• 中国科学论文统计源期刊
  • 中国科技核心期刊
  • 美国化学文摘(CA)来源期刊
  • 日本科学技术振兴机构数据库(JST)
临床输血与检验

临床输血与检验 ›› 2019, Vol. 21 ›› Issue (3): 264-267.DOI: 10.3969/j.issn.1671-2587.2019.03.011

• 临床输血 • 上一篇    下一篇

盐城市无偿献血者血液核酸筛查无效结果分析*

刘专, 姜斌, 尹诗雨, 王晖   

  1. 224000 江苏省盐城市中心血站血液检测中心
  • 收稿日期:2018-11-16 出版日期:2019-06-20 发布日期:2019-06-17
  • 通讯作者: 王晖,男,主管技师,主要从事血液检测与临床输血研究,（E-mail）9856wang@163.com。
  • 作者简介:刘专,女,江苏盐城人,技师,硕士,主要从事血液检测与临床输血研究,（E-mail）liuzhuan813@163.com。
  • 基金资助:
    *本课题受盐城市医学科技发展计划项目（No.YK2017048）资助

Analysis of the Invalid Results by the Nucleic Acid Test in the Blood Screening in Yan Cheng

LIU Zhuan, JIANG Bin, YIN Shi-yu, et al   

  1. Yancheng Blood Center,Yancheng 224005, China
  • Received:2018-11-16 Online:2019-06-20 Published:2019-06-17

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摘要： 目的 分析无偿献血者血液筛查Cobas s201核酸检测系统无效结果发生情况及相关原因。方法 统计2015年1月~2017年12月本室核酸检测系统无效结果发生的次数和类型分布,分析不同检测时间、试剂批号等与无效结果的相关关系。结果 本室共检测核酸标本21 032个pools （94 397份）,无效结果总发生率为0. 26% （55/21 032）。2015~2017年无效结果发生率分别为0.35%（25/7 055）,0.29%（20/6 785）和0.14%（10/7 192）,差异有统计学意义（χ2=6. 755,P<0. 05） 。2015~2017年无效结果发生率不断降低,随年度呈降低趋势,经卡方趋势检验,χ2趋势=6.348,P=0.012。核酸检测无效结果以加样失败或样本中有凝块或气泡导致扩增无效占比最大,为61.82%（34/55）,与其他无效结果情况相比差异有统计学意义,χ2=6.145,P=0.013。不同年份的无效结果发生构成不同,χ2=25.485,P=0.004。各月份无效结果发生率的差异无统计学意义（P>0. 05）;; 按试剂批号统计,无效结果发生率最高为批号5,达1. 22%（4 /329）,各批号间的结果无效发生率的差异有统计学意义（χ2=10 342.525,P<0. 001）。 结论 本室血液筛查Cobas s201核酸检测系统无效结果发生率处于正常范围,且呈逐年降低趋势,发生原因与试剂批号有一定相关性,监测结果无效率有助于持续监控核酸试验性能。;

关键词: 血液筛查, 核酸检测, Cobas, s201, 结果无效率, 分析

Abstract: Objective To analyze the occurrence and the related causes of the invalid Results in Roche Cobas s201 nucleic acid detection systems （NAT） for blood screening．Methods The number and types of invalid Results in NAT from January 2015 to December 2017 were identified and calculated. The relationship among the result invalidation and detection time and the reagent lots etc were analyzed. Results Among 21 032 pools （94 397） tested by Roche Cobas s201, 55 invalid pools were found. The total rate of result invalidation in the lab was 0. 26% （55 /21 032）. From 2015 to 2017, the rates of result invalidation were 0.35% （25/7 055）, 0.29% （20/6 785）and 0.14% （10/7 192）, respectively. There were significant differences in different years （χ2=6. 755,P<0. 05）. The rate of result invalidation in the lab was decreasing with trend test （trend for χ2 was 6.334 8, P=0.012）.The causes were mainly due to spotting failure or clot or air bubble in samples 61.82%（34/55）, There were significant differences compared with other invalid Results （χ2=6.145,P=0. 013）. There were significant differences among the invalid Results of different years, χ2=25.485, P=0.004.. There were no significant differences in the rates of the result invalidation in different months （P>0. 05）. The rates of the result invalidation were the highest in reagent Lot 5. It was 1. 22% （4 /329）. There were significant differences in the rates of the result invalidation among different reagent lots （χ2 =10 342.525,P<0. 001）. Conclusion The invalidation rate of NAT in the lab was in normal and decreasing year by year. There was some correlation between different reagent lots and result invalidation. Monitoring the invalid rates of NAT Results can help to monitor the nucleic acid test performance continuously．

Key words: Blood screening, Nucleic acid detection, Cobas s201, Rate of the result invalidation, Analysis

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