Test Catalog

Test Id : HBAGQ

Hepatitis B Virus Surface Antigen, Quantitative, Serum

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

Monitoring of progression of chronic hepatitis B in individuals who are confirmed to be positive for hepatitis B surface antigen

 

Monitoring of response to antiviral therapy in individuals who have chronic hepatitis B but are negative for hepatitis B e antigen and positive for hepatitis B e antibody

Highlights

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

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.

Yes

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

HBs Ag, Quantitative, S

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

HBAGQ

HBsAg quant

HBV s antigen quant

HBV surface antigen quant

Hepatitis B surface antigen quant

Hepatitis Bs Ag quant

Hepatitis Bs antigen quant

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test should only be requested in individuals with chronic hepatitis B, confirmed positive hepatitis B surface (HBs) antigen, negative HBe antigen (HBe Ag), and positive HBe antibody (anti-HBe) results.

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 core-related antigen (HBCRQ / Hepatitis B Virus Core-Related 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 to -80 degrees C (up to 60 days) until shipment on dry ice.

Necessary Information

Date of collection is required.

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

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL

Collection Instructions:

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

2. Transfer serum into aliquot tube.

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

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
Refrigerated 14 days
Ambient 7 days

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

Monitoring of progression of chronic hepatitis B in individuals who are confirmed to be positive for hepatitis B surface antigen

 

Monitoring of response to antiviral therapy in individuals who have chronic hepatitis B but are negative for hepatitis B e antigen and positive for hepatitis B e antibody

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum or plasma at 6 to 16 weeks following exposure to hepatitis B virus (HBV). In acute infection, HBsAg usually disappears in 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months in duration indicates development of either a chronic carrier state or chronic HBV infection.

 

Production of HBsAg is modulated by the interplay between the virus and host immune response, and HBsAg level in serum is inversely correlated with the immune control of HBV: the higher the immune control, the lower the HBsAg level in the infected individual. Quantitative HBsAg level in serum or plasma reflects the amount and the transcriptional activity of covalently closed circular DNA (cccDNA) inside hepatocytes of individuals with chronic hepatitis B (CHB). Therefore, quantitative HBsAg provides information concerning disease activity over and above an estimation of viral replication. In general, together with HBV DNA in serum or plasma, quantification of HBsAg in the same specimen is useful in the diagnosis of the true inactive HBV carrier state and in monitoring the clinical response to pegylated-interferon (PegIFN) and/or nucleoside/nucleotide analog (NA) therapy for CHB.

 

Inactive HBV carrier state is often defined by persistently normal alanine aminotransferase levels and low HBV DNA level in serum or plasma (<2000 IU/mL) in an individual negative for hepatitis B e antigen (HBeAg) with no or minimal liver injury. These individuals can have very good prognosis without the need of antiviral therapy, despite having fluctuating levels of HBV DNA over time. Some patients have low HBV DNA levels at one time but viral and biochemical reactivation at a later time. The HBsAg levels in serum or plasma of inactive HBV carriers tend to change very slowly with time and remain at low levels (ie, <1000 IU/mL), serving as a useful adjunct to HBV DNA level to aid in the identification of these individuals.

 

Clinical studies have shown that the change of HBsAg level in serum or plasma during PegIFN therapy mimics the change of both intrahepatic cccDNA and intrahepatic HBsAg, suggesting that a decline of HBsAg level in serum or plasma is associated with the induction of an effective anti-HBV immune response for monitoring CHB patients treated with PegIFN. Since decline of HBsAg level in serum or plasma during PegIFN therapy is confined mainly to patients who achieve therapeutic response, monitoring of HBsAg levels help distinguish patients likely to achieve a response from those who will not. On-treatment, HBsAg levels at weeks 12 and 24 of PegIFN therapy have high negative predictive values for therapeutic response and are useful to serve as stopping rules for the non-responders.

 

Although HBV DNA remains the key molecular marker to monitor the response and adherence of NA treatment in CHB patients, monitoring of HBsAg level every 6 months can give an estimate on the duration of NA treatment needed to achieve HBsAg seroclearance. HBsAg levels may be useful to predict HBV reactivation or sustained response after cessation of NA therapy. Currently, HBsAg seroclearance is still the acceptable endpoint to stop NA in HBeAg-negative patients.

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.

<0.005

Interpretation
Provides information to assist in interpretation of the test results

This assay quantifies hepatitis B surface antigen (HBsAg) in serum within the range of 0.005 to 150 IU/mL.

