Usefulness of ED036 kit for measuring serum PIVKA-II levels in small hepatocellular carcinoma

As a tumor marker for hepatocellular carcinoma (HCC), serum protein induced by vitamin K absence or antagonist-II (PIVKA-II) has high specificity, yet its sensitivity is relatively low, marking it less suitable to serve as an adjunct in the diagnosis of small HCC. Recently, the ED036 kit (Eisai, Tok...

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Bibliographic Details
Published in:Journal of gastroenterology 1997-08, Vol.32 (4), p.507-512
Main Authors: Kuromatsu, R, Tanaka, M, Shimauchi, Y, Shimada, M, Tanikawa, K, Watanabe, K, Yokoo, T
Format: Article
Language:English
Subjects:
Adult
Aged
Biomarkers
Biomarkers, Tumor - blood
Biopsy
Carcinoma, Hepatocellular - blood
Carcinoma, Hepatocellular - diagnosis
Female
Hepatocellular carcinoma
Humans
Liver cancer
Liver diseases
Liver Diseases - blood
Liver Diseases - diagnosis
Liver Neoplasms - blood
Liver Neoplasms - diagnosis
Male
Middle Aged
Protein Precursors - analysis
Prothrombin - analysis
Reagent Kits, Diagnostic
Sensitivity and Specificity
Tumor markers
Tumors
Vitamin K
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Summary:As a tumor marker for hepatocellular carcinoma (HCC), serum protein induced by vitamin K absence or antagonist-II (PIVKA-II) has high specificity, yet its sensitivity is relatively low, marking it less suitable to serve as an adjunct in the diagnosis of small HCC. Recently, the ED036 kit (Eisai, Tokyo, Japan), whose detection limit is approximately ten times superior to that of a conventional kit (Eitest MONOP II, Eisai) has been developed. In this study, serum PIVKA-II levels in serum samples from 83 patients with benign chronic liver diseases (CLD) and 129 patients with HCC were measured with those two kits. With the ED036 kit, the cut-off value was set at 40 mAU/ml. For PIVKA-II measured with the ED036 kit, sensitivity was 45.0%, specificity 92.8%, and accuracy 63.7%, when we discriminated patients with HCC from those with CLD without HCC. While maintaining a high specificity, of 92.8%, the ED036 kit showed a significantly higher sensitivity than the conventional kit (45.0% versus 27.9%; P < 0.0001). With patients who had HCC consisting of a single nodule 30 mm or less in diameter, the positivity rate for serum PIVKA-II with the ED036 kit was significantly greater than the rate with the conventional kit (21.4% versus 9.5%; P < 0.005). Thus, the ED036 kit was thought to be more useful than the conventional kit as a tumor marker for small HCC.
ISSN:0944-1174
1435-5922
DOI:10.1007/bf02934091