Clinical performance evaluation on dry chemistry method of Vitros 350 for the determination of serum bilirubin / 国际检验医学杂志

ABSTRACT

Objective To evaluate clinical performance on dry chemistry method of Vitros 350 for the determination of serum bilirubin in order to ensure the quality of examination.Methods Evaluation protocols were employed to evaluate the precision,the trueness and the linearity of total bilirubin(TBIL),unconjugated bilirubin (Bu)and conjugated bilirubin (Bc)by dry chemistry method,to verify the reference ranges of TBIL,Bu and Bc simultaneously.Results The precision and trueness of TBIL,Bu and Bc were within the allowable ranges of Clinical and Laboratory Ltandards Institute (CLSI).The linear range of TBIL,Bu and Bc in our laboratory were 6.57-428.83 μmol/L,4.5-320.1 μmol/L and 4.5-364.9 μmol/L respectively.Conclusion Both technical per-formance evaluation and diagnostic performance verification of bilirubin by dry chemical detection system could meet the needs of the clinic.