Test Id : HBCRQ
Hepatitis B Virus Core-Related Antigen, Quantitative, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Highlights
This test measures the level of hepatitis B (HB) core-related antigen in the serum of patients with chronic hepatitis B (CHB) being monitored for response to antiviral therapy. Such measurement is especially useful in those individuals who are receiving immunotherapy or new antiviral agents to cure CHB with negative HBe antigen, positive HBe antibody, positive HB surface antigen, but undetectable or low hepatitis B virus DNA levels (eg, <500 IU/mL) in serum.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Method Name
A short description of the method used to perform the test
Chemiluminescent Enzyme Immunoassay
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
HBCRQ
HBcr Ag
HBV cr antigen
HBV core related antigen
Hepatitis B core related antigen
Hepatitis Bcr Ag
Hepatitis Bcr antigen
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Specimen Type
Describes the specimen type validated for testing
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 degrees C (up to 60 days) until shipment, and transport on dry ice.
Necessary Information
Collection date is required.
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: 2 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Forms
f not ordering electronically, complete, print, and send 1 of the following:
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.
0.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
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 | Frozen (preferred) | 28 days | |
| Ambient | 7 days | ||
| Refrigerated | 14 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For more information see Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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
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.
<1,000 U/mL
Interpretation
Provides information to assist in interpretation of the test results
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).
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Given the complex kinetics of hepatitis B virus (HBV) replication in chronic hepatitis B, a single undetectable result of hepatitis B core-related antigen (HBcrAg) in the serum specimen of an individual receiving antiviral therapy for chronic hepatitis B does not indicate cure or the absence of this virus in this individual. Serial measurements of HBcrAg and other tests, such as HBV DNA (HBVQN / Hepatitis B Virus DNA Detection and Quantification by Real-Time PCR, Serum) and HBsAg (HBAGQ / Hepatitis B Virus [HBV] Surface Antigen, Quantitative, Serum) levels, would be helpful or necessary to determine the definitive infection status in such individuals.
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Grossly lipemic (triolein level of >3000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Containing particulate matter
-Cadaveric specimens
Clinical Reference
Recommendations for in-depth reading of a clinical nature
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
Method Description
Describes how the test is performed and provides a method-specific reference
The Lumipulse G hepatitis B core-related antigen (HBcrAg) assay includes a set of immunoassay reagents for the detection and quantification of HBcrAg in specimens based on chemiluminescent enzyme immunoassay technology with a two-step immunoassay method and the LUMIPULSE G System. Pre-treatment solution containing a detergent is added to clinical serum specimens, HBcrAg calibrator, and assay controls to the pre-treatment solution. HBcr antibodies present in clinical serum specimens are inactivated in this step. HBcr antibody-coated particles are then added to the pre-treated clinical specimens, HBcrAg calibrator, and assay controls, followed by incubation. HBcrAg present in each sample specifically bind to HBcr antibodies present on the microparticles to form antigen-antibody immunocomplexes. Excess microparticles and unbound materials are removed by washing, followed by addition and incubation with alkaline phosphatase-labeled HBcr antibodies that specifically binds to HBcrAg in the antigen-antibody immunocomplexes attached to the microparticles to form larger immunocomplexes. After additional washes to remove unbound materials, a substrate solution is added to allow an enzymatic reaction to generate luminescence that is detected by the analyzer. The resulting luminescent signal is proportionate to the amount of HBcrAg present in the sample.(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
Tuesday
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.
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
Indicates the location of the laboratory that performs the test
Fees :
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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 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
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.
CPT codes are provided by the performing laboratory.
82397
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 |
|---|---|---|
| HBCRQ | HBcr Ag, Quantitative, S | 97152-3 |
| 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.
|
|---|---|---|
| HBCQ2 | HBcr Ag, Quantitative, S | 97152-3 |