| Autor: |
Henry L Y Chan, Arndt Vogel, Thomas Berg, Enrico N 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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
JGH Open, Vol 6, Iss 5, Pp 292-300 (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2397-9070 |
| DOI: |
10.1002/jgh3.12720 |
| Popis: |
Abstract 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. |
| Databáze: |
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| Externí odkaz: |
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