Evaluation of Clauss Fibrinogen Assay Clot Waveform Analysis for the Detection of Dysfibrinogenemia on Sysmex CN-6000

IF 2.3 4区医学 Q3 HEMATOLOGY

International Journal of Laboratory Hematology Pub Date : 2025-04-22 DOI:10.1111/ijlh.14484

Kevin Horner, Steve Kitchen

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引用次数: 0

Abstract

Introduction

Dysfibrinogenemia is associated with thrombosis and bleeding. Identification is important as it correlates with adverse clinical outcomes. Clot waveform analysis (CWA) measures optical changes during clot formation to generate a clot waveform curve. Mathematical interpretation allows for the determination of velocity through the first derivative (Min1). Clauss Fibrinogen (CF) Min1 correlates with fibrinogen antigen (FbAg) levels. After calibration, estimated fibrinogen antigen (eAg) can be calculated. Studies have established a ratio of functional fibrinogen activity (FbAc) to eAg (FbAc/eAg) threshold of 0.7 effective for identifying dysfibrinogenemia.

Methods

Samples were analysed by CN-6000 (Sysmex) for PT-derived fibrinogen, Thrombin and Reptilase Times, CF (Dade Innovin, Thromboclotin, Baxotrobin and Dade Thrombin respectively, Siemens) and FbAg (Liaphen Fibrinogen, Hyphen), along with CF-CWA. The effectiveness of eAg for quantifying fibrinogen was compared to traditional FbAg measurements, along with the efficacy of FbAc/eAg in identifying dysfibrinogenemia relative to the classical FbAc/Ag ratio.

Results

Strong correlations between FbAg and eAg were evident in normal (R ² 0.9559) and hypofibrinogenemic (R ² 0.9119) cohorts; however, a weak correlation was observed in dysfibrinogenemic cohorts (R ² 0.3987). In the dysfibrinogenemic cohort, modification of the test dilution for calculating eAg was assessed; however, these changes did not enhance correlation. eAg values by both dilutions did not impair the ability of the FbAc/eAg ratio to distinguish dysfibrinogenemia from normal and hypofibrinogenemia cohorts, proving as effective as the FbAc/Ag ratio.

Conclusion

Our results endorse the reliability of the FbAc/eAg ratio as a cost-effective parameter for identifying dysfibrinogenemia, despite eAg quantification limitations in dysfibrinogenemia cases.

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Sysmex CN-6000上克劳斯纤维蛋白原测定血块波形分析检测异常纤维蛋白原血症的评价。

简介：异常纤维蛋白原血症与血栓和出血有关。鉴别很重要，因为它与不良临床结果相关。血块波形分析（CWA）通过测量血块形成过程中的光学变化来生成血块波形曲线。数学解释允许通过一阶导数（Min1）来确定速度。纤维蛋白原（CF） Min1与纤维蛋白原抗原（FbAg）水平相关。校准后，可以计算估计的纤维蛋白原抗原（eAg）。研究已经建立了功能性纤维蛋白原活性（FbAc）与eAg的比值（FbAc/eAg）阈值为0.7，可有效识别纤维蛋白异常血症。方法：采用CN-6000 （Sysmex）对样品进行pt衍生纤维蛋白原、凝血酶和Reptilase Times、CF （Dade Innovin、Thromboclotin、Baxotrobin和Dade Thrombin， Siemens）和FbAg （Liaphen fibrinogen, Hyphen）以及CF- cwa分析。将eAg定量纤维蛋白原的有效性与传统的FbAg测量方法进行比较，并将FbAc/eAg相对于经典的FbAc/Ag比率识别异常纤维蛋白原血症的有效性进行比较。结果：在正常（R2 0.9559）和低纤维蛋白原性（R2 0.9119）队列中，FbAg与eAg之间存在明显的强相关性；然而，在纤维蛋白异常队列中观察到弱相关性（R2 0.3987）。在纤维蛋白异常队列中，评估了用于计算eAg的试验稀释度的修改；然而，这些变化并没有增强相关性。两种稀释的eAg值都没有损害FbAc/eAg比值区分异常纤维蛋白原血症与正常和低纤维蛋白原血症的能力，证明与FbAc/Ag比值一样有效。结论：我们的研究结果支持了FbAc/eAg比值作为鉴别纤维蛋白异常原血症的成本效益参数的可靠性，尽管在纤维蛋白异常原血症病例中eAg的定量限制。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Laboratory Hematology 医学-血液学

CiteScore

4.50

自引率

6.70%

发文量

211

审稿时长

6-12 weeks

期刊介绍： The International Journal of Laboratory Hematology provides a forum for the communication of new developments, research topics and the practice of laboratory haematology. The journal publishes invited reviews, full length original articles, and correspondence. The International Journal of Laboratory Hematology is the official journal of the International Society for Laboratory Hematology, which addresses the following sub-disciplines: cellular analysis, flow cytometry, haemostasis and thrombosis, molecular diagnostics, haematology informatics, haemoglobinopathies, point of care testing, standards and guidelines. The journal was launched in 2006 as the successor to Clinical and Laboratory Hematology, which was first published in 1979. An active and positive editorial policy ensures that work of a high scientific standard is reported, in order to bridge the gap between practical and academic aspects of laboratory haematology.