X Qin1, G Tang2, R Gao1, Z Guo1, Z Liu1, S Yu1, M Chen3, Z Tao4, S Li5, M Liu6, L Wang7, L Hou1, L Xia1, X Cheng1, J Han1, L Qiu1. 1. Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China. 2. Department of Cardiology, Beijing Hospital of the Ministry of Health, Beijing, China. 3. Department of Clinical Laboratory, Third Affiliated Hospital of Third Military Medical University, Chongqing, China. 4. Department of Clinical Laboratory, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. 5. Department of Clinical Laboratory, The First Affiliated Hospital of Dalian Medical University, Dalian, China. 6. Department of Clinical Laboratory, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. 7. Department of Clinical Laboratory, Xinjiang Medical University, Urumuqi, China.
Abstract
INTRODUCTION: The aim of this study was to investigate the reference interval of protein-induced vitamin K absence or antagonist-II (PIVKA-II) in China population and to evaluate its medical decision level for hepatocellular carcinoma (HCC) diagnosis. METHODS: To determine the reference range for Chinese individuals, a total of 855 healthy subjects in five typical regions of China were enrolled in this study to obtain a 95% reference interval. In a case-control study which recruited the subjects diagnosed with HCC, metastatic liver cancer, bile duct cancer, hepatitis, cirrhosis, other benign liver diseases and the subjects administrated anticoagulant, receiver operating characteristic analysis was used to determine PIVKA-II cutoff value for a medical decision. RESULTS: The concentration of PIVKA-II had no relationship with age or gender and that region was a significant factor associated with the level of PIVKA-II. The 95% reference interval determined in this study for PIVKA-II in Chinese healthy individuals was 28 mAU/mL, and the cutoff value which to distinguish patients with HCC from disease control groups is 36.5 mAU/mL. CONCLUSION: In clinical applications, it is recommended that each laboratory chooses their own reference interval based on the regional population study or cutoff value for disease diagnosis.
INTRODUCTION: The aim of this study was to investigate the reference interval of protein-induced vitamin K absence or antagonist-II (PIVKA-II) in China population and to evaluate its medical decision level for hepatocellular carcinoma (HCC) diagnosis. METHODS: To determine the reference range for Chinese individuals, a total of 855 healthy subjects in five typical regions of China were enrolled in this study to obtain a 95% reference interval. In a case-control study which recruited the subjects diagnosed with HCC, metastatic liver cancer, bile duct cancer, hepatitis, cirrhosis, other benign liver diseases and the subjects administrated anticoagulant, receiver operating characteristic analysis was used to determine PIVKA-II cutoff value for a medical decision. RESULTS: The concentration of PIVKA-II had no relationship with age or gender and that region was a significant factor associated with the level of PIVKA-II. The 95% reference interval determined in this study for PIVKA-II in Chinese healthy individuals was 28 mAU/mL, and the cutoff value which to distinguish patients with HCC from disease control groups is 36.5 mAU/mL. CONCLUSION: In clinical applications, it is recommended that each laboratory chooses their own reference interval based on the regional population study or cutoff value for disease diagnosis.
Authors: Vandana M Sagar; Kathyrn Herring; Stuart Curbishley; James Hodson; Peter Fletcher; Salil Karkhanis; Homoyon Mehrzad; Pankaj Punia; Tahir Shah; Shishir Shetty; Yuk Ting Ma Journal: Oncotarget Date: 2021-11-23