English
Objective
The Access HBsAg and Access HBsAg Confirmatory assays have been shown to provide accurate detection of hepatitis B surface antigen across various clinical settings. This validation study aimed to establish the clinical and analytical performance characteristics of integrating the Access HBsAg assays on the DxI 9000 Access Immunoassay Analyzer into the diagnostic pathway for patients with suspected hepatitis B virus infection and blood donor screening programs.*
Study Design†
- Clinical performance evaluation was conducted using a multicenter, prospective design. Fresh and frozen plasma/serum samples were collected from 7,534 subjects across three populations (blood donors, hospitalized patients, and HBsAg positive patients) at five collection sites between January 2020 and December 2021.*
- Comparative analysis was constructed to assess diagnostic accuracy by testing samples in parallel with Access HBsAg and Access HBsAg Confirmatory assays against established reference methods (Abbott Architect, Abbott PRISM, and Roche Elecsys HBsAg assays) to determine sensitivity, specificity, and analytical performance characteristics
Key Study Findings
The Access HBsAg assay demonstrated excellent clinical performance with 100% sensitivity (99.19-100%) and 99.92% specificity (99.82-99.97%). The Access HBsAg Confirmatory assay achieved 100% sensitivity (99.19-100%) on positive samples. Analytical sensitivity ranged from 0.022-0.025 IU/mL on WHO standards.*
HBV genotypes A through H and a total of 30 HBsAg mutant samples were successfully detected. The high positive algorithm (S/CO ≥100) was validated, eliminating the need for repeat testing and confirmatory testing in 96.98% of initially reactive samples. Sample carryover was negligible, and the assay demonstrated robust performance across multiple sample types with low volume requirements (45 μL) and rapid turnaround time (29 minutes).
Summary Table
Category |
Finding |
Clinical Impact |
| Clinical Sensitivity | 100% (99.19-100%) | Perfect detection rate for HBsAg-positive samples, ensuring reliable detection of all HBsAg-infected individuals, preventing critical false negatives. |
| Clinical Specificity | 99.92% (99.82-99.97%) | Minimal false positives in screening populations |
| Analytical Sensitivity | 0.022-0.025 IU/mL | Excellent early infection detection capability |
| False initial reactive rate (IRR) | 0.04% (95% CI: 0.01%–0.13%) | Significantly reduces unnecessary follow-up testing and improves laboratory workflow efficiency by correctly identifying negative samples initially |
Conclusions
The HBsAg and Confirmatory assays demonstrate robust clinical performance, 100% sensitivity & 99.92% specificity, allowing accurate HBsAg screening and diagnosis of HBV infections. These assays offer practical benefits, including high analytical sensitivity, a low false initial reactive rate of 0.04%, reliable variant detection, and robustness across various sample types with no carryover. Both assays offer a simplified workflow that utilizes a validated high-positive algorithm, reducing unnecessary repeats and confirmation testing.
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IVD: In Vitro Diagnostic Products. These products are labeled “For In Vitro Diagnostic Use."
CE-IVD, CE: Products intended for in vitro diagnostic use and conforming to Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
NOTE: Devices may be CE marked to non-IVD directives and/or regulations.
*Not intended for blood-donor screening programs in the U.S.
†These claims have not been validated outside of the European Union.
2025-14986
