Comparison of five point-of-care D-dimer assays with the standard laboratory method

• Published in: International journal of laboratory hematology 2012-10, Vol.34 (5), p.495-501
• Main Authors: ANTOVIC, J. P., HÖÖG HAMMARSTRÖM, K., FORSLUND, G., EINTREI, J., STEN-LINDER, M.
• Format: Article
• Language: English
• Subjects: Clinical Laboratory Techniques - methods; Clinical Laboratory Techniques - standards; D-dimer; Enzyme-Linked Immunosorbent Assay - methods; Enzyme-Linked Immunosorbent Assay - standards; Fibrin Fibrinogen Degradation Products - analysis; Humans; Medicin och hälsovetenskap; point-of-care; Point-of-Care Systems - standards; Reproducibility of Results; Sensitivity and Specificity; venous thromboembolism; Venous Thromboembolism - blood; Venous Thromboembolism - diagnosis
• ISSN: 1751-5521; 1751-553X; 1751-553X
• DOI: 10.1111/j.1751-553X.2012.01421.x

Summary Introduction:  D‐dimer (DD) assays are effective for the exclusion of deep‐vein thrombosis (DVT), but point‐of‐care (POC) DD assays have not been fully evaluated. Methods:  We have compared five POC DD assays (Pathfast, Cardiac, Vidas, Stratus and NycoCard) with our routine DD method (Tinaquant), testing 60 samples from patients with suspected DVT. Results:  Using 0.5 μg/mL as a cut‐off value, four samples tested negative with Tinaquant were positive with Pathfast. There were no Tinaquant‐positive samples tested negative with Pathfast, while the overall agreement (k = 0.81) was very good. Four samples were discrepant between Tinaquant and Cardiac (cut‐off, 0.4 μg/mL), while k = 0.72. One of two Tinaquant‐negative samples was shown to be positive for either Vidas (cut‐off, 0.5 μg/mL) or Stratus (cut‐off, 0.4 μg/mL), respectively. The agreement with Tinaquant was excellent for both Vidas (k = 0.92) and Stratus (k = 0.94). Total CV was