A multicenter study on PIVKA reference interval of healthy population and establishment of PIVKA cutoff value for hepatocellular carcinoma diagnosis in China.
BACKGROUND
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.


CONCLUSIONS
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.
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
X
X
Qin
Department of Cardiology, Beijing Hospital of the Ministry of Health, Beijing, China.
G
G
Tang
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
R
R
Gao
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
Z
Z
Guo
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
Z
Z
Liu
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
S
S
Yu
Department of Clinical Laboratory, Third Affiliated Hospital of Third Military Medical University, Chongqing, China.
M
M
Chen
Department of Clinical Laboratory, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Z
Z
Tao
Department of Clinical Laboratory, The First Affiliated Hospital of Dalian Medical University, Dalian, China.
S
S
Li
Department of Clinical Laboratory, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
M
M
Liu
Department of Clinical Laboratory, Xinjiang Medical University, Urumuqi, China.
L
L
Wang
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
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L
Hou
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
L
L
Xia
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
X
X
Cheng
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
J
J
Han
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
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http://orcid.org/0000-0002-0734-8144
L
Qiu
D000328:Adult; D015415:Biomarkers / Q000097:blood*; D014408:Biomarkers, Tumor; D006528:Carcinoma, Hepatocellular / Q000097:blood* / Q000175:diagnosis* / Q000209:etiology; D016022:Case-Control Studies; D002681:China; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000097:blood* / Q000175:diagnosis* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011498:Protein Precursors / Q000097:blood*; D011516:Prothrombin; D012372:ROC Curve; D012016:Reference Values
D015415:Biomarkers; D014408:Biomarkers, Tumor; D011498:Protein Precursors; C008208:acarboxyprothrombin; D011516:Prothrombin
Protein-induced vitamin K absence or antagonist-II; hepatocellular carcinoma