基于微流控技术的检测系统在献血初筛中的应用评估  

Application evaluation of detection system based on microfluidic technology in initial screening of blood donors

作　　者：傅立强 桑列勇 王琴 余波 张凯君 赵逸祥 吴和晋 FU Liqiang;SANG Lieyong;WANG Qin;YU Bo;ZHANG Kaijun;ZHAO Yixiang;WU Hejin(Shaoxing Central Blood Station,Shaoxing 312000,China;Zhejiang Pushkang Biotechnology Co Ltd)

机构地区：[1]绍兴市中心血站,浙江绍兴312000 [2]浙江普施康生物科技有限公司

出　　处：《中国输血杂志》2024年第4期449-454,共6页Chinese Journal of Blood Transfusion

基　　金：绍兴市卫生健康科技计划研究项目(2022KY063)。

摘　　要：目的 评价便携式微流控生化分析仪在献血者献血前检测中的筛查效果与应用价值。方法 收集献血者标本、临床血液标本及定值质控品,参照ISO15189和国家卫生行业标准(WS/T)相关文件,用微流控生化分析仪MS200进行血红蛋白(Hb)与丙氨酸氨基转移酶(ALT)检测项目的精密度、准确度等验证,同时与其他检测系统进行比较。结果 微流控生化分析仪MS200 Hb检测批内精密度在1.40%~1.46%,批间精密度在1.91%~1.94%,准确度偏倚在-0.9%~-1.3%,ALT检测批内精密度在3.77%~4.86%,批间精密度在4.92%~6.02%,准确度偏倚在-3.0%~-4.8%,2者均在行业标准质量要求的范围内;MS200生化仪与Hb201分析仪同时对1 189份献血者末梢血标本进行Hb检测,结果无差异(P>0.05)。65份标本MS200生化仪与XS-900i血细胞分析仪2者Hb检测结果相关性分析显示呈正相关(R^(2)=0.986,P=0.000);1 065份标本MS200生化仪与AU480生化分析仪2者ALT检测所有结果相关性分析显示其呈正相关(R^(2)=0.965,P=0.000);ALT增高标本对Hb的检测结果、Hb值异常标本对ALT检测结果均不产生影响,2项目间检测无干扰。结论 基于微流控技术的MS200生化分析仪其方法学性能可靠,能满足献血前检测需求。Objective To evaluate the screening efficacy and practical value of the portable microfluidic biochemical analyzer in the detection of blood donors before blood donation.Methods Blood donor samples,clinical blood samples and constant quality control products were collected.Referring to the documents of ISO15189 and National Health Industry Standard,the precision and accuracy of hemoglobin(Hb)and alanine aminotransferase(ALT)were verified and compared with other detection systems.Results The MS200 biochemistry instrument has an intra-batch precision of 1.40%to 1.46%,inter-batch precision of 1.91%to 1.94%,and correctness bias of-0.9%to-1.3%for Hb test,and an intra-batch precision of 3.77%to 4.86%,inter-batch precision of 4.92%to 6.02%,and correctness bias of-3.0%to-4.8%for ALT test,which were within the range of quality requirements of industry standard.Comparison of Hb test results between MS200 biochemistry and Hb201 analyser on 1189 peripheral blood samples from donors showed no statistically significant difference(P>0.05).65 samples showed positive correlation between MS200 biochemistry and XS-900i automated hematology analyzer on Hb test results(R^(2)=0.986,P=0.000).Correlation analysis of all the results of ALT detection by MS200 biochemical analyzer and AU480 biochemical analyzer in 1065 samples showed a positive correlation(R^(2)=0.965,P=0.000).The elevated ALT samples did not affect the Hb test results,and the samples with abnormal Hb value did not affect the ALT test results,with no interference between the two items in the detection.Conclusion The MS200 biochemical analyzer based on microfluidic technology has reliable methodological performance and can meet the need of pre-donation testing.

关 键 词：离心微流控 献血前检测 HB ALT 性能验证 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]