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Enzyme-linked immunosorbent assay to detect hepatitis C virus serological groups 1 to 6
M Kobayashi1, K Chayama, Y Arase
1Department of Liver Research Laboratory, Toranomon Hospital, Kawasaki, Japan.
Insights
The Murex HCV serotyping assay shows promise for identifying hepatitis C virus genotypes beyond conventional methods. This enzyme-linked immunosorbent assay (ELISA) offers improved serotyping for various HCV genotypes, aiding in diagnosis.
Area of Science:
- Virology
- Immunology
- Diagnostic Assays
Background:
- Conventional serological grouping methods for hepatitis C virus (HCV) are limited to specific genotypes (1a, 1b, 2a, 2b).
- Accurate HCV genotyping is crucial for effective treatment and management.
- There is a need for reliable serotyping assays that cover a broader range of HCV genotypes.
Purpose of the Study:
- To evaluate the performance of the Murex HCV serotyping 1 to 6 assay for serologically grouping various HCV genotypes.
- To determine the sensitivity, specificity, and concordance of the Murex assay across different HCV genotypes (1a, 1b, 2a, 2b, 3a, 3b).
Main Methods:
- The study utilized the Murex HCV serotyping 1 to 6 assay, an enzyme-linked immunosorbent assay (ELISA).
- The assay employs genotype-specific peptides from the NS4 region of the hepatitis C virus.
- 365 patients infected with HCV genotypes 1a, 1b, 2a, 2b, 3a, or 3b were included in the study.
Main Results:
- The Murex assay demonstrated high overall sensitivity (78.4%) and specificity (98.6%).
- Sensitivity varied by genotype, ranging from 50.0% (3a) to 100% (1a).
- Overall concordance was 77.5%, with genotype-specific concordance rates also reported.
Conclusions:
- The Murex HCV serotyping 1 to 6 assay is a valuable tool for identifying hepatitis C virus genotypes, particularly when conventional methods are insufficient.
- This assay can aid in serotyping when genotypes other than 1a, 1b, 2a, or 2b are suspected or when results from other assays are indeterminate.
- The assay's performance suggests its utility in diverse ethnic groups and clinical settings requiring broader HCV genotype identification.
Abstract:
By conventional serological grouping methods, it is possible to determine hepatitis C virus (HCV) serological groups for genotypes 1a, and 1b, and genotypes 2a, and 2b, but not for other genotypes, i.e., 3a, 3b, 4a, 5a, and 6a. In this study, we attempted to serologically group HCV with the Murex HCV serotyping 1 to 6 assay (Murex Diagnostics, Kent, UK), using an enzyme-linked immunosorbent assay (ELISA) based on genotype-specific peptides from the NS4 region. The subjects of this study were 365 patients infected with HCV of genotype 1a, 1b, 2a, 2b, 3a, or 3b. The sensitivity of the assay was 100% in patients with genotype 1a, 82.7% in those with 1b, 68.5% in those with 2a, 84.2% in those with 2b, 50.0% in those with 3a, and 76.5% in those with genotype 3b. The overall sensitivity was 78.4%. The specificity of the assay was 100% in the subjects with genotype 1a, 98.8% in those with 1b, 98.4% in those with 2a, 96.9% in those with 2b, 100% in those with 3a, and 100% in those with genotype 3b. The overall specificity was 98.6%. The concordance of the assay was 100% in subjects with genotype la, 81.7% in those with 1b, 67.4% in those with 2a, 81.6% in those with 2b, 50.0% in those with 3a, and 76.5% in those with genotype 3b. The overall concordance was 77.5%. We believe it would be better to serotype with the Murex HCV serotyping 1 to 6 assay, if other than serological group (Gr) 1 or Gr 2 is suspected in particular ethnic groups or in subjects with an indeterminate result with the Immucheck HCV Gr assay (Kokusai, Kobe, Japan), assuming that the genotype must be other than 1a, 1b, 2a, or 2b.