Implications of grey zone results for routine hepatitis C virus screening with the ARCHITECT HCV‐Ag assay

Arribas, Jorge; Benito, Rafael; Cebollada, Rocío; Bellés, Alba Bellés; Bueno, Jessica; Cumbraos, M.J.; Gil, Joaquín Navarro

doi:10.1111/jam.14517

Cited by 2 publications

(2 citation statements)

References 35 publications

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“…On retesting, none of them tested negative. Previous studies have shown that gray-zone results found to be negative on retesting do not require additional confirmatory testing 33 .…”

Section: Discussionmentioning

confidence: 96%

Improving Diagnosis of Hepatitis C Virus Infection Using Hepatitis C Core Antigen Testing in a Resource-Poor Setting

Kannan

Biswas

Kumar

et al. 2021

Rev. Soc. Bras. Med. Trop.

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Introduction: We compared the hepatitis C virus (HCV) core antigen test with the HCV RNA assay to confirm anti-HCV results to determine whether the HCV core antigen test could be used as an alternative confirmatory test to the HCV RNA test. Methods: Sera from 156 patients were analyzed for anti-HCV and HCV core antigen using a chemiluminescent microparticle immunoassay (Architect i2000SR) and for HCV RNA using the artus HCV RG RT-PCR Kit (QIAGEN) in a Rotor-Gene Q instrument. Results: The diagnostic sensitivity, specificity, and positive and negative predictive values of the HCV core antigen assay compared to the HCV RNA test were 77.35%, 100%, 100%, and 89.38%, respectively. HCV core antigen levels showed a good correlation with those from HCV RNA quantification (r = 0.872). However, 13 samples with a viral load of less than 4000 IU/mL were negative in the HCV core antigen assay. All gray-zone reactive samples were also RNA positive and were positive on repeat testing. Conclusions: The Architect HCV core antigen assay is highly specific and has an excellent positive predictive value. At the present level of sensitivity (77%), the study is still relevant in a low-income setting in which most of the HCV-positive patients would go undiagnosed, since HCV RNA testing is not available and/or not affordable. HCV core antigen testing can also help determine the true burden of infection in a population, considering the fact that almost 50% of the anti-HCV positive cases are negative for HCV RNA.

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“…On retesting, none of them tested negative. Previous studies have shown that gray-zone results found to be negative on retesting do not require additional confirmatory testing 33 .…”

Section: Discussionmentioning

confidence: 96%

Improving Diagnosis of Hepatitis C Virus Infection Using Hepatitis C Core Antigen Testing in a Resource-Poor Setting

Kannan

Biswas

Kumar

et al. 2021

Rev. Soc. Bras. Med. Trop.

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“…The other 8 GzR samples were non-reactive on retesting and on HCV-RNA test. 22 No significant differences were found on comparing HCV-cAg values. This confirms that, even though GzR occur, HCV-cAg is a robust alternative to HCV-RNA detection in the active detection of infections, except in donor screening scenarios, where the use of molecular methods would be advisable.…”

Section: Hcv-cag Expression Highly Agreement With That Of Hcv-rnamentioning

confidence: 91%

HCV core antigen plays an important role in the fight against HCV as an alternative to HCV‐RNA detection

Wang

Jiang

et al. 2021

Clinical Laboratory Analysis

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Objective: To discuss the clinical significance of HCV-cAg testing in the diagnosis, activity determination, and monitoring of therapeutic effectiveness of HCV infection and its advantages compared with HCV-RNA and anti-HCV antibodies detection. Methods:By summarizing the published literature, the advantages and significance of HCV core antigen detection were sought.Results: The expression of HCV-cAg is highly consistent with that of HCV-RNA, but compared with HCV-RNA, detection of HCV-cAg is easy to operate, time saving, and low cost. HCV-cAg can be detected within 12~15 days after infection, and the window period can be shortened by5~7 weeks. HCV-cAg is a serological indicator of virus replication, which can distinguish previous infection of HCV or current infection.HCV-cAg detection is more suitable for immunocompromised, hemodialysis, organ transplant patients. HCV-cAg also can be used to monitor antiviral efficacy and predict sustained virological response (SVR). Conclusion:HCV core antigen has similar clinical sensitivity to NAT and can be used as a substitute for HCV-RNA in the diagnosis of virus infection. Combined detection of HCV-cAg and antibody serology can help doctors detect HCV infection earlier, accurately diagnose different stages of HCV infection, and evaluate the therapeutic effect of antiviral drugs, which are beneficial in the prevention and treatment of hepatitis C.

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Implications of grey zone results for routine hepatitis C virus screening with the ARCHITECT HCV‐Ag assay

Cited by 2 publications

References 35 publications

Improving Diagnosis of Hepatitis C Virus Infection Using Hepatitis C Core Antigen Testing in a Resource-Poor Setting

Improving Diagnosis of Hepatitis C Virus Infection Using Hepatitis C Core Antigen Testing in a Resource-Poor Setting

HCV core antigen plays an important role in the fight against HCV as an alternative to HCV‐RNA detection

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