雷度ABL825血气分析仪性能评价

目的　评价丹麦Radiometer（雷度）公司ABL825型血气分析仪检测人体血液酸碱度（potential of hydrogen，pH）、二氧化碳分压（partial pressure of carbon dioxide，PCO₂）、氧分压（oxygen partial pressure，PO₂）、钙离子（calcium ion，Ca²⁺）、乳酸（lactic acid，Lac）的检测性能。方法　根据美国临床和实验室标准化协会（CLSI）的EP15-A2文件，对ABL825血气分析仪于2021年1月到3月期间检测各质控品和临床样本进行非随机对照试验研究，对检测pH、PCO₂、PO₂、Ca²⁺和Lac的精密度、准确度进行评价，同时与另一台认可仪器ABL825的检测结果进行一致性验证；依据《中华人民共和国医药行业标准/电解质分析仪YY/T 0589/2016》评价仪器检测Ca²⁺的稳定性和携带污染率。结果　ABL825检测系统检测各项目高低2个浓度总不精密度分别为：pH 0.001和0.001，PCO₂ 0.78%和1.31%，PO₂ 1.31%和2.03%，Ca²⁺ 1.07%和1.27%，Lac 4.60%和3.67%；批内不精密度分别为：pH 0和0，PCO₂ 0.50%和0.77%，PO₂ 1.26%和1.30%，Ca²⁺ 0和0，Lac 2.75%和1.02%；二者均小于厂家声明，符合实验室要求。两个检测系统pH、PCO₂、PO₂、Ca²⁺、Lac相关系数（R₂）分别为0.989 8、0.993 9、0.997 5、0.995 5、0.979 5，均R²>0.95，两个检测系统相关性较好，相对偏倚小于厂家申明，准确度高。稳定性：钙离子波动百分比（R）为0。携带污染率：低浓度到高浓度的携带污染率（C_LH）为0.50%，从高浓度到低浓度的携带污染率（C_HL）为1.49%，符合文件要求。结论　ABL825血气分析仪主要仪器性能达到实验室要求，检测结果可靠，可满足临床检测需求。

Performance evaluation of ABL825 blood gas analyzer purchased from Radiometer

Objective　To evaluated the performance of ABL825 blood gas analyzer purchased from Radiometer, Denmark in the detection of potential of hydrogen (pH), partial pressure of carbon dioxide (PCO₂), partial pressure of oxygen (PO₂), calcium ion (Ca²⁺), lactate (Lac), and other indicators in human blood. Methods　From January to March 2021, a non-randomized controlled experimental study was conducted on various quality control substances and clinical samples tested by the ABL825 blood gas analyzer according to the EP15-A2 file of the American Clinical Laboratory Standardization Institute (CLSI). The precision and accuracies in detecting pH, PCO₂, PO₂, Ca²⁺, and Lac were evaluated. The consistency of the test results was verified with another approved ABL825. The stability evaluation and carry-over pollution in detecting Ca²⁺ were evaluated according to People's Republic of China Pharmaceutical Industry Standard/Electrolyte Analyzer YY/T 0589/2016. Results　The total CV's of different concentrations of each item detected by the two systems of ABL825 were as bellow: pH 0.001 and 0.001, PCO₂ 0.78% and 1.31%, PO₂ 1.31% and 2.03%, Ca²⁺ 1.07% and 1.27%, and Lac 4.60 % and 3.67%; and the within-run CV's were as bellow: pH 0 and 0, PCO₂ 0.50% and 0.77%, PO₂ 1.26% and 1.30%, Ca²⁺ 0 and 0, and Lac 2.75% and 1.02%; which were smaller than the manufacturer's declaration and met the laboratory requirements. The correlation coefficients (R²) of pH, PCO₂, PO₂, Ca²⁺, and Lac of the two detection systems were 0.989 8, 0.993 9, 0.997 5, 0.995 5, and 0.979 5, and all R²>0.95; it had a good correlation with another ABL825; the relative bias was smaller than the manufacturer's declaration; the detection results had high accuracy. Stability: the fluctuation percentage of Ca²⁺ (R) was 0. Carrying pollution rate: the carrying pollution rate from low to high concentration (C_LH) was 0.50%, and the carrying pollution rate from high to low concentration (C_HL) was 1.49%, which corresponded to the requirements of the document. Conclusion　The performance of ABL825 blood gas analyzer has confirmed the laboratory requirements, and the test results are reliable, which meet the needs of clinical testing.