title: Evaluation of performance including influence by interfering substances of the Innovance D-dimer assay on the Sysmex coagulation analyzer.
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.
authors.affiliation: Department of Laboratory Medicine, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Seo-Jin
authors.initials: SJ
authors.lastname: Park
authors.forename: Hyun-Sook
authors.initials: HS
authors.lastname: Chi
authors.forename: Soh Hyun
authors.initials: SH
authors.lastname: Chun
authors.forename: Seongsoo
authors.initials: S
authors.lastname: Jang
authors.forename: Chan-Jeoung
authors.initials: CJ
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001663:Bilirubin / Q000378:metabolism*; D001780:Blood Coagulation Tests / Q000295:instrumentation*; D015153:Blotting, Western; D002648:Child; D002675:Child, Preschool; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; D006454:Hemoglobins; C036309:fibrin fragment D; D001663:Bilirubin