无偿献血者血液筛查中Tigris核酸检测系统检测结果无效的原因分析

Analysis of invalid test results of Tigris nucleic acid test system for blood screening of voluntary blood donors

目的探讨无偿献血者血液筛查中,Tigris核酸检测(NAT)系统检测结果无效的具体情况及原因。方法选择2018和2019年,成都市血液中心Tigris系统NAT结果无效的3 752份无偿献血者血液标本为研究对象。其中,2018年NAT结果无效标本为2 397份,2019年为1 355份。采用回顾性分析方法,收集本中心2018和2019年Tigris系统NAT的总检测标本数、总检测结果无效标本数、无效工作列表数等数据资料,以及导致Tigris系统NAT结果无效的原因。2018和2019年Tigris系统NAT的无效检测率、工作列表无效运行率、有效工作列表中标本的无效检测率、工作列表无效运行原因构成比、有效工作列表中检测结果无效原因构成比等计数资料比较,采用χ^(2)检验。结果2018年和2019年成都市血液中心Tigris系统NAT结果无效的情况如下。① 2018年总无效检测率为2.31%(2 397/103 777),高于2019年的1.10%(1 355/12 2897),并且差异有统计学意义(χ^(2)=503.726,P<0.001)。② 2018和2019年工作列表无效运行率分别为2.35%(25/1 062)和1.34%(14/1 045),二者比较,差异无统计学意义(χ^(2)=2.983,P=0.084)。2018年有效工作列表中标本的无效检测率为0.20%(205/101 585),高于2019年的0.15%(187/121 729),并且差异有统计学意义(χ^(2)=7.336,P=0.006)。③ 2018和2019年工作列表无效运行原因构成比、有效工作列表中检测结果无效原因的构成比分别比较,差异均有统计学意义(χ^(2)=10.708、86.966,P=0.013、<0.001)。2018和2019年工作列表无效运行的主要原因均为校准物/质控品无效,其导致的无效运行工作列表数分别占88%(22/25)和50%(7/14)。2018年导致有效工作列表中检测结果无效的主要原因为标本容量验证失败(VVFS),占40.0%(82/205);而2019年则以磁力洗站液面感应错误(ML)为主,占50.8%(95/187)。结论Tigris系统的校准物、质控品无效和仪器故障问题是引起NAT结果无效的重要原因。对采供血机构Tigris系统NAT结果无效的原因进行分析、总结,有助于尽早发现导致NAT结果无效的原因,并及时采取相应的处理措施,从而减少无效NAT结果的产生,提高NAT的质量和效率。

Objective To explore specific situation and causes of invalid test results of Tigris nucleic acid test(NAT)system for blood screening of voluntary blood donors.Methods From 2018 to 2019,a total of 3752 specimens of voluntary blood donors whose NAT results were invalid by Tigris system in Chengdu Blood Center were selected as research objects.Among them,there were 2397 specimens with invalid NAT results in 2018 and 1355 specimens in 2019.A retrospective analysis method was used to collect the total number of test specimens,total number of specimens with invalid test results,number of invalid work lists,as well as the causes for invalid NAT results of Tigris system in 2018 and 2019.Chi-square test was used comparison of count data such as invalid test rate,invalid operation rate of work lists,invalid test rate of specimens in effective work lists,composition ratios of work lists invalid operation causes,invalid test results causes in effective work lists between 2018 and 2019.Results The invalid NAT results of Tigris system in Chengdu Blood Center from 2018 to 2019 were as follows.①The total invalid test rate in 2018 was 2.31%(2397/103777),which was higher than that of 1.10%(1355/122897)in 2019,and the difference was statistically significant(χ^(2)=503.726,P<0.001).②The invalid operation rates of work lists in 2018 and 2019 were 2.35%(25/1062)and 1.34%(14/1045)respectively.There was no significant difference between them(χ^(2)=2.983,P=0.084).The invalid test rate of specimens in effective work lists in 2018 was 0.20%(205/101585),which was higher than that of 0.15%(187/121729)in 2019,and the difference was statistically significant(χ^(2)=7.336,P=0.006).③Between 2018 and 2019,the composition ratios of work lists invalid operation causes and invalid test results causes in effective work lists were compared respectively,and the differences were both statistically significant(χ^(2)=10.708,86.966;P=0.013,<0.001).The main invalid operation cause in 2018 and 2019 were invalidity of calibrators/quality control materials,which accounts for 88.0%(22/25)and 50.0%(7/14)of invalid operation work lists respectively.The main invalid test results causes in effective work lists in 2018 was volume verification failure sample(VVFS),accounting for 40.0%(82/205).In 2019,level sense failure in magnetic wash station(ML)was the main cause,accounting for 50.8%(95/187).Conclusions The invalidity of calibrators/quality control materials of Tigris system and instrument failure were important causes for invalid results.Analyzing and summarizing causes of invalid test results of Tigris system in blood collection and supply institutions will help to find causes of invalid test results as soon as possible and take corresponding treatment measures in time,so as to reduce generation of invalid test results and improve quality and efficiency of NAT.