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

Xue Zheng Wong,Chye Chung Gan,Soo Kun Lim,Rosmawati Mohamed,Shubash Ganapathy,Rosnawati Yahya,Soek Siam Tan

doi:10.1186/s12882-020-02154-4

Xue Zheng Wong, Chye Chung Gan + Show 5 more

Open Access

https://doi.org/10.1186/s12882-020-02154-4

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Abstract

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.MethodsWe 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.ResultsWe 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.ConclusionsAlthough 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.

Highlights

Hepatitis C virus (HCV) infects more than 71 million people worldwide and chronic HCV infection increases the risk of liver cirrhosis and failure
This is observed in low- and middle-income countries (LMICs), such as Malaysia with limited resources and many competing health needs from its citizens to organize a full-scale, nationwide initiatives to eliminate HCV
One hundred and twelve HCV seropositive patients were recruited based on their HCV serology result reported on Malaysia Dialysis and Transplantation Registry (MDTR)

Summary

Introduction

Hepatitis C virus (HCV) infects more than 71 million people worldwide and chronic HCV infection increases the risk of liver cirrhosis and failure. Hepatitis C virus (HCV) causes a significant worldwide burden and infects more than 185 million people worldwide, in which 71 millions of them are chronically infected [1]. Despite having good treatment options, most of the people with HCV are undiagnosed, which leads to a low treatment rate. This is observed in low- and middle-income countries (LMICs), such as Malaysia with limited resources and many competing health needs from its citizens to organize a full-scale, nationwide initiatives to eliminate HCV. A concept of “Micro-elimination”, which entails a phased approach to achieve national elimination goals in defined segments of the population through the engagement of multistakeholders who are most knowledgeable about the needs of the specific populations to tailor interventions within these settings to eliminate HCV [3]

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