Test Catalog

Test Id : PHEP

Previous Hepatitis (Unknown Type), Serum

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

Determining if an individual has been infected following exposure to an unknown type of hepatitis

 

Obtaining baseline serologic markers of an individual exposed to a source with an unknown type of hepatitis

 

Determining immunity to hepatitis A and B viral infections

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
HAIGG Hepatitis A IgG Ab, S Yes Yes
HBAG HBs Antigen, S Yes Yes
HBAB HBs Antibody, S Yes Yes
HBC HBc Total Ab, S Yes Yes
HCVDX HCV Ab w/Reflex to HCV PCR, S Yes Yes

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
HBGNT HBs Antigen Confirmation, S No No
HCVQN HCV RNA Detect/Quant, S Yes No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis C virus (HCV) antibody is reactive, then HCV RNA detection and quantification by real-time reverse transcription polymerase chain reaction will be performed at an additional charge.

 

If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge.

 

See the following:

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

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

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

HAIGG: Chemiluminescent Microparticle Immunoassay (CMIA)

HBAG, HBAB, HBC, HCVDX, HBGNT: Chemiluminescence Immunoassay (CIA)

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

Previous Hepatitis Profile

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

PHEP

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis C virus (HCV) antibody is reactive, then HCV RNA detection and quantification by real-time reverse transcription polymerase chain reaction will be performed at an additional charge.

 

If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge.

 

See the following:

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

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

Specimen Type
Describes the specimen type validated for testing

Serum

Serum SST

Necessary Information

Date of draw is required.

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

Both 0.5 mL of refrigerated serum and 2.5 mL of frozen serum are preferred for this test.

 

Patient Preparation: For 24 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 3 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 0.5 mL serum into an aliquot tube labeled as HAIGG, and ship refrigerate (required)

3. Transfer remaining 2.5 mL serum into a second aliquot tube labeled as SST Serum, and ship frozen (preferred).

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

Forms

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

-Gastroenterology and Hepatology Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

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

2.5 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
Heat-inactivated specimen 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 Refrigerated (preferred) 5 days
Serum SST Frozen (preferred) 28 days
Refrigerated 5 days

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

Determining if an individual has been infected following exposure to an unknown type of hepatitis

 

Obtaining baseline serologic markers of an individual exposed to a source with an unknown type of hepatitis

 

Determining immunity to hepatitis A and B viral infections

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis C virus (HCV) antibody is reactive, then HCV RNA detection and quantification by real-time reverse transcription polymerase chain reaction will be performed at an additional charge.

 

If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge.

 

See the following:

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

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

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

Hepatitis A:

Hepatitis A virus (HAV) is an RNA virus that accounts for 20% to 25% of the viral hepatitis in United States adults. HAV infection is spread by the oral/fecal route and produces acute hepatitis that follows a benign, self-limited course. Spread of the disease is usually associated with contaminated food or water caused by poor sanitary conditions. Outbreaks frequently occur in overcrowded situations and in institutions or high density centers such as prisons and health care centers. Epidemics may occur following floods or other disaster situations. Chronic carriers of HAV have never been observed.

 

Hepatitis B:

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 by drug addicts). The virus is also found in virtually every type of human body fluid and 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; it is not commonly transmitted transplacentally. After a course of acute illness, HBV persists in approximately 10% of patients. Some of these chronic carriers are asymptomatic, others develop chronic liver disease, including cirrhosis and hepatocellular carcinoma.

 

Hepatitis C:

Hepatitis C virus (HCV) is an RNA virus that is a significant cause of morbidity and mortality worldwide. HCV is transmitted through contaminated blood or blood products or through other close, personal contacts. It is recognized as the cause of most cases of posttransfusion hepatitis. HCV shows a high rate of progression (>50%) to chronic disease. In the United States, HCV infection is quite common, with an estimated 3.5 to 4 million chronic HCV carriers. Cirrhosis and hepatocellular carcinoma are sequelae of chronic HCV.

 

The following algorithms are available:

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

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-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.

