الفهرس 
Hepatitis C Virus
Hepatitis C virus Core Antigen- Role in Diagnosis, Disease Monitoring and TreatmentOnly 14 pages are availabe for public view
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Abstract
To this day, hepatitis C virus infection represents a
global burden. The long term impact of HCV infection is
highly variable, ranging from minimal effects to severe
extra-hepatic complications.
The goal of therapy is to eradicate HCV and in light
of the advances in HCV therapy, simplification of diagnosis
confirmation, pre-treatment diagnostic workup and
treatment monitoring is required to ensure broad access to
these new therapies.
HCV RNA monitoring using NAATs with a lower
detection level of 15 IU/ml is the gold standard for defining
sustained virologic response after DAA treatment. Yet it is
an expensive and time-consuming assay which raises the
need to establish cheaper assays without compromising
reliability. HCV core antigen quantification might be a
valid alternative.
The aim of this study is to assess the accuracy of
HCV core antigen in defining a sustained virologic
response, and its predictive value as a monitoring test in the
course of treatment, by comparing it to the standard of care
monitoring with a quantitative PCR test in patients who
receive DAA regimens.
This prospective study was conducted on 90 chronic
HCV infected patients that have received DAA treatment.Overall the HCV core antigen assay demonstrated a
cut off value of 0.71 pg/ml, a test sensitivity of 63.6 %,
specificity of 98.7 %, PPV of 98.6 % and NPV of 89.3 %.
The accuracy of the test was 90.5 %. A strong correlation
between the logarithmic values of HCV RNA and HCV Ag
had been observed.
It was possible to calculate that 1 pg/ml of total HCV
core Ag is equivalent to approximately 8,000 HCV RNA
IU/ml and the calculated cut off value of our study of 0.71
pg/ml is consequently equivalent to approximately 6000
IU/ml.
In summary, total HCV core Ag quantification is an
accurate and precise indirect marker of replication in HCVinfected
patients. Total HCV core antigen quantification can
be used in various settings in which there is a need to
monitor viral load, although clinically relevant decision
thresholds need to be established in prospective clinical
trials.
A new assay with better sensitivity relying on
chemiluminescent assay rather than enzyme-linked
immunosorbent assay or enzyme immunoassay is now
being tested by various researches with outstanding results
as compared to ELISA kits.