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Test Code HEVML Hepatitis E Virus IgM Antibody Confirmation, Serum

Reporting Name

HEV IgM Ab Confirmation, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Confirmation of reactive hepatitis E virus IgM antibody screening test results for the diagnosis of acute or recent (<6 months) hepatitis E infection

Method Name

Line Immunoassay (LIA)


Necessary Information


Date of collection is required.



Specimen Required


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.


Specimen Type

Serum SST

Specimen Minimum Volume

0.2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred)
  Refrigerated  7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Reference Values

Negative

Interpretation

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.

Day(s) Performed

Every other Friday

Report Available

1 to 21 days

Test Classification

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

86790

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HEVML HEV IgM Ab Confirmation, S 14212-5

 

Result ID Test Result Name Result LOINC Value
61903 HEV IgM Ab Confirmation, S 14212-5

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)

Testing Algorithm

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