Abstract
BackgroundA treatment of HCV infection depends on the genotype and sub-genotype. Therefore, accurate HCV genotyping is critical for selecting the appropriate treatment regimen.MethodThis study included 280 plasma samples to evaluate the performance of 6 HCV Genotyping 9G test. The performance of 6 HCV Genotyping 9G test for accurate detection of HCV 1a, 1b, 2, 3, 4, and 6 genotypes was evaluated by comparing it with LiPA 2.0 assay and sequencing.Results6 HCV Genotyping 9G test and LiPA 2.0 assay demonstrated 83.9% (n = 235) agreement. 39/45 samples that showed discrepant results between the two tests were analyzed by sequencing. Sequencing genotyped 39 discrepant samples as 0 (HCV 1a), 24 (HCV 1b), 1 (HCV 6f), 12 (HCV 6i), and 2 (HCV-negative). Results of 6 HCV Genotyping 9G test were very similar to the sequencing as it detected 1, 23, 1, 12, and 2 samples as HCV 1a, 1b, 3 & 6a or 6f, 6i or 6n, and negative, respectively. However, LiPA 2.0 assay showed complete disagreement with sequencing, as it did not detect any of these 39 samples correctly. These results indicate that LiPA 2.0 assay has limitations in identifying HCV genotypes 1b, and 6. The sensitivity, specificity, PPV, and NPV of 6 HCV Genotyping 9G test were 99.5, 98.8, 99.5, and 98.8%, respectively. It is important to note that HCV Genotyping 9G test showed 98.3 and 100% sensitivity for HCV 1b and 6 genotyping, respectively. However, LiPA 2.0 assay demonstrated 57.9 and 71.7% sensitivity for these genotypes.Conclusions6 HCV Genotyping 9G test identifies HCV 1a, 1b, 2, 3, and 6 with good agreement with sequencing. Hence, 6 HCV Genotyping 9G test has a high clinical value because it can provide critical information to physicians and assist them to use the correct drug for efficient hepatitis C treatment.
Highlights
A treatment of hepatitis C virus (HCV) infection depends on the genotype and sub-genotype
Results of 6 HCV Genotyping 9G test were very similar to the sequencing as it detected 1, 23, 1, 12, and 2 samples as HCV 1a, 1b, 3 & 6a or 6f, 6i or 6n, and negative, respectively
These results indicate that LiPA 2.0 assay has limitations in identifying HCV genotypes 1b, and 6
Summary
A treatment of HCV infection depends on the genotype and sub-genotype. Infection of hepatitis C virus (HCV) results in Hepatitis C, a liver disease. Approximately 700,000 out of 150 million people with chronic HCV infection succumb each year to the hepatitis C-related liver diseases such as cirrhosis, hepatocellular carcinoma, and liver failure [1, 2]. Varieties in genotypes and subtypes of HCV complicated the treatment of HCV infection. The mortality attributable to HCV infection continues to increase [3]. There are 7 HCV genotypes and more than 90 subtypes with diverse patterns of geographic distribution. Identification of the HCV genotype and sub-genotype is crucial for a proper antiviral treatment and cure of HCV-infected individuals [2, 6]
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