Establishment the reference interval of adult protein-induced vitamin K absence/antagonist Ⅱ by chemiluminescent microparticle immunoassay

doi:10.3969/j.issn.1673-8640.2019.12.003

Abstract

Abstract:

Objective To establish the reference interval of adult protein-induced vitamin K absence/antagonist Ⅱ（PIVKA-Ⅱ） in Mianyang by chemiluminescent microparticle immunoassay（CMIA）,and to investigate the change of PIVKA-Ⅱ levels in patients with viral hepatitis,cirrhosis and hepatocellular carcinoma（HCC）. Methods Serum PIVKA-Ⅱ levels were determined by CMIA in 674 healthy subjects,147 viral hepatitis patients,90 cirrhosis patients and 98 HCC patients. The reference interval of PIVKA-Ⅱwas established by x±1.96s. The diagnostic efficiency of PIVKA-Ⅱto viral hepatitis,cirrhosis and HCC was evaluated by receiver operating characteristic（ROC） curve. Results The results of serum PIVKA-Ⅱ determination of 674 healthy subjects showed approximate normal distribution（z=1.428,P=0.034）,and there was no statistical significance between males and females（P>0.05）. The subjects were classified according to ages（18-30-year-old,31-44-year-old,45-59-year-old,60-69-year-old and ≥70-year-old groups）,and there was no statistical significance in these groups（P>0.05）. The data were merged,and the reference interval established by x±1.96s was 8.75-36.72 U/L. Compared to healthy control group,serum PIVKA-Ⅱ levels in viral hepatitis group,cirrhosis group and HCC group increased（P<0.001）. Serum PIVKA-Ⅱ levels in HCC group were higher than those in viral hepatitis group and cirrhosis group（P<0.001）,and there was no statistical significance between viral hepatitis group and cirrhosis group（P>0.05）. By ROC curve analysis,the areas under curve（AUC） of serum PIVKA-Ⅱ for viral hepatitis,cirrhosis and HCC were 0.656,0.663 and 0.900,and the optimal cut-off values were 27.27,29.86 and 40.36 U/L,the sensitivities were 49.7%,52.2% and 80.6%,and the specificities were 75.7%,80.8% and 94.5%,respectively. Conclusions The reference interval of serum adult PIVKA-Ⅱ by CMIA in Mianyang has preliminarily been established. PIVKA-Ⅱ increases in various degrees in patients with non-liver cancer,such as viral hepatitis and cirrhosis,and it should not be used alone as a marker of HCC.

Key words: Protein-induced vitamin K absence/antagonist Ⅱ, Reference interval, Chemiluminescent microparticle immunoassay, Hepatocellular carcinoma

CLC Number:

R446.1

TANG Jie, YANG Yuwei, WANG Kun, YU Jing. Establishment the reference interval of adult protein-induced vitamin K absence/antagonist Ⅱ by chemiluminescent microparticle immunoassay[J]. Laboratory Medicine, 2019, 34(12): 1072-1076.

Figures/Tables 4

References 10

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组别	例数	PIVKA-Ⅱ（U/L）
18~30岁组	15	24.10±7.92
31~44岁组	179	22.99±7.17
45~59岁组	310	23.13±6.92
60~69岁组	128	21.61±7.34
≥70岁组	42	21.75±7.61
F值		1.409
P值		0.229

组别	例数	PIVKA-Ⅱ（U/L）
18~30岁组	15	24.10±7.92
31~44岁组	179	22.99±7.17
45~59岁组	310	23.13±6.92
60~69岁组	128	21.61±7.34
≥70岁组	42	21.75±7.61
F值		1.409
P值		0.229

组别	例数	PIVKA-Ⅱ（U/L）
HCC组	98	1 091.38（13.29~283 389.09）
肝硬化组	90	30.09（9.05~324.08）
病毒性肝炎组	147	27.02（8.46~77.14）
正常对照组	674	22.24（6.03~44.82）
F值		282.667
P值		<0.001

组别	例数	PIVKA-Ⅱ（U/L）
HCC组	98	1 091.38（13.29~283 389.09）
肝硬化组	90	30.09（9.05~324.08）
病毒性肝炎组	147	27.02（8.46~77.14）
正常对照组	674	22.24（6.03~44.82）
F值		282.667
P值		<0.001

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