An adaptable platform for in-house hepatitis C serology

Serology-based diagnosis remains one of the major tools for diagnosis and surveillance of infectious diseases. However, for many neglected diseases no or only few commercial assays are available and often with prices prohibiting large scale testing in low and middle-income countries (LMICs). We deve...

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Bibliographic Details
Published in:Journal of virological methods 2022-10, Vol.308, p.114586-114586, Article 114586
Main Authors: Pedersen, Jannie, Moukandja, Irène Pegha, Ndidi, Stella, Sørensen, Anna-Louise, Koumakpayi, Ismaël Hervé, Lekana-Douki, Jean-Bernard, Vachon, Marie-Louise, Weis, Nina, Kobinger, Gary, Fausther-Bovendo, Hugues
Format: Article
Language:English
Subjects:
ELISA
Hepatitis C virus
Maltose binding protein
Non-specific binding
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Summary:Serology-based diagnosis remains one of the major tools for diagnosis and surveillance of infectious diseases. However, for many neglected diseases no or only few commercial assays are available and often with prices prohibiting large scale testing in low and middle-income countries (LMICs). We developed an adaptable enzyme-linked immunoassay (ELISA) using hepatitis C virus (HCV) as a proof-of-concept application. By combining the maltose-binding-protein with a multiepitope HCV protein, we were able to obtain a high concentration of protein suitable for downstream applications. Following optimization, the assay was verified using previously tested human samples from Canada, Denmark and Gabon in parallel with the use of a commercial protein. Sensitivity and specificity were calculated to 98 % and 97 % respectively, after accounting for non-specific binding and assay optimization. This study provides a thorough description of the development, and validation of a multiepitope ELISA-based diagnostic assay against HCV, which could be implemented at low cost. The described methodology can be readily adapted to develop novel ELISA-based diagnostic assays for other infectious pathogens with well-described immunogenic epitopes. This method could improve the diagnosis of neglected diseases for which affordable diagnostic assays are lacking. •Serology-based assays is a major tool for diagnosis of infectious diseases.•Maltose-binding-protein with a multiepitope hepatitis C virus protein.•Enzyme-linked immunoassay (ELISA) with sensitivity 98 % and specificity 97 %.•Evaluation of methods for assay optimization.•Assay adaptable to other pathogens with well-described immunogenic epitopes.
ISSN:0166-0934
1879-0984
DOI:10.1016/j.jviromet.2022.114586