{"title":"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。","authors":"Kevin Horner, Steve Kitchen","doi":"10.1111/ijlh.14484","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Introduction</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Strong correlations between FbAg and eAg were evident in normal (<i>R</i>\n <sup>2</sup> 0.9559) and hypofibrinogenemic (<i>R</i>\n <sup>2</sup> 0.9119) cohorts; however, a weak correlation was observed in dysfibrinogenemic cohorts (<i>R</i>\n <sup>2</sup> 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.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>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.</p>\n </section>\n </div>","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"47 5","pages":"915-922"},"PeriodicalIF":2.3000,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluation of Clauss Fibrinogen Assay Clot Waveform Analysis for the Detection of Dysfibrinogenemia on Sysmex CN-6000\",\"authors\":\"Kevin Horner, Steve Kitchen\",\"doi\":\"10.1111/ijlh.14484\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Introduction</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Strong correlations between FbAg and eAg were evident in normal (<i>R</i>\\n <sup>2</sup> 0.9559) and hypofibrinogenemic (<i>R</i>\\n <sup>2</sup> 0.9119) cohorts; however, a weak correlation was observed in dysfibrinogenemic cohorts (<i>R</i>\\n <sup>2</sup> 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>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.</p>\\n </section>\\n </div>\",\"PeriodicalId\":14120,\"journal\":{\"name\":\"International Journal of Laboratory Hematology\",\"volume\":\"47 5\",\"pages\":\"915-922\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-04-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Laboratory Hematology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/ijlh.14484\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Laboratory Hematology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/ijlh.14484","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}
Evaluation of Clauss Fibrinogen Assay Clot Waveform Analysis for the Detection of Dysfibrinogenemia on Sysmex CN-6000
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 (R2 0.9559) and hypofibrinogenemic (R2 0.9119) cohorts; however, a weak correlation was observed in dysfibrinogenemic cohorts (R2 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.
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.
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