Detection of hepatitis C virus core antigen for early diagnosis of hepatitis C virus infection in plasma donor in China

Zhang, He-Qiu; Li, Shaobo; Wang, Guohua; Chen, Kun; Song, Xi; Xia, Feng

doi:10.3748/wjg.v13.i19.2738

Cited by 13 publications

(14 citation statements)

References 26 publications

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“…Additionally, two studies performed convenience sampling (30, 31) and it was unclear in both studies whether the index test and reference tests were performed on the same sample or within 30 days from the same participant and whether the index test was performed in accordance with manufacturer recommendations. For the Hunan Jynda test, patient selection was unclear in one study (26), timing of index test and reference test was unclear in one study (27), and one study enrolled only healthy blood donors (36). For the Lumispot test, both studies had unclear participant selection (37, 38).…”

Section: Resultsmentioning

confidence: 99%

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Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

Freiman¹,

Tran²,

Schumacher³

et al. 2016

Ann Intern Med

161

148

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Background Diagnosis of chronic Hepatitis C Virus (HCV) infection requires both a positive HCV antibody screen and confirmatory nucleic acid test (NAT). HCV core antigen (HCVcAg) is a potential alternative to NAT. Purpose This systematic review evaluated the accuracy of diagnosis of active HCV infection among adults and children for five HCVcAg tests compared to NAT. Data Sources EMBASE, PubMed, Web of Science, Scopus, and Cochrane from 1990 through March 31, 2016. Study Selection Cohort, cross-sectional, and randomized controlled trials were included without language restriction Data Extraction Two independent reviewers extracted data and assessed quality using an adapted Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Data Synthesis 44 studies evaluated 5 index tests. Studies for the ARCHITECT had the highest quality, while those for Ortho ELISA were the lowest. From bivariate analyses, the sensitivity and specificity with 95% CI were: ARCHITECT 93.4% (90.1, 96.4) and 98.8% (97.4, 99.5), Ortho ELISA 93.2% (81.6, 97.7) and 99.2% (87.9, 100), and Hunan Jynda 59.5% (46.0, 71.7) and 82.9% (58.6, 94.3). Insufficient data were available for a meta-analysis for Lumipulse and Lumispot. In three quantitative studies using ARCHITECT, HCVcAg correlated closely with HCV RNA above 3000 IU/mL. Limitations There was insufficient data on covariates such as HIV or HBV status for sub-group analyses. Few studies reported genotypes of isolates and there were scant data for genotypes 4, 5, and 6. Most studies were conducted in high resource settings within reference laboratories. Conclusions HCVcAg assays with signal amplification have high sensitivity, high specificity, and good correlation with HCV RNA above 3000 IU/mL. HCVcAg assays have the potential to replace NAT in high HCV prevalence settings.

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Section: Resultsmentioning

confidence: 99%

“…Four studies assessed the Hunan Jynda Bioengineering Group HCV Core Ag ELISA (26–28, 36). Two studies each had a cohort or cross-sectional design.…”

Section: Resultsmentioning

confidence: 99%

Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

Freiman¹,

Tran²,

Schumacher³

et al. 2016

Ann Intern Med

161

148

View full text Add to dashboard Cite

show abstract

“…We found (2) patients with high viral load and low optical densities (OD) obtained by detecting the core antigen with ELISA. Daniel et al (2007) and Zhang et al, (2007) explained the high virus load (10 6 ) and low core antigen level in five patients may be attributed to ongoing anti-viral therapy. While the statistical analysis of relative results of HCV RNA and HCV cAg assays did not have statistically significant differences (p= 0.07) ().…”

Section: Discussionmentioning

confidence: 98%

Evaluation Of An Enzyme Immunoassay For Hepatitis C Virus Core Antigen As A Diagnostic Test For Detection Of Hepatitis C Virus Infection In Comparison To Real-Time RT-PCR

El-Kholy¹,

Kasem²,

Khalil³

et al. 2017

AJVS

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Key words:HCV, ELISA, real-time RT-PCR, HCV core antigen Hepatitis C virus (HCV) is a global public health care problem. Diagnosis of HCV infection was mainly based on the detection of anti-HCV antibodies as a screening test with serum samples and detection of HCV RNA by using real-time RT-PCR, which considered as a golden standard test. In this study, we compared the HCV core antigen (HCV cAg) test with the HCV RNA assay for confirming anti-HCV results to determine whether the HCV cAg test may be used as an alternative confirmatory test to the HCV RNA test and to assess its diagnostic values by determining the specificity and sensitivity rates compared to the realtime RT-PCR test. Sera samples from 100 persons were analyzed by ELISA for anti-HCV and HCV core antigen and with the molecular HCV RNA assay as a confirmatory test. The diagnostic sensitivity, specificity, positive and negative predictive values of the HCV cAg assay compared to the HCV RNA test were 76.1%, 86.2%, 80%, and 82.5%, respectively. The HCV cAg levels showed a poor correlation with those from the HCV RNA quantification (r = 0.321, p= 0.079). In conclusion, the core antigen detection test can be more valuable in HCV diagnosis than anti-HCV antibodies but it cannot replace HCV RNA in confirmation of the diagnosis of HCV because the sensitivity of the HCV cAg detection assay is significantly lower than that of real-time RT-PCR based methods

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“…A sharp drop in post-transfusional hepatitis C was observed when screening assays for HCV antibodies were applied to blood donors [15] . However, patients of posttransfusion and sporadic hepatitis C infection were still reported.…”

Section: Introductionmentioning

confidence: 99%

“…However, patients of posttransfusion and sporadic hepatitis C infection were still reported. Thus, these assays are prone to false-negative results, which demonstrates that the current EIA is not yet perfect [15][16][17] .…”

Section: Introductionmentioning

confidence: 99%

Antigenic Heterogeneity of the NS3 Proteins in Hepatitis C Virus Genotypes 1 and 6

Qiao¹,

Xie²,

Cai

2010

Intervirology

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Objective: To investigate the effect of sequence variability between different genotypes of hepatitis C virus (HCV) on the antigenic properties of the NS3 proteins, and to evaluate the significance of the proteins in the serological diagnosis. Methods: The recombinant expression plasmids of pET/NS3-1 and pET/NS3-6 were constructed with the NS3 region fragments from HCV genotypes 1 and 6, respectively. The antigenic reactivity of the recombinant NS3 proteins was determined. The NS3 nucleotide sequences were aligned with 6 HCV full-length strains representing different genotypes. Results: The two recombinant NS3 proteins were generated and enzyme immunoassay tests were developed. The positive rates of anti-NS3 were 61.2 and 58.8% by using the NS3 antigens from HCV genotypes 1 and 6, respectively. This difference had no statistical significance (p > 0.05). However, it was interesting that 16 samples gave a discordant result for different genotype NS3 antigens.The two partial NS3 sequences shared approximately 63.9–79.9% identity with the different genotype strains. Conclusion: The primary structure of the HCV NS3 region is highly variable. Thus, sequence variability has a profound effect on the antigenic properties of the NS3 regions, and the antigenic differences should be taken into account for the development of more effective diagnostic tests.

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Detection of hepatitis C virus core antigen for early diagnosis of hepatitis C virus infection in plasma donor in China

Cited by 13 publications

References 26 publications

Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

Evaluation Of An Enzyme Immunoassay For Hepatitis C Virus Core Antigen As A Diagnostic Test For Detection Of Hepatitis C Virus Infection In Comparison To Real-Time RT-PCR

Antigenic Heterogeneity of the NS3 Proteins in Hepatitis C Virus Genotypes 1 and 6

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