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

摘要:目的?对3种稀释蝰蛇毒磷脂时间试验(dRVVT)的狼疮抗凝物(LA)检测方法进行性能评价，比较不同系统间检测结果的一致性，并初步探讨不同检验流程对检测结果的影响。方法?按照美国临床和实验室标准协会(CLSI)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3种LA检测方法的精密度、携带污染率进行评价，验证3种方法检测LA的参考区间(RI)/cut-off值，并分析检验结果一致性和不同检验流程对检测结果的影响。结果?3种dRVVT检测方法重复性以CV表示为0.44%～1.69%；期间精密度以CV表示，为1.43%～2.43%。3种检测方法携带污染率绝对值<3.00%。系统1和2的RI验证通过，系统3验证未通过。3种不同系统筛选试验、确认试验及比值间结果差异有统计学意义(P=0.000)。3种不同系统阴阳性判断结果间差异有统计学意义(χ2=11.333，P=0.000)。系统3以说明书推荐流程分析结果，与筛选/确认比值(R)或标准化比值(NR)结果表示方式相比，53例阴性结果中2例为假阴性。结论?3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。

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)

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 (c_²=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.