Development of qualitative analysis for plasma fibrinogen utilizing clot waveform analysis

2021 Fiscal Year Final Research Report

• Project/Area Number: 19K16977
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 52010:General internal medicine-related
• Research Institution: Nagoya University
• Principal Investigator: Atsuo Suzuki 名古屋大学, 医学部附属病院, 主任臨床検査技師 (80835398)
• Project Period (FY): 2019-04-01 – 2022-03-31
• Keywords: フィブリノゲン / 凝固波形解析

Outline of Final Research Achievements

In this study, we adopted the Clauss-CWA method for an autoanalyzer to automatically measure the antigenic estimate (eAg) of fibrinogen in addition to the functional amount (Ac), and to thus provide the Ac/eAg ratio as a qualitative indicator. Performance was validated by receiver operating characteristics (ROC) and precision recall (PR) curve analyses using a patient cohort. We obtained an optimal cutoff of 0.65 for Ac/eAg by ROC curve analysis of the training cohort, offering superior sensitivity (> 0.9661) and specificity (1.000). This cutoff was validated in the validation cohort, providing positive predictive value > 0.933 and negative predictive value > 0.998. PR curve analysis also showed that Clauss-CWA provided excellent performance for detecting qualitative fibrinogen anomalies. The Clauss-CWA method may represent a useful approach for detecting qualitative fibrinogen abnormalities in routine laboratory testing.

Free Research Field

血栓止血学

Academic Significance and Societal Importance of the Research Achievements

フィブリノゲン異常症は量的異常と質的異常に区分されるが、特に質的異常は通常の臨床検査で診断することが困難であり、無症候症例も多いことからその診断や実態（有病率）の把握は困難であった。本研究成果は、追加コストが不要で、一般的な検査室へと普及が可能な検査法を確立できたことにあり、医療経済的にも高い意義を有していると考えられる。また、今後、多くの施設にて本検査法（Clauss-CWA法）を用いることで、正確な有病率の掌握ならびにフィブリノゲン異常症の診断が容易になることが期待される。