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.
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.
摘要：
背景：这项研究旨在提高纤维蛋白原（Fib）凝血酶原时间衍生（PT-der）方法的准确性。为了实现这一点，引入了一种用于校准的值传递方法，并对其有效性进行了评估。
方法：PT-derFib测定通过三种不同的方式通过合并样品（通过vonClauss方法分配）进行校准：1）使用自动稀释系统进行多点校准，2）使用手动稀释法进行多点校准，和3)使用多个浓度的手动校准。通过比较vonClauss方法与PT-der方法的检测结果，获得了三个校准方程（1、2和3），并选择了最佳方程。随后，评估了最优方程的精度极限，按照CLSI发布的指南(EP15-A和EP6-A)进行线性分析和参考区间验证.
结果：与其他两个方程式（方程式1和2）相比，方程3，可从手动校准多个浓度，在主要队列(n=208)中显示出更好的PT-der测定性能，并且验证了良好的一致性（1.52和6.30g/L之间的99％的结果是可互换的）（n=3226）。在几乎所有健康个体中也验证了参考区间(39/40)。然而,在几个特定条件下观察到两种方法之间的差异，比如纤溶亢进.
结论：多种浓度的手动校准对于FibPT-der方法测定更好。作为一个快速的，准确,经济测试，FibPT-der方法的性能已经得到验证，可能比以前更适用。
方法：PT-derFib测定通过三种不同的方式通过合并样品（通过vonClauss方法分配）进行校准：1）使用自动稀释系统进行多点校准，2）使用手动稀释法进行多点校准，和3)使用多个浓度的手动校准。通过比较vonClauss方法与PT-der方法的检测结果，获得了三个校准方程（1、2和3），并选择了最佳方程。随后，评估了最优方程的精度极限，按照CLSI发布的指南(EP15-A和EP6-A)进行线性分析和参考区间验证.
结果：与其他两个方程式（方程式1和2）相比，方程3，可从手动校准多个浓度，在主要队列(n=208)中显示出更好的PT-der测定性能，并且验证了良好的一致性（1.52和6.30g/L之间的99％的结果是可互换的）（n=3226）。在几乎所有健康个体中也验证了参考区间(39/40)。然而,在几个特定条件下观察到两种方法之间的差异，比如纤溶亢进.
结论：多种浓度的手动校准对于FibPT-der方法测定更好。作为一个快速的，准确,经济测试，FibPT-der方法的性能已经得到验证，可能比以前更适用。
