Hepatitis E Virus (HEV) Antibody, IgM
Also known as: HEV IGM
Use
The preferred test for diagnosing acute HEV infection, the Hepatitis E Virus (HEV) Antibody, IgM test is a qualitative assay used to detect IgM antibodies to Hepatitis E Virus. A positive result indicates recent or current HEV infection, whereas a negative result suggests the absence of detectable HEV IgM antibodies. This test is useful in evaluating patients with symptoms consistent with viral hepatitis and in identifying HEV as the causative agent. It is especially significant given the potential public health implications of HEV infections, primarily associated with sporadic cases and outbreaks in developing countries, but increasingly recognized in developed countries as well.
Special Instructions
The serum separator tube is recommended for specimen collection, but red (clot activator), lavender (EDTA), and pink (K2EDTA) tubes are also acceptable. Once collected, the serum must be separated from cells as soon as possible or within 2 hours. Transfer 0.5 mL of serum to an ARUP Standard Transport Tube. Specimens should be refrigerated during transportation and handling.
Limitations
This test was developed and its performance characteristics were determined by ARUP Laboratories. The test is not FDA approved and was performed in a CLIA-certified laboratory for clinical purposes. It is a laboratory-developed test with the potential for limitations in specificity and sensitivity as with any qualitative assay. Repeated freeze/thaw cycles of the specimen should be avoided to maintain integrity. Although the test is New York state approved, it has not been cleared for other specific regulatory approvals and may not be suitable for all populations due to regional differences in HEV genotypes.
New York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 2010157
- 14212-5
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.5 mL
Minimum Volume
0.3 mL
Container
ARUP Standard Transport Tube
Collection Instructions
Collect serum separator tube. Also acceptable: Red (clot activator), lavender (EDTA), pink (K2EDTA). Separate from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum to an ARUP Standard Transport Tube.
Storage Instructions
Refrigerated.
Causes for Rejection
Specimens containing particulate material.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | 2 weeks |
| Frozen | Indefinitely (avoid repeated freeze/thaw cycles) |