Test Catalog

Test Id : HEVM

Hepatitis E Virus IgM Antibody Screen with Reflex to Confirmation, Serum

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

Diagnosis of acute or recent (<6 months) hepatitis E infection

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
HEVML HEV IgM Ab Confirmation, S Yes No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis E virus (HEV) IgM antibody screen is reactive or borderline, HEV IgM antibody confirmation will be performed.

 

For more information see Hepatitis E: Testing Algorithm for Diagnosis and Management.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Enzyme Immunoassay (EIA)-Screening Procedure

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

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HEV IgM Ab Screen, S

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

Anti-HEV IgM

HEV IgM antibody

Anti-hepatitis E IgM

Hepatitis E IgM antibody

Hepatitis E screen

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis E virus (HEV) IgM antibody screen is reactive or borderline, HEV IgM antibody confirmation will be performed.

 

For more information see Hepatitis E: Testing Algorithm for Diagnosis and Management.

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

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.

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:

-Gastroenterology and Hepatology Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

-Microbiology Test Request (T244)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.1 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

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)
Refrigerated 24 hours

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

Diagnosis of acute or recent (<6 months) hepatitis E infection

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis E virus (HEV) IgM antibody screen is reactive or borderline, HEV IgM antibody confirmation will be performed.

 

For more information see Hepatitis E: Testing Algorithm for Diagnosis and Management.

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 transmitted 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 feces.

 

In immunocompetent patients, viremia and virus shedding in the feces 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 IgM is the serologic marker of choice for diagnosis of acute HEV infection.

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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

Positive results suggest the presence of acute or recent (in the preceding 6 months) hepatitis E infection.

 

Negative results indicate absence of acute or recent hepatitis E infection. If clinical suspicion persists, submit new specimen for retesting in 1 to 2 weeks.

 

Borderline results may be seen in acute hepatitis E infection with rising level of anti-hepatitis E virus (HEV) IgM,  recent hepatitis E infection with declining level of anti-HEV IgM, or cross-reactivity with nonspecific antibodies (ie, false-positive results).

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Despite having a high specificity rate, the positive predictive value of the hepatitis E virus (HEV) IgM antibody screening test may be low (ie, relatively high frequency of false-positive test results) due to low prevalence of acute hepatitis E in the patient population being screened. HEV IgM antibody confirmatory test is helpful and necessary to determine the true infection status of patients with reactive HEV IgM antibody screening test results.

 

A negative test result does not exclude the presence of recent hepatitis E infection, especially in immunocompromised patients. Repeat testing of serum for anti-HEV IgM in 2 to 4 weeks may be necessary for diagnosis of acute in such patients.

 

Performance characteristics of this assay have not been established for serum specimens that are heat-inactivated, icteric, lipemic, hemolyzed, or contain particulate matter.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Aggarwal R, Jameel S: Hepatitis E. Hepatology. 2011 Dec;54(6):2218-2226

2. Hoofnagle JH, Nelson KE, Purcell RH: Hepatitis E. New Engl J Med. 2012 Sep;367(13):1237-1244

3. Aggarwal R: Diagnosis of hepatitis E. Nat Rev Gastroenterol Hepatol. 2013 Jan;10(1):24-33

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

The Mikrogen recomWell hepatitis E virus (HEV) is a qualitative, in vitro test for the detection and identification of IgM antibodies specifically against HEV in human serum. This assay is a screening test based on the principle of an indirect sandwich enzyme-linked immunosorbent assay.

 

Highly purified recombinant HEV-ORF2 viral antigens (specific for HEV genotypes 1 and 3) are fixed to microplate wells. Diluted patient serum specimens are incubated in the wells, in which antibodies bind specifically to the HEV recombinant antigens coating the surface of the wells. Unbound antibodies are then washed away. Anti-human immunoglobulin antibodies (IgM), which are coupled to horseradish peroxidase, are then added to the wells and incubated. Unbound conjugate antibodies are then washed away. Specifically, bound antibodies are detected by a peroxidase-catalyzed color reaction. Intensity of the color, as measured with a photometric analyzer, is proportionate to the quantity of bound HEV IgM antibodies present in the serum specimen.(Package insert: recomWell HEV IgG/IgM kit. MIKROGEN GmbH; rev 11/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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.

Tuesday, Thursday

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.

1 to 7 days

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

14 days

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

Rochester

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 Regional Manager. 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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US 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 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.

86790

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
HEVM HEV IgM Ab Screen, S 14212-5
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.
86212 HEV IgM Ab Screen, S 14212-5

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports