HCV core antigen is an alternative marker to HCV RNA for evaluating active HCV infection: implications for improved diagnostic option in an era of affordable DAAs

Wasitthankasem, Rujipat; Vichaiwattana, Preeyaporn; Auphimai, Chompoonut; Siripon, Nipaporn; Klinfueng, Sirapa; Tangkijvanich, Pisit; Vongpunsawad, Sompong; Poovorawan, Yong

doi:10.7717/peerj.4008

Cited by 27 publications

(26 citation statements)

References 39 publications

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“…This gives a speci city of 100% and a sensitivity of 90.7%. A lower detection rate compared to HCV RNA is consistent with previous studies [7], [9], [10], [17], [19]. Both HCV Ag and HCR RNA tests showed a signi cant correlation, with Spearmen test coe cient of 0.833 (p<0.001).…”

Section: Discussionsupporting

confidence: 91%

Hepatitis C Core Antigen Testing to Diagnose Active Hepatitis C Infection Among Haemodialysis Patients

Wong

Gan

et al. 2020

Preprint

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BACKGROUNDHepatitis C virus (HCV) infects more than 71 million people worldwide and chronic HCV infection increases the risk of liver cirrhosis and failure. Haemodialysis (HD) is one of the renal replacement therapies with risk of HCV transmission. Anti-HCV antibodies are the serological screening test for HCV infection that does not detect active phase of infection. Majority HCV infected HD patients in Malaysia do not have further HCV RNA performed due to high cost and thus HCV treatment is less frequently offered. HCV Core Antigen (HCV Ag) can potentially be used to diagnose active HCV infection in HD population in comparison to HCV RNA, at lower cost. METHODS We conducted a cross-sectional study to assess the correlation between HCV Ag and HCV RNA and to identify the prevalence of active HCV infection among HCV seropositive HD patients from dialysis centres across West Malaysia from July 2019 to May 2020. Pre-dialysis blood was taken and tested for both HCV Ag and HCV RNA tests. HCV Ag was tested with Abbott ARCHITECT HCV Ag test.RESULTS We recruited 112 seropositive HD patients from 17 centres with mean age of 54.04±11.62 years, HD vintage of 14.1±9.7 years, and male constitute 59.8% (67) of the study population. HCV Ag correlates well with HCV RNA (Spearman test coefficient 0.833, p<0.001). The sensitivity was 90.7%, specificity 100%, positive predictive value (PPV) 100%, negative predictive value (NPV) 76.5%, and accuracy 92.9%. For HCV RNA level >3000 IU/mL, HCV Ag had a higher sensitivity of 95.1% and greater correlation (Spearman test coefficient 0.897, p<0.001). The prevalence of active HCV infection was 76.8% among HCV seropositive HD patients. CONCLUSIONS Although HCV Ag is less sensitive, it shows an excellent correlation with HCV RNA and has 100% PPV. HCV Ag can be considered as an alternative diagnostic tool for chronic active HCV infection among HD cohort, who can then be considered for HCV treatment. For seropositive HD patient with negative HCV Ag, we recommend to follow-up with HCV RNA test.

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Section: Discussionsupporting

confidence: 91%

Hepatitis C Core Antigen Testing to Diagnose Active Hepatitis C Infection Among Haemodialysis Patients

Wong

Gan

et al. 2020

Preprint

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“…There is an increasing need for a simple, costeffective and supplemental assay besides the costly HCV RNA testing for evaluation HCV disease severity (Wasitthankasem et al, 2017). Also, many studies documented the relation between the liver disease severity and HCV proteins in hepatic tissues (Kasprzak et al, 2004;Galy et al, 2007).…”

Section: Discussionmentioning

confidence: 99%

“…The core antigen of HCV has been reported to be an indirect marker for HCV replication comparable to the detection of HCV RNA. It can serve as a trustworthy marker to diagnose active infection of HCV as well as to evaluate the treatment response (Wasitthankasem et al, 2017). NS4 antigen detection rate was superior to that have been found by using similar polyclonal or monoclonal anti-NS4 antibodies (Gerlach et al, 2005).…”

