Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis
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...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2022-01-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-021-04464-5 |
| _version_ | 1818332888633966592 |
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| author | Atsuo Suzuki Nobuaki Suzuki Takeshi Kanematsu Sho Shinohara Hiroshi Kurono Nobuo Arai Shuichi Okamoto Naruko Suzuki Shogo Tamura Ryosuke Kikuchi Akira Katsumi Tetsuhito Kojima Tadashi Matsushita |
| author_facet | Atsuo Suzuki Nobuaki Suzuki Takeshi Kanematsu Sho Shinohara Hiroshi Kurono Nobuo Arai Shuichi Okamoto Naruko Suzuki Shogo Tamura Ryosuke Kikuchi Akira Katsumi Tetsuhito Kojima Tadashi Matsushita |
| author_sort | Atsuo Suzuki |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T13:42:54Z |
| format | Article |
| id | doaj.art-bab0b468fae849ba97a1aa9089dfc33a |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-12-13T13:42:54Z |
| publishDate | 2022-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-bab0b468fae849ba97a1aa9089dfc33a2022-12-21T23:43:31ZengNature PortfolioScientific Reports2045-23222022-01-011211910.1038/s41598-021-04464-5Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysisAtsuo Suzuki0Nobuaki Suzuki1Takeshi Kanematsu2Sho Shinohara3Hiroshi Kurono4Nobuo Arai5Shuichi Okamoto6Naruko Suzuki7Shogo Tamura8Ryosuke Kikuchi9Akira Katsumi10Tetsuhito Kojima11Tadashi Matsushita12Department of Medical Technique, Nagoya University HospitalDepartment of Transfusion Medicine, Nagoya University HospitalDepartment of Clinical Laboratory, Nagoya University HospitalSysmex CorporationSysmex CorporationSysmex CorporationDepartment of Clinical Laboratory, Nagoya University HospitalDepartment of Hematology-Oncology, Nagoya University Graduate School of MedicineDivision of Cellular and Genetic Sciences, Department of Integrated Health Sciences, Nagoya University Graduate School of MedicineDepartment of Medical Technique, Nagoya University HospitalDepartment of Hematology, National Centre for Geriatrics and GerontologyAichi Health Promotion FoundationDepartment of Transfusion Medicine, Nagoya University HospitalAbstract 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.https://doi.org/10.1038/s41598-021-04464-5 |
| spellingShingle | Atsuo Suzuki Nobuaki Suzuki Takeshi Kanematsu Sho Shinohara Hiroshi Kurono Nobuo Arai Shuichi Okamoto Naruko Suzuki Shogo Tamura Ryosuke Kikuchi Akira Katsumi Tetsuhito Kojima Tadashi Matsushita Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis Scientific Reports |
| title | Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis |
| title_full | Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis |
| title_fullStr | Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis |
| title_full_unstemmed | Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis |
| title_short | Development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis |
| title_sort | development and validation of a novel qualitative test for plasma fibrinogen utilizing clot waveform analysis |
| url | https://doi.org/10.1038/s41598-021-04464-5 |
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