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


Shipping Instructions


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



Specimen Required


Supplies: Aliquot Tube, 5 mL (T465)

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.


Useful For

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

Method Name

Real-Time Polymerase Chain Reaction

Reporting Name

HBV DNA Detect/Quant, S

Specimen Type

Serum SST

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

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

Clinical Information

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 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 in Special Instructions:

-HBV Infection-Diagnostic Approach and Management Algorithm

-HBV Infection-Monitoring Before and After Liver Transplantation

Reference Values

Undetected

Interpretation

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.

Clinical Reference

1. Bonino F, Piratvisuth T, Brunetto MR, et al: Diagnostic markers of chronic hepatitis B infection and disease. Antiviral Therapy 2010;15(3):35-44

2. World Health Organization: Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. Geneva: World Health Organization; 2015. Available at www.apps.who.int/iris/bitstream/10665/154590/1/9789241549059_eng.pdf?ua=1&ua=1

3. Terrault NA, Bzowej NH, Chang K-M, et al: AASLD guidelines for treatment of chronic hepatitis B. Hepatology 2016;63:261-283

4. World Health Organization: Guidelines on hepatitis B and C testing. Geneva: World Health Organization; 2017. Avaliable at www.apps.who.int/iris/bitstream/10665/254621/1/9789241549981-eng.pdf?ua=1

Day(s) and Time(s) Performed

Monday through Saturday; 7 a.m.-4 p.m.

Analytic Time

Monday through Thursday, 1 day; Friday and Saturday, 3 days

Test Classification

This test has been cleared, approved or is exempt 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

87517

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HBVQN HBV DNA Detect/Quant, S 42595-9

 

Result ID Test Result Name Result LOINC Value
65555 HBV DNA Detect/Quant, S 42595-9

Forms

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

-General Request (T239)

-Gastroenterology and Hepatology Client Test Request (T728)

Mayo Clinic Laboratories | Gastroenterology Catalog Additional Information:

mml-gi-liver-hepatitis