Test ID: AHEPR
Acute Hepatitis Profile with Hepatitis C Virus Reflex
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
Differential diagnosis of acute viral hepatitis
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 |
| HAVM | Hepatitis A IgM Ab, S | Yes | Yes |
| HBIM | HBc IgM Ab, S | Yes | Yes |
| HCPCR | HCV Ab Scrn w/Reflex to HCV PCR, 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 |
|---|---|---|---|
| HCVQU | HCV RNA Detect/Quant, S | Yes | No |
| 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.
If hepatitis C virus (HCV) antibody screen is reactive, then HCV RNA detection and quantification 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
-Viral Hepatitis Serologic Profiles
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
HBAG/9013, HAVM/8342, HBIM/9015, HCPCR/60707, HBGNT/84396: Chemiluminescence Immunoassay
HCVQU/83142: Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
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
Anti-HCV (Hepatitis C Virus)
Anti-Hepatitis A
Anti-Hepatitis Bc
Anti-Hepatitis Bc (IgM) (Immunoglobulin M)
Antibody to Hepatitis Bc
Antibody to Hepatitis C Virus
HAA (Hepatitis A Antibody)
HBsAg (Hepatitis Bs Antigen)
HBV (Hepatitis B Virus)
HCV (Hepatitis C Virus) Antibody
HCV (Hepatitis C Virus) Quantitation
HCV (Hepatitis C Virus) Titer
HCV (Hepatitis C Virus) Viral Load
Hepatitis A Antibody (Anti-HAV)
Hepatitis B Virus (HBV)
Hepatitis Bc
Hepatitis Bs
Hepatitis C
Hepatitis Profiles
Hepatitis Screen
Non-A, Non-B Hepatitis
Viral Load
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
Collection Instructions: Spin down and remove serum from clot within 6 hours.
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 | |
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 (an enterovirus) that accounts for 20% to 25% of the viral hepatitis in United States adults. HAV infection is spread by the oral/fecal route and results in acute hepatitis with usually 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, and sharing of needles by drug addicts. The virus is also found in all types 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, but it is not commonly transmitted transplacentally. After a course of acute illness, HBV persists in approximately 10% of patients. While 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.
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 A IgM ANTIBODY
Negative
HEPATITIS B CORE ANTIBODY, IgM
Negative
HEPATITIS C ANTIBODY SCREEN
Negative
Interpretation depends on clinical setting.
Interpretation Provides information to assist in interpretation of the test results
Hepatitis A
Antibody against hepatitis A antigen is usually detectable by the onset of symptoms (usually 15 to 45 days after exposure). The initial antibody consists almost entirely of IgM subclass antibody. Antibody to hepatitis A virus (anti-HAV) IgM usually falls to undetectable levels 3 to 6 months after infection.
Hepatitis B
Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 16 weeks following 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.
Initially, hepatitis B core antibody (anti-HBc) consists almost entirely of the IgM subclass. Anti-HBc, IgM can be detected shortly after the onset of symptoms and is usually present for 6 months. Anti-HBc may be the only marker of a recent HBV infection detectable following the disappearance of HBsAg, and prior to the appearance of anti-HBs, ie, window period.
Hepatitis C
Hepatitis C antibody is usually not detectable during the early months following infection and is almost always detectable by the late convalescent stage of infection. Hepatitis C antibody is not neutralizing and does not provide immunity.
If HBsAg, anti-HAV (IgM), and anti-HCV are negative and patient's condition warrants, consider testing for Epstein-Barr virus or cytomegalovirus.
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
If screening test results for hepatitis A virus, hepatitis B virus, and hepatitis C virus infection are negative in a patient with signs and symptoms consistent with acute hepatitis, consider testing for Epstein-Barr virus or cytomegalovirus as possible etiologic agents.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Positive results for hepatitis A virus IgM antibody, hepatitis B core IgM antibody, and hepatitis B surface antigen confirmation tests are required by law in many states to be reported by the patient care providers to the respective State Department of Health.
Performance characteristics have not been established for the following types of specimen:
-Grossly icteric (total bilirubin level of >15 mg/dL)
-Grossly lipemic (triolein level of >3,000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Presence of particulate matter
-Cadaveric specimen
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Nainan OV, Xia G, Vaughan G, Margolis HS: Diagnosis of hepatitis A infection: a molecular approach. Clin Microbiol Rev 2006;19:63-79
2. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis 2004;8:267-281
3. Carithers RL, Marquardt A, Gretch DR: Diagnostic testing for hepatitis C. Semin Liver Dis 2000;20(2):159-171
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 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)
Hepatitis A IgM Antibody
An antibody class capture technique is used. This involves the dilution of the sample and the simultaneous reaction of IgM in the diluted sample with biotinylated mouse monoclonal antihuman IgM antibody. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing. Horseradish peroxidase (HRP)-labeled mouse monoclonal anti-hepatitis A virus (anti-HAV) IgM, which has been complexed with recombinant HAV antigen (conjugate), is then captured by anti-HAV-specific IgM bound to the wells. Unbound material 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 is indicative of the concentration of anti-HAV IgM present in the sample. (Package insert: VITROS Anti-HAV IgM Reagent Pack, no. GEM1235A, version 3.0; Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626-5101, 8/18/2009)
Hepatitis B Core (HBc) IgM Antibody
An antibody class capture technique is used. This involves the dilution of the sample and the simultaneous reaction of IgM in the diluted sample with biotinylated mouse monoclonal antihuman IgM antibody. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing. Horseradish peroxidase (HRP)-labeled mouse monoclonal anti-hepatitis B core (anti-HBc) IgM antibody, which has been complexed with recombinant HBc antigen (conjugate), is then captured by anti-HBc specific IgM bound to the wells. Unbound material is removed by washing.
The bound HRP conjugate is measured by a luminescent reaction. 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 light signals are read by the VITROS ECi System. The amount of HRP conjugate bound is indicative of the concentration of anti-HBc IgM present in the sample. (Package insert: VITROS Anti-HBc IgM assay, Ortho-Clinical Diagnostics, Raritan, NJ)
Hepatitis C Virus (HCB) 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, horseradish peroxidase (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).
See individual test ID for reflex tests.
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.
80074-Acute hepatitis panel (includes hepatitis A IgM antibody [CPT code 86709], hepatitis B core antibody, IgM [CPT code 86705], hepatitis B surface antigen [CPT code 87340], and hepatitis C antibody [CPT code 86803])
87341-Hepatitis B surface antigen confirmation (if appropriate)
87522-Hepatitis C, quantification (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 |
|---|---|---|
| HAVM | Hepatitis A IgM Ab, S | 22314-9 |
| HBIM | HBc IgM Ab, S | 31204-1 |
| H_BAG | HBs Antigen, S | 5195-3 |
| HCVA2 | HCV Ab Screen, S | 16128-1 |
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