Section: Introductionmentioning

confidence: 95%

“…HCV infection diagnosis depend on detection of anti-HCV antibodies by recombinant immunoblot assays and viral RNA detection by PCR (Salas-Villalobos et al, 2017). However, anti-HCV antibody assay cannot distinguish between present and past infection and need additional HCV-RNA testing to assure active infection (Wasitthankasem et al, 2017). In addition, the laboratory setup for detection HCV-RNA requires expensive reagents and equipment, technical expert, and dedicated procedure areas (Kamili et al, 2012).…”

Section: Introductionmentioning

confidence: 99%

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Isolation of Hepatitis C Virus Antigen El and Establishment of a Comparison of its Level in Different Fibrosis Stages in Patients Infected with Chronic Hepatitis C

Mohamedin¹,

El-Morsi²,

Abuzaid³

et al. 2018

Journal of Plant Production

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Hepatitis C virus (HCV) is the main causative agent of chronic liver diseases that accounting for significant morbidity and mortality worldwide. Screening for HCV antigens presents an alternative marker to viral antibodies and RNA. Thus, this work aimed to detect HCV-E1 antigen level in different liver fibrosis stages and to evaluate the possible relationship between this level and the disease severity. The study was performed among one-hundred and forty one participants categorized into two groups (35 healthy individual and 106 chronic hepatitis C patients). All involved patients were recruited from Tropical Medicine Department, Mansoura University Hospitals, Mansoura, Egypt. HCV-E1 antigen was identified using western blotting and its level was quantified by ELISA. Fibrosis was staged according to METAVIR scoring system as the following: patients with fibrosis stage F1: 32.1% (34/106) of cases, F2: 29.2% (31/106) of cases, F3: 20.8% (22/106) of cases and F4: 19.7% (19/106) of cases. HCV-EI was identified at 38 kDa using their respective specific monoclonal antibody. HCV-EI antigen level (OD) significantly increased (P< 0.0001) with liver fibrosis progression, it was 0.77±0.27, 0.55±0.17,0.43 ±0.16, and 0.30 ±0.09, in F4, F3,F2, and F1;respectively. HCV-EI antigen level seems to be associated with progression of HCV infection. It could be served as a good supplemental assay for HCV-RNA and could be used to diagnose active HCV infection.

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“…However, since its sensitivity is lower than molecular tests, only a positive result of HCV core antigen makes the HCV RNA test unnecessary [32] . Moreover, core antigen disappears later than RNA so it can be used to detect later phases of HCV infection when HCV RNA is undetectable [31] .…”

Section: Alternatives To Molecular Testsmentioning

confidence: 99%

Nanotechnology: A reality for diagnosis of HCV infectious disease

Arca-Lafuente

Martínez-Román

Maté-Cano

et al. 2020

Journal of Infection

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Hepatitis C virus (HCV) is the primary etiologic agent of liver cirrhosis or hepatocellular carcinoma. HCV elevated infection rates are mostly due to the lack of an accurate and accessible screening and diagnosis, especially in low-and middle-income countries. Conventional HCV diagnostic algorithm consists of a serological test followed by a nucleic acid test. This sequence of tests is time consuming and not affordable for low-resource settings. Nanotechnology have introduced new promising tests for the diagnose of infectious diseases. Based on the employment of nanoparticles and other nanomaterials which lead to highly sensitive and specific nanoscale tests, most of them target pathogen genome. Implementation of nanoscale tests, which are affordable, portable and easy to use by non-specialized personal, would improve HCV diagnosis algorithm. In this review, we have summed up the current emerging nanotechnology tools, which will improve actual screening and treatment programs, and help to reach HCV elimination proposal.

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HCV core antigen is an alternative marker to HCV RNA for evaluating active HCV infection: implications for improved diagnostic option in an era of affordable DAAs

Cited by 27 publications

References 39 publications

Hepatitis C Core Antigen Testing to Diagnose Active Hepatitis C Infection Among Haemodialysis Patients

Hepatitis C Core Antigen Testing to Diagnose Active Hepatitis C Infection Among Haemodialysis Patients

Isolation of Hepatitis C Virus Antigen El and Establishment of a Comparison of its Level in Different Fibrosis Stages in Patients Infected with Chronic Hepatitis C

Nanotechnology: A reality for diagnosis of HCV infectious disease

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