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Test ID: HEPS
Hepatitis Screening Panel, Serum

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

200830

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

Screening to determine a patient's previous exposure to hepatitis

 

Determining immunity to hepatitis A and B

 

Determining if a patient has been infected following exposure to an unknown type of 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
HAVABHepatitis A Total Ab, w/Reflex, SYesYes
HBAGHBs Antigen, SYesYes
HBABHBs Antibody, SYesYes
CORABHBc Total Ab, w/Reflex, 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
HAVMHepatitis A IgM Ab, SYesNo
HBIMHBc IgM Ab, SYesNo

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

Confirmatory testing will be performed at an extra charge on all reactive hepatitis B surface antigen prenatal specimens as well as all other reactive specimens that have a signal-to-cutoff ratio (S/CO) of < or =50.0.

Specimens with an S/CO of >50.0 that are not prenatal specimens do not require confirmation.

 

If hepatitis Bc antibody total is positive, then hepatitis Bc antibody IgM is performed at an additional charge. If hepatitis A antibody total is positive, then hepatitis A antibody IgM is 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 (CIA)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Hepatitis Screening Panel, S

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

Hepatitis Screening Profile, Serum

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: 1.5 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.

0.6 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

NA

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 endemic throughout the world, occurring most commonly, however, in areas of poor hygiene and low socioeconomic conditions. The virus, which is transmitted primarily by the fecal-oral route, is spread by close person-to-person contact and by food- and water-borne epidemics. Outbreaks frequently occur in overcrowded situations and in high-density institutions and centers, such as prisons and health-care or day-care centers. Viral spread by parenteral contact (with blood or oropharyngeal secretions) is possible but rare, because infected individuals are viremic for a short period of time (usually <3 weeks). There is little or no evidence of transplacental transmission from mother to fetus or of newborns contracting HAV infection during delivery.

 

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.

 

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.

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 A ANTIBODY, IgG & IgM

Negative

 

HEPATITIS B SURFACE ANTIGEN

Negative

 

HEPATITIS B SURFACE ANTIBODY

Unvaccinated: negative

Vaccinated: positive

 

HEPATITIS B SURFACE ANTIBODY, QUANTITATIVE

Unvaccinated: <5.0

Vaccinated: > or =12.0

 

HEPATITIS B CORE TOTAL

Negative

 

HEPATITIS C VIRUS ANTIBODY SCREEN

Negative

Interpretation Provides information to assist in interpretation of the test results

Hepatitis A virus (HAV) infection

Anti-HAV is usually detectable by the onset of symptoms (15-45 days after exposure). Serological diagnosis of acute HAV infection depends on the detection of IgM antibody and its presence indicates recent exposure and potential infectivity.

 

Hepatitis B virus (HBV) infection

Hepatitis B surface antigen (HBsAg) is the first serological marker present following HBV infection. A positive result is diagnostic of acute or chronic HBV infection and is associated with infectivity. In acute cases, HBsAg usually disappears 1 to 2 months following 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 core antibody (anti-HBc) IgM can be detected in serum shortly after the onset of symptoms and is usually present up to 6 months. Anti-HBc IgM may be the only serologic marker of a recent HBV infection and is detectable following the disappearance of HBsAg and prior to the appearance of hepatitis Bs antibody (anti-HBs) (ie, core window period).

 

Hepatitis C virus (HCV) infection

Anti-HCV is usually not detectable during the early months of infection with HCV. A negative chemiluminescence immunoassay (CIA) antibody test result does not exclude the possibility of exposure to or infection with HCV. Negative results in individuals with prior exposure to HVC may be due to antibody levels below the limit of detection of this assay or lack of reactivity to the HCV antigens used in this assay. Patients with recent infections with HCV may have false-negative results due to the time required for seroconversion (an average of 8 to 9 weeks). If HCV infection is suspected, qualitative HCV RNA testing is recommended.

 

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

 

A positive CIA screen result suggests the presence of anti-HCV as a result of past or present HCV infection.

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 result should be reported by the attending physician to the State Department of Health as required by law in some states.

 

A weakly positive anti-hepatitis B core (HBc) test result unaccompanied by other hepatitis B serologic markers, elevated liver enzymes, or a history of risk factors may be a false-positive result.

 

Passively acquired anti-hepatitis B surface (HBs) (eg, transfusion, recent immune globulin treatment) does not signify immunity.

 

Anti-HBs may fall below detectable levels with time.

 

Infants born to hepatitis C infected mothers may have delayed seroconversion to anti-hepatitis C virus (HCV) antibody.

 

Not useful for detection of early acute hepatitis C infection.

 

Not useful for differentiation between resolved and chronic hepatitis C infections.

 

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

1. Containing particulate matter

2. Heat inactivated specimens

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

1. Ergun GA, Miskovitz PF: Viral hepatitis: the new ABC's. Postgrad Med 1990 October;88(5):69-76

2. Sherlock S: Hepatitis B: the disease. Vaccine 1990;8 Suppl:S6-S9

3. Lemon SM: Type A viral hepatitis: epidemiology, diagnosis, and prevention. Clin Chem 1997 August;43:(8 pt 2)1494-1499

4. Ciocca M: Clinical course and consequences of hepatitis A infection. Vaccine 2000;18 Suppl 1: S71-74

5. Choo QL, Weiner AJ, Overby LR, et al: Hepatitis C virus: the major causative agent of viral non-A, non-B hepatitis. Brit Med Bull 1990 April;46(2):423-441

Method Description Describes how the test is performed and provides a method-specific reference

See individual unit codes.

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 Friday, Sunday

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.

2 days

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

4 days

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

1 month

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

New England

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.

86704-HBc Total Ab

86706-HBs Antibody, S

86708-Hepatitis A Ab, IgG & IgM

86803-Hepatitis C Ab (Anti-HCV), CIA, S

87340-HBs Antigen, S

86705-HBc IgM Ab, S (if appropriate)

86709-Hepatitis A, IgM (if appropriate)

87341-HBs 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
CORABHBc Total Ab, w/Reflex, S16933-4
HAVABHepatitis A Total Ab, w/Reflex, S20575-7
HB_ABHBs Antibody, S22322-2
H_BAGHBs Antigen, S5195-3
HCVAHCV Ab Screen, S16128-1
HBSQNHBs Antibody, Quantitative, S16935-9