Department of Laboratory Medicine, West China Second University Hospital, Sichuan University, Chengdu, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Chengdu, China.
Clin Appl Thromb Hemost. 2021 Jan-Dec;27:10760296211048897. doi: 10.1177/10760296211048897.
On an international scale, guidelines and proposals for lupus anticoagulant detection have been published over the last 20 years, but until now, standardization has not been completely realized. The aim of this study was to evaluate the different ways of interpreting the results of lupus anticoagulant detection for standardization. A retrospective review of 15 447 instances of lupus anticoagulant detection by the diluted Russell Viper Venom test for female patients presenting with problems relating to the areas of reproduction, gynecology and obstetrics was performed. Lupus anticoagulant data were compared between different departments, months, reagent lots and cutoffs. Significant differences were found in patient data between different reagent lots, especially between lots of screening reagents (monthly average: highest 37.96 s vs lowest 33.88 s) and in the positive rates of lupus anticoagulant by different detection cutoffs (47.58% by using LA1/LA2 > 1.20 without normalization as a cutoff in Lot 1 vs 1.52% by using LA1 > 44 s as a cutoff in Lot 3). Compared with the cutoff using the value above the 99th percentile of LA1 for the healthy donors per lot, the cutoff using integrated tests with normalization had the smaller deviation of positive rate between different reagent lots. Pregnant women had higher LA1/LA2 levels than nonpregnant women. Based on the results, normalization is needed because there are significant lot-to-lot variations. Integrated tests with normalization might be a better standard by which to confirm lupus anticoagulant. Pregnant women should have population-specific cutoffs because they have higher LA1/LA2 levels.
在国际范围内，过去 20 年来已经发布了关于狼疮抗凝物检测的指南和建议，但到目前为止，尚未完全实现标准化。本研究旨在评估狼疮抗凝物检测结果解释方法的差异，以实现标准化。我们对 15447 例女性复发性生殖、妇产科疾病患者的稀释 Russell 蝰蛇 venom 试验狼疮抗凝物检测结果进行了回顾性分析。狼疮抗凝物数据在不同科室、月份、试剂批次和检测截点之间进行了比较。不同试剂批次之间的患者数据存在显著差异，尤其是筛选试剂批次之间（每月平均：最高 37.96s 与最低 33.88s），以及不同检测截点的狼疮抗凝物阳性率之间存在显著差异（在第 1 批试剂中，LA1/LA2＞1.20 且未校正时的截点为 47.58%，而在第 3 批试剂中 LA1＞44s 时的截点为 1.52%）。与使用各批试剂健康供者的 LA1 第 99 百分位数以上值作为截点相比，使用校正后整合检测的截点在不同试剂批次之间的阳性率偏差更小。与非妊娠女性相比，妊娠女性的 LA1/LA2 水平更高。基于这些结果，需要进行校正，因为存在显著的试剂批次间差异。校正后整合检测可能是一种更好的标准化检测方法。由于妊娠女性的 LA1/LA2 水平更高，因此应采用特定人群的截点。
