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CC BY-NC-ND 4.0 · J Lab Physicians 2023; 15(04): 533-538
DOI: 10.1055/s-0043-1768633
Original Article

Performance Evaluation of an Improved HBsAg Assay (HBsAg NEXT) for the Detection of HBsAg Levels

Ekta Gupta 
1   Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
,
Arjun Bhugra
1   Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
,
Jasmine Samal 
1   Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
,
Arvind Khodare
1   Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
,
Keshaw Singh
1   Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, India
,
Aayushi Rastogi
2   Department of Epidemiology, Institute of Liver and Biliary Sciences, New Delhi, India
,
Manoj Kumar Sharma
3   Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India
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Abstract

Objectives Detection of hepatitis B surface antigen (HBsAg) plays an important role in the screening and diagnosis of hepatitis B virus (HBV) infections. There is a need of highly sensitive assays with an improved lower limit of detection (LoD). Here, we evaluate the performance characteristics of the HBsAg NEXT (HBsAg new) assay in the detection of HBsAg in clinical samples.

Materials and Methods This was a cross-sectional study conducted at a tertiary care liver center in North India. The study included 439 clinical samples. The HBsAg new assay was compared to the conventional chemiluminescence-based assay (HBsAg old assay, Architect, Abbott Diagnostics, United States). The analytical sensitivity of the HBsAg new assay was evaluated by checking its performance with the second World Health Organization (WHO) international standards for HBsAg.

Results Out of 439 blood samples that were retrieved from the departmental repository stored at –80°C, 100 samples were positive and 339 samples were negative for HBsAg as per the HBsAg old assay. The HBsAg new assay showed incremental detection of HBsAg in 11 additional samples. Out of these, 5 samples were confirmed as occult HBV infection and the remaining 6 were classified as “exposed-to-virus” samples (HBV core total antibody-positive). The HBsAg new assay demonstrated a high positive significant correlation with the HBsAg old assay (r = 0.881, p-value < 0.001). The HBsAg new assay could effectively detect the second WHO international standards to the level of 0.0033 IU/mL.

Conclusion The HBsAg NEXT assay is a highly sensitive assay with an improved lower LoD.

Keywords

hepatitis B - immunoassay - HBsAg - occult hepatitis B - HBsAg NEXT - CHB

Consent for Publication

The study was performed on deidentified, anonymous, leftover archived clinical plasma samples. Hence, the requirement for individual patient consent forms was waived off.


Authors' Contributions

Conceptualization: E.G., M.K.S.; Methodology: E.G., A.K., A.B.; Data curation: A.R., A.B.; Validation: K.S., A.K.; Formal Analysis: A.R., A.B.; Funding acquisition: E.G.; Investigation: A.K., K.S., A.B.; Project administration: E.G; Resources: E.G.; Supervision: E.G.; Writing-original draft: E.G., A.B., A.K.; Writing, review, and editing: E.G., A.B., and J.S.




Publication History

Received: 02 December 2022

Accepted: 15 March 2023

Article published online:
12 May 2023

© 2023. The Indian Association of Laboratory Physicians. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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