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HelpTest ID: HBCRQ Hepatitis B Virus Core-Related Antigen, Quantitative, Serum
Ordering Guidance
This test should be requested only in individuals with all the following:
-Chronic hepatitis B
-Confirmed positive hepatitis B surface (HBs) antigen
-Negative hepatitis B e antigen (HBeAg)
-Positive hepatitis B e antibody (anti-HBe)
-Undetectable or low hepatitis B viral DNA levels (eg, <500 IU/mL) in serum
Additional Testing Requirements
Testing for hepatitis B virus (HBV) DNA (HBVQN / Hepatitis B Virus [HBV] DNA Detection and Quantification by Real-Time PCR, Serum) and surface antigen (HBAGQ / Hepatitis B Virus Surface Antigen, Quantitative, Serum) levels in serum will be helpful in monitoring response to curative antiviral therapy for chronic hepatitis B.
Shipping Instructions
Ship specimen frozen on dry ice only. If shipment will be delayed for more than 24 hours, freeze serum at -20 degrees to -80° C (up to 60 days) until shipment, and transport on dry ice.
Necessary Information
Collection date is required.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial
Useful For
Monitoring of response to antiviral therapy in individuals with chronic hepatitis B who are negative for hepatitis B e antigen (HBeAg), positive for hepatitis B e antibody, and undetectable or low hepatitis B virus DNA levels (eg, <500 IU/mL) in serum
Special Instructions
Method Name
Chemiluminescent Enzyme Immunoassay
Reporting Name
HBcr Ag, Quantitative, SSpecimen Type
SerumSpecimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 28 days | |
| Refrigerated | 14 days | ||
| Ambient | 7 days |
Clinical Information
During antiviral treatment of chronic hepatitis B (CHB), measurement of hepatitis B virus (HBV) DNA in serum or plasma is used as a marker of treatment efficacy, providing an estimate of the viral replicative activity in the treated individual. However, with nucleoside/nucleotide analogues (NA) acting on limited steps of the viral replication cycle, the production of HBV intermediate proteins (such as hepatitis B core antigen [HBcAg], hepatitis B surface antigen [HBsAg], and hepatitis B e antigen [HBeAg]) may not be affected significantly during such treatment. Therefore, measurement of such HBV proteins in serum or plasma can be useful in monitoring treatment efficacy, especially in patients receiving NA therapy when serum or plasma HBV DNA levels are undetectable. Another recently discovered group of HBV intermediate proteins, hepatitis B core-related antigens (HBcrAgs), comprises 3 related proteins sharing an identical 149 amino acid sequence: HBcAg, HBeAg, and a truncated 22-kDa precore protein.
HBcrAg levels in serum or plasma of individuals with CHB showed good correlation with intrahepatic covalently closed circular DNA (cccDNA) and total HBV DNA, serum HBV DNA, and HBsAg to a lesser extent. In situations where serum HBV DNA levels become undetectable or HBsAg loss is achieved, HBcrAg can still be detectable. Serum HBcrAg concentration correlates strongly with the serum HBV DNA concentration in a positive and linear manner, regardless of the HBeAg status. Intrahepatic total HBV DNA also correlates well with serum HBcrAg in treatment-naive or -experienced individuals. For these reasons, HBcrAg levels in serum or plasma can estimate the intrahepatic cccDNA quantity and serve as a useful marker for disease monitoring, predicting treatment response and disease outcome of CHB.
HBcrAg levels in serum or plasma are also helpful in differentiating HBeAg-negative CHB from HBeAg-positive CHB, predicting spontaneous or treatment-induced HBeAg seroconversion, sustained response to NA therapy, risk of HBV reactivation in occult HBV infection under immunosuppressive therapies, and risk of hepatocellular carcinoma (HCC) development as well as post-operative HCC recurrence.
Reference Values
<1,000 U/mL
Interpretation
This assay has a limit of detection of 158 U/mL and quantifies hepatitis B core-related antigen (HBcrAg) in serum within the range of 1000 to 7,500,000 U/mL (or 3.00 log to 6.88 log U/mL).
Result of <1000 U/mL indicates that the HBcrAg level present in the serum specimen tested is less than 1000 U/mL (the lower limit of quantification of this assay).
Clinical Reference
1.Chen EQ, Feng S, Wang ML, et al. Serum hepatitis B core-related antigen is a satisfactory surrogate marker of intrahepatic covalently closed circular DNA in chronic hepatitis B. Sci Rep. 2017;7(1):173. doi:10.1038/s41598-017-00111-0
2. Zhang ZQ, Zhang XN, Lu W, et al. Distinct patterns of serum hepatitis B core-related antigen during the natural history of chronic hepatitis B. BMC Gastroenterol. 2017;17:140. doi:10.1186/s12876-017-0703-9
3. Mak, LY,Wong DK, Cheung KS, et al. Hepatitis B core-related antigen (HbcrAg): an emerging marker for chronic hepatitis B virus infection. Aliment Pharmacol Ther. 2018;47(1):43-54. doi:10.1111/apt.14376
4. Van Halewijn GJ, Geurtsvankessel CH, Klaasse J, et al. Diagnostic and analytical performance of the hepatitis B core related antigen immunoassay in hepatitis B patients. J Clin Virol. 2019;114:1-5. doi:10.1016/j.jcv.2019.03.003
Day(s) Performed
Tuesday
Report Available
1 to 7 daysTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
82397
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HBCRQ | HBcr Ag, Quantitative, S | 97152-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HBCQ2 | HBcr Ag, Quantitative, S | 97152-3 |
Testing Algorithm
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Forms
f not ordering electronically, complete, print, and send 1 of the following:
mml-gi-liver-hepatitis