无偿献血者血红蛋白检测精准化的研究

Research on the Precision of Hemoglobin Detection in Voluntary Blood Donors

目的比较血红蛋白(Hb)仪和全自动血细胞分析仪的相关性和一致性,评估HemoCue Hb301(Hb301)血红蛋白仪应用于无偿献血前检测Hb的适用性。方法用Hb301血红蛋白仪检测高、中、低值标本各1份,计算其批内精密度;用Hb301检测原厂质控品,计算其日间精密度;分别用Hb301和SYSMEX XP-100(XP-100)检测Hb,分析两种仪器的相关性;绘制受试者工作特征曲线,确立本站符合《献血者健康检查要求》的Hb值对应Hb301检测的正常值;验证本站校正后的正常值的符合率。结果Hb301检测高、中、低值标本批内精密度分别为0.74%、0.58%、1.11%;Hb301检测高、中、低值质控品日间精密度分别为0.79%、0.50%、1.75%;与XP-100检测结果对比,Hb301线性回归方程为Y=1.123 X-6.269,相关系数R 2=0.993;本站用Hb301检测献血者Hb,其正常值分别为122.5 g/L(女)和126.5 g/L(男);校正后Hb301检测结果与XP-100结果符合率分别为99.71%(男)、97.42%(女),Kappa值分别为0.80(男)、0.83(女)。结论Hb301检测Hb正常值校正后,可用于无偿献血者献血前Hb检测。

Objective To compare the correlation and consistency between the hemoglobin(Hb)meter analyzer and the automatic blood cell analyzer,and to evaluate the applicability of the HemoCue Hb301(Hb301)hemoglobin analyzer for detecting Hb before voluntary blood donation.Methods Hb301 hemoglobin analyzer,one sample of high,medium,and low value was detected,and calculated its precision;Use Hb301 to test the original quality control products and calculate their intra-day precision;Detect Hb with Hb301 and SYSMEX XP-100(XP-100)respectively,and analyze the correlation between two instruments;Draw a receiver operating characteristic curve to establish the Hb value corresponding to the normal value detected by Hb301 in accordance with the"Health Examination Requirements for Blood Donors"of this station;Verify the compliance rate of the corrected normal value of the station.Results The intra batch precision of Hb301 for detecting high,medium,and low value specimens was 0.74%,0.58%,and 1.11%,respectively;The daytime precision of Hb301 for detecting high,medium,and low value quality control products was 0.79%,0.50%and 1.75%,respectively;Compared with the XP-100 test results,the Hb301 linear regression equation is Y=1.123 X-6.269,R 2=0.993;this station uses Hb301 to detect Hb in blood donors,and the normal values are 122.5 g/L for women and 126.5 g/L for men,respectively;after correction,the coincidence rates between the Hb301 test results and the XP-100 results were 99.71%(male)and 97.42%(female),respectively,Kappa=0.80(male)and 0.83(female).Conclusion After correcting the normal value of Hb detected by Hb301,it can be used to detect Hb before voluntary blood donation.