Comparison of a Newly Developed Automated and Quantitative Hepatitis C Virus (HCV) Core Antigen Test with the HCV RNA Assay for Clinical Usefulness in Confirming Anti-HCV Results

Keşli, Recep; Polat, Hakkı; Terzi, Yüksel; Kurtoğlu, Muhammet Güzel; Uyar, Yavuz

doi:10.1128/jcm.05292-11

Cited by 63 publications

(70 citation statements)

References 29 publications

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“…Our specificity and positive predictive values were found as 100% and similar results were obtained in comparison with the other studies showing that there were no false-positive results 4,6,13 . However, our sensitivity (86,5%) and negative predictive value (59.4%) were a little bit lower than those of the other studies 4,6,13 . This was due to our higher rate of false negative results.…”

supporting

confidence: 74%

“…Furthermore, in a similar comparison of 212 serum samples with anti-HCV antibody positivity, Kesli et al 4 found that sensitivity, specificity and positive and negative predictive values were 96.3%, 100%, 100% and 89.7%, respectively. In addition, Park et al 6 obtained similar results comparing HCV RNA with HCV core Ag in 282 serum samples; sensitivity, specificity and positive and negative predictive values were determined to be 90.2%, 100%, 100% and 86,4%, respectively.…”

Section: Leary Et Almentioning

confidence: 98%

“…It has been reported that immunosuppression can also be a reason for an insufficient antibody response in a large number of patients 3 . Thus, anti-HCV assay results that show values under the critical value designated by EIA or CLIA must be confirmed by an additional confirmatory test, such as the HCV ribonucleic acid (RNA) test, or with the preconfirmatory HCV core antigen(Ag) assay 4 . Nucleic acid testing (NAT) for the detection of HCV RNA remains the gold standard for diagnosing active HCV infections.…”

Section: Introductionmentioning

confidence: 99%

“…In the last decade, several HCV core Ag assays have been developed, due to the problems associated with HCV RNA assays 4,6 . The results of recent studies indicated that measurements of HCV core Ag in serum or plasma can be used as indirect markers of HCV replication 7, 8, 9, 10. The majority of the previously used enzyme-linked immunosorbent assays (ELISAs) or EIAs detecting HCV core Ag may have required time and skill to conduct.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of HCV core antigen and anti-HCV with HCV RNA results

Buket¹,

Aynali²,

Kaya³

et al. 2015

Afr H. Sci.

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Background: The measurement of anti-HCV antibodies using immunological methods and the confirmation of viral nuclear acid based on molecular methods is important in diagnosis and follow-up of the HCV infection. Objectives: In this study, we aimed to analyse HCV core Antigen positivity among anti-HCV antibody positive sera to determine the significance of testing of HCV core Ag for the laboratory diagnosis of HCV infection, by considering the correlation between serum HCV core Ag and HCV RNA levels. Methods: 115 patients suspected of having hepatitis C and who were positive for anti-HCV antibody were investigated using chemiluminescent and molecular methods. Anti-HCV antibody, HCV core Ag and HCV RNA levels were detected by the Vitros ECiQ immunodiagnostic system, Architect i2000 system and RT-PCR, respectively. Results: The sensitivity, specificity, positive and negative predictive values and accuracy rate of HCV core Antigen assay were detected as 86.5%(83/96), 100%(19/19), 100%(83/83), 59.4%(19/32), 88.7%(102/115) respectively. Conclusion: HCV core Ag assay could be used for diagnosis of HCV infection as it is easy to perform, cost-effective, has high specificity and positive predictive value. However, it should be kept in mind that it may have lack of sensitivity and negative predictive value.

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supporting

confidence: 74%

Section: Leary Et Almentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparison of HCV core antigen and anti-HCV with HCV RNA results

Buket¹,

Aynali²,

Kaya³

et al. 2015

Afr H. Sci.

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“…This interpretation was agreed with previous studies which also found that some individuals during pre-seroconversion period may have low viral load « is 04) and their HCV cAg cannot be detected through this examination (Lunel et al, 2003). Kesli et al, (2011) recorded that the diagnostic specificity and positive predictive values of the HCV cAg test compared with the HCV RNA test were 100%, 100%, respectively. The levels of HCV core antigen showed a good correlation with those from the HCV RNA quantification (r = 0.907).…”

Section: Discussionsupporting

confidence: 79%

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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Minimum target prices for production of direct‐acting antivirals and associated diagnostics to combat hepatitis C virus

et al. 2015

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Combinations of direct-acting antivirals (DAAs) can cure hepatitis C virus (HCV) in the majority of treatment-naïve patients. Mass treatment programs to cure HCV in developing countries are only feasible if the costs of treatment and laboratory diagnostics are very low. This analysis aimed to estimate minimum costs of DAA treatment and associated diagnostic monitoring. Clinical trials of HCV DAAs were reviewed to identify combinations with consistently high rates of sustained virological response across hepatitis C genotypes. For each DAA, molecular structures, doses, treatment duration, and components of retrosynthesis were used to estimate costs of large-scale, generic production. Manufacturing costs per gram of DAA were based upon treating at least 5 million patients per year and a 40% margin for formulation. Costs of diagnostic support were estimated based on published minimum prices of genotyping, HCV antigen tests plus full blood count/clinical chemistry tests. Predicted minimum costs for 12-week courses of combination DAAs with the most consistent efficacy results were: US$122 per person for sofosbuvir+daclatasvir; US$152 for sofosbuvir+ribavirin; US$192 for sofosbuvir+ledipasvir; and US$115 for MK-8742+MK-5172. Diagnostic testing costs were estimated at US$90 for genotyping US$34 for two HCV antigen tests and US$22 for two full blood count/clinical chemistry tests. Conclusions: Minimum costs of treatment and diagnostics to cure hepatitis C virus infection were estimated at US$171-360 per person without genotyping or US$261-450 per person with genotyping. These cost estimates assume that existing large-scale treatment programs can be established. (Hepatology 2015;61:1174–1182)

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Comparison of a Newly Developed Automated and Quantitative Hepatitis C Virus (HCV) Core Antigen Test with the HCV RNA Assay for Clinical Usefulness in Confirming Anti-HCV Results

Cited by 63 publications

References 29 publications

Comparison of HCV core antigen and anti-HCV with HCV RNA results

Comparison of HCV core antigen and anti-HCV with HCV RNA results

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

Minimum target prices for production of direct‐acting antivirals and associated diagnostics to combat hepatitis C virus

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