三种稀释蝰蛇毒磷脂时间试验检测狼疮抗凝物分析性能评估
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北京协和医院

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Performance evaluation of three lupus anticoagulant assays based on diluted Russell viper venom time SHOU Weiling, CHEN Qian, Fan Liankai. Zhang Jianping,WU Wei, (Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese Academic Medical Science and Peking Union Medical College, Beijing 100730, China)
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    摘要:

    目的 对三种稀释蝰蛇毒磷脂时间试验(diluted Russell viper venom time,dRVVT)的狼疮抗凝物检测方法进行分析性能评估,比较不同系统间检测结果一致性,并初步探讨不同检验流程对检测结果的影响。方法 按照美国临床实验室标准化协会文件及临床血液学检测常规项目分析质量文件(WS/T 406-2012),对三种LA检测方法的精密度、携带污染率进行评估,验证三种方法检测LA的参考范围(reference interval,RI)/Cut-off值,并对检验结果一致性和不同检验流程对检测结果的影响进行分析。结果 1. 三种dRVVT检测方法重复性CV(%)为0.44%~1.69%。期间精密度CV(%)为1.43%~2.43%。2. 三种检测方法法携带污染率绝对值<3.00%。3. 系统1和2参考范围验证通过,系统3验证未通过。4. 三种不同系统筛选试验、确认试验及比值间结果存在差异,差异具有统计学意义(P=0.000)。5. 三种不同系统阴阳性判断之间差异有统计学意义(c2=11.333,P=0.000)。6. 系统3以说明书推荐流程,53例筛选阴性样本2例为假阴性。结论 三种dRVVT检测系统性能良好,适于临床常规使用。但各实验室应验证或建立适合本实验室的RI/Cut-off值,确定合理的检测流程,关注检测分析前中后影响因素,合理解释检测结果。

    Abstract:

    Objectives To conduct a comprehensive performance evaluation and comparison of three lupus anticoagulant assays based on diluted Russell viper venom time. Methods According to the Clinical and Laboratory Standards Institute (CLSI) standardizations and Analytical quality specifications for routine tests in clinical hematology (WS/T 406-2012), all the projects were detected in three analysis systems to evaluate the within-run and between-run precision, carryover rate and method comparison. The reference range (RI) /Cut-off values were also validated. Results 1. The within-run precision of the three assays were 0.44%~1.69%. The between-run precision of the three assays were 1.43%~2.43%. 2. The absolute values of carryover rates of the three assays were less than 3.00%. 3. The (RI) /Cut-off values validation of System 1 and 2 were passed, while the validation of system 3 was failed. 4. There was statistical significance of screen test, confirm test, normalized ratio and ratio between the three assays (P=0.000). 5. There was statistical significance between the three methods in the evaluation of positive and negative results (c2=11.333,P=0.000). 6. For system 3, there were 2 false negative samples according to the recommended process of the manual. Conclusions The three dRVVT analysis systems have good performance and are suitable for clinical routine use. However, each laboratory should verify or establish local RI / cut off value, chose a suitable testing process, pay attention to the effective factors of the whole process of analysis, and reasonably interpret the testing results.

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寿玮龄,陈倩,范连凯,张建平,吴卫.三种稀释蝰蛇毒磷脂时间试验检测狼疮抗凝物分析性能评估[J].临床检验杂志,2020,(10):734-737

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  • 收稿日期:2019-12-31
  • 最后修改日期:2020-11-11
  • 录用日期:2020-10-27
  • 在线发布日期: 2021-03-24
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