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Development of new IL28B genotyping method using Invader Plus assay.

Satomi Kani¹, Yasuhito Tanaka, Kentaro Matsuura

¹Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Japan.

Microbiology and Immunology

|April 28, 2012

Summary

The Invader Plus assay accurately genotypes IL28B single nucleotide polymorphisms (SNPs) for predicting chronic hepatitis C treatment response. This convenient method aids clinicians in determining patient outcomes with pegylated interferon-alpha/ribavirin therapy.

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Area of Science:

Genetics and Genomics
Hepatology
Clinical Diagnostics

Background:

Interleukin-28B (IL28B) single nucleotide polymorphisms (SNPs) significantly influence treatment response in chronic hepatitis C patients receiving pegylated interferon-alpha with ribavirin (PEG-IFN-α/RBV).
Accurate and reliable genotyping of IL28B SNPs is crucial for predicting treatment efficacy and optimizing patient management.

Purpose of the Study:

To evaluate the Invader Plus assay as a clinical tool for genotyping IL28B SNPs (rs8099917 and rs12979860).
To assess the assay's accuracy, precision, and limit of detection for potential use in clinical practice.

Main Methods:

The Invader Plus assay was compared against direct sequencing and TaqMan assays for genotyping IL28B SNPs in 512 Japanese chronic hepatitis C patients.
Accuracy, intra-assay and inter-assay precision, and the limit of detection were determined for the Invader Plus assay.

Main Results:

The Invader Plus assay demonstrated high accuracy (99% for rs8099917, 100% for rs12979860) compared to direct sequencing.
The assay exhibited sufficient intra-assay and inter-assay precision for clinical use, with a detection limit of 1ng DNA/assay.
Genotyping revealed specific distributions of IL28B SNP types, with higher response rates in major homozygous types and non-response rates in minor heterozygous/homozygous types for HCV genotype 1 patients.

Conclusions:

The Invader Plus assay is an accurate and precise method for IL28B genotyping in clinical settings.
This convenient genotyping assay can assist in predicting treatment outcomes for chronic hepatitis C patients, potentially guiding therapeutic decisions.