Dataset Information

Performance evaluation of serum PIVKA-II measurement using HISCL-5000 and a method comparison of HISCL-5000, LUMIPULSE G1200, and ARCHITECT i2000.

ABSTRACT:

Background

Protein induced by vitamin K antagonist-II (PIVKA-II), in addition to alpha-fetoprotein, is a useful tumor marker for diagnosis of hepatocellular carcinoma (HCC). We evaluated the analytical performance of the HISCL-5000 analyzer (Sysmex Corporation) in the measurement of serum PIVKA-II.

Methods

We evaluated the precision and linearity of PIVKA-II assays using the HISCL-5000 analyzer. Methods using HISCL-5000, LUMIPULSE G1200 (Fujirebio Diagnostics), and ARCHITECT i2000 (Abbott Diagnostics) were compared according to the guidelines of the Clinical and Laboratory Standards Institute. A total of 501 subjects (median age 59 years, age range 24-90 years) were enrolled. Among them, 335 were HCC patients, 46 were patients with non-HCC liver disease, and 120 were healthy individuals. Non-HCC liver disease included liver cirrhosis, chronic hepatitis, HBV or HCV carrier, hepatic adenoma, and intrahepatic cholangiocarcinoma.

Results

Repeatability (%CV) in low- and high-level controls and pooled serum was 2.81%-10.30%, and within-laboratory precision was 4.24%-8.86%. In a linearity test, the coefficient of determination (R² ) was 0.9957, ranging from 11 to 69 897 mAU/mL. In comparison, the coefficient of correlation (r) was 0.9561-0.9644, agreement was 93.4%-97.6%, and the κ value was 0.855-0.945 among the three analyzers. About 99.2% of healthy individuals and 84.8% of non-HCC liver disease patients were below the cutoff value (40 mAU/mL) on HISCL-5000.

Conclusions

A PIVKA-II assay using HISCL-5000 showed acceptable analytical performance including precision, linearity, and method comparison. This indicates that HISCL-5000 can be potentially helpful in clinical laboratories.

SUBMITTER: Ryu MR

PROVIDER: S-EPMC6642327 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Performance evaluation of serum PIVKA-II measurement using HISCL-5000 and a method comparison of HISCL-5000, LUMIPULSE G1200, and ARCHITECT i2000.

Ryu Mi Ra MR Kang Eun-Suk ES Park Hyung-Doo HD

Journal of clinical laboratory analysis 20190526 6

<h4>Background</h4>Protein induced by vitamin K antagonist-II (PIVKA-II), in addition to alpha-fetoprotein, is a useful tumor marker for diagnosis of hepatocellular carcinoma (HCC). We evaluated the analytical performance of the HISCL-5000 analyzer (Sysmex Corporation) in the measurement of serum PIVKA-II.<h4>Methods</h4>We evaluated the precision and linearity of PIVKA-II assays using the HISCL-5000 analyzer. Methods using HISCL-5000, LUMIPULSE G1200 (Fujirebio Diagnostics), and ARCHITECT i2000 ...[more]

PMID: 31131509

Similar Datasets

Project description:Background: The aim of the present study was to develop an improved diagnostic and prognostic model for HBV-associated HCC by combining AFP with PIVKA-II and other potential serum/plasma protein biomarkers. Methods: A total of 578 patients, including 352 patients with HBV-related HCC, 102 patients with HBV-associated liver cirrhosis (LC), 124 patients with chronic HBV, and 127 healthy subjects (HS), were enrolled in the study. The serum levels of AFP, PIVKA-II, and other laboratory parameters were collected. Univariate and multivariate logistic regression and Cox regression analyses were performed to identify independent diagnostic and prognostic factors, respectively. The diagnostic efficacy of the nomogram was evaluated using receiver operator curve (ROC) analysis and the prognostic performance was measured by Harrell’s concordance index (C-index). Results: AFP and PIVKA-II levels were significantly increased in HBV-related HCC, compared with those in HBV-associated LC and chronic HBV participants (p < 0.05 and p < 0.001, respectively). The diagnostic nomogram, which included age, gender, AFP, PIVKA-II, prothrombin time (PT), and total protein (TP), discriminated patients with HBV-HCC from those with HBV-LC or chronic HBV with an AUC of 0.970. In addition, based on the univariate and multivariate Cox regression analysis, PIVKA-II, γ-glutamyl transpeptidase, and albumin were found to be significantly associated with the prognosis of HBV-related HCC and were incorporated into a nomogram. The C-index of the nomogram for predicting 3-year survival in the training and validation groups was 0.75 and 0.78, respectively. The calibration curves for the probability of 3-year OS showed good agreement between the nomogram prediction and the actual observation in the training and the validation groups. Furthermore, the nomogram had a higher C-index (0.74) than that of the Child−Pugh grade (0.62), the albumin−bilirubin (ALBI) score (0.64), and Barcelona Clinic Liver Cancer (0.56) in all follow-up cases. Conclusion: Our study suggests that the nomograms based on AFP, PIVKA-II, and potential serum protein biomarkers showed a better performance in the diagnosis and prognosis of HCC, which may help to guide therapeutic strategies and assess the prognosis of HCC.

Dataset Information

Performance evaluation of serum PIVKA-II measurement using HISCL-5000 and a method comparison of HISCL-5000, LUMIPULSE G1200, and ARCHITECT i2000.

Background

Methods

Results

Conclusions

Publications

Performance evaluation of serum PIVKA-II measurement using HISCL-5000 and a method comparison of HISCL-5000, LUMIPULSE G1200, and ARCHITECT i2000.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets