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Development of a sensitive enzyme-linked immunosorbent assay for detection of hepatitis B surface antigen using novel monoclonal antibodies

Yazdani, Y. and Roohi, A. and Khoshnoodi, J. and Shokri, F. (2010) Development of a sensitive enzyme-linked immunosorbent assay for detection of hepatitis B surface antigen using novel monoclonal antibodies. Avicenna Journal of Medical Biotechnology, 2 (4). pp. 207-214. ISSN 20082835 (ISSN)

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Abstract

Hepatitis B virus (HBV) infection is the 10th leading cause of death worldwide. The most important diagnostic and screening marker for HBV infection is Hepatitis B surface antigen (HBsAg), and the most widely used HBsAg screening test is Enzyme-linked Immunosorbent Assay (ELISA). In this study, an ELISA assay has been developed for detection of HBsAg using two novel monoclonal antibodies (mAb) as capture layer and a polyclonal biotinylated Ab as detector phase. We evaluated the sensitivity, specificity, detection limit, seroconversion time, positive and negative predictive values and reproducibility of our assay with standard panels and different serum samples. The results were compared with a well established commercial kit. Both assays showed similar detection limit values of 0.5 to 0.7 ng/ml and the same seroconversion periods of 42 and 65 days for "ad" and "ay" serotypes of HBsAg, respectively. Sensitivity and specificity of the assay were 98.98% and 99.6%, respectively. The positive and negative predictive values of our assay were also calculated as 99.49% and 99.2%, respectively. Analysis of reproducibility of the present assay demonstrated 3.96% and 5.85% intra-and inter-assay coefficient of variations, respectively, which were less than those obtained by the commercial kit. There was a highly significant correlation between our designed assay and the commercial ELISA kit (p < 0.0001, r = 0.957). Altogether, our results indicate that the designed assay is comparable to the commercial kit in terms of sensitivity, specificity, positive and negative predictive values and reproducibility and could be employed for diagnosis of HBV infection in blood samples. © 2010, Avicenna Journal of Medical Biotechnology. All rights reserved.

Item Type: Article
Additional Information: Unmapped bibliographic data: LA - English [Field not mapped to EPrints] J2 - Avicenna J. Med. Biotechnol. [Field not mapped to EPrints] AD - Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran [Field not mapped to EPrints] AD - Department of Molecular Medicine, Faculty of Advanced Medical Science Technologies, Golestan University of Medical Sciences, Gorgan, Iran [Field not mapped to EPrints] AD - Monoclonal Antibody Research Center, Avicenna Research Institute, ACECR, Tehran, Iran [Field not mapped to EPrints] DB - Scopus [Field not mapped to EPrints]
Uncontrolled Keywords: ELISA, Hepatitis B, Hepatitis B surface antigens, Monoclonal antibody, hepatitis B surface antigen, monoclonal antibody, monoclonal antibody 31D4 H12, monoclonal antibody 33D7 S4, monoclonal antibody 34D7 S3, monoclonal antibody 35C6 S11, monoclonal antibody 35G9 S15A, monoclonal antibody 37C5 S7, monoclonal antibody 38F3 S6, monoclonal antibody 40B9 S13, monoclonal antibody 48A4 H14, monoclonal antibody NE3, monoclonal antibody NE5, polyclonal antibody, unclassified drug, antibody detection, article, blood sampling, controlled study, diagnostic kit, diagnostic test accuracy study, enzyme linked immunosorbent assay, hepatitis B, human, intermethod comparison, predictive value, reproducibility, sensitivity and specificity, seroconversion, serotype, Hepatitis B virus
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 15 Apr 2015 09:20
Last Modified: 20 Jun 2015 08:48
URI: http://eprints.goums.ac.ir/id/eprint/2183

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