期刊
JOURNAL OF PHARMACY AND PHARMACOLOGY
卷 67, 期 2, 页码 209-214出版社
WILEY
DOI: 10.1111/jphp.12333
关键词
anti-Xa; chromogenic; dalteparin; enoxaparin; haemolysis
资金
- New Zealand Pharmacy Education and Research Foundation (NZPERF) grant
ObjectivesEnoxaparin is a low-molecular weight heparin (LMWH) widely used for the treatment of thrombosis and measured through a chromogenic assay (anti-Xa). The aim of this project was to investigate the impact of patient and sampling sources of variation on an anti-Xa assay for enoxaparin. MethodsCOATEST was used in accordance with manufacturer's instructions. A standard curve of LMWH concentration (0.1-1.0IU/ml) was prepared. The shelf-life and freeze-thaw stability of Xa over a 6-month period were investigated. The effects of blood sample haemolysis and plasma antithrombin-III (AT) concentration were examined. Key findingsThe standard curve performed well with high accuracy (average bias of 8.1%) and precision (average CV of 2.8%). The shelf-life of Xa once reconstituted could be extended from 1 month to 4 months if aliquots were frozen at -20 degrees C. Some loss of anti-Xa activity was observed on freeze-thawing (bias up to 25%). Haemolysis of 2.5% was found to interfere with the assay. AT level as low as 50% did not affect assay accuracy. ConclusionsXa standards when frozen immediately after reconstitution could be used for the following 4 months. Haemolysis interferes with the assay, but a 50% reduction in AT does not significantly affect the assay result.
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