Sorted By Test Name - Mayo Medical Laboratories

QHBV
82416
serum (after it had become undetectable) or an increase in HBV DNA levels (following an initial decline).
See HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions and HBV
Infection-Monitoring Before and After Liver Transplantation in Special Instructions.
Useful For: Confirmation of chronic hepatitis B virus (HBV) infection Quantification of HBV DNA in
serum of patients with chronic HBV infection (previously hepatitis B surface antigen-positive)
Monitoring disease progression in chronic HBV infection and/or response to anti-HBV therapy
Interpretation: The quantification range of this assay is 20 to 170,000,000 IU/mL (1.30-8.23 log
IU/mL). An "Undetected" result indicates that hepatitis B virus (HBV) DNA was not detected in the
specimen. A "Detected" result with the comment, "HBV DNA level is 8.23 log IU/mL). This
assay cannot accurately quantify HBV DNA above this level" indicates that the HBV DNA level is above
the upper limit of quantification for this assay. An indeterminate result with the comment "Inconclusive
Result: Submit a new specimen for testing if clinically indicated" indicates that inhibitory substances may
be present in the specimen. When clinically indicated, collection and testing of a new specimen is
recommended.
Reference Values:
Undetected
Clinical References: 1. Pawlotsky JM: Hepatitis B virus (HBV) DNA assays (methods and practical
use) and viral kinetics. J Hepatol 2003;39:S31-S35 2. Servoss JC, Friedman LS: Serologic and molecular
diagnosis of hepatitis B virus. Clin Liver Dis 2004;8:267-281 3. Goedel S, Rullkoetter M, Weisshaar S, et
al: Hepatitis B virus (HBV) genotype determination by the COBAS AmpliPrep/COBAS TaqMan HBV
test, v2.0 in serum and plasma matrices. J Clin Virol 2009;45:232-236 4. Chevaliez S, Bouvier-Alias M,
Laperche S, et al: Performance of version 2.0 of the Cobas AmpliPrep/Cobas TaqMan Real-Time PCR
Assay for hepatitis B virus DNA quantification. J Clin Microbiol 2010;48:3641-3647 5. Lok ASF,
McMahon BJ: Chronic hepatitis B: Update 2009. Hepatology 2009;50:661-662
Hepatitis B Virus DNA Quantification by bDNA, Serum
Clinical Information: Hepatitis B virus (HBV) is a causative agent of viral hepatitis, with >50% of
those infected developing symptoms of acute hepatitis (jaundice, nausea, anorexia, malaise, and fatigue).
Progression to chronic hepatitis B, which occurs in 5% of adults and up to 90% of newborns, is of great
public health concern. There are an estimated 300 million chronic carriers of HBV worldwide. Up to 25%
of these chronically infected individuals subsequently develop cirrhosis and liver failure or hepatocellular
carcinoma. HBV is found in the blood and other body fluids of those with acute or chronic HBV
infection, and person-to-person transmission of HBV infection occurs via sexual contacts, childbirth (with
HBV-infected mothers), shared use of contaminated needles, or organ transplantation. While serologic
markers are routinely used to determine the diagnosis of acute and chronic HBV infection, they often do
not reflect the true disease progression. Presence of detectable HBV DNA levels in serum is an accurate
marker of active viral replication. During the convalescent phase of acute hepatitis B, detectable HBV
DNA levels persisting for longer than 8-week duration may indicate progression to chronic hepatitis B. In
patients with chronic hepatitis B, HBV DNA levels in serum correlate with risk of cirrhosis and
hepatocellular carcinoma. Thus, the ability to detect HBV DNA in serum has prognostic value for the
outcome of acute and chronic HBV infection. Effective antiviral treatment is available for patients with
chronic hepatitis B and include interferon-alpha, nucleoside analogs (lamivudine, entecavir, telbivudine),
and a nucleotide analog (adefovir). Goals of anti-HBV therapy are to reduce serum HBV viral load to
undetectable level and to achieve hepatitis B surface antigen (HBsAg) seroconversion (anti-HBs
positivity). See The Laboratory Approach to the Diagnosis and Monitoring of Hepatitis B Infection in
Publications.
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