HEPATITIS B SURFACE ANTIGEN

Negative

 

HEPATITIS B SURFACE ANTIGEN CONFIRMATION

Negative

 

HEPATITIS B SURFACE ANTIBODY, QUALITATIVE/QUANTITATIVE

Hepatitis B Surface Antibody

Unvaccinated: negative

Vaccinated: positive

 

Hepatitis B Surface Antibody, Quantitative

Unvaccinated: <5.0 mIU/mL

Vaccinated: > or =12.0 mIU/mL

 

HEPATITIS B CORE TOTAL ANTIBODIES

Negative

 

HEPATITIS A IgG ANTIBODY

Unvaccinated: negative

Vaccinated: positive

 

HEPATITIS C ANTIBODY

Negative

 

HEPATITIS C VIRUS RNA DETECTION and QUANTIFICATION by REAL-TIME RT-PCR

Undetected

 

Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles.

Interpretation
Provides information to assist in interpretation of the test results

Hepatitis A:

Antibody against hepatitis A antigen (anti-HAV) is almost always detectable by the onset of symptoms (usually 15-45 days after exposure). The initial antibody consists almost entirely of the IgM subclass of antibody. Anti-HAV IgM usually falls to undetectable levels 3 to 6 months after infection. Anti-HAV IgG levels rise quickly once the virus is cleared and persist for many years.

 

Hepatitis B:

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 16 weeks following hepatitis B virus (HBV) infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Hepatitis B surface antibody (anti-HBs) appears with the resolution of HBV infection after the disappearance of HBsAg. Anti-HBs also appears as the immune response following a course of inoculation with the hepatitis B vaccine.

 

Hepatitis B core antibody (anti-HBc) appears shortly after the onset of symptoms of HBV infection and may be the only serologic marker remaining years after exposure to hepatitis B.

 

Hepatitis C:

Hepatitis C virus antibody (anti-HCV) is usually not detectable during the early months following infection, but is almost always detectable by the late convalescent stage of infection. Anti-HCV is not neutralizing and does not provide immunity.

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

Consider administration of immune globulin to the individual exposed to hepatitis A.

 

Consider administration of hepatitis B immune globulin and/or hepatitis B vaccine to the individual exposed to hepatitis B.

 

Positive hepatitis B surface antigen test results should be reported by the attending physician to the State Department of Health, as required by law in some states.

 

Type-specific tests should be used to evaluate individuals who have been exposed to a source with a known type of hepatitis (eg, hepatitis A, hepatitis B, hepatitis C).

 

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 >3,000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Containing particulate matter

-Cadaveric specimens

-Immunocompromised or immunosuppressed specimens

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

1. Roque-Afonso AM, Desbois D, Dussaix E: Hepatitis A virus: serology and molecular diagnostics. Future Virology. 2010;5(2):233-242

2. de Paula VS: Laboratory diagnosis of hepatitis A. Future Virology. 2012;7(5):461-472

3. Bonino F. Piratvisuth T, Brunetto MR, Liaw YFet: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15(Suppl. 3):35-44

4. Wasley A, Fiore A, Bell BP: Hepatitis A in the era of vaccination. Epidemiol Rev. 2006;28:101-111

5. American Association for the Study of Liver Diseases/Infectious Diseases Society of America/International Antiviral Society-USA: Recommendations for Testing, Managing, and Treating Hepatitis C. Accessed on September 29, 2020. Available at www.hcvguidelines.org

6. LeFebre 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;161:58-66. doi:10.7326/M14-1018

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

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

9. WHO Guidelines Development Group: World Health Organization guidelines on hepatitis B and C testing. World Health Organization; 2017. Available at www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en/

10. Centers for Disease Control and Prevention. Testing and public health management of persons with chronic hepatitis B virus infection. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

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

Hepatitis A IgG Antibody:

The ARCHITECT HAVAb-IgG assay is an automated immunoassay designed for the qualitative detection of hepatitis A virus (HAV)-specific IgG antibody in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) method. Patient's sample, assay diluent, and HAV-coated paramagnetic microparticles are combined first in a reaction well. Anti-HAV IgG present in the patient sample binds to the HAV-coated microparticles. After washing, the acridinium-labeled antihuman IgG conjugate is added to bind to anti-HAV IgG. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The presence or absence of anti-HAV IgG in the patient sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an ARCHITECT HAVAB-G calibration. Specimens with signal to cutoff (S/Co) values at or above 1.00 are considered positive for anti-HAV IgG. Specimens with S/Co values below 1.00 are considered negative.(Package insert: HAVAB-G. Abbott Laboratories; 02/2016)

 

Hepatitis B Surface Antigen:

Specimens are first tested by the VITROS HBsAg assay. With modification to the assay manufacturer's instructions for use, specimens yielding S/Co at or above 1.00, but less than or equal to 100.0 will be confirmed by the VITROS hepatitis B surface antigen (HBsAg) Confirmatory assay. Specimens that are strongly positive (ie, S/Co >100.0) do not require this confirmation.

