Mohd Anuar, Ismail
(2008)
The role of hepatitis b core as screening test.
Other.
Universiti Sains Malaysia.
(Submitted)
Abstract
Qualitative detection of antibody to hepatitis B virus core antigen (anti-HBc) is an
important aid in diagnosis of acute, chronic, or resolved HBV infection in conjunction
with other lab results and clinical information. A multi-center prospective study was
conducted to validate the performance of the AxSYM CORE 2.0 assay in a diagnostic
population by evaluating precision and performing method comparison. AxSYM CORE
2.0 is a competitive microparticle enzyme immunoassay (MEIA) for use on the AxSYM
system for the qualitative detection of anti-HBc in human adult and pediatric serum or
plasma.
A multi-center prospective study was conducted to validate the performance of the
HbsAg and HbsAg Confirmatory assays in a diagnostic population. Assay performance
was measured by evaluating precision and performing method comparison. Qualitative
detection and confinnation of hepatitis B surface antigen (HbsAg) is an important aid in
diagnosis of HBV infection. The HbsAg and HbsAg Confirmatory assays are
chemiluminescent microparticle immunoassays for the qualitative detection and
confirmation ofHbsAg in human adult.
There are about 350 million chronic hepatitis B virus (HBV) carriers worldwide. A
proactive approach to the management of this disease is likely to reduce the morbidity
and mortality caused by HBV. This study aimed to approach the HB core test as a
screening tool in blood bank. The test is designed to rapidly and accurately detect both
the HBV surface antigen (HBsAg) and the HBV e antigen (HB Core). A cohort of316
subjects was tested. The serum clinical sensitivity of the hepatitis B sAg or Hb core test
was 99.75 and 96.37% for HBsAg and HB Core, respectively. Serum clinical specificity
was 99.32% for HBsAg and 98.99% for HB core. Analytical sensitivity was satisfactory
for the purposes of population screening. Visual evaluation showed that the test signals
were stable for at least 3 h after the recommended evaluation time. No interference or
cross-reactivity was observed with known interfering substances and virologic markers.
These results indicate that the hepatitis B sAg/ core test is well suited to the accurate
detection of HBV carriers. In addition to the good clinical specificity and sensitivity of
this test, its stability and user-friendly design mean that a correct performance, even under
field conditions, is highly likely. Consequently, the hepatitis B sAg/core test has the
potential to identify subjects who require HBV vaccination (HBsAg- and HBeAg-) and
HBV -infected individuals who might benefit most from antiviral therapy (HBsAg + and
HBeAgl.
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