一种全自动血型仪应用于TPPA试验的适用性研究  

The applicability of Beckman PK7300 fully automatic blood group instrument for TPPA detection

作　　者：贾俊杰[1] 刘正敏[1] 王瑞[1] 高楠[1] 刘蕊[1] 郭瑾[1] JIA Junjie;LIU Zhengmin;WANG Rui;GAO Nan;LIU Rui;GUO Jin(Beijing Red Cross Blood Center,Beijing 10088,China)

机构地区：[1]北京市红十字血液中心,北京10088

出　　处：《中国输血杂志》2023年第1期72-75,共4页Chinese Journal of Blood Transfusion

摘　　要：目的 探讨使用Beckman PK7300全自动血型分析仪对献血者抗-TP反应性标本进行TPPA试验的适用性。方法 1)Beckman PK7300全自动血型仪TPPA试验(简称仪器法)建立及性能验证:与手工法比较,计算总符合率、阳性符合率和阴性符合率;评估本方法的重复性。2)评估仪器法适用性:连续6 d对555份抗-TP反应性标本使用仪器法进行TPPA试验,分析可判读率、凝集强度分布及其他控制方式等。结果 1)仪器法和手工法检测TPPA的总符合率、阳性符合率和阴性符合率均为100%(kappa值=1),手工法判读为“++”的标本对应仪器法SPC值均≤3、手工法判读为“-”的标本对应仪器法SPC值均≥20。2种方法符合性佳。仪器法对同1份标本重复12次,正确率均为100%(12/12),仪器法的重复性佳。2) 555份抗-TP反应性标本进行TPPA试验总体可判读率为99.82%(554/555);TPPA阴性和阳性结果对应的致敏颗粒及未致敏颗粒的凝集相与非凝集相SPC值分布于判定值两侧、无交叉;仪器法采用自动化方式对试验前、中、后均有控制及监测。结论 Beckman PK7300全自动血型仪进行TPPA试验适用于血站实验室对抗TP反应性标本的确证实验,实现TPPA试验自动化和标准化。Objective To investigate the applicability of Beckman PK7300 for TPPA testing on anti-TP reactive specimens from blood donors. Methods 1) The TPPA test using Beckman PK7300(abbreviated as instrument method) had been established and the performance was verificated by calculating the total compliance rate, positive compliance rate and negative compliance rate as compared with the manual method. The repeatability of this instrument method was also evaluated. 2) The applicability of the instrument method was evaluated by examing 555 TP-reactive samples for 6 consecutive days, so as to analyze the readable reading rate, agglutination strength distribution and other control methods. Results 1) The total, positive, and negative compliance rates of TPPA detection by both instrumental and manual methods were 100%(kappa value =1). The SPC value of samples, read manually as "++", was less than or equal to 3 by Beckman PK7300;the SPC value of samples, read manually as "-", was greater than or equal to 20 by Beckman PK7300. The two methods were well consistent. The instrument method was repeated for 12 times for the same samples, and the accuracy rate was 100%(12/12), with good repeatability.2) The results of the TPPA test in 555 anti-TP reactivity specimens showed an overall readable rate of 99.82%(554/555). The SPC values of the negative and unsensitized particles of TPPA were distributed on both sides of the determination value without crossover. The control and monitor thoughout the test were carried out automatically by the instrument. Conclusion The TPPA test conducted by the Beckman PK7300 fully automatic blood group instrument is suitable for the confirmatory experiment of anti-TP reactive specimens in blood center laboratories, which could realize the automation and standardization of TPPA detection.

关 键 词：全自动血型仪 梅毒螺旋体特异性抗体 梅毒螺旋体明胶颗粒凝集试验 SPC 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学] R377.1