携氧/释氧分析仪氧分压和血氧饱和度计量校准方法

Metrological calibration methods of oxygen partial pressure and oxygen saturation measurement about oxygen binding-dissociation analyzer

为实现半氧饱和度分压的计量溯源性,评价携氧/释氧分析仪的性能,分别建立氧分压和血氧饱和度的计量校准方法。根据国际临床化学和实验室医学联盟文件标准,以去离子水为样品,国家一级标准物质气体为气源建立氧分压参考测量方法。根据美国临床实验室标准协会C46-A2相关文件以及多功能血气分析仪中血氧饱和度示值的计量校准方法,以牛血红蛋白溶液为样品,使用高精度酶标仪建立血氧饱和度测量方法。氧分压相对示值误差分别为-2.82%和-1.35%,变异系数(CV)分别为0.31%和0.74%;血氧饱和度测量数据为(96.83±0.85)%,变异系数为0.88%,携氧/释氧分析仪测量结果为(96.68±0.67)%,变异系数为0.69%。该方法可分别实现氧分压和血氧饱和度的量值溯源,确保测得的P50值的计量溯源性。

In order to realize the traceability of P50 and evaluate the performance of the oxygen binding-dissociation analyzer,the metrological calibration methods of oxygen partial pressure and oxygen saturation were established.According to the standard document of International Union of Clinical Chemistry and Laboratory Medicine,the reference method of oxygen partial pressure was established,the deionized water was used as sample,and the national primary reference material was used as gas source.According to the relevant documents of the American Society of Clinical Laboratory Standards C46-A2 and the measurement and calibration method of blood oxygen saturation indication of the national multi�function blood gas analyzer,the reference method of blood oxygen saturation was established by using the calibrated high�precision microplate reader with the bovine hemoglobin solution as sample.The relative indication errors of oxygen partial pressure were-2.82% and-1.35%,and the coefficient of variation(CV)was 0.31%and 0.74%respectively;the blood oxygen saturation measurement data was(96.83±0.85)%,and the coefficient of variation was 0.88%.The measurement result of the oxygen carrying/releasing oxygen analyzer was(96.68±0.67)%,and the coefficient of variation was 0.69%.The measurement reference method of oxygen partial pressure and oxygen saturation of the oxygen binding-dissociation analyzer are successfully established,which can realize the traceability of oxygen partial pressure and oxygen saturation and ensure the traceability of P50.