Performance evaluation of the Elecsys PIVKA-II and Elecsys AFP assays for hepatocellular carcinoma diagnosis

  • 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.
Metadaten
Author: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
URN:urn:nbn:de:hebis:30:3-836069
DOI:https://doi.org/10.1002/jgh3.12720
ISSN:2397-9070
Parent Title (English):JGH Open
Publisher:Wiley
Place of publication:London
Document Type:Article
Language:English
Date of Publication (online):2022/05/07
Date of first Publication:2022/05/07
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2024/04/24
Tag:acarboxyprothrombin; alpha-fetoprotein; diagnosis; hepatocellular carcinoma; prothrombin induced by vitamin K absence-II
Volume:6
Issue:5
Page Number:9
First Page:292
Last Page:300
Note:
This study was funded by Roche Diagnostics GmbH (Penzberg, Germany).
HeBIS-PPN:519220579
Institutes:Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - CC BY-NC-ND - Namensnennung - Nicht kommerziell - Keine Bearbeitungen 4.0 International