Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
The following algorithms are available in Special Instructions:
-HBV Infection-Diagnostic Approach and Management Algorithm
-HBV Infection-Monitoring Before and After Liver Transplantation
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Real-Time Polymerase Chain Reaction (PCR)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HBV DNA Detect/Quant, S
HBV DNA Quantitation
HBV Viral Load
Hepatitis B Quantitation
Hepatitis B Viral Load
HBV Viral Load
Hepatitis B Quantitation
Hepatitis B Viral Load
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: Polypropylene vial (Supply T465)
Specimen Volume: 1.5 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 OK; Gross OK
Mild OK; Gross OK
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Diagnosis of acute or chronic hepatitis B virus (HBV) infection is based on the presence of HBV serologic markers such as hepatitis B surface antigen (HBsAg) and hepatitis B core IgM antibody (anti-HBc IgM), or the presence of HBV DNA detected by molecular assays. Although the diagnosis of acute and chronic HBV infection is usually made by serologic methods, detection and quantification of HBV DNA in serum are useful to:
-Diagnose some cases of early acute HBV infection (before the appearance of HBsAg)
-Distinguish active from inactive HBV infection
-Monitor a patient's response to anti-HBV therapy
The presence of HBV DNA in serum is a reliable marker of active HBV replication. HBV DNA levels are detectable by 30 days following infection, generally reach a peak at the time of acute hepatitis, and gradually decrease and disappear when the infection resolves spontaneously. In cases of acute viral hepatitis with equivocal HBsAg test results, testing for HBV DNA in serum may be a useful adjunct in the diagnosis of acute HBV infection, since HBV DNA can be detected approximately 21 days before HBsAg typically appears in the serum.
Patients with chronic HBV infection fail to clear the virus and remain HBsAg-positive. Such cases may be further classified as chronic active (replicative) HBV (high HBV levels, hepatitis Be antigen [HBeAg]-positive) or chronic inactive (nonreplicative) HBV (low or undetectable HBV DNA levels, HBeAg-negative). HBV DNA levels in serum are useful in determining the status of chronic HBV infection, by differentiating between active and inactive disease states. Patients with chronic active HBV are at greater risk for more serious liver disease and are more infectious than patients with inactive HBV infection. Reactivation of inactive chronic HBV infection (HBeAg-negative state) may occur with or without reappearance of HBeAg in serum. In patients with HBeAg-negative disease, detection of HBV DNA is the only reliable marker of active HBV replication.
The therapeutic goal of anti-HBV therapy in patients who are HBeAg-positive is to achieve long-term suppression of viral replication with undetectable HBV DNA, HBe seroconversion and loss of HBeAg. The therapeutic goal in patients with HBeAg-negative disease is typically long-term viral suppression. The emergence of drug-resistant HBV strains (in response to treatment with nucleos(t)ide analogs, eg, lamivudine, adefovir, entecavir, tenofovir), is characterized by either the reappearance of HBV DNA in 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.
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.
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 <20 IU/mL (<1.30 log IU/mL). This assay cannot accurately quantify HBV DNA below this level" indicates that the HBV DNA level is below the lower limit of quantification for this assay. When clinically indicated, follow-up testing with 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.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not licensed by the FDA as a screening test for hepatitis B virus (HBV) infections or a diagnostic test to confirm the presence of HBV infection.
Laboratory evaluation of HBV infection status should begin with HBV serologic testing, including testing for the presence of hepatitis B surface antigen. A diagnosis of chronic HBV infection should not be based solely on the presence of detectable or quantifiable HBV DNA in a single serum specimen.
An "Undetected" HBV DNA test result in conjunction with a positive anti-HBV antibody status does not exclude the possibility of a resolved HBV infection. When clinically indicated, patients should be retested for HBV DNA in 1 to 2 months, to distinguish between past/resolved HBV infection and chronic HBV infection with episodic viral replication.
Quantitative HBV DNA results generated by this assay may be more than 0.5 log IU/mL lower than those of the VERSANT HBV DNA 3.0 Assay (bDNA) among some clinical serum specimens. Patient care providers are encouraged to use the same HBV DNA quantification assay for serial monitoring of HBV DNA levels in individual patient.
This assay was confirmed to have a lower limit of quantification (LLoQ) of 20 IU/mL based on probit analysis (95% hit rate), with good correlation to expected results and good linearity over the quantification range of the assay. Accuracy of results among hepatitis B virus (HBV) genotypes A to H was also confirmed. The mean difference in HBV viral load results between the VERSANT HBV DNA 3.0 Assay (bDNA) and the COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 was 0.30 log IU/mL, with 96.1% (49 of 51 specimens with quantifiable results by both assays) of the differences falling within 0.85 log IU/mL of the mean difference and the individual differences ranging from 1.83 log IU/mL to -0.28 log IU/mL. A total of 25.5% (13 of 51 specimens) of the VL differences were >0.5 log IU/mL, and 5.9% (3 of 51 specimens) of the differences were >1.0 log IU/mL. No bias was observed over the range of HBV DNA levels tested. Similar viral load differences of >1.0 log IU/mL were observed in a published evaluation of this assay.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
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
Method Description Describes how the test is performed and provides a method-specific reference
The COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 is an FDA-approved in vitro nucleic acid amplification test for the quantification of hepatitis B virus (HBV) DNA in human serum using the COBAS AmpliPrep instrument for automated viral nucleic acid extraction (generic silica-based capture technique) and the COBAS TaqMan analyzer for automated amplification and detection of the viral nucleic acid target. This assay targets the highly conserved pre-Core/Core region of the HBV genome and generates amplification products that are detected real-time by a sequence-specific TaqMan probe during amplification. The probe contains a reporter fluorophore and a quencher dye that absorbs light emitted by the reporter. Cleavage of the probe physically separates the quencher from the reporter, enabling light emitted by the latter to be detected by a photomultiplier tube. Because amplification and detection are performed simultaneously, amplification products are measured during the exponential phase of DNA amplification regardless of the initial target concentration.(Package insert: COBAS AmpliPrep/COBAS TaqMan HBV Test v2.0; Roche Molecular Systems, Inc., Branchburg, NJ, 9/2010)
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; Varies
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 has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
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|
|88634||HBV DNA Detect/Quant, S||42595-9|