Significance of specific antibody assay for genotyping of hepatitis C virus

Tanaka, Takeshi; Tsukiyama-Kohara, Kyoko; Yamaguchi, K; Yagi, Shusuke; Tanaka, Satoshi; Hasegawa, Akira; Ohta, Yoshikazu; Hattori, Nobu; Kohara, Michinori

doi:10.1002/hep.1840190605

Cited by 192 publications

(86 citation statements)

References 27 publications

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“…have been very rare (Tanaka et al 1994;Mizoguchi et al 1996). However, in this study, at least 1.8% (3/166) of serotype 1 patients were infected with HCV of genotype 2 without specific amino acid mutations in the NS4 region.…”

Section: Discussionmentioning

confidence: 52%

“…Because the HCV serotype test is approved by the Japanese public health insurance but the HCV genotype test is not, only the serotype is checked in most patients with HCV infection in Japan. This was based on previous reports showing that the results of serotype and genotype agreed well (Tanaka et al 1994;Mizoguchi et al 1996) and the cost of the serotype test is lower.…”

Section: Introductionmentioning

confidence: 82%

“…Because HCV genotyping has not been approved by the public insurance in Japan, serotyping is commonly used. The serotyping method detects antibodies against type-specific recombinant proteins in the NS4 region by ELISA (Tanaka et al 1994 Table 3. Clinical characteristics of the four patients with serotype 1 HCV whose DS tests to detect NS5A RAVs for genotype 1b HCV failed.…”

Section: Discussionmentioning

confidence: 99%

“…This study was approved by the institutional ethics committees in Tohoku University Hospital and the associated hospitals. HCV serotype (Tanaka et al 1994) and genotype (Okamoto et al 1996;Ohno et al 1997) were determined as described previously. The NS5A RAVs were tested with a commercial-based DS method targeting genotype 1b HCV (El-Shamy et al 2008;Suzuki et al 2012;Kudoh et al 2015) or a commercial-based PCR-invader method (Tadokoro et al 2014).…”

Section: Patientsmentioning

confidence: 99%

“…In the enzyme-linked immunosorbent assay (ELISA) for serotyping, a group 1-specific peptide C14-1 and a group 2-specific peptide C14-2 (amino acids 1676-1760) were used (Tanaka et al 1994), but there were no specific amino acid mutations or recombination in the region (Fig. 4B).…”

Section: Virological Analysis Of the Serotype 1 Patients Whose Ds Tesmentioning

confidence: 99%

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Identification of Genotype 2 HCV in Serotype-1 Hepatitis C Patients Unresponsive to Daclatasvir plus Asunaprevir Treatment

Inoue

Kanno

Wakui

et al. 2017

Tohoku J. Exp. Med.

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It is important to determine the genotypes or serotypes of hepatitis C virus (HCV) in patients before treatment with direct-acting antiviral agents (DAAs), because the effects of DAAs differ among genotypes. In Japan, two tests for HCV typing are available clinically, but only serotyping, not genotyping, is approved by the public health insurance. Although most serotype-1 Japanese patients are infected with genotype 1b HCV, it is known that a small proportion of patients show different results from two typing methods. This study focused on such patients and the effectiveness of treatment with daclatasvir plus asunaprevir (DCV/ ASV) was evaluated. We analyzed 644 DCV/ASV-treated patients with serotype 1 or genotype 1b, and among them, 166 serotype-1 patients received a commercial-based direct sequencing (DS) test for resistant-associated variants of genotype 1b HCV. We found four patients (2.4%) with DS test failure, suggesting that the PCR primers targeting genotype 1b may not match. Importantly, none of the four patients achieved a sustained virological response. Our in-house DS test analyzing the 5′-untranslated region and coding regions for NS4 and NS5B of HCV showed that three of the four patients were infected with genotype 2 HCV, and one patient was infected with genotype 1a HCV. No recombinant virus of different genotypes was found. This study indicates that a subset of serotype-1 hepatitis C patients is infected with HCV of genotype 2 or 1a in Japan and that DCV/ASV is not effective for such patients. Thus, attention should be paid to DAA treatment without HCV genotyping.

