Henry Lik Yuen Chan, Arndt Vogel, Thomas Berg, Enrico de Toni, Masatoshi Kudo, Jörg Trojan, Anja Eiblmaier, Hanns-Georg Klein, Johannes Kolja Hegel, Ashish Sharma, Kairat Madin, Vinzent Rolny, Marcus-Rene Lisy, Teerha Piratvisuth
- Background and Aims: Prothrombin induced by vitamin K absence-II (PIVKA-II) is a serum biomarker linked to hepatocellular carcinoma (HCC), showing superiority to alpha-fetoprotein (AFP) for early disease detection. We aimed to assess the clinical and analytical performance of the Elecsys® PIVKA-II immunoassay in diagnosing HCC and evaluate PIVKA-II's technical performance.
Methods: Serum samples from adult cases (i.e. patients with a first-time HCC diagnosis; n = 168) and disease controls (i.e. patients without HCC with an at-risk condition; n = 208) were assessed. An AFP cut-off of 20 ng/mL was used to differentiate between HCC cases and disease controls. Clinical performance of the Elecsys PIVKA-II assay was compared with that of comparator assays (Lumipulse G PIVKA-II, μTASWako DCP, ARCHITECT PIVKA-II) using receiver operating characteristic curve analysis to determine the area under the curve (AUC) values.
Results: The Elecsys PIVKA-II assay compared favorably with comparator assays. Using a 28.4 ng/mL cut-off, the Elecsys PIVKA-II assay detected HCC with 86.9% sensitivity and 83.7% specificity. Clinical performance of the Elecsys PIVKA-II assay (AUC: 90.8%) was equivalent to that of comparator assays (AUC: 88.3–89.6%). Relatively high PIVKA-II concentrations were observed for cholangiocarcinoma and pancreatic cancer with the Elecsys assay in specificity panel analyses, indicating that high PIVKA-II concentrations should not be used alone in the absence of other clinical data.
Conclusions: The Elecsys PIVKA-II assay showed good analytical performance under routine laboratory conditions, comparing favorably with comparator assays. These findings support the suitability of the Elecsys PIVKA-II assay as an aid in HCC diagnosis.
MetadatenVerfasserangaben: | Henry Lik Yuen ChanORCiD, Arndt VogelORCiDGND, Thomas BergORCiDGND, Enrico de ToniORCiDGND, Masatoshi KudoORCiDGND, Jörg TrojanORCiDGND, Anja Eiblmaier, Hanns-Georg KleinGND, Johannes Kolja HegelORCiD, Ashish Sharma, Kairat Madin, Vinzent RolnyORCiD, Marcus-Rene LisyGND, Teerha PiratvisuthORCiD |
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URN: | urn:nbn:de:hebis:30:3-836069 |
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DOI: | https://doi.org/10.1002/jgh3.12720 |
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ISSN: | 2397-9070 |
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Titel des übergeordneten Werkes (Englisch): | JGH Open |
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Verlag: | Wiley |
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Verlagsort: | London |
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Dokumentart: | Wissenschaftlicher Artikel |
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Sprache: | Englisch |
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Datum der Veröffentlichung (online): | 07.05.2022 |
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Datum der Erstveröffentlichung: | 07.05.2022 |
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Veröffentlichende Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Datum der Freischaltung: | 24.04.2024 |
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Freies Schlagwort / Tag: | acarboxyprothrombin; alpha-fetoprotein; diagnosis; hepatocellular carcinoma; prothrombin induced by vitamin K absence-II |
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Jahrgang: | 6 |
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Ausgabe / Heft: | 5 |
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Seitenzahl: | 9 |
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Erste Seite: | 292 |
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Letzte Seite: | 300 |
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Bemerkung: | This study was funded by Roche Diagnostics GmbH (Penzberg, Germany). |
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Institute: | Medizin |
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DDC-Klassifikation: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Lizenz (Deutsch): | Creative Commons - CC BY-NC-ND - Namensnennung - Nicht kommerziell - Keine Bearbeitungen 4.0 International |
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