Quality assurance for point-of-care testing of oral anticoagulation: a large-scale evaluation of the Hemochron Junior Signature Microcoagulation System
Summary We report the first large‐scale evaluation of the Hemochron Junior Signature (HJS) Microcoagulation System for community monitoring of oral anticoagulation and establishment of a programme of internal and external quality assurance. Over 1600 HJS results, with a simultaneous venous sample fo...
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Published in | International journal of laboratory hematology Vol. 31; no. 2; pp. 142 - 150 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford, UK
Blackwell Publishing Ltd
01.04.2009
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Subjects | |
Online Access | Get full text |
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Summary: | Summary
We report the first large‐scale evaluation of the Hemochron Junior Signature (HJS) Microcoagulation System for community monitoring of oral anticoagulation and establishment of a programme of internal and external quality assurance. Over 1600 HJS results, with a simultaneous venous sample for central analysis, were obtained over a 19 month period. Monitoring of an initial period of HJS results (n = 135) revealed an International Normalized Ratio (INR) over estimation (mean +1.05), with only 27% of results within 0.5 of the central laboratory INR. A correction factor was introduced which reduced the INR bias to +0.07 and improved the percentage of results within 0.5 of the central laboratory INR to 76% (n = 353). A revised correction factor was later introduced to adjust for an under estimation at higher INR values. This changed the INR bias to –0.05, with 76% of results within 0.5 of the central laboratory INR (n = 1174). Local external quality assurance samples were distributed monthly with a total of 791 samples during the study period. 84% of test results were within 15% of the median value (range 73–97% per month). These results emphasize the value of a robust quality assurance programme when using point‐of‐care devices for community monitoring of oral anticoagulation. |
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Bibliography: | ArticleID:IJLH1013 istex:214378D82EBAAD8A1A384AD5FB21A9BD06AC2FC3 ark:/67375/WNG-N29C1G9F-9 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 1751-5521 1751-553X |
DOI: | 10.1111/j.1751-553X.2007.01013.x |