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Section: Discussionmentioning

confidence: 52%

Section: Introductionmentioning

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Patientsmentioning

confidence: 99%

Section: Virological Analysis Of the Serotype 1 Patients Whose Ds Tesmentioning

confidence: 99%

See 3 more Smart Citations

Identification of Genotype 2 HCV in Serotype-1 Hepatitis C Patients Unresponsive to Daclatasvir plus Asunaprevir Treatment

Inoue

Kanno

Wakui

et al. 2017

Tohoku J. Exp. Med.

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Detection and clinical features of hepatitis C virus type 6 infections in blood donors from Hong Kong

Prescott

Simmonds

Lai³

et al. 1996

J. Med. Virol.

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The genotype distribution of hepatitis C virus (HCV) was investigated in 212 viraemic blood donors from Hong Kong. A subset of the samples was investigated using three different genotyping assays to establish the accuracy of each in this population. These assays were restriction fragment length polymorphism (RFLP) of amplified 5' noncoding region (5'NCR) sequences, RFLP of the core region, and a serotyping assay using peptides from two antigenic regions of NS4. Genotypes detected in Hong Kong blood donors were 1a (6.2%), 1b (58.8%), 2a (1.4%), 2b (1.4%), 3a (1.9%), and 6a (27.0%). All genotyping assays produced concordant results. No evidence was obtained for the presence of type 6 group variants recently identified in Southeast Asia, other than type 6a. A serotyping assay based upon the detection of type-specific antibody to epitopes in NS4 produced similar results to the genotyping assays (98% concordance), but a reduced sensitivity (75%) compared with genotyping methods. Sequence variation in NS4 was not the cause of the reduced rate of detection of type 6 antibody in this population. Eighty-four percent donors infected with type 6a were male, compared to 75% donors infected with type 1b. The median alanine transaminase (ALT) level in type 6 infected donors was lower than in type 1b, (43.8 and 51.1 U/l, respectively) although these values were not statistically significant (P = 0.094). There was no significant difference between the ages of donors infected with types 1b and 6a. Risk factors for HCV infection in the blood donors included blood transfusion, intravenous drug abuse, and tattooing. A significantly greater number of donors infected with HCV-6a reported a history of drug abuse (66%) than donors infected with HCV-1b (7%).

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Serotyping and genotyping of hepatitis C virus (HCV) strains in chronic HCV infection

et al. 1997

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Hepatitis C virus (HCV) genotypes can be established by methods based on PCR typing and serological typing. The accuracy of these methods depends on their sensitivity and specificity. These should be compared with the reference method, direct sequencing, and analysis of viral genomes. Among the serologic methods recently developed, the performance of a new serotyping assay (RIBA HCV 3.0 SIA, Chiron corporation, Emeryville) was assessed using a panel of 147 well-characterized French isolates from chronic hepatitis C patients. Definitive genotypes of the isolates were established by direct sequencing in 5' NC and in some cases in NS-5B. HCV serotypes 1, 2, and 3 were determined by measuring type specific antibodies to core and NS-4 derived peptide antigens. Of the 147 sera, serotypic-specific antibodies were detected in 136 (sensitivity, 92.5%). The specificity of the RIBA SIA HCV serotyping assay was 92.6% (including samples with mixed results); without these, the specificity was 80.1%. Analysis of the 28 discrepant samples showed that (1) a different serotype was found in 18 samples including five for genotype 1, three for genotype 2, two for genotype 3, five for genotype 4, and three for genotype 5, and that (2) ten patients showed a reactivity with mixed serotypes, one had circulating antibodies to type 1 or 2, and nine had circulating antibodies to type 1 or 3. In summary, except for genotypes 4 and 5, the results of the test were well correlated (85.7%) with those of direct sequence genotyping. The former test is rapid and does not require the strict HCV RNA storage and preservation conditions of the latter. This new method may thus be considered as an alternative for HCV typing. However, although it is convenient, its lower sensitivity compared to the molecular typing method and the discrepant results limit its routine use in a clinical context.

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Significance of specific antibody assay for genotyping of hepatitis C virus

Cited by 192 publications

References 27 publications

Identification of Genotype 2 HCV in Serotype-1 Hepatitis C Patients Unresponsive to Daclatasvir plus Asunaprevir Treatment

Identification of Genotype 2 HCV in Serotype-1 Hepatitis C Patients Unresponsive to Daclatasvir plus Asunaprevir Treatment

Detection and clinical features of hepatitis C virus type 6 infections in blood donors from Hong Kong

Serotyping and genotyping of hepatitis C virus (HCV) strains in chronic HCV infection

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