 

This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal hepatitis B surface antibody (anti-HBs) coated onto the wells and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs antibody in the conjugate. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, no. GEM1201_EN_US, version 13.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

 

Hepatitis Bs Antigen Confirmation:

The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: 1 aliquot is incubated with a neutralizing reagent containing high titer anti-HBs (the confirmatory antibody); the second aliquot is incubated with a non-neutralizing control reagent (the sample diluent). The confirmatory antibody binds to HBsAg in the sample inhibiting its reaction in the VITROS HBsAg assay. This leads to a reduced result compared to that for the non-neutralized control sample.(Package insert: VITROS HBsAg Confirmation assay, no. GEM4201_EN_US, version 13.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

 

Hepatitis Bs Antibody:

The VITROS anti-HBs quantitative assay is

a chemiluminescent immunoassay based on an immunometric technique in which the anti-HBs present in the clinical serum sample reacts with HBsAg (ad and ay subtypes) coated onto the assay reaction wells. A HRP-labeled HBsAg conjugate (ad and ay subtypes) then complexes with the bound anti-HBs forming an "antigen sandwich." Unbound materials are removed by washing.

 

A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. HRP in the bound conjugate catalyzes the oxidation of the luminol derivative to produce light. The electron transfer agent increases the level and duration of the light produced. The light signals are detected by the system. The amount of HRP conjugate bound is directly proportional to the concentration of anti-HBs antibody present.(Package insert: VITROS Anti-HBs Quantitative Assay no. GEM1208 EN, v 13.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

 

Hepatitis B Core Total Antibody:

The VITROS anti-hepatitis B core (anti-HBc) assay is a competitive immunoassay method based on the reaction of anti-HBc in the sample with hepatitis B core antigen (HBcAg)-coated wells. Unbound sample is removed by washing. HRP-labeled antibody conjugate (mouse monoclonal anti-HBc) is then allowed to react with the remaining exposed HBcAg on the well surface. Unbound conjugate is removed by washing.

 

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the concentration of anti-HBc present in the sample.(Package insert: VITROS Anti-HBc Assay, no. GEM1208_EN_US, version 14.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

 

Hepatitis C Virus Antibody:

The VITROS anti-HCV assay is performed using an immunometric technique involving a 2-stage reaction. In the first stage, HCV antibody present in the sample binds to HCV recombinant antigens coated on the reaction wells, and unbound sample is removed by washing. In the second stage, HRP-labeled antibody conjugate (mouse monoclonal antihuman IgG) binds to human IgG captured on the well in the first stage. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminal derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminal derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The emitted light signals are detected and measured by the system. The amount of HRP conjugate bound is directly proportional to the level of anti-HCV antibodies present in a given sample.(Package insert: VITROS Anti-HCV Assay, no. GEM1243_EN_US, version 14.1. Ortho-Clinical Diagnostics, Inc; 09/06/2019)

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.

HAIGG, HCVDX: Monday through Saturday

HBAG, HBAB: Monday through Friday, Sunday

HBC: Monday through Sunday

HBGNT: Monday, Wednesday, Friday

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 2 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 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.

86704

86706

86708

86803

87340

87341 (if appropriate)

87522 (if appropriate)

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
PHEP Previous Hepatitis Profile 92890-3
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.
HBC HBc Total Ab, S 13952-7
HB_AB HBs Antibody, S 10900-9
HBSQN HBs Antibody, Quantitative, S 5193-8
H_BAG HBs Antigen, S 5196-1
HAIGG Hepatitis A IgG Ab, S 40724-7
HCVA4 HCV Ab, S 40726-2

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