Test Catalog

Test Id : HBVQN

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Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection and quantification of hepatitis B virus (HBV) DNA in serum of patients with chronic HBV infection (ie, hepatitis B surface antigen-positive)

 

Monitoring disease progression in chronic HBV infection

 

Monitoring response to anti-HBV therapy

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HBV DNA Detect/Quant, S

Aliases
Lists additional common names for a test, as an aid in searching

HBV DNA

HBV PCR

HBV Quantification

HBV DNA Quantitation

HBV Viral load

Hepatitis B Viral Load

Hepatitis B Quantitation

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum SST

Shipping Instructions

1. Ship specimen frozen on dry ice only.

2. If shipment will be delayed for more than 24 hours, freeze serum at -20 to -80 degrees C (up to 84 days) until shipment on dry ice.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Gastroenterology and Hepatology Test Request (T728)

-Microbiology Test Request (T244)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.8 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 84 days
Refrigerated 6 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection and quantification of hepatitis B virus (HBV) DNA in serum of patients with chronic HBV infection (ie, hepatitis B surface antigen-positive)

 

Monitoring disease progression in chronic HBV infection

 

Monitoring response to anti-HBV therapy

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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, the 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 nucleoside/nucleotide 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).

 

The following algorithms are available:

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-HBV Infection-Monitoring Before and After Liver Transplantation

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.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

The quantification range of this assay is 10 to 1,000,000,000 IU/mL (1.00 log to 9.00 log IU/mL).

 

An "Undetected" result indicates that hepatitis B virus (HBV) DNA was not detected in the serum specimen.

 

A result of "<10 IU/mL (<1.00 log IU/mL)" indicates that HBV DNA is detected, but the HBV DNA level present cannot be quantified accurately below this lower limit of quantification of 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 result of ">1,000,000,000 IU/mL (>9.00 log IU/mL)" indicates the presence of active HBV viral replication, and the HBV DNA level present cannot be quantified accurately above this upper limit of quantification of this assay.

 

An “Inconclusive” result with the comment "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 US Food and Drug Administration as a screening test for hepatitis B virus (HBV) infections.

 

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 and resolved HBV infection and chronic HBV infection with episodic viral replication.

 

Patient care providers are encouraged to use the same HBV DNA quantification assay for serial monitoring of HBV DNA levels in individual patient.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15 Supply 15:35-44

2. World Health Organization: Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. World Health Organization; March 2015. Accessed May 12, 2023. Available at www.who.int/publications/i/item/9789241549059

3. Terrault NA, Bzowej NH, Chang KM, Hwang JP, Jonas MM, Murad MH: AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016;63(1):261-283

4. World Health Organization: Guidelines on hepatitis B and C testing. World Health Organization; February 2017. Accessed May 12, 2023. Available at www.who.int/publications/i/item/9789241549981

Method Description
Describes how the test is performed and provides a method-specific reference

The cobas HBV is a US Food and Drug Administration-approved in vitro nucleic acid amplification test for the quantification of hepatitis B virus (HBV) DNA in human serum, using the using the cobas 6800 or 8800 instrument for automated viral nucleic acid extraction (silica-based capture technique), purification, 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 HBV-Quantitative nucleic acid test for use on the cobas 6800/8800 Systems. Roche Molecular Systems, Inc., Doc rev. 2.0, 12/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US 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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87517

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HBVQN HBV DNA Detect/Quant, S 42595-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
65555 HBV DNA Detect/Quant, S 42595-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports