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Abstract
Plasma fibrinogen is commonly examined by Clauss fibrinogen assay, which cannot distinguish between quantitative and qualitative fibrinogen anomalies. However, our previously reported Clauss fibrinogen assay utilizing clot waveform analysis (Clauss-CWA) provides additional information that contributes to the classification of fibrinogen anomalies. 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, consisting of a training cohort (n = 519) and a validation cohort (n = 523), both of which contained cases of congenital (hypo)dysfibrinogenemia as qualitative defects. 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.
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1 Nagoya University Hospital, Department of Medical Technique, Nagoya, Japan (GRID:grid.437848.4) (ISNI:0000 0004 0569 8970)
2 Nagoya University Hospital, Department of Transfusion Medicine, Nagoya, Japan (GRID:grid.437848.4) (ISNI:0000 0004 0569 8970)
3 Nagoya University Hospital, Department of Clinical Laboratory, Nagoya, Japan (GRID:grid.437848.4) (ISNI:0000 0004 0569 8970)
4 Sysmex Corporation, Kobe, Japan (GRID:grid.419812.7) (ISNI:0000 0004 1777 4627)
5 Nagoya University Graduate School of Medicine, Department of Hematology-Oncology, Nagoya, Japan (GRID:grid.27476.30) (ISNI:0000 0001 0943 978X)
6 Nagoya University Graduate School of Medicine, Division of Cellular and Genetic Sciences, Department of Integrated Health Sciences, Nagoya, Japan (GRID:grid.27476.30) (ISNI:0000 0001 0943 978X)
7 National Centre for Geriatrics and Gerontology, Department of Hematology, Obu, Japan (GRID:grid.437848.4)
8 Aichi Health Promotion Foundation, Nagoya, Japan (GRID:grid.490738.1)
9 Nagoya University Hospital, Department of Transfusion Medicine, Nagoya, Japan (GRID:grid.437848.4) (ISNI:0000 0004 0569 8970); Nagoya University Hospital, Department of Clinical Laboratory, Nagoya, Japan (GRID:grid.437848.4) (ISNI:0000 0004 0569 8970)