TY  - JOUR
A1  - Chan, Henry Lik Yuen
A1  - Vogel, Arndt
A1  - Berg, Thomas
A1  - Toni, Enrico de
A1  - Kudo, Masatoshi
A1  - Trojan, Jörg
A1  - Eiblmaier, Anja
A1  - Klein, Hanns-Georg
A1  - Hegel, Johannes Kolja
A1  - Sharma, Ashish
A1  - Madin, Kairat
A1  - Rolny, Vinzent
A1  - Lisy, Marcus-Rene
A1  - Piratvisuth, Teerha
T1  - Performance evaluation of the Elecsys PIVKA-II and Elecsys AFP assays for hepatocellular carcinoma diagnosis
T2  - JGH Open
N2  - 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.
KW  - acarboxyprothrombin
KW  - alpha-fetoprotein
KW  - diagnosis
KW  - hepatocellular carcinoma
KW  - prothrombin induced by vitamin K absence-II
Y1  - 2022
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/83606
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-836069
SN  - 2397-9070
N1  - This study was funded by Roche Diagnostics GmbH (Penzberg, Germany).
VL  - 6
IS  - 5
SP  - 292
EP  - 300
PB  - Wiley
CY  - London
ER  -