Mayo Test Catalog, (Sorted By Test Name) - Mayo Medical ...

QHBV
82416
this assay is recommended in 1 to 2 months. A quantitative result expressed in IU/mL and log IU/mL
indicates the degree of active HBV viral replication in the patient. Monitoring HBV DNA levels over time
is important for assessing disease progression or monitoring a patient's response to anti-HBV therapy. A
"Detected" result with the comment, "HBV DNA level is >170,000,000 IU/mL (>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.
Useful For: Quantification of hepatitis B virus (HBV) DNA levels in serum of patients with
confirmed chronic HBV infection (known to have detectable HBV DNA in serum) Monitoring
progression of chronic HBV infection and responses to anti-HBV therapy
Interpretation: This assay has a quantification range of 357 to 17,900,000 IU/mL (2.55-7.25 log
IU/mL). Results are reported as integers in IU/mL (rounded to 3 significant figures) and log IU/mL. A
result of 7.25 log IU/mL) indicates that the HBV DNA level is above
the upper limit of quantification for this assay.
Reference Values: