Test Code HEVML Hepatitis E Virus IgM Antibody Confirmation, Serum
Reporting Name
HEV IgM Ab Confirmation, SUseful For
Confirmation of reactive hepatitis E virus IgM antibody screening test results for the diagnosis of acute or recent (<6 months) hepatitis E infection
Performing Laboratory
Mayo Clinic Laboratories in RochesterSpecimen Type
Serum SSTNecessary 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 Minimum Volume
0.2 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum SST | Frozen (preferred) | ||
Refrigerated | 7 days |
Reference Values
Negative
Day(s) Performed
Every other Friday
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 |
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.
Clinical Reference
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
Report Available
1 to 21 daysMethod Name
Line Immunoassay (LIA)
Testing Algorithm
For information see Hepatitis E: Testing Algorithm for Diagnosis and Management.
Special Instructions
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)