Performance Evaluation of New Automated Hepatitis B Viral Markers in the Clinical Laboratory

Abstract

We evaluated quantitative hepatitis B surface antigen (qHBsAg) assays and a hepatitis B virus (HBV) core-related antigen (HBcrAg) assay. A total of 529 serum samples from patients with hepatitis B were tested. HBsAg levels were determined by using the Elecsys (Roche Diagnostics, Indianapolis, IN) and Architect (Abbott Laboratories, Abbott Park, IL) qHBsAg assays. HBcrAg was measured by using Lumipulse HBcrAg assay (Fujirebio, Tokyo, Japan). Serum aminotransferases and HBV DNA were respectively quantified by using the Hitachi 7600 analyzer (Hitachi High-Technologies, Tokyo, Japan) and the Cobas AmpliPrep/Cobas TaqMan test (Roche). Precision of the qHBsAg and HBcrAg assays was assessed, and linearity of the qHBsAg assays was verified. All assays showed good precision performance with coefficients of variation between 4.5% and 5.3% except for some levels. Both qHBsAg assays showed linearity from 0.1 to 12,000.0 IU/mL and correlated well (r = 0.9934). HBsAg levels correlated with HBV DNA (r = 0.3373) and with HBcrAg (r = 0.5164), and HBcrAg also correlated with HBV DNA (r = 0.5198; P < .0001). This observation could provide impetus for further research to elucidate the clinical usefulness of the qHBsAg and HBcrAg assays.

Correlation of Quantitative Assay of HBsAg and Hepatitis B Virus DNA Levels Among Chronic HBV Patients Attending Pathologist Lancet Laboratory in Nairobi, Kenya

“…The variations in the correlation between HBsAg and HBV-DNA levels was attributed to differences in disease stage, HBeAg status, HBV genotypes involved, and types/phases of treatment (16,25) and should always be considered in HBV DNA and HBsAG level correlation studies. Even though most of these factors were not established in the current study, similar to the report by Ganji et al (9), this study highlights a significant insight into differences in HBsAg levels between HBeAg positive and negative patients, which appear to be affected by HBeAg status.…”

“…Using the Lemeshow et al (15) formula for estimating population proportion with specified absolute precision, setting α at 0.05, and correlation rates of 34% (16) for HBsAg and HBV DNA levels, a total of 172 HBV patients were recruited to achieve 0.95 power and to obtain a total of 344 matched HBsAg and HBV DNA level tests. Consenting adult patients were enrolled in the study.…”

Introduction of an Automated System for the Diagnosis and Quantification of Hepatitis B and Hepatitis C Viruses

“…The most widely used is the Architect assay, but HBsAg quantification may also be performed using the Elecsys platform (HBsAg Quant Package Insert, Roche Diagnostics 2011) [15-17]. …”

“…A new assay was developed for measuring HBV core-related antigen (HBcrAg), which consists of a core, e antigen (HBeAg), and the precore HBV proteins (22-kD precore fragment, amino acids 28-150); HBcrAg levels correlated well with HBV DNA levels [15]. A recent study showed that the serum HBcrAg concentration was related to the level of intrahepatic cccDNA [16].…”

“…A recent study showed that the serum HBcrAg concentration was related to the level of intrahepatic cccDNA [16]. Until recently, and for more than a decade, only 1 commercial qHBsAg assay was available [15]. …”