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新型体外直接口服抗凝剂清除方法减少了狼疮抗凝物检测中的干扰。

Novel Ex Vivo DOAC Removal Methods Reduce Interference in Lupus Anticoagulant Testing.

作者信息

Savola Paula, Lemponen Marja, Joutsi-Korhonen Lotta, Helin Tuukka A

机构信息

Department of Clinical Chemistry, HUS Diagnostic Center, Helsinki University Hospital and University of Helsinki, 00290 Helsinki, Finland.

出版信息

Diagnostics (Basel). 2022 Oct 17;12(10):2520. doi: 10.3390/diagnostics12102520.

Abstract

Direct oral anticoagulants (DOAC) interfere in laboratory coagulation testing. The aim here was to study how commercial DOAC removal methods, DOAC Filter and DOAC-Stop™, perform to eliminate DOAC concentrations and false positive results in lupus anticoagulant (LAC) testing. We acquired 50 patient samples with high concentrations of DOACs: apixaban (n = 18, range 68-572 ng/mL), dabigatran (n = 8, range 47-154 ng/mL), edoxaban (n = 8, range 35-580 ng/mL) and rivaroxaban (n = 16, range 69-285 ng/mL). DOACs were removed ex vivo with either DOAC Filter (n = 28) or DOAC-Stop™ (n = 22). Additionally, commercial control and calibrator samples were studied (n = 13 for DOAC Filter, n = 14 for DOAC-Stop™). LAC screening was performed before and after DOAC removal. Both DOAC Filter and DOAC-Stop™ were effective in removing DOAC concentrations in samples: DOAC concentrations decreased to median of 0 ng/mL (range 0-48 ng/mL). Only one sample had more than residual 25 ng/mL of DOAC (apixaban). Before DOAC removal, 96% (48/50) of patient samples and over 90% (12/13 DOAC Filter, 13/14 DOAC-Stop™) of control/calibrator samples were positive in the LAC screening. In patient samples, LAC screening turned negative in 61% (17/28) after DOAC Filter and 45% (10/22) after DOAC-Stop™ treatment. All control samples became negative after DOAC removal. In conclusion, DOAC removal ex vivo reduces false positives in LAC screening. DOAC removal halved the need for confirmation or mixing tests- Although a subset of patients would require further testing, DOAC removal reduces unnecessary repeated LAC testing.

摘要

直接口服抗凝剂(DOAC)会干扰实验室凝血检测。本研究旨在探讨商业化的DOAC去除方法——DOAC Filter和DOAC-Stop™,在消除DOAC浓度及狼疮抗凝物(LAC)检测中的假阳性结果方面的表现。我们采集了50份DOAC浓度较高的患者样本:阿哌沙班(n = 18,范围68 - 572 ng/mL)、达比加群(n = 8,范围47 - 154 ng/mL)、依度沙班(n = 8,范围35 - 580 ng/mL)和利伐沙班(n = 16,范围69 - 285 ng/mL)。使用DOAC Filter(n = 28)或DOAC-Stop™(n = 22)对样本进行体外DOAC去除。此外,还研究了商业化的对照和校准样本(DOAC Filter为n = 13,DOAC-Stop™为n = 14)。在DOAC去除前后进行LAC筛查。DOAC Filter和DOAC-Stop™在去除样本中的DOAC浓度方面均有效:DOAC浓度降至中位数0 ng/mL(范围0 - 48 ng/mL)。只有一个样本的DOAC残留量超过25 ng/mL(阿哌沙班)。在DOAC去除前,96%(48/50)的患者样本以及超过90%(DOAC Filter为12/13,DOAC-Stop™为13/14)的对照/校准样本在LAC筛查中呈阳性。在患者样本中,DOAC Filter处理后61%(17/28)的LAC筛查转为阴性,DOAC-Stop™处理后45%(10/22)转为阴性。DOAC去除后所有对照样本均转为阴性。总之,体外DOAC去除可减少LAC筛查中的假阳性。DOAC去除使确认或混合试验的需求减半——尽管有一部分患者需要进一步检测,但DOAC去除减少了不必要的重复LAC检测。

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