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Prevalence Estimation of Dysfibrinogenemia Using the Clauss-CWA Approach
Atsuo Suzuki1, Nobuaki Suzuki2, Shuichi Okamoto3
1Department of Medical Technique, Nagoya University Hospital, Nagoya, Japan.
Insights
Dysfibrinogenemia prevalence is unknown due to asymptomatic patients and screening limitations. A new Clauss-CWA test identified four cases, revealing impaired fibrin polymerization and structural abnormalities in patients with dysfibrinogenemia.
Area of Science:
- Hematology
- Clinical Chemistry
- Medical Diagnostics
Background:
- Dysfibrinogenemia and hypodysfibrinogenemia prevalence remains largely unknown.
- Asymptomatic patients and limitations of the Clauss fibrinogen assay hinder accurate diagnosis.
- A novel high-throughput screening test (Clauss-CWA) was developed for specific dysfibrinogenemia detection.
Purpose of the Study:
- To estimate the prevalence of dysfibrinogenemia using Clauss-CWA technology.
- To identify and confirm cases of suspected dysfibrinogenemia in a hospital setting.
Main Methods:
- Single-center, observational study screening 25,471 patients.
- Utilized Clauss-CWA technology for initial screening.
- Confirmatory analyses included antigenic fibrinogen, reptilase time, and fibrin polymerization studies.
Main Results:
- Five patients with suspected dysfibrinogenemia were identified.
- Four patients were confirmed with decreased functional to antigenic fibrinogen ratio and prolonged reptilase time.
- Impaired fibrin polymerization and structural abnormalities were observed; some cases showed normal functional fibrinogen due to inflammation.
Conclusions:
- Functional fibrinogen levels alone may not detect all functional fibrinogen abnormalities.
- The study identified a low prevalence of dysfibrinogenemia in the screened population.
- Further nationwide studies are recommended to establish the true epidemiology of dysfibrinogenemia.
Introduction:
The actual prevalence of the qualitative fibrinogen abnormalities dysfibrinogenemia and hypodysfibrinogenemia is unknown. The major reasons are that patients with dysfibrinogenemia are frequently asymptomatic, and a recommended screening test, the Clauss fibrinogen assay, cannot completely distinguish qualitative from quantitative abnormalities. We previously established a high-throughput screening test (Clauss-CWA) to identify dysfibrinogenemia with high specificity and sensitivity by the Clauss fibrinogen assay alone.
Aim And Methods:
This was a single-center, observational study to estimate the prevalence of dysfibrinogenemia using Clauss-CWA technology. A total of 25 471 patients in Nagoya University Hospital were screened to identify patients with suspected dysfibrinogenemia. The suspected patients were investigated by further confirmatory analyses, such as antigenic fibrinogen determination, reptilase time, fibrin polymerization analysis, and scanning electron microscopy.
Results And Conclusions:
Of the 25 471 enrolled patients, five with suspected dysfibrinogenemia were identified. Unfortunately, one patient was not confirmed due to a lack of plasma samples. The ratio of functional to antigenic fibrinogen was decreased, and the reptilase time was prolonged in the four patients. Interestingly, two of them showed normal functional fibrinogen levels due to acute inflammatory responses. Fibrin polymerization was impaired, and structural abnormalities were found in the fibrinogen from the patients. In some cases, functional fibrinogen levels may not be effective for identifying functional fibrinogen abnormalities. Further nationwide studies are needed to more precisely understand the epidemiology of dysfibrinogenemia.
