Hepatitis B Virus DNA Quantification by bDNA, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Branched DNA (bDNA) Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HBV DNA Quantification, S
Hepatitis B Virus (HBV) DNA quantification
Hepatitis B Virus (HBV) DNA quantitation
Hepatitis B Virus (HBV) viral load by bDNA assay
Hepatitis B Virus (HBV) DNA quantitation
Hepatitis B Virus (HBV) viral load by bDNA assay
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
1. Spin down and separate serum from gel within 6 hours of draw.
2. Freeze specimen immediately, and ship frozen on dry ice.
3. If shipment will be delayed for >24 hours, freeze specimen at -70 degrees C (up to 35 days) until shipment on dry ice
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild reject; Gross reject
Mild OK; Gross OK
Red top tube
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum SST||Frozen (preferred)|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
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 <357 IU/mL (or <2.55 log IU/mL) indicates that either the specimen contains no detectable hepatitis B virus (HBV) DNA or the HBV DNA level is below the lower limit of quantification for this assay.
A result of >17,900,000 IU/mL (or >7.25 log IU/mL) indicates that the HBV DNA level is above the upper limit of quantification for this assay.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Due to the potential for false-positive results, this assay should NOT be used for initial detection of hepatitis B virus (HBV) DNA in patients with suspected chronic HBV infection. Laboratory evaluation of HBV status should begin with HBV serological marker tests, including hepatitis B surface antigen.
A result of <357 IU/mL (<2.55 log IU/mL) does not rule out the presence of HBV DNA in the specimen.
The lower limit of quantification was 357 IU/mL (the lowest quantifiable hepatitis B virus [HBV] DNA level that shows <35% coefficient of variation, %CV, and within 0.1 log IU/mL from the linearized expected level). Total %CV ranged from 17.6% to 24.5% for analytical standards with HBV DNA levels within the quantification range of this assay. There was very good correlation (r = 0.999) between the observed and linearized expected mean values of HBV DNA levels ranging from 357 to 17,229,857 IU/mL.
All 300 serum or EDTA-plasma specimens collected from healthy blood donors showed HBV DNA titers of <357 IU/mL, yielding an analytical specificity of 100% (lower 95% confidence limit at 99%).
Deming regression analysis of paired results on 48 serum specimens tested by this assay using the Versant 440 Molecular System and S340 bDNA System showed good correlation (r = 0.997) between the 2 assays with the regression equation, y = 0.996x + 0.013. The mean difference in HBV DNA levels obtained between the 2 assays was -0.01 log IU/mL, with the differences ranging from -0.22 to 0.11 log IU/mL, and 95.8% (46 of 48 specimens) of these differences were within 0.15 log IU/mL (1.96 SD) from the mean difference. There was no assay bias observed across the range of HBV DNA levels tested.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis 2004;8:267-281
2. Valsamakis A: Molecular testing in the diagnosis and management of chronic hepatitis B. Clin Microb Rev 2007;20(3):426-439
3. 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
4. Vivekanandan P, Singh MV: Molecular methods in the diagnosis and management of chronic hepatitis B. Expert Rev Mol Diagn 2010;10(7):921-935
Method Description Describes how the test is performed and provides a method-specific reference
The VERSANT HBV DNA 3.0 Assay (bDNA) is based on a target signal amplification method for the quantification of hepatitis B virus (HBV) DNA in human serum and plasma. In an overnight incubation, HBV DNA is liberated from virions, and its capture to a microwell is mediated by a set of specific, synthetic oligonucleotide capture probes (capture extenders). A set of target probes (label extenders) is also hybridized to the viral DNA during this incubation step. The 2 sets of target probes bind to conserved regions of the S and C genes of the HBV genome. These target probes have been specifically designed to capture and quantify all HBV genotypes equally. After overnight incubation, the preamplifier and amplifier probes are hybridized to the target probes (label extenders). Multiple copies of an alkaline phosphatase-conjugated probe (label probe) are then hybridized to the immobilized complex. Detection is achieved by incubating the complex with a chemiluminescent substrate and measuring the light emission generated by the bound alkaline phosphatase reacting with the chemiluminescent substrate. Light emission is directly proportional to the amount of HBV DNA present in each specimen. Results are recorded as relative light units by the VERSANT 440 Molecular System. A standard curve is defined by light emission from 5 analytical standards containing known concentrations of recombinant bacteriophage. Concentrations of HBV DNA in specimens are then determined from this standard curve.(Package insert: VERSANT HBV DNA 3.0 Assay [bDNA], Siemens Healthcare Diagnostics Inc., Tarrytown, NY, 06868486 Rev. A, 2007-12)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 12 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test uses a reagent or kit labeled by the manufacturer as Research Use Only. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|82416||HBV DNA Quantification, S||N/A|