Test Catalog

Test Id : HEVML

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Hepatitis E Virus IgM Antibody Confirmation, Serum

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Overview

Test Catalog

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

Confirmation of reactive hepatitis E virus IgM antibody screening test results for the 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.

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

Line Immunoassay (LIA)

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 Confirmation, S

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

Acute hepatitis E confirmation

Hepatitis E IgM antibody confirmation

Anti-hepatitis E IgM confirmation

HEV IgM antibody confirmation

Anti-HEV IgM confirmation

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

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 and aliquot 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 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

0.2 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 7 days

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

Confirmation of reactive hepatitis E virus IgM antibody screening test results for the 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.

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, non-enveloped RNA virus is from animal reservoirs (eg, hogs) and is transmitted 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 individuals who have traveled to disease-endemic areas. Transmission of HEV may also occur rarely from direct person-to-person contact or transfusion of blood or blood products. Clinically severe cases occur in young to middle-aged adults. Unusually high mortality (approximately 20%) occurs in women infected during the third trimester of pregnancy. Although there is no carrier state associated with HEV, patients who are immunocompromised may have prolonged periods (eg, months) of viremia and virus shedding in the stool.

 

In immunocompetent individuals, 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, patients infected withHEV 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.

 

The positive predictive value of a given diagnostic laboratory test is dependent on the prevalence rate of the disease for which the test is being used. Screening tests for detection of diseases with low prevalence rates, such as acute hepatitis E, will have low positive predictive values (ie, relatively high rates of false-positive test results), despite having high specificity rates for such tests. Therefore, an 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.

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 confirm 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.

 

Indeterminate results may be seen in:

1. Acute hepatitis E infection with rising level of anti-hepatitis E virus (HEV) IgM

2. Recent hepatitis E infection with declining level of anti-HEV IgM

3. Acute hepatitis E infection due to HEV genotype 2 strains

4. Cross-reactivity with nonspecific antibodies (ie, false-positive results).

Repeat testing of serum for anti-HEV IgM and anti-HEV IgG in 4 to 6 weeks is recommended to determine the definitive HEV infection status.

 

Unreadable results indicate the presence of unusually strong, nonspecific reactivity of the assay strip background that obscures proper reading of the bands. Such findings are usually due to nonspecific binding of non-hepatitis E IgM antibodies in patient's serum to the HEVM antigens present on the assay strip. Repeat testing with anti-HEV IgM screen and anti-HEV IgG in 4 to 6 weeks is recommended.

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, especially in patients who are immunocompromised. Repeat testing of serum for anti-hepatitis E virus (HEV) IgM in 2 weeks may be necessary for diagnosis of acute or recent hepatitis E infection.

 

A positive result does not always indicate the presence of active disease.

 

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

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

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

2. Pas SD, Streefkerk RH, Pronk M, et al. Diagnostic performance of selected commercial HEV IgM and IgG ELISAs for immunocompromised and immunocompetent patients. J Clin Virol. 2013;58(4):629-634. doi:10.1016/j.jcv.2013.10.010

3. Webb GW, Dalton HR. Hepatitis E: an underestimated emerging threat. Ther Adv Infect Dis. 2019;6:2049936119837162. doi:10.1177/2049936119837162

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

Highly purified recombinant hepatitis E virus (HEV) antigens (O2N, O2C, and O3 from genotypes 1 and 3, and O2M from genotype 1) are fixed to nitrocellulose membrane test strips. The test strips are incubated with the diluted patient serum sample, allowing virus-specific human IgM antibodies to bind to the antigens present on the test strips. Unbound human antibodies are then washed away. In the second step, the strips are incubated with anti-human IgM antibodies coupled with horseradish peroxidase enzyme. Unbound conjugate antibodies are then washed away. Specifically bound human IgM antibodies are detected with a staining reaction catalyzed by the peroxidase. A dark band will appear on the strip at the corresponding point if a reaction has taken place.(Package insert: recomLine HEV IgG/IgM kit. Mikrogen Diagnostik; rev 10/2014)

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.

Every other Friday

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 21 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 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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It 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
HEVML HEV IgM Ab Confirmation, 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.
61903 HEV IgM Ab Confirmation, 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 | PHP Pdf | CMS 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