Hepatitis C core antigen testing to diagnose active hepatitis C infection among haemodialysis patients

Abstract

Background Hepatitis 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.

Time to complete hepatitis C cascade of care among patients identified during mass screening campaigns in rural Rwanda: a retrospective cohort study

“…There are currently two major approaches to providing point of care testing. The first replaces viral RNA test with core antigen tests, which can provide results in 60 min [ 30 – 32 ]. Core antigen tests have been approved by the WHO as an alternative for confirmatory viral load testing [ 33 , 34 ], and may also provide an alternative approach for assessing SVR12 [ 35 ].…”

Laboratory Evaluation of Hepatitis C Virus Infection in Patients Undergoing Hemodialysis from North East India

“…However, few recently concluded works outside India recommended core anti-gen-based assays for hemodialysis setups in resource scanty areas due to its excellent correlation to HCV RNA level in blood and 100% PPV. 36,37 Combined HCV antigen-antibody kit-based study in subjects undergoing dialysis is rare from India. We found few from abroad and one such French study concluded that combined kits detect HCV infection much earlier (21.6 days) than antibody detection assays.…”

Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

“…One cost implication study conducted in Malaysia estimates the feasibility of HCV cAg as an alternate diagnostic algorithm for detecting active HCV infection among HCV-hemodialysis (i.e., HCV/HD) population [ 115 ]. HCV RNA analysis is costly in the country due to which anti-HCV Abs positive HD patients do not undergo active infection confirmation.…”

“…Cost-mapping demonstrated that a biphasic testing strategy involving anti-HCV Ab as an initial screening, followed by HCV cAg for active infection confirmation on anti-HCV Ab positive and HCV RNA on HCV cAg negative patients can be considered as a modest cost-saving HCV diagnostic approach for HCV/HD patients as compared to standard diagnostic algorithms. This alternate cost-effective approach could also be relevant to HCV/HD and HCV/CKD infected patients in many LMICs to scale up HCV diagnosis and further linkage to care [ 115 ].…”