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作 者:蔡县成 CAI Xian-cheng(Shangrao Central Blood Station,Jiangxi Shangrao 334000)
出 处:《中国医疗器械信息》2024年第10期43-45,共3页China Medical Device Information
基 金:上饶市医疗卫生科技计划项目(项目名称:应用Becman PK7300全自动血型仪进行TPPA试验的可行性研究,项目编号:2023CZDX98)。
摘 要:目的:比较Beckman PK7300全自动血型仪与传统手工法在献血者梅毒螺旋体特异性抗体(Anti-TP)反应性标本梅毒螺旋体明胶颗粒凝集试验(TPPA)中的应用效果。方法:选取本中心无偿献血者肝素钠抗凝血浆标本596份,连续7d使用血型仪对596份标本进行TPPA试验,并计算血型仪分析结果的可判读率,评估方法的重复性。随机选取经检测为抗-TP反应性阳性和阴性的标本各25份,计算两种方法的符合率和Kappa值。结果:596份肝素钠抗凝血浆标本经血型仪检测抗-TP反应性标本不明确3例,总体可判读率为99.50%,对每1份标本重复9次,正确率均为100%。血型仪和手工法检测肝素钠抗凝血浆标本的符合率为100%、Kappa值=1。结论:相较于传统手工法,利用Beckman PK7300全自动血型仪进行TPPA试验,可以很大程度上避免人为因素的干扰,且设置规范精细的自动化操作流程,可以有效提高检测结果判读的标准化,提升检测效率。Objective:To compare the application effect of Beckman PK7300 automatic blood group instrument and traditional manual method in treponema pallidum particle agglutination test(TPPA)of blood donors with treponema pallidum specific antibody(Anti-TP)reactive specimens.Methods:A total of 596 heparin sodium anticoagulant plasma samples from voluntary blood donors in our center were selected,and the TPPA test was performed on 596 samples by blood group meter for 7 consecutive days.The interpretable rate of the results of blood group meter was calculated,and the repeatability of the method was evaluated.25 anti-TP positive and 25 Anti-TP negative samples were randomly selected,and the coincidence rate and Kappa value of the two methods were calculated.Results:Among 596 heparin sodium anticoagulative plasma samples tested by blood group meter,3 samples were not clear,the overall interpretation rate was 99.50%,and each sample was repeated 9 times,and the correct rate was 100%.The coincidence rate of blood group instrument and manual method in the detection of heparin sodium anticoagulant plasma samples was 100%,and the Kappa value was 1.Conclusions:Compared with the traditional manual method,the TPPA test performed by Beckman PK7300 automatic blood group instrument can avoid the interference of human factors to a large extent,and set up a standardized and fine automatic operation process,which can effectively improve the standardization of test results interpretation and improve the detection efficiency.
关 键 词:梅毒螺旋体明胶颗粒凝集试验 全自动血型仪 梅毒螺旋体特异性抗体
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