Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis

Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis

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 contribut...

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Published in:Scientific reports Vol. 12; no. 1; p. 434
Main Authors: Suzuki, Atsuo, Suzuki, Nobuaki, Kanematsu, Takeshi, Shinohara, Sho, Kurono, Hiroshi, Arai, Nobuo, Okamoto, Shuichi, Suzuki, Naruko, Tamura, Shogo, Kikuchi, Ryosuke, Katsumi, Akira, Kojima, Tetsuhito, Matsushita, Tadashi
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 21-01-2022
Nature Publishing Group
Nature Portfolio
Subjects:
692/699/1541
692/700/139/1420
Adolescent
Adult
Aged
Aged, 80 and over
Child
Child, Preschool
Clinical Laboratory Techniques - methods
Female
Fibrinogen
Fibrinogen - analysis
Humanities and Social Sciences
Humans
Infant
Infant, Newborn
Laboratory tests
Male
Middle Aged
multidisciplinary
Plasma - chemistry
ROC Curve
Science
Science (multidisciplinary)
Training
Waveform analysis
Young Adult
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Summary: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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ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-021-04464-5