Test Id : AHEP
Acute Viral Hepatitis Profile, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Differential diagnosis of recent 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 |
|---|---|---|---|
| HAIGM | Hepatitis A IgM Ab, S | Yes | Yes |
| HBAG | HBs Antigen, S | Yes | Yes |
| HBIM | HBc IgM 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 |
|---|---|---|---|
| HCVQN | HCV RNA Detect/Quant, S | Yes | No |
| HBGNT | HBs Antigen Confirmation, S | Yes | No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If the hepatitis C virus (HCV) antibody result is reactive, then HCV RNA detection and quantification by real-time reverse transcription-polymerase chain reaction will be performed at an additional charge.
If the hepatitis B surface antigen result is reactive, then confirmation will be performed at an additional charge.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-Hepatitis C: Testing Algorithm for Screening and Diagnosis
Method Name
A short description of the method used to perform the test
HAIGM, HBAG, HBIM, HCVDX, HBGNT: Electrochemiluminescence Immunoassay (ECLIA)
HCVQN: Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
AHEP
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If the hepatitis C virus (HCV) antibody result is reactive, then HCV RNA detection and quantification by real-time reverse transcription-polymerase chain reaction will be performed at an additional charge.
If the hepatitis B surface antigen result is reactive, then confirmation will be performed at an additional charge.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-Hepatitis C: Testing Algorithm for Screening and Diagnosis
Specimen Type
Describes the specimen type validated for testing
Serum SST
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
Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
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: 2.7 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 2 mL serum into a plastic vial 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:
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.
1.9 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 SST | Frozen (preferred) | 84 days | |
| Refrigerated | 6 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Differential diagnosis of recent acute viral hepatitis
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
If the hepatitis C virus (HCV) antibody result is reactive, then HCV RNA detection and quantification by real-time reverse transcription-polymerase chain reaction will be performed at an additional charge.
If the hepatitis B surface antigen result is reactive, then confirmation will be performed at an additional charge.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
-Hepatitis C: Testing Algorithm for Screening and Diagnosis
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 acute viral hepatitis in adults in the United States. Hepatitis A is spread by the oral/fecal route and produces acute hepatitis, which 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 institutions or high-density centers such as prisons and healthcare 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 an endemic DNA virus 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 also found in virtually every 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 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. The infection is transmitted through contaminated blood or blood products or other close, personal contacts. It is recognized as the cause of most cases of posttransfusion hepatitis. Hepatitis C shows a high rate of progression (~75%) to chronic infection and disease and accounts for the majority of chronic viral hepatitis In the United States. Cirrhosis and hepatocellular carcinoma are sequelae of chronic infection with this virus.
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 CORE IgM ANTIBODY
Negative
HEPATITIS A IgM ANTIBODY
Negative
HEPATITIS C ANTIBODY
Negative
HEPATITIS C VIRUS RNA DETECTION AND QUANTIFICATION BY REAL-TIME RT-PCR
Undetected
Interpretation
Provides information to assist in interpretation of the test results
Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles
Hepatitis A Virus (HAV):
HAV-specific antibodies are usually detectable by the onset of symptoms (usually 15 to 45 days after exposure). The initial antibody consists almost entirely of IgM subclass antibody. Anti-HAV IgM usually falls to undetectable levels 3 to 6 months after infection.
Hepatitis B Virus (HBV):
HBsAg is the first serologic marker appearing in the serum 6 to 8 weeks following HBV infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Anti-HBs appears with the resolution of HBV infection after the disappearance of HBsAg. Anti-HBs also appear as the immune response following a course of inoculation with the hepatitis B vaccine.
During acute hepatitis B in symptomatic individuals, detectable anti-HBc consists almost entirely of the IgM subclass. Anti-HBc IgM can be detected shortly after the onset of symptoms and usually remains detectable for 6 months. Anti-HBc IgM and Anti-HBc total may be the only serologic markers of a recent HBV infection detectable in the "window period", during which HBsAg has declined to become undetectable and anti-HBs has not yet become detectable.
Hepatitis C Virus (HCV):
In immunocompetent individuals, HCV-specific IgG and IgM antibodies are usually not detectable in the first 2 months after exposure to HCV, and this "window period: may be as long as 6 months in immunocompromised individuals. HCV antibodies are not neutralizing and does not provide immunity against subsequent HCV infection.
If HBsAg, anti-HAV IgM, and anti-HCV are negative and patient's condition warrants, consider testing for Epstein-Barr virus or cytomegalovirus.
The following algorithms are available:
-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Consider administration of human immune globulin to individuals exposed to patients with hepatitis A.
Consider administration of hepatitis B immune globulin and/or hepatitis B vaccine to individuals exposed to hepatitis B patient's blood or body fluids.
Positive hepatitis B surface antigen (HBsAg) or positive anti-hepatitis A virus (HAV) IgM test results should be reported by the attending physician to the State Department of Health, as required by law in some states.
