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

Reporting Name

HEV IgM Ab Screen, S
Seattle Children's Hospital Note:

Clinical System Name: Hepatitis E Virus IgM

Useful For

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

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HEVML HEV IgM Ab Confirmation, S Yes No

Testing Algorithm

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

 

See Testing Algorithm for the Diagnosis of Hepatitis E in Special Instructions.

Performing Laboratory

Mayo Medical Laboratories in Rochester

Specimen Type

Serum SST


Specimen Required


Collection Container/Tube: Serum gel       

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL


Seattle Children's Hospital Note:

Collect 1.0 mL whole blood in a Red top.

Specimen Minimum Volume

0.1 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum SST Frozen (preferred)
  Refrigerated  24 hours

Reference Values

Negative

Day(s) and Time(s) Performed

Tuesday, Thursday; Varies

Seattle Children's Hospital Note:

TAT: 8 - 10 days

Test Classification

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 U.S. Food and Drug Administration.

CPT Code Information

86790

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HEVM HEV IgM Ab Screen, S 14212-5

 

Result ID Test Result Name Result LOINC Value
86212 HEV IgM Ab Screen, S 14212-5

Method Description

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 antihuman IgM 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 IgM 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 IgM antibodies present in the serum specimen.(Package insert: recomWell HEV IgG/IgM kit, catalog no. 5004/5005,; MIKROGEN GmbH, Foster, Neuried, Germany, rev 3/2016)

Reject Due To

Hemolysis

Mild OK; Gross Reject

Lipemia

Mild OK; Gross Reject

Icterus

Mild OK; Gross Reject

Other

NA

Method Name

Enzyme Immunoassay (EIA)-Screening Procedure