²，Matumi Mphogo²，Florence Marule²，Donald M Tanyanyiwa³,⁴
1. 南非约翰内斯堡卫生与实验室及血液服务部
2. 南非约翰内斯堡国家卫生实验室服务中心化学病理学部
3. 南非金山大学化学病理学部
4. 南非比勒陀利亚塞法科·马卡托健康科学大学化学病理学部
*通讯作者：Ernest Philani Buthelezi¹，南非约翰内斯堡卫生与实验室及血液服务部；电话：[phone]；移动电话：[phone]；电子邮箱：[e-mail]

摘要
引言：实验室实践中，引入新检测方法或新型分析仪是常见场景。自1950年代Astrup研发出首台血气分析仪以来，血气分析仪的检测范畴已从基础pH、氧分压（pO2）、二氧化碳分压（pCO2）的检测，拓展至多种血红蛋白形式、血清电解质及其他代谢物的检测。此类分析仪是床旁检测（point-of-care testing, POCT）的最优解决方案。当启用新的床旁检测分析仪时，需将其检测性能与中心实验室或替换用原有分析仪进行对比评估。
研究目的：评估罗氏（Roche）Cobas OMNI S b221动脉血气（arterial blood gas, ABG）分析仪对pH、pCO2、pO2、葡萄糖、乳酸及电解质的检测方法性能。
材料与方法：通过将40份样本在Cobas b221分析仪上的检测结果，与Radiometer ABL700、GEM PREMIER分析仪的全参数检测结果，以及罗氏Hitachi 917分析仪的两项电解质（Na+、K+）检测结果进行对照，以此分析Cobas b221分析仪对pH、pO2、pCO2、葡萄糖、乳酸及电解质（Na+、K+、Ca²+）的检测方法性能。对每一组配对仪器（ABL 700与GEM PREMIER、ABL 700与OMNI S b221）的检测结果计算相关系数；采用散点图评估不同分析仪检测方法性能的可比性。
结果：配对分析平台间的相关系数均介于0.81至0.99之间，表明二者具有良好的相关性；所有检测参数的变异系数（coefficient of variation, CV）均小于2，同样体现出优异的精密度。
结论：ABG b221分析仪与原有ABG ABL 700分析仪、GEM PREMIER血气分析仪及中心实验室的罗氏Hitachi 917分析仪均具有良好的相关性，因此可验证其为开展动脉血气样本检测的优质平台。