Hepatitis E Virus IgG Antibody, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosis of past exposure to hepatitis E virus
Enzyme Immunoassay (EIA)-Screening Procedure
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HEV IgG Ab, S
Hepatitis E screen
Hepatitis E IgG antibody
Anti-hepatitis E IgG
HEV IgG antibody
Hepatitis E IgG antibody
Anti-hepatitis E IgG
HEV IgG antibody
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: 0.5 mL
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.
Mild OK; Gross; OK
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum SST||Frozen (preferred)|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Hepatitis E virus (HEV) causes an acute, usually self-limited infection. This small, nonenveloped RNA virus is from animal reservoir (eg, hogs) to humans via the fecal-oral route. HEV is endemic in Southeast and Central Asia, with several outbreaks observed in the Middle East, northern and western parts of Africa, and Mexico. In developed countries, HEV infection occurs mainly in persons who have traveled to disease-endemic areas. Transmission of HEV may also occur parenterally, and direct person-to-person transmission is rare. Clinically severe cases occur in young to middle-aged adults. Unusually high mortality (approximately 20%) occurs in patients infected during the third trimester of pregnancy. Although there is no carrier state associated with HEV, immunocompromised patients may have prolonged periods (eg, months) of viremia and virus shedding in the stool.
In immunocompetent patients, viremia and virus shedding in the stool occur in the pre-icteric phase, lasting up to 10 days into the clinical phase. After an incubation period ranging from 15 to 60 days, HEV-infected patients develop symptoms of hepatitis with appearance of anti-HEV IgM antibody in serum, followed by detectable anti-HEV IgG within a few days. Anti-HEV IgM may remain detectable up to 6 months after onset of symptoms, while anti-HEV IgG usually persists for many years after infection. Anti-HEV IgG is the serologic test of choice to determine past exposure to HEV.
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.
Positive results indicate past or resolved hepatitis E infection.
Negative results indicate absence of previous exposure to hepatitis E virus (HEV).
Borderline results may be seen in: 1) acute or recent hepatitis E infection with rising level of anti-HEV IgG, or 2) cross-reactivity with nonspecific antibodies (ie, false-positive results). Repeat testing of serum for anti-HEV IgG in 4 to 6 weeks is recommended to determine the definitive HEV infection status.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A negative test result does not exclude the presence of recent hepatitis E infection (<2 month duration), especially in immunocompromised patients. Repeat testing for anti-hepatitis E virus (HEV) IgM and anti-HEV IgG in 1 to 2 months is necessary for diagnosis of recent hepatitis E.
Performance characteristics of this assay have not been established for serum specimens that are lipemic, hemolyzed, or contain particulate matter.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Aggarwal R, Jameel S: Hepatitis E. Hepatology 2011;54(6):2218-2226
2. Hoofnagle JH, Nelson KE, Purcell RH: Hepatitis E. New Engl J Med 2012;367:1237-1244
3. Aggarwal R: Diagnosis of hepatitis E. Nat Rev Gastroenterol Hepatol 2013;10:24-33
Method Description Describes how the test is performed and provides a method-specific reference
Highly purified recombinant hepatitis E virus (HEV)-ORF2 (from HEV genotypes 1 and 3) viral antigens are fixed to microplate wells. Diluted patient serum specimen is incubated in the well, in which antibodies bind specifically to the HEV recombinant antigens coating the surface of the well. Unbound human antibodies are then washed away, followed by addition of anti-human IgG antibodies that are conjugated to horseradish peroxidase enzyme for incubation. Unbound conjugate antibodies are then washed away, and a chromogenic substrate is added to the well. Human anti-HEV IgG antibodies specifically bound to the HEV antigens in the wells are detected by the peroxidase-catalyzed color reaction. Intensity of the color as measured with a photometric analyzer is proportionate to the quantity of bound HEV IgG antibodies present in the serum specimen.(Package insert: recomWell HEV IgG/IgM kit, catalog no. 5004/5005, Mikrogen GmbH, Foster, Neuried, Germany, rev.2/2009)
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.
Tuesday, Friday; 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.
This test uses a reagent or kit labeled by the manufacturer as Research Use Only. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
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.
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|
|86211||HEV IgG Ab, S||In Process|