Test ID: CHSUP
Chronic Hepatitis Profile (Type Unknown)
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Diagnosis and evaluation of patients with symptoms of hepatitis with a duration >6 months
Distinguishing between chronic hepatitis B and chronic hepatitis C
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 |
|---|---|---|---|
| HBAG | HBs Antigen, S | Yes | Yes |
| HBAB | HBs Antibody, S | Yes | Yes |
| HBC | HBc Total Ab, S | Yes | Yes |
| HCV | HCV Ab Screen, S | Yes | Yes |
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBGNT | HBs Antigen Confirmation, S | No | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If hepatitis B surface antigen (HBsAg) is reactive, then HBsAg confirmation will be performed at an additional charge.
The following algorithms are available in Special Instructions:
-HBV Infection-Diagnostic Approach and Management Algorithm
-Testing Algorithm for the Diagnosis of Hepatitis C
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Chemiluminescence Immunoassay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
HBV (Hepatitis B Virus)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 3 mL
Additional Information: Date of draw is required.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| Other | Plasma |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | |
| Refrigerated | 7 days | |
| Ambient | 24 hours | |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 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.
Publications: Advances in the Laboratory Diagnosis of Hepatitis C (2002)
The following algorithms are available in Special Instructions:
-HBV Infection-Diagnostic Approach and Management Algorithm
-Testing Algorithm for the Diagnosis of Hepatitis C
-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 ANTIBODY, QUALITATIVE/QUANTITATIVE
Hepatitis B Surface Antibody
Unvaccinated: negative
Vaccinated: positive
Hepatitis B Surface Antibody, Quantitative
Unvaccinated: <5.0
Vaccinated: > or =12.0
HEPATITIS B CORE TOTAL ANTIBODIES
Negative
HEPATITIS C ANTIBODY SCREEN
Negative
Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles in Special Instructions.
Interpretation Provides information to assist in interpretation of the test results
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. Persistence of HBsAg for more than 6 months indicates development of either a chronic carrier state or chronic liver disease.
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. The IgM subclass usually falls to undetectable levels within 6 months, while the IgG subclass may remain for many years and may be the only serologic marker remaining years after exposure to hepatitis B.
If HBsAg and anti-HBc (total antibody) are positive and the patient's condition warrants, consider testing for hepatitis B envelope antigen (HBeAg), hepatitis B envelope antibody (anti-HBe), HBV-DNA, or hepatitis delta virus antibody (anti-HDV).
Hepatitis C
Hepatitis C virus (HCV) antibody is usually not detectable during the early months following infection, but is almost always detectable by the late convalescent stage of infection. The serologic tests currently available do not differentiate between acute and chronic HCV infections. HCV antibody is not neutralizing and does not provide immunity.
Publications: Advances in the Laboratory Diagnosis of Hepatitis C (2002)
The following algorithms are available in Special Instructions:
-HBV Infection-Diagnostic Approach and Management Algorithm
-Testing Algorithm for the Diagnosis of Hepatitis C
-Viral Hepatitis Serologic Profiles
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Positive hepatitis B surface antigen (HBsAg) test results should be reported by the attending physician to the State Department of Health, as required by law in some states.
Consider administration of hepatitis B immune globulin and hepatitis B vaccine to individuals exposed to the patient's blood and/or body fluids.
If clinically indicated, testing for HBIM/9015 Hepatitis B Core Antibody, IgM (Anti-HBc, IgM), Serum should be ordered to confirm an acute or recent infection.
Neonates (<1 month old) with positive anti-HBc total antibody results from this assay method should be tested for anti-HBc IgM antibody to rule out possible maternal anti-HBc total antibody causing false-positive results. Repeat testing for anti-HBc total antibody within 1 month is also recommended in these anti-HBc total antibody-positive neonates.
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
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Wietzke P, Schott P, Braun F, et al: Clearance of HCV RNA in a chronic hepatitis C virus-infected patient during acute hepatitis B virus superinfection. Liver 1999;19:348-353
2. Villari D, Pernice M, Spinella S, et al: Chronic hepatitis in patients with active hepatitis B virus and hepatitis C virus combined infections: a histological study. Am J Gastroenterol 1995;90:955-958
3. Schmilovitz-Weiss H, Levy M, Thompson N, Dusheiko G: Viral markers in the treatment of hepatitis B and C. Gut 1993;34 (2 Suppl):S26-S35
Method Description Describes how the test is performed and provides a method-specific reference
Hepatitis B Surface Antigen (HBsAg)
Specimens are first tested by the VITROS HBsAg assay. With modification to the assay manufacturer's instructions for use, specimens yielding S/CO > or =1.00 but < or =50.0 will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/CO >50.0) 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) antibody 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 VITROS ECi System. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample. (Package insert: VITROS HBsAg assay, no. J03798, version 1.0; Ortho-Clinical Diagnostics, Inc. Rochester, NY)
HBsAg 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. J10583, version 1.0; Ortho-Clinical Diagnostics, Inc., Rochester, NY)
HBs Antibody
VITROS anti-HBs quantitative assay is performed using the VITROS Anti-HBs Quantitative Reagent Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrators on the automated VITROS ECi/ECiQ Immunodiagnostic System.
This chemiluminescence immunoassay is 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 VITROS ECi/ECiQ Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of anti-HBs antibody present. (Package insert: Publication no. GEM1208 EN, v 2.0; VITROS Anti-HBs Quantitative Assay, Ortho-Clinical Diagnostics, Inc., Rochester, NY)
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 hepatitis B core antigen 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 VITROS ECi 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. J20866, version 2.0; Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626-5101)
Hepatitis C Virus (HCV) Antibody Screen
The VITROS anti-HCV assay is performed using the VITROS Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator on the VITROS 3600 Immunodiagnostic System (Ortho-Clinical Diagnostics, Inc., Raritan, NJ). An immunometric technique is used, 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 VITROS 3600 Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the level of anti-HCV antibodies present in a given sample. (Ismail N, Fish GE, Smith MN: Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus. J Clin Microbiol 2004;42:610-617)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86704-Hepatitis B core total antibodies
86706-Hepatitis B surface antibody, qualitative/quantitative
86803-Hepatitis C antibody screen
87340-Hepatitis B surface antigen
87341-Hepatitis B surface antigen confirmation (if appropriate)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| HBC | HBc Total Ab, S | 22327-1 |
| HB_AB | HBs Antibody, S | 22322-2 |
| H_BAG | HBs Antigen, S | 5195-3 |
| HCVA | HCV Ab Screen, S | 16128-1 |
| HBSQN | HBs Antibody, Quantitative, S | 16935-9 |
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