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Peer-reviewedCC BY-NC-ND 4.0iScience

A dual recombinant strategy to quantify PreS1 antibody in hepatitis B patients with genotype B or C virus by ELISA

Abstract

Elevated levels of anti-preS1 antibodies in patients correlate with faster hepatitis B virus (HBV) clearance, since preS1 is vital for viral entry. However, accurate quantification of preS1 antibodies is hindered by the variation of HBV genotypes. Herein, a quantitative preS1 antibody assay was developed for Chinese patients with predominant HBV genotypes B and C. First, to address genotype diversity, we constructed a dual recombinant protein combining genotype B and C preS1. Second, a mouse-human chimeric antibody with high and comparable affinity for both B and C preS1 is developed as the standard for quantification by screening and cloning. An optimized ELISA kit using these components demonstrated good specificity, accuracy, reproducibility and stability, with a linear range of 10-100 ng/mL. This approach extends the patient coverage in China to over 95%, providing a valuable diagnostic tool. This work demonstrates a proof-of-concept model for developing broad-coverage assays for other multi-genotype viral diseases.

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BibTeX
@article{li2026dual,
  title = {{A dual recombinant strategy to quantify PreS1 antibody in hepatitis B patients with genotype B or C virus by ELISA}},
  author = {Yumin Li and Xiaoyu Wen and Jing Zhan and Tingting Cao and Xiumei Chi and Huanyi Cheng and Qingrui Huang and Wenyi Zhang and Junqi Niu and Huan Du and Zhenning Liu},
  journal = {iScience},
  year = {2026},
  month = oct,
  doi = {10.1016/j.isci.2026.117857},
  url = {https://www.cell.com/iscience/fulltext/S2589-0042(26)03238-4},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - A dual recombinant strategy to quantify PreS1 antibody in hepatitis B patients with genotype B or C virus by ELISA
AU  - Yumin Li
AU  - Xiaoyu Wen
AU  - Jing Zhan
AU  - Tingting Cao
AU  - Xiumei Chi
AU  - Huanyi Cheng
AU  - Qingrui Huang
AU  - Wenyi Zhang
AU  - Junqi Niu
AU  - Huan Du
AU  - Zhenning Liu
PY  - 2026
DA  - 2026/10/13
JO  - iScience
DO  - 10.1016/j.isci.2026.117857
UR  - https://www.cell.com/iscience/fulltext/S2589-0042(26)03238-4
AB  - Elevated levels of anti-preS1 antibodies in patients correlate with faster hepatitis B virus (HBV) clearance, since preS1 is vital for viral entry. However, accurate quantification of preS1 antibodies is hindered by the variation of HBV genotypes. Herein, a quantitative preS1 antibody assay was developed for Chinese patients with predominant HBV genotypes B and C. First, to address genotype diversity, we constructed a dual recombinant protein combining genotype B and C preS1. Second, a mouse-human chimeric antibody with high and comparable affinity for both B and C preS1 is developed as the standard for quantification by screening and cloning. An optimized ELISA kit using these components demonstrated good specificity, accuracy, reproducibility and stability, with a linear range of 10-100 ng/mL. This approach extends the patient coverage in China to over 95%, providing a valuable diagnostic tool. This work demonstrates a proof-of-concept model for developing broad-coverage assays for other multi-genotype viral diseases.
SN  - 2589-0042
ER  -