A monoclonal antibody-based VZV glycoprotein E quantitative assay and its application on antigen quantitation in VZV vaccine
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| 024 | 7 | 0 | |a 10.1007/s00253-015-6602-5 |2 doi |
| 035 | |a (NATIONALLICENCE)springer-10.1007/s00253-015-6602-5 | ||
| 245 | 0 | 2 | |a A monoclonal antibody-based VZV glycoprotein E quantitative assay and its application on antigen quantitation in VZV vaccine |h [Elektronische Daten] |c [Jian Liu, Rui Zhu, Xiangzhong Ye, Lianwei Yang, Yongmei Wang, Yanying Huang, Jun Wu, Wei Wang, Jianghui Ye, Yimin Li, Qinjian Zhao, Hua Zhu, Tong Cheng, Ningshao Xia] |
| 520 | 3 | |a Varicella-zoster virus (VZV) is a highly infectious agent that causes varicella and herpes zoster (HZ), which may be associated with severe neuralgia. Vaccination is the most effective way to reduce the burden of the diseases. VZV glycoprotein E (gE) is the major and most immunogenic membrane protein that plays important roles in vaccine efficacy. A quantitative assay for gE content is desirable for the VZV vaccine process monitoring and product analysis. In this study, 70 monoclonal antibodies (mAbs) were obtained after immunizing mice with purified recombinant gE (rgE). The collection of mAbs was well-characterized, and a pair of high-affinity neutralization antibodies (capture mAb 4A2 and detection mAb 4H10) was selected to establish a specific and sensitive sandwich enzyme-linked immunosorbent assay (ELISA) to quantify the native and recombinant gE. The detection limit of this assay was found to be 1.95ng/mL. Furthermore, a reasonably good correlation between the gE content (as measured by the mAb-based quantitative ELISA) and the virus titer (as measured by the "gold standard” plaque assay) was observed when both assays were performed for tracking the kinetics of virus growth during cell culture. A total of 16 batches of lyophilized VZV vaccine were tested using the newly developed quantitative ELISA and classical plaque assay, demonstrating reasonably good correlation between gE content and virus titer. Therefore, this mAb-based gE quantitative assay serves as a rapid, stable, and sensitive method for monitoring viral antigen content, one additional quantitative method for VZV vaccine process and product characterization. This quantitative ELISA may also serve as a complementary method for virus titering. | |
| 540 | |a Springer-Verlag Berlin Heidelberg, 2015 | ||
| 690 | 7 | |a Varicella-zoster virus (VZV) |2 nationallicence | |
| 690 | 7 | |a VZV vaccine |2 nationallicence | |
| 690 | 7 | |a Glycoprotein E |2 nationallicence | |
| 690 | 7 | |a Sandwich ELISA |2 nationallicence | |
| 690 | 7 | |a Virus titer |2 nationallicence | |
| 700 | 1 | |a Liu |D Jian |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Zhu |D Rui |u National Institute of Diagnostics and Vaccine Development in infectious diseases, School of Public Health, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Ye |D Xiangzhong |u Beijing Wantai Biological Pharmacy Enterprise, 102206, Beijing, China |4 aut | |
| 700 | 1 | |a Yang |D Lianwei |u Beijing Wantai Biological Pharmacy Enterprise, 102206, Beijing, China |4 aut | |
| 700 | 1 | |a Wang |D Yongmei |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Huang |D Yanying |u National Institute of Diagnostics and Vaccine Development in infectious diseases, School of Public Health, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Wu |D Jun |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Wang |D Wei |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Ye |D Jianghui |u National Institute of Diagnostics and Vaccine Development in infectious diseases, School of Public Health, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Li |D Yimin |u Beijing Wantai Biological Pharmacy Enterprise, 102206, Beijing, China |4 aut | |
| 700 | 1 | |a Zhao |D Qinjian |u National Institute of Diagnostics and Vaccine Development in infectious diseases, School of Public Health, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Zhu |D Hua |u Department of Microbiology and Molecular Genetics, New Jersey Medical School, Rutgers University, 225 Warren Street, 070101, Newark, NJ, USA |4 aut | |
| 700 | 1 | |a Cheng |D Tong |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | |
| 700 | 1 | |a Xia |D Ningshao |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | |
| 773 | 0 | |t Applied Microbiology and Biotechnology |d Springer Berlin Heidelberg |g 99/11(2015-06-01), 4845-4853 |x 0175-7598 |q 99:11<4845 |1 2015 |2 99 |o 253 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s00253-015-6602-5 |q text/html |z Onlinezugriff via DOI |
| 898 | |a BK010053 |b XK010053 |c XK010000 | ||
| 900 | 7 | |a Metadata rights reserved |b Springer special CC-BY-NC licence |2 nationallicence | |
| 908 | |D 1 |a research-article |2 jats | ||
| 949 | |B NATIONALLICENCE |F NATIONALLICENCE |b NL-springer | ||
| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s00253-015-6602-5 |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Liu |D Jian |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Zhu |D Rui |u National Institute of Diagnostics and Vaccine Development in infectious diseases, School of Public Health, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ye |D Xiangzhong |u Beijing Wantai Biological Pharmacy Enterprise, 102206, Beijing, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Yang |D Lianwei |u Beijing Wantai Biological Pharmacy Enterprise, 102206, Beijing, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Wang |D Yongmei |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Huang |D Yanying |u National Institute of Diagnostics and Vaccine Development in infectious diseases, School of Public Health, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Wu |D Jun |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Wang |D Wei |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ye |D Jianghui |u National Institute of Diagnostics and Vaccine Development in infectious diseases, School of Public Health, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Li |D Yimin |u Beijing Wantai Biological Pharmacy Enterprise, 102206, Beijing, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Zhao |D Qinjian |u National Institute of Diagnostics and Vaccine Development in infectious diseases, School of Public Health, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Zhu |D Hua |u Department of Microbiology and Molecular Genetics, New Jersey Medical School, Rutgers University, 225 Warren Street, 070101, Newark, NJ, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Cheng |D Tong |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Xia |D Ningshao |u State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, 361102, Xiamen, China |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t Applied Microbiology and Biotechnology |d Springer Berlin Heidelberg |g 99/11(2015-06-01), 4845-4853 |x 0175-7598 |q 99:11<4845 |1 2015 |2 99 |o 253 | ||