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Test ID: AHPS
Acute Hepatitis Profile

Secondary ID A test code used for billing and in test definitions created prior to November 2011

9022

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

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

The differential diagnosis of recent acute 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 IDReporting NameAvailable SeparatelyAlways Performed
HBAGHBs Antigen, SYesYes
HAVMHepatitis A IgM Ab, SYesYes
HBIMHBc IgM Ab, SYesYes
HCVHCV Ab Screen, SYesYes

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 IDReporting NameAvailable SeparatelyAlways Performed
HBGNTHBs Antigen Confirmation, SNoNo

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis B surface (HBs) antigen is reactive, then HBs antigen 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

Acute Hepatitis Profile

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

Acute Hepatitis Profile, Serum
Hepatitis Acute Profile, Serum
Hepatitis Screen
HCV HAV
HBV (Hepatitis B Virus)

Specimen Type Describes the specimen type needed for testing

Serum SST

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: 2.5 mL

Collection Instructions: Spin down within 6 hours of draw.

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.

2 mL

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 TypeTemperatureTime
Serum SSTFrozen (preferred)
 Refrigerated 7 days
 Ambient 24 hours

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 (enterovirus) that accounts for 20% to 25% of the viral hepatitis in U.S. adults. HAV infection 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 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.

 

See Advances in the Laboratory Diagnosis of Hepatitis C (2002) in Publications, and HBV Infection-Diagnostic Approach and Management Algorithm and Testing Algorithm for the Diagnosis of Hepatitis C in Special Instructions.

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.

See Viral Hepatitis Serologic Profile in Special Instructions.

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 15-45 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 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.

 

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.

 

See HBV Infection-Diagnostic Approach and Management Algorithm in Special Instructions.

 

Hepatitis C

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

 

See Advances in the Laboratory Diagnosis of Hepatitis C (2002) in Publications and Testing Algorithm for the Diagnosis of Hepatitis C in Special Instructions.

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 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) and/or positive hepatitis A virus antibody (anti-HAV) IgM test results should be reported by the attending physician to the State Department of Health, as required by law in some states.

 

Performance characteristics have not been established for the following specimen characteristics:

-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)

-Containing particulate matter

-Cadaveric specimens

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Lemon SM: Type A viral hepatitis: epidemiology, diagnosis, and prevention. Clin Chem 1997;43:1494-1499

2. Marcus EL, Tur-Kaspa R: Viral hepatitis in older adults. J Am Geriatr Soc 1997;45:755-763

3. Mahoney FJ: Update on diagnosis, management, and prevention of hepatitis B virus infection. Clin Microbiol Rev 1999;12:351-366

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 hepatitis B surface antigen (HBsAg) assay. With modification to the assay manufacturer's instructions for use, specimens yielding S/CO ratio of > or =1.00 but < or =50.0 will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/CO ratio >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) coated onto the wells and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs 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 Immunodiagnostic System. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample. (Package insert: VITROS HBsAg assay, version 3.0; Ortho-Clinical Diagnostics, Inc., Rochester, NY, 8/19/2009)

 

Hepatitis A Antibody (Anti-HAV) IgM

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. HRP-labeled mouse monoclonal 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 Immunodiagnostic 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, version 3.0, Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626-5101, 8/18/2009)

 

Hepatitis B Core Antibody (Anti-HBc) IgM

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. HRP-labeled mouse monoclonal anti-HBc IgM, 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 Immunodiagnostic 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, version 6.0, Ortho-Clinical Diagnostics, Raritan, NJ, 3/5/2010)

 

Hepatitis C Virus (HCV) Antibody Screen

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 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)

 

HBs Antigen (HBsAg) Confirmation (REFLEX: only if appropriate)

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, version 4.0, Ortho-Clinical Diagnostics, Inc., Rochester, NY, 5/12/2009)

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.

1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

2 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

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.

This test has been cleared or approved by the U.S. 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 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)

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 IDReporting NameLOINC Code
HAVMHepatitis A IgM Ab, S22314-9
HBIMHBc IgM Ab, S31204-1
H_BAGHBs Antigen, S5195-3
HCVAHCV Ab Screen, S16128-1