Test Catalog

Test Id : HBNTP

Not Orderable

Hepatitis B Virus Surface Antigen Confirmation, Prenatal, Serum

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Overview

Test Catalog

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

Diagnosis of acute, recent, or chronic hepatitis B in prenatal patients

 

This test is not useful during the "window period" of acute hepatitis B (ie, after disappearance of hepatitis B virus surface antigen [HBsAg] and prior to appearance of HBs antibody).

 

This test is not suitable as stand-alone prenatal screening test of HBsAg status in pregnant women.

 

This test is not offered as a HBsAg screening or confirmatory test for blood donor specimens.

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

Only orderable as a reflex. For more information see HBAGP / Hepatitis B Virus Surface Antigen Prenatal, Serum.

 

Electrochemiluminescence Immunoassay (ECLIA)

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 Confirmation Prenatal, S

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

HBs Neutralization

Hepatitis B Surface Neutralization

HBsAg Neutralization

Hepatitis B Surface Antigen Neutralization

HBNTP

Specimen Type
Describes the specimen type validated for testing

Serum SST

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

Only orderable as a reflex. For more information see HBAGP / Hepatitis B Virus Surface Antigen Prenatal, Serum.

 

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel (red-top tubes are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.8 mL

Collection Instructions:

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

2. Aliquot serum into a plastic vial.

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. The minimum volume is sufficient for one attempt at testing.

0.7 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 SST Ambient 72 hours
Refrigerated 6 days
Frozen (preferred) 90 days

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

Diagnosis of acute, recent, or chronic hepatitis B in prenatal patients

 

This test is not useful during the "window period" of acute hepatitis B (ie, after disappearance of hepatitis B virus surface antigen [HBsAg] and prior to appearance of HBs antibody).

 

This test is not suitable as stand-alone prenatal screening test of HBsAg status in pregnant women.

 

This test is not offered as a HBsAg screening or confirmatory test for blood donor specimens.

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

Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles among injection drug users). The virus is found in various human body fluids, and it is known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted transplacentally.

 

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum at 6 to 8 weeks following exposure to 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.

 

For more information see:

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

-HBV Infection-Monitoring Before and After Liver Transplantation

-Viral Hepatitis Serologic Profiles

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.

Only orderable as a reflex. For more information see HBAGP / Hepatitis B Virus Surface Antigen Prenatal, Serum.

 

Negative

Interpretation
Provides information to assist in interpretation of the test results

A reactive screen result (cutoff index values > or =1.00) confirmed as positive by a hepatitis B surface antigen (HBsAg) confirmatory test is indicative of acute or chronic hepatitis B or chronic hepatitis B virus (HBV) carrier state.

 

Specimens with reactive screen results but negative (ie, not confirmed) HBsAg confirmatory test results are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. If clinically indicated, repeat testing, at a later date, is recommended.

 

Confirmed presence of HBsAg is frequently associated with HBV replication and infectivity, especially when accompanied by presence of hepatitis B e (HBe) antigen or detectable HBV DNA.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This assay has not been licensed by the US Food and Drug Administration  for the screening of blood, plasma, and tissue donors.

 

For diagnostic purposes, results should always be assessed in conjunction with the patient’s medical history, clinical examination, and other findings.

 

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

 

Positive HBsAg test results will need to be reported by the healthcare provider to their state department of health surveillance units, as required by law in some states.

 

Current methods for the detection of HBsAg may not detect all infected individuals.

 

A negative test result does not exclude with certainty a possible exposure to or on infection with the hepatitis B virus (HBV). Negative test results obtained for persons with a past exposure may be caused by an antigen concentration below the detection limit of this assay or the lack of reactivity of the antigens to the antibodies used in this assay.

 

Performance characteristics of this assay have not been established for testing of newborns or when used in conjunction with other manufacturers’ assays for specific HBV serological markers. 

 

Assay performance characteristics have not been established for the following specimen characteristics or specimen types:

-Grossly icteric (total bilirubin level of >40 mg/dL)

-Grossly lipemic (Intralipid level of >2200 mg/dL)

-Grossly hemolyzed (hemoglobin level of >2200 mg/dL)

-Containing particulate matter

-Cadaveric specimens

-Specimen types other than serum

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

1. LeFevre ML, U.S. Preventive Services Task Force. Screening for hepatitis B virus infection in nonpregnant adolescents and adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(1):58-66. doi:10.7326/M14-1018

2. Jackson K, Locarnini S, Gish R. Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis. 2018;12(1):5-11. doi:10.1002/cld.729

3. Coffin CS, Zhou K, Terrault NA. New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019;156(2):355-368. doi:10.1053/j.gastro.2018.11.037

4. WHO guidelines on hepatitis B and C testing. Geneva: World Health Organization; February 2017. Accessed December 19, 2023. Available at www.who.int/publications/i/item/9789241549981

5. Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and testing for hepatitis B virus infection: CDC recommendations - United States, 2023. MMWR Recomm Rep. 2023;72(1):1-25. doi:10.15585/mmwr.rr7201a1

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

The Elecsys HBsAg (hepatitis B virus surface antigen) II Auto Confirm assay is performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. This test is based on 2 parallel measurements. Patient's sample is treated first with the control pretreatment reagent (PT2) prior to immunoreaction. This measurement serves as a reference. For the second measurement the sample is treated with the confirmatory pretreatment reagent (PT1) prior to immunoreaction. During incubation with confirmatory pretreatment, unlabeled polyclonal anti-HBs are bound to the sample HBsAg and thereby block the binding sites for the labeled antibodies used in the following immunoreaction. The confirmation result (%) is automatically assessed by determining the ratio of both measurements.

 

During testing, the auto-diluted sample is incubated with control pretreatment and confirmatory pretreatment, followed by formation of sandwich complexes of biotinylated monoclonal anti-HBs and a mixture of monoclonal anti-HBs and polyclonal anti-HBs labeled with a ruthenium complex. After addition of streptavidin-coated microparticles (solid phase), the complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then washed away, and voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. The result is determined by comparing the electrochemiluminescence signal generated from the reaction product in the patient's samples to the cutoff index (COI) value set from reagent lot-specific assay calibration. The confirmation result (%) is calculated from the ratio of the COI obtained for the measurement with confirmatory pretreatment to the COI obtained for the measurement of control pretreatment reaction.(Package insert: Elecsys HBsAg II Auto Confirm. Roche Diagnostics; v1.0, 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.

Same day/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

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 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.

87341

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
HBNTP HBs Ag Confirmation Prenatal, S 7905-3
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.
HBNTP HBs Ag Confirmation Prenatal, S 7905-3

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