Serum specimens from individuals taking biotin supplements at 20 mg or more per day may have false-negative results for anti-HAV IgM, anti-HBc IgM, and anti-HCV Ab, due to interference of biotin with the assay. Such individuals should stop taking these biotin-containing dietary supplements for minimum 12 hours before blood collection for this test.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >25 mg/dL)
-Grossly lipemic (intralipid level of >1000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >1000 mg/dL)
-Containing particulate matter
-Cadaveric specimens
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. LeFevre ML, et al. 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 (Hoboken). 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.e3. doi:10.1053/j.gastro.2018.11.037
4. World Health Organization. Guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed October 8, 2024. Available at www.who.int/hepatitis/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. Published 2023 Mar 10. doi:10.15585/mmwr.rr7201a1
Method Description
Describes how the test is performed and provides a method-specific reference
Hepatitis B Surface Antigen Screen:
The Elecsys HBsAg (hepatitis B surface antigen) II assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HBsAg present in the patient's sample reacts with two biotinylated monoclonal anti-HBs, and a mixture of monoclonal anti-HBs and polyclonal anti-HBs labeled with a ruthenium complex react to form a sandwich 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 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. Test result is determined by comparing the electrochemiluminescence signal generated from the reaction product in the patient's sample to the cutoff index (COI) value set from reagent lot-specific assay calibration.(Package insert: Elecsys HBsAG II. Roche Diagnostics; v3.0, 02/2022)
Hepatitis B Surface Antigen Confirmation:
The Elecsys HBsAg II Auto Confirm assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. This test is based on 2 parallel measurements. For the first measurement, the sample is treated 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. Results are determined by comparing the electrochemiluminescence signal generated from the reaction product to the cutoff index 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 with control pretreatment.(Package insert: Elecsys HBsAg II Auto Confirm. Roche Diagnostics; v1.0, 12/2020)
Hepatitis A IgM Antibody:
The Elecsys Anti-HAV (hepatitis A virus) IgM assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HAV-specific IgM antibody (anti-HAV IgM) in the patient's serum sample is pretreated with anti-Fdy reagent to block specific IgG in the presence of monoclonal anti-HAV antibodies labeled with ruthenium complex. After addition of biotinylated monoclonal human-IgM-specific antibodies, HAV antigen, and streptavidin-coated microparticles, patient's anti-HAV IgM form a sandwich complex with the HAV antigen and the ruthenium-labeled anti-HAV antibody which becomes bound 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, and unbound substances are washed away. Voltage is applied to the electrode and induces chemiluminescent emissions that are measured by a photomultiplier. Test result is determined automatically by the assay-specific software program by comparing the electrochemiluminescence signal generated from the patient's sample to the COI value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HAV IgM. Roche Diagnostics; v5.0, 11/2022)
Hepatitis B Core IgM Antibody:
The Elecsys Anti-HBc (hepatitis B core) IgM assay is based on the sandwich immunoassay principle and performed with an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. Anti-HBc IgM present in patient's sample is pretreated with anti-Fdy reagent to block specific IgG. After addition of biotinylated monoclonal human-IgM-specific antibodies, the complexes formed from reaction of ruthenium-labeled HBc antigen, streptavidin-coated microparticles (solid phase), anti-HBc IgM present in the sample, and the biotinylated anti-human IgM 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, and unbound substances are washed away. Voltage is applied to the electrode that induces chemiluminescent emissions, which are measured by a photomultiplier. Test result is determined by comparing the electrochemiluminescence signal generated from the sample to the COI value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HBc IgM. Roche Diagnostics; v1.0, 09/2020)
Hepatitis C Virus Antibody:
The Elecsys Anti-HCV (hepatitis C virus) II assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the fully automated cobas e 801 immunochemistry analyzer. HCV antibodies present in the patient's sample react with biotinylated HCV-specific antigens and a reagent containing HCV-specific antigens labeled with a ruthenium complex to form a sandwich complex. After addition of streptavidin-coated microparticles (solid phase), these complexes bind to the solid phase via interaction of biotin and streptavidin. The reaction mixture is 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. Test result is determined by comparing the electrochemiluminescence signal generated from the patient's sample to the COI value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HCV II. Roche Diagnostics v1.0, 03/2023)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
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
Indicates the location of the laboratory that performs the test
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.
CPT codes are provided by the performing laboratory.
80074 (if all 4 initial tests are performed)
86709 (if all 4 are not performed)
86705 (if all 4 are not performed)
87340 (if all 4 are not performed)
86803 (if all 4 are not performed)
87522 (if appropriate)
87341 (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 |
|---|---|---|
| AHEP | Acute Hepatitis Profile | 24363-4 |
| 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.
|
|---|---|---|
| HBIM | HBc IgM Ab, S | 24113-3 |
| H_BAG | HBs Antigen, S | 5196-1 |
| HAIGM | Hepatitis A IgM Ab, S | 13950-1 |
| HCVA4 | HCV Ab, S | 40726-2 |