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Published on: April 1, 2015
Screening method for congenital dysfibrinogenemia using clot waveform analysis with the Clauss method
Shinpei Arai1, Tomu Kamijo2, Fumiaki Hayashi3
1Department of Biomedical Laboratory Sciences, School of Health Sciences, Shinshu University, Matsumoto, Japan.
Insights
Clot waveform analysis (CWA) using the Clauss method effectively screens for congenital fibrinogen disorders (CFDs), distinguishing them from acquired conditions. This method, particularly the Clauss/dH plus Clauss/Min1 ratio, improves diagnostic accuracy for dysfibrinogenemia and hypofibrinogenemia.
Area of Science:
- Hematology
- Clinical Chemistry
- Diagnostic Laboratory Medicine
Background:
- Congenital fibrinogen disorders (CFDs) are categorized by fibrinogen function and antigen levels, including afibrinogenemia, hypofibrinogenemia (Hypo), dysfibrinogenemia (Dys), and hypodysfibrinogenemia (Hypodys).
- Routine laboratory fibrinogen measurement via the Clauss method complicates differentiation between CFDs and acquired hypofibrinogenemia (aHypo) due to reliance on functional rather than antigenic levels.
- Developing a reliable screening method for CFDs is crucial for accurate diagnosis and patient management.
Purpose of the Study:
- To investigate the utility of clot waveform analysis (CWA) parameters derived from the Clauss method for screening congenital fibrinogen disorders (CFDs).
- To compare the diagnostic performance of CWA parameters against traditional Clauss/PT-derived ratios in differentiating CFDs from acquired hypofibrinogenemia.
Main Methods:
- Fibrinogen concentrations were measured using Clauss and PT-derived methods in 67 aHypo and CFD cases.
- Clot waveform analysis (CWA) parameters, specifically dH (maximum transmittance change) and Min1 (maximum velocity of transmittance change), were automatically analyzed.
- The study compared Clauss/PT-derived ratios with Clauss/dH plus Clauss/Min1 ratios for their ability to detect different types of fibrinogen disorders.
Main Results:
- Clauss/PT-derived ratios identified 18 cases of Dys and Hypodys but failed to detect Hypo.
- Clauss/dH plus Clauss/Min1 ratios detected 21 cases of Dys and Hypodys and one Hypo case.
- Combined analysis of Clauss/PT-derived and Clauss/dH plus Clauss/Min1 ratios identified 22 Dys/Hypodys cases and one Hypo case.
Conclusions:
- Clot waveform analysis (CWA) parameters, specifically the Clauss/dH plus Clauss/Min1 ratio, demonstrate superior screening capability for dysfibrinogenemia (Dys) compared to Clauss/PT-derived ratios.
- The Clauss/dH plus Clauss/Min1 ratio effectively screened Dys patients at a higher rate, offering a promising approach for CFD screening.
- This study highlights the potential of CWA in improving the laboratory diagnosis of congenital fibrinogen disorders.
Introduction:
Congenital fibrinogen disorders (CFDs) are classified as afibrinogenemia or hypofibrinogenemia (Hypo), dysfibrinogenemia (Dys), or hypodysfibrinogenemia (Hypodys), according to functional and antigenic fibrinogen concentrations. However, in routine laboratory tests, plasma fibrinogen levels are mostly measured using the functional Clauss method and not as an antigenic level. Therefore, it is difficult to discriminate CFD from acquired hypofibrinogenemia (aHypo). To establish a screening method for CFD, we investigated the parameters of clot waveform analysis (CWA) from the Clauss method.
Methods:
We compared fibrinogen concentrations determined using Clauss and prothrombin time (PT)-derived methods for 67 aHypo and CFD cases (19 Dys, 4 Hypodys, and 1 Hypo determined using antigen levels and DNA sequence analysis) with a CS-2400 instrument, and the CWA parameters, dH and Min1, were analyzed automatically with an on-board algorithm. dH and Min1 are the maximum change in transmittance at the end of coagulation and the maximum velocity of transmittance change during coagulation, respectively.
Results:
Clauss/PT-derived ratios detected 18 cases of Dys and Hypodys but no Hypo cases, whereas Clauss/dH plus Clauss/Min1 ratios were calculated from fibrinogen concentration using the Clauss method and CWA parameters detected 21 cases of Dys and Hypodys and one Hypo case. Moreover, the Clauss/PT-derived ratio and Clauss/dH plus Clauss/Min1 ratio detected 22 cases of Dys and Hypodys cases and one Hypo case.
Conclusion:
This report demonstrates that CWA parameters of the Clauss method, Clauss/dH plus Clauss/Min1 ratio, screened Dys patients with a higher rate, whereas Clauss/PT-derived ratios did not.
