Related Experiment Video
Updated: Feb 9, 2026
Detection of Neutralization-sensitive Epitopes in Antigens Displayed on Virus-Like Particle VLP-Based Vaccines Using a Capture Assay
Published on: February 10, 2022
An ultra-sensitive Abbott ARCHITECT® assay for the detection of hepatitis B virus surface antigen (HBsAg)
Sheng Lou1, Russell Taylor1, Sandra Pearce1
1Diagnostics Research, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL,60064, USA.
Background:
Critical to the identification of HBV infection and the prevention of transfusion transmitted disease is the sensitive and accurate detection of Hepatitis B virus surface antigen (HBsAg). Improvements in HBsAg assay sensitivity approaching the performance of nucleic acid testing (NAT) are essential to further reduce the detection window for acute HBV infection in regions where NAT is not widely available.
Objectives And Study Design:
An improved HBsAg assay on the fully-automated Abbott ARCHITECT® platform was developed to improve sensitivity, mutant and genotype detection.
Results:
The analytical sensitivity of the improved prototype assay is 5.2 mIU/ml, which is 3.86- to 14.54-fold more sensitive than comparator assays based on the WHO International Reference Standard. The enhanced sensitivity was also demonstrated with 27 HBV seroconversion panels, detecting more panel members (191 of 364) vs. the ARCHITECT® Qual I (144), Qual II (160) and PRISM® (148) HBsAg assays. Further, the assay detected 7 of 12 HBV DNA positive/HBsAg negative samples, and detected all evaluated mutants and genotypes with higher sensitivity than the comparator assays. The improvement in sensitivity did not diminish assay specificity, attaining 100% (95% CI, 99.97-100%) on 10,633 blood donors.
Conclusions:
An Abbott ARCHITECT® HBsAg assay with clinical performance approaching that of mini-pool NAT (approximately 100 copies/ml was developed. The assay has superior HBsAg mutant and genotype detection and specificity, all of which are important for the diagnosis and management of HBV infection.
Related Concept Videos
00:50What are Viruses?
01:08Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment
01:21Hepatic Portal System
At its core, the hepatic portal vein is the result of a confluence of the superior and inferior mesenteric veins along with the splenic vein. Each of these veins has a unique role. The superior mesenteric vein is...
01:26Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow
01:22Antigen Presenting Cells
T cells require the help of antigen-presenting cells (APCs), which process foreign antigens into smaller fragments that can be recognized by T cells. These APCs are highly specialized cells that efficiently internalize antigens...
01:16Surface Tension and Surface Energy
Consider a beaker filled with liquid. The bulk molecules in the liquid experience equal attractive forces on all sides with the surrounding molecules. However, the surface molecules experience a net attractive force downward due to the bulk molecules. The surface of the liquid behaves like a stretched membrane,...