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Discordant hepatitis C serological testing in Australia and the implications for organ transplant programs
A K Le Page1, P Robertson, W D Rawlinson
1School of Medical Sciences, Faculty of Medicine, University of New South Wales, Kensington, NSW 2052, Australia.
Insights
Discordant hepatitis C (HCV) serology testing occurs in 1 in 185 high-risk patients. Most discordant results are false positives, indicating a very low HCV infection risk in deceased organ donors.
Area of Science:
- Hepatology
- Infectious Diseases
- Transplantation Immunology
Background:
- Discordant hepatitis C virus (HCV) serology poses challenges for deceased organ donor (DOD) transplant allocation.
- Accurate assessment of allograft infection status is critical for transplant success.
Purpose of the Study:
- To determine the prevalence and follow-up of discordant HCV serotesting in an Australian at-risk population.
- To model the prevalence of discordant HCV testing within the Australian DOD population.
Main Methods:
- Retrospective analysis of de-identified discordant HCV serology results from a referral laboratory (2008-2011).
- Review of prior and follow-up serology testing.
- Prevalence calculation using Bayes' theorem for the DOD population, incorporating Australian DOD rates and HCV seroprevalence.
Main Results:
- The study population exhibited a 6.6% HCV seroprevalence.
- Discordant serotesting occurred at a rate of 0.54%, with no new definite HCV infections identified.
- Modeling estimated 1.8 discordant tests annually in the Australian DOD population.
Conclusions:
- Discordant HCV serotesting affects approximately 1 in 185 individuals in high-risk groups.
- The majority of discordant results are likely false positives, with a small possibility of seroreversion.
- For Australian DOD, this translates to 1-2 discordant cases yearly, posing minimal HCV infectious risk if donors lack risk factors and are RNA-negative.
Background:
Discordant and equivocal hepatitis C (HCV) serology testing is problematic for making decisions regarding deceased organ donor (DOD) transplant allocation based on allograft infection status.
Objectives:
This study aimed to analyse the prevalence and follow-up testing of discordant HCV tested patients from an Australian population at increased risk of HCV infection, with prevalence modelling for the Australian DOD population.
Study Design:
De-identified patient discordant HCV serology results (primary chemiluminescent microparticle immunoassay and secondary Bio-Rad MonoLisa HCV Ag/Ab Ultra assay) were retrospectively identified in a general referral laboratory between May 2008 and August 2011. Prior and follow-up serology testing was reviewed. Discordant result prevalencewas calculated using Bayes' theorem for the DOD population using Australian DOD rates and HCV seroprevalence.
Results:
The tested population had a 6.6% HCV seroprevalence. The rate of discordant serotesting was 0.54%, with no cases identified as having definite HCV infection at follow-up. Two patients had evidence of definite HCV seropositivity before the index discordant test. Modelling for the Australian DOD population of 337 per year estimated a discordant test prevalence of 1.8 per year.
Conclusions:
Discordant HCV serotesting may occur for 1 of 185 patients tested in higher risk populations. The majority of such tests represent falsely reactive tests although a small number may reflect partial seroreversion. Amongst Australian DOD, this represents 1 or 2 discordant cases per year. It is likely that if this discordant sample were from a donor with no blood borne virus risk factors, and was concurrently RNA negative, that HCV infectious risk would be extremely low.
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