Key result
The Abbott HCV RealTime Genotype Plus RUO assay successfully genotyped 93.7% of genotype 1 samples without subtype and 62.2% of indeterminate samples, showing 84.7% and 65.2% concordance with sequencing, respectively.
Why the study?
Challenges existed in identifying subtypes of HCV genotype-1 and indeterminate genotypes, prompting evaluation of the Abbott HCV RealTime Genotype Plus RUO assay against 5' UTR sequencing.
Does the Abbott HCV RealTime Genotype Plus RUO assay improve the detection and characterization of HCV genotypes in patients with genotype 1 without subtype or indeterminate genotype?
Observational (n=100)
Yes
Does the Abbott HCV RealTime Genotype Plus RUO assay improve the detection and characterization of HCV genotypes in patients with genotype 1 without subtype or indeterminate genotype?
The Abbott RealTime HCV GT Plus RUO assay provides improved diagnostic performance in characterizing HCV genotypes, particularly for resolving genotype 1 without subtype and indeterminate results from the standard assay.
Answers are grounded in this paper and cite their sources.
May aid lab resolution of indeterminate HCV genotypes; leaves open prospective validation before practice change.
BACKGROUND AND AIMS: Hepatitis C virus (HCV) genotyping is a pivotal tool for epidemiological investigation, guiding management and antiviral treatment. Challenge existed in identifying subtypes of genotype-1 (G-1) and genotype (GT) of indeterminate. Recently, the Abbott HCV RealTime Genotype Plus RUO assay (HCV GT Plus) has been developed aiming to overcome the limitations. We aimed to evaluate the performance of the assay compared with 5' UTR sequencing in clinical samples. MATERIALS AND METHODS: Eligible individuals were treatment chronic hepatitis C patients that were enrolled consecutively in a medical center and two core regional hospitals in southern Taiwan from Oct 2017 through Aug 2018. The patient with genotype 1 without subtype and indeterminate previously genotyped by Abbott RealTime HCV GT II will further determinate by Abbott HCV RealTime HCV GT Plus. All of the genotype results were validated by 5' UTR sequencing as a reference standard. RESULTS: A total of 100 viremic CHC patients were recruited, including 63 G-1 patients (male: 28), and 37 patients (male: 15) of indeterminate genotyped by Abbott RealTime HCV GT II assay (HCV GT II), respectively. The detection rate of 63 GT1 samples without subtype were 93.7% (59/63), 37 indeterminate samples without genotype were 62.2 (23/37) by HCV GT Plus. 5' UTR sequencing confirmed HCV GT Plus characterized results for 84.7% (50/59) of type1, with 100% (4/4), 82.8 (24/29) and 84.6% (22/26) for 1a, 1b and type6; 65.2% (15/23) of indeterminate with 100% (3/3) and 60% (12/20) for 1b and type 6 samples, respectively. CONCLUSIONS: The Abbott RealTime HCV GT Plus RUO assay provides additional performance in GT detection.
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Huang et al. (2021) conducted an observational in Chronic hepatitis C (n=100). Abbott HCV RealTime Genotype Plus RUO assay vs. 5' UTR sequencing was evaluated on Concordance rate with 5' UTR sequencing for genotype 1 samples. The Abbott HCV RealTime Genotype Plus RUO assay successfully genotyped 93.7% of genotype 1 samples without subtype and 62.2% of indeterminate samples, showing 84.7% and 65.2% concordance with sequencing, respectively.
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