Hepatitis E Virus IgM Antibody Confirmation, Serum
Use
This test is used for the confirmation of reactive hepatitis E virus IgM antibody screening test results, which assists in diagnosing acute or recent hepatitis E infection that occurred within the last 6 months. Given the often low prevalence of acute hepatitis E, this confirmatory test is crucial to ascertain true infection status and prevent false positives, thereby ensuring accurate diagnosis and appropriate management of patients.
Special Instructions
Not provided.
Limitations
This assay's performance characteristics are not established for use with serum samples that have high levels of icterus, lipemia, hemolysis, or particulate matter. A negative result doesn't exclude recent infection, especially in immunocompromised patients, and a follow-up test may be necessary. A positive result does not necessarily indicate active disease. Consider conducting repeat testing of serum for anti-hepatitis E virus (HEV) IgM and anti-HEV IgG after 4 to 6 weeks if results are indeterminate, considering false positives from nonspecific antibodies or HEV genotype 2.
New York Approved
Methodology
Immunoassay (Line Immunoassay (LIA))
Biomarkers
HEV IgM
Protein
LOINC Codes
- 14212-5 - HEV IgM Ser Ql
- 14212-5 - HEV IgM Ser Ql
Result Turnaround Time
1-21 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.5 mL
Minimum Volume
0.2 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per the manufacturer's instructions. Aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis, Gross lipemia, Gross icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |