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Development of a Lateral Flow Assay for the Detection of the Hepatitis C Virus Core Antigen
Erick Joan Vidal-Alcántara1, Sonia Hernández Antón2, Paloma Rueda2
1Unidad de Infección Viral e Inmunidad, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, 28220 Madrid, Spain.
Insights
A new lateral flow assay detects hepatitis C core antigen (HCVcAg), offering a rapid and cost-effective screening tool. This assay enhances accessibility for hepatitis C virus (HCV) testing, particularly in resource-limited settings.
Area of Science:
- Virology
- Immunology
- Biotechnology
Background:
- Hepatitis C virus (HCV) infection is a significant global health concern.
- Current diagnostic methods for HCV are complex, expensive, and have limited accessibility.
Purpose of the Study:
- To develop a lateral flow immunochromatography assay for detecting hepatitis C core antigen (HCVcAg).
- To create a rapid, cost-effective, and user-friendly diagnostic tool for HCV screening.
Main Methods:
- Utilized a double antibody sandwich format with four specific monoclonal antibodies.
- Evaluated latex and colloidal gold as detector nanoparticles.
- Tested recombinant HCVcAg from five genotypes and assessed matrix effects in serum samples.
Main Results:
- Identified optimal antibody pairs through evaluation of 32 combinations.
- Developed the LN17 assay with a target sensitivity of 10 ng/strip.
- Gained insights into matrix effects for improved clinical application.
Conclusions:
- The developed assay shows potential for rapid and cost-effective HCV screening.
- The assay can improve accessibility to hepatitis C testing in high-risk populations and resource-limited areas.
Background:
Hepatitis C virus (HCV) infection remains a global health challenge, with millions of people affected annually. Current diagnostic methods, reliant on antibody screening and viral RNA detection, are complex, costly, and often inaccessible, particularly in resource-limited settings.
Aim:
Development of a lateral flow immunochromatography-based assay for detecting the highly conserved hepatitis C core antigen (HCVcAg).
Methods:
The assay relies on the interaction of four highly specific and cross-reactive monoclonal antibodies with recombinant HCVcAg from five different genotypes in a double antibody sandwich format. Latex and colloidal gold were evaluated as detector nanoparticles.
Results:
Extensive evaluation of 32 antibody combinations led to identifying the most sensitive antibody pairs. The chosen assay, named LN17, demonstrated a target sensitivity of 10 ng/strip, with potential clinical implications for detecting HCV. Furthermore, the study examined matrix effects in serum samples, providing valuable insights for future clinical application.
Conclusions:
The developed assay holds promise as a rapid, cost-effective, and user-friendly tool to enhance accessibility to hepatitis C screening, especially in high-risk populations and resource-limited environments.
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