3种稀释蝰蛇毒磷脂时间试验检测狼疮抗凝物的性能评价

Performance evaluation of three diluted Russell viper venom time tests for the detection of lupus anticoagulant

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(χ^2=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。

Objective To evaluate the performance of three diluted Russell viper venom time(dRVVT)tests for the detection of lupus anticoagulant(LA),compare the consistency of detection results from different systems,and preliminarily investigate the influence of different test processes on the detection results.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),the precision and carry-over contamination rates of three dRVVT tests were evaluated,the reference interval(RI)/cut-off values of three dRVVT tests for the detection of LA were validated,and the consistency of detection results and the influence of different procedures on the detection results were analyzed.Results The within-run and between-run coefficients of variation(CV)of three dRVVT tests were 0.44%to 1.69%and 1.43%to 2.43%,respectively.The absolute values of carryover contamination rates of three tests were less than 3.00%.The verification of RI/cut-off values of system 1 and 2 were passed,while that of system 3 was failed.There were statistical differences in the results of screening tests,confirmatory tests and normalized ratios of three systems(P=0.000).There were significant differences in the evaluation of positive and negative results for three systems(χ^2=11.333,P=0.000).When the results of system 3 were analyzed with the recommended process of the manual and the results were compared with those expressed by LA-R or LA-NR,2 out of 53 negative results were false negative.Conclusion Three dRVVT detection systems have good performance and are suitable for clinical routine use.However,each laboratory should verify or establish a suitable RI/cut-off value for the laboratory,determine a suitable testing process,pay attention to the influencing factors of the whole process of analysis,and reasonably interpret the detection results.