Improving the Application of Prothrombin Time-Derived Fibrinogen Assay Through Value Transfer from the Von Clauss Method.

ABSTRACT

BACKGROUND: This study aimed to improve the accuracy of the fibrinogen (Fib) prothrombin time-derived (PT-der) method. To achieve this, a value transfer method was introduced for calibration, and its effectiveness was assessed. METHODS: The PT-der Fib assay was calibrated by pooled samples (assigned by the von Clauss method) in three different ways 1) multipoint calibration using an automatic dilution system, 2) multipoint calibration using a manual dilution method, and 3) manual calibration with multiple concentrations. Three calibration equations (1, 2, and 3) were obtained and an optimal equation was selected by comparing the detection results of the von Clauss method with the PT-der method. Subsequently, the optimal equation was assessed for an accuracy limit, and linear analysis and reference interval verification were performed following the guidelines (EP15-A and EP6-A) issued by the CLSI. RESULTS: Compared with the other two equations (equation 1 and 2), equation 3, available from manual calibration with multiple concentrations, showed a better performance for the PT-der determination in a primary cohort (n = 208), and a good agreement (99% of the results between 1.52 and 6.30 g/L were interchangeable) was validated (n = 3226). The reference interval was also verified in almost all healthy individuals (39/40). However, the discrep-ancy between the two methods was observed in several specific conditions, such as hyperfibrinolysis. CONCLUSIONS: Manual calibration with multiple concentrations is better for the Fib PT-der method assay. As a rapid, accurate, and economical test, the performance of the Fib PT-der method has been verified and may be more applicable than before.