核酸检测实验室质量监控指标的探讨
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摘要
目的分析华益美血液筛查核酸检测系统数据,探讨应用实验室质量监控指标监控NAT过程。方法统计分析2017年3月—2018年7月核酸检测系统数据。结果共计检测238 300人份标本(29 809个pools),拆分阳性率为45.26%(105/232),其中有9个NAT混检阳性pools各拆分出来2份NAT阳性标本,NAT阳性率为0.48‰(114/238 300);NAT总的pools结果无效率为1.31%(393/30 202),批结果无效率0.46%(2/435),扩增曲线异常引起结果无效类型占比最多47.07%(185/393)。NAT共用9个试剂批号,试剂消耗率97.60%(33 917/34 752),试剂有效利用率85.78%(29 809/34 752);仪器运行故障率0.69%(3/435);参与室间质评结果符合率为98.09%(103/105)。结论通过实验室质量监控指标的统计和分析能有效反映核酸检测实验室运行情况,有助于质量体系的持续改进。
Objective To analyze the quality monitoring indicators of BACME nucleic acid test(NAT) blood screening system and explore new application of quality monitoring indicators for process improvement and monitoring during NAT assays. Methods NAT results data from March 2017 to July 2018 in our center were summarized and analyzed. Results A total of 238 300 samples(in 29 809 pools) were tested by BACME NAT blood screening system on a eight sample mix mode, the positive rate of the split test was 45.26%(105/232). And 2 NAT positive samples were confirmed in 9 pools reactivity in the mixed test, yielding a positive rate of 0.48‰(114/238 300).The percentage of total invalid pools was 1.31%(393/302 02); the percentage of invalid batches was 0.46%(2/435); the percentage of invalid detection caused by abnormal amplification curve was the highest(47.07%,185/393). Reagents from nine batches were used in NAT; the rate of reagent consumption and reagent effective utilization were 97.60%(33 917/34 752) and 85.78%(29 809/34 752), respectively. The incidence of machine operation failure was 0.69%(3/435).The coincidence rate of external quality assessment was 98.09%(103/105). Conclusion It can effectively understand the running status of NAT laboratory and contribute to the continuous improvement of the quality system through statistical analysis of quality monitoring indicators in the laboratory.
Objective To analyze the quality monitoring indicators of BACME nucleic acid test(NAT) blood screening system and explore new application of quality monitoring indicators for process improvement and monitoring during NAT assays. Methods NAT results data from March 2017 to July 2018 in our center were summarized and analyzed. Results A total of 238 300 samples(in 29 809 pools) were tested by BACME NAT blood screening system on a eight sample mix mode, the positive rate of the split test was 45.26%(105/232). And 2 NAT positive samples were confirmed in 9 pools reactivity in the mixed test, yielding a positive rate of 0.48‰(114/238 300).The percentage of total invalid pools was 1.31%(393/302 02); the percentage of invalid batches was 0.46%(2/435); the percentage of invalid detection caused by abnormal amplification curve was the highest(47.07%,185/393). Reagents from nine batches were used in NAT; the rate of reagent consumption and reagent effective utilization were 97.60%(33 917/34 752) and 85.78%(29 809/34 752), respectively. The incidence of machine operation failure was 0.69%(3/435).The coincidence rate of external quality assessment was 98.09%(103/105). Conclusion It can effectively understand the running status of NAT laboratory and contribute to the continuous improvement of the quality system through statistical analysis of quality monitoring indicators in the laboratory.
引文
[1] 中华人民共和国卫生部.血站实验室质量管理规范.2006.
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[3] 张妍,唐建华,李英莲,等.核酸检测实验室常用质量监控指标的探讨.中国输血杂志,2014,27(6):620-622.
[4] CLSI - GP35P.Development and use of quality indicators for process improvement and monitoring of laboratory quality.Proposed Guide -line,2009.
[5] 汪德海,王瑞,葛红卫.血站核酸检测实验室质量监控指标应用.中国输血杂志,2012,25(6):524-527.
[6] 王瑞,吴硕,高峰,等.血站实验室质量监控指标体系的建立及其应用.中国输血杂志,2011,24(8):713-715.
[7] 王艺芳,李俊英,葛文超,等.核酸检测无效结果原因分析.中国输血杂志,2018,31(5):531-533.
[2] 国家卫生计生委.血站技术操作规程(2015版).2015-12-17.
[3] 张妍,唐建华,李英莲,等.核酸检测实验室常用质量监控指标的探讨.中国输血杂志,2014,27(6):620-622.
[4] CLSI - GP35P.Development and use of quality indicators for process improvement and monitoring of laboratory quality.Proposed Guide -line,2009.
[5] 汪德海,王瑞,葛红卫.血站核酸检测实验室质量监控指标应用.中国输血杂志,2012,25(6):524-527.
[6] 王瑞,吴硕,高峰,等.血站实验室质量监控指标体系的建立及其应用.中国输血杂志,2011,24(8):713-715.
[7] 王艺芳,李俊英,葛文超,等.核酸检测无效结果原因分析.中国输血杂志,2018,31(5):531-533.