title: Fluorescence immunoassay of human D-dimer in whole blood.
abstract: BACKGROUND
  D-dimer is a widely used biomarker for the initial clinical assessment of suspected deep vein thrombosis and pulmonary embolism. Here, we presented a new fluorescence (FL) D-dimer assay system, which was developed with a platform of point-of-care test (POCT) for clinical applications.
  
  
  METHODS
  Whole blood was mixed with FL-labeled anti-D-dimer detector antibody, and then loaded onto a disposable cartridge. After 12 min of incubation, the FL intensity was acquired by scanning of test cartridge and converted as level of D-dimer in a laser FL scanner. The analytical performance of FL immunoassay was evaluated by linearity, recovery, and precision tests. The comparability of the developed assay was examined with automated reference methods.
  
  
  RESULTS
  The FL assay system showed a good linearity, and the analytical mean recovery of control was 103% in a dynamic working range. The imprecision of intra- and inter-as-say of coefficient of variations from assay system was less than 8%. The developed FL assay system showed strong correlation with two automated reference assays, Vidas D-dimer (r = 0.973) and Stalia D-dimer (r = 0.971).
  
  
  CONCLUSIONS
  The new FL immunoassay for D-dimer is a user-friendly, precise, and reproducible platform of POCT in whole blood.
authors.affiliation: Department of Biomedical Science, Hallym University, Chuncheon, South Korea; BodiTech Med, Inc, Chuncheon, South Korea.
authors.forename: Tae Kyum
authors.initials: TK
authors.lastname: Kim
authors.forename: Sang Wook
authors.initials: SW
authors.lastname: Oh
authors.forename: Young Joon
authors.initials: YJ
authors.lastname: Mok
authors.forename: Eui Yul
authors.initials: EY
authors.lastname: Choi
mesh_terms: D002138:Calibration; D002846:Chromatography, Affinity; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D005455:Fluorescent Antibody Technique; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; D011933:Reagent Kits, Diagnostic; C036309:fibrin fragment D
keywords: D-dimer; fluorescence; immunochromatographic assay; point-of-care test (POCT); whole blood