Laboratory Assessment of Novel Oral Anticoagulants: Method Suitability and Variability between Coagulation Laboratories
Laboratory Assessment of Novel Oral Anticoagulants: Method Suitability and Variability between Coagulation Laboratories
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DOI：
10.1373/clinchem.2012.198788
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发表时间：
2013-05-01
影响因子：
9.3
通讯作者：
Joutsi-Korhonen, Lotta
中科院分区：
文献类型：
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作者：
Helin, Tuukka A.;Pakkanen, Anja;Joutsi-Korhonen, Lotta
背景：评估新型口服抗凝剂（NOAC）的实验室检查正在评估中。常规监测是不必要的，但在特殊情况下，生物活性评估变得至关重要。我们分析了NOAC对凝血试验的影响，并在不同的laborators.METHODS的可用性的具体分析：血浆样品加标达比加群（达比; 120和300 μ g/L）或利伐沙班（Riva; 60，146，和305 μ g/L）被送往115和38个欧洲实验室，分别。分析所有样本的国际标准化比值（INR）和活化部分凝血活酶时间（APTT）;专门分析Dabi的凝血酶时间（TT），校准Riva的抗活化因子X（抗Xa）活性。结果：73家实验室报告了达比样本的检测结果（13种INR试剂和9种APTT试剂），22家实验室报告了Riva样本的检测结果（5种INR试剂和4种APTT试剂）。两种NOAC均增加INR值;达比加群酯的增加幅度较小，但较大，CV较高，尤其是使用Quick（vs Owren）方法。两种NOAC均剂量依赖性延长APTT。同样，达比的延长和CV更大。INR和APTT结果呈试剂依赖性变化（P < 0.005），患者样本中的延长较少。TT结果（达比）和校准的抗Xa结果（里瓦）报告，只有11个和8个实验室，respectively.CONCLUSIONS：筛选试验INR和APTT是次优的评估NOAC，具有较高的试剂依赖性和较低的灵敏度和特异性。如果实验室认识到它们的局限性，它们可以提供信息。变异性可能会增加，并且临床样本的灵敏度不同。具体的测定方法可以准确地测量NOAC;然而，很少有实验室应用它们。(C)2013年美国临床化学协会
BACKGROUND: Laboratory tests to assess novel oral anticoagulants (NOACs) are under evaluation. Routine monitoring is unnecessary, but under special circumstances bioactivity assessment becomes crucial. We analyzed the effects of NOACs on coagulation tests and the availability of specific assays at different laboratories.METHODS: Plasma samples spiked with dabigatran (Dabi; 120 and 300 mu g/L) or rivaroxaban (Riva; 60, 146, and 305 mu g/L) were sent to 115 and 38 European laboratories, respectively. International normalized ratio (INR) and activated partial thromboplastin time (APTT) were analyzed for all samples; thrombin time (TT) was analyzed specifically for Dabi and calibrated anti-activated factor X (anti-Xa) activity for Riva. We compared the results with patient samples.RESULTS: Results of Dabi samples were reported by 73 laboratories (13 INR and 9 APTT reagents) and Riva samples by 22 laboratories (5 INR and 4 APTT reagents). Both NOACs increased INR values; the increase was modest, albeit larger, for Dabi, with higher CV, especially with Quick (vs Owren) methods. Both NOACs dose-dependently prolonged the APTT. Again, the prolongation and CVs were larger for Dabi. The INR and APTT results varied reagent-dependently (P < 0.005), with less prolongation in patient samples. TT results (Dabi) and calibrated anti-Xa results (Riva) were reported by only 11 and 8 laboratories, respectively.CONCLUSIONS: The screening tests INR and APTT are suboptimal in assessing NOACs, having high reagent dependence and low sensitivity and specificity. They may provide information, if laboratories recognize their limitations. The variation will likely increase and the sensitivity differ in clinical samples. Specific assays measure NOACs accurately; however, few laboratories applied them. (C) 2013 American Association for Clinical Chemistry