Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis.
Sci Rep
; 12(1): 434, 2022 01 21.
Article
em En
| MEDLINE
| ID: mdl-35064141
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fibrinogênio
/
Técnicas de Laboratório Clínico
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
/
Qualitative_research
Limite:
Adolescent
/
Adult
/
Aged
/
Aged80
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Child
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Child, preschool
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Female
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Humans
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Infant
/
Male
Idioma:
En
Revista:
Sci Rep
Ano de publicação:
2022
Tipo de documento:
Article