Performance Evaluation of Automatic Biochemical Analyzer in D-Dimer Test

Objective To evaluate the performance feature of Hitachi 7170 automatic biochemical analyzer in D-dimer test.Methods According to the evaluation protocols documents and peninent litemture,and by combining our actual work,the precision,accuracy,analyticai sensitivity,analytical measurement range,and the biological reference range of D-dimer were verified and evaluated.Results The inexactitude within-batch and day was superior to the standard of manufacturer.The related biases between results measured for calibrator at four levels and target valule was less 15%.Functional sensitivity was 0.46 μg/mL.Analytical measurement range was 0.30-42.95 μg/mL,that lower t than the manufacturer's claim slightly.The biological reference range was1 μg/mL,within manufacturer's claimed.Different concentrations of free bilirubin,direct bilirubin,chylomicrons,hemoglobin will not influence D-Dimer detection.Conclusion The main analytical performances of D-Dimer test with automatic biochemical analyzer are consistent with the claim defined by manufacturer,and could be satisfied in the clinical determination.