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Evaluation of performance including influence by interfering substances of the Innovance D-dimer assay on the Sysmex coagulation analyzer.

Title
Evaluation of performance including influence by interfering substances of the Innovance D-dimer assay on the Sysmex coagulation analyzer.
Authors
Seo-Jin Park;Hyun-Sook Chi;Chan-Jeoung Park;Seongsoo Jang;Soh Hyun Chun
Issue Date
2011
Journal Title
Annals of Clinical and Laboratory Science
ISSN
0091-7370
Citation
Annals of Clinical and Laboratory Science, Vol.41(1) : 20~24, 2011
Abstract
D-dimer is formed during activation of the coagulation system and is commonly assayed in order to diagnose disseminated intravascular coagulation, deep vein thrombosis, and pulmonary embolism. Enzyme-linked immunosorbent assay has been validated as the reference method, but it is a time-consuming procedure. The objective of this study was to evaluate a new immunoturbidimetric, particle-enhanced, Innovance(®) D-dimer immunoassay. A total of 129 plasma samples from apparently healthy individuals and 298 samples from patients were collected for linearity, precision, and correlation studies. Testing the precision of low- and high-controls yielded CV values of 2.08% and 1.76%, respectively. The central 95% non-parametric reference interval estimated from healthy controls was 0.093-0.68 mg/L Fibrinogen Equivalent Units (FEU; median, 0.26 mg/L FEU). Comparison analysis yielded acceptable correlation with the STA Liatest(®) D-dimer assay (R(2) = 0.9471). At a cut-off level of <0.5 mg/L FEU, the sensitivity and specificity indices of the Innovance D-dimer assay were 99.7% and 89.1%, respectively. Thus the Innovance D-dimer method showed acceptable precision and linearity, and the assay results showed acceptable correlation with the STA Liatest D-dimer method. The Innovance method was relatively unaffected by potential interfering substances such as bilirubin and hemoglobin. In conclusion, the Innovance D-dimer assay is suitable for monitoring D-dimer concentrations in various clinical conditions and should be useful in clinical laboratories.
URI
http://www.annclinlabsci.org/content/41/1/20.long

http://ir.ymlib.yonsei.ac.kr/handle/22282913/95171
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Laboratory Medicine
Yonsei Authors
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