 

Result of <0.005 IU/mL indicates that HBsAg is present in the serum specimen at a level below 0.005 IU/mL (the lower limit of quantification of this assay).

 

Result of >150 IU/mL indicates that HBsAg is present in the serum specimen at a level above 150 IU/mL (the upper limit of quantification of this assay).

 

In untreated hepatitis B e antigen (HBeAg)-positive patients, HBsAg levels of >100,000 IU/ml are associated with high replicative HBsAg carrier (immune tolerance). In untreated, HBeAg-negative patients, HBsAg levels of <1000 IU/ml and hepatitis B virus DNA <2000 IU/ml in serum or plasma are associated with lower risk for hepatocellular carcinoma, while HBsAg levels of <100 IU/ml are associated with high rates of spontaneous HBsAg clearance.

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 surface antigen (HBsAg) in the serum specimen of an HBV-infected individual receiving antiviral therapy does not indicate cure or the absence of this virus in this individual. Serial measurements of HBsAg and other tests, such as HBV DNA (HBVQN / Hepatitis B Virus [HBV] DNA Detection and Quantification by Real-Time PCR, Serum) would be helpful or necessary to determine the definitive infection status in such individuals.

 

Individuals, especially neonates and children, who recently received hepatitis B vaccination may have transient positive HBsAg test results because of the large dose of HBsAg used in the vaccine relative to the individual's body mass.

 

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 >2000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >98 mg/dL)

-Containing particulate matter

-Cadaveric specimens

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

1. Wong GLH, Chan HLY: Use of quantitative hepatitis B surface antigen with hepatitis B virus DNA in clinical practice. Clin Liver Dis. 2013 Feb;2(1):8-10. doi: 10.1002/cld.165

2. Tseng TC, Kao JH: Clinical utility of quantitative HBsAg in natural history and nucleos(t)ide analogue treatment of chronic hepatitis B: new trick of old dog. J Gastroenterol. 2013 Jan;48(1):13-21. doi: 10.1007/s00535-012-0668-y

3. Choi SJ, Park Y, Lee EY,et al: Performance evaluation of LUMIPULSE G 1200 autoimmunoanalyzer for the detection of serum hepatitis B virus markers. J Clin Lab Anal. 2013 May;27(3):204-206. doi: 10.1002/jcla.21584

4. Yang R, Song G, Guan W, Wang Q, Liu Y, Wei L: The Lumipulse G HBsAg-Quant assay for screening and quantification of the hepatitis B surface antigen. J Virol Methods. 2016 Feb;228:39-47

5. Cornberg M, Wong VWS, Locarnini S, Brunetto M, Janssen HLA, Chan HLY: The role of quantitative hepatitis B surface antigen revisited. J Hepatol. 2017 Feb;66(2):398-411. doi: 10.1016/j.jhep.2016.08.009

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

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

Lumipulse G hepatitis B surface antigen (HBsAg Quant is an assay system, including a set of immunoassay reagents, for the quantitative detection of HBsAg in specimens based on chemiluminescent enzyme immunoassay technology using a 2-step sandwich immunoassay method. Specimen or HBsAg-Quant calibrator and sample treatment solution are added to the antibody-coated particle solution and mixed. HBsAg in specimens specifically binds to anti hepatitis B surface (anti-HBs) monoclonal antibodies on the particles, and antigen-antibody immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Alkaline phosphatase (ALP)-labeled anti-HBs monoclonal antibodies specifically bind to HBsAg of the immunocomplexes formed. The particles are washed and rinsed to remove unbound materials. Substrate solution is added and mixed with the particles. AMDPPD (3-[2'-spiroadamantane]-4-methoxy-4-[3'-phosphoryloxy]phenyl-1,2-dioxetance disodium salt) contained in the substrate solution is dephosphorylated by the catalysis of ALP indirectly conjugated to particles. Luminescence (at a maximum wavelength of 477 nm) is generated by the cleavage reaction of dephosphorylated AMPPD. The luminescent signal reflects to the amount of HBsAg.(Package insert: Lumipulse G HBsAg-Quant, 2OQ04TE, ver. 2. Fujirebio Inc; 06/2015)

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.

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.

1 to 7 days

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

14 days

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 Regional Manager. 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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test 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.

82397

LOINC® Information

Test Id Test Order Name Order LOINC Value
HBAGQ HBs Ag, Quantitative, S 63557-3
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
HBSQ1 HBs Ag, Quantitative, S 63557-3

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