MethodsĮCAT (External quality Control of diagnostic Assays and Tests) is a proficiency testing program (external quality assessment) for clinical laboratories.
In this study, we sought to determine what tests clinical laboratories are using, if any, to monitor these new anticoagulants, and to determine how well the assays are performing in clinical laboratories internationally. Several tests are commercially available, but unfortunately, there are no FDA-approved laboratory tests for monitoring dabigatran or rivaroxaban in the United States. In addition, dabigatran and rivaroxaban interfere with many other coagulation tests 1- 7, and laboratories may need to test for these anticoagulants to avoid reporting erroneous results. However, a laboratory test to assess the amount of anticoagulation would be helpful in a number of situations, including patients with renal insufficiency, a bleeding or thrombotic event, prior to emergency surgery, checking patient compliance, and possibly other conditions such as extremes of body weight or age. Unlike warfarin, they do not require routine laboratory monitoring to ensure their efficacy and safety. © 2016 Wiley Periodicals, Inc.ĭabigatran and rivaroxaban are among the newest anticoagulants to emerge in the past few years, and the first anticoagulants since vitamin K antagonists (such as warfarin) that can be taken orally. About 10% of results received failing Z scores or passed but fell in a range that require the laboratory to investigate for bias or other inaccuracy in their method. Homemade dabigatran calibrators differed from commercially available calibrators, and there was a statistically significant difference between some of the rivaroxaban reagents. In conclusion, inter-laboratory precision could be improved for both dabigatran and rivaroxaban assays. There were no significant differences among the different rivaroxaban calibrators or instruments. One reagent gave lower results than other reagents at 100 ng/mL but not at 300 ng/mL. Ten different anti-Xa reagents were in use for rivaroxaban testing. The 3 reagents with the lowest number of users had poor inter-laboratory precision. There were no significant differences among the instruments or the 5 reagents in use, but results showed inter-laboratory variability that could have clinical significance. With dabigatran, some homemade calibrators gave higher results than the commercially available calibrators. Failing Z scores were not associated with any particular method. Most laboratories received a passing grade ( Z score <3) for the results of their dabigatran and rivaroxaban testing. We analyzed data from the ECAT proficiency program to determine how well the assays are performing in clinical laboratories internationally. Rivaroxaban and dabigatran are among the newest anticoagulants, and measuring their concentration in patients is a new challenge for clinical laboratories.
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