Hepatitis E Virus RNA Detection and Quantification, Real-Time RT-PCR, Serum
Use
Hepatitis E virus (HEV) is a causative agent of acute self-limited or fulminant hepatitis and is primarily transmitted through waterborne and zoonotic infections. In immunocompetent individuals, it is mostly a self-limited infection. However, in immunocompromised patients, such as organ transplant recipients, HEV may become chronic. This test is crucial for detecting and confirming HEV infection in such individuals and for monitoring HEV RNA levels to assess response to antiviral therapy. It serves as an important tool for diagnosing acute or chronic HEV infection due to its limitations in serological testing for patients who are immunosuppressed.
Special Instructions
Follow the Hepatitis E Diagnostic Testing Algorithm for optimal test utilization. Ensure specimens are handled and shipped according to stability requirements to prevent inaccurate results. Complete necessary request forms if ordering manually and include them with the specimen submission.
Limitations
This assay is optimized for HEV genotypes 1 to 4, but mismatches in primer sequences may yield 'Undetected' results even if HEV RNA is present. HEV RNA results should be interpreted with caution, considering potential risk factors and analytical sensitivity. False negative results can occur if viruses are present at low numbers near the limit of detection. Serial monitoring should be performed using the same molecular assay to ensure consistency.
New York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 69961-1
- 69961-1
Result Turnaround Time
1-14 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.8 mL
Minimum Volume
0.8 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions, aliquot serum into a plastic vial, freeze serum immediately, ship specimen frozen on dry ice.
Storage Instructions
If shipment is delayed for more than 24 hours, freeze serum at -20 to -80°C until shipping.
Causes for Rejection
None specified for gross hemolysis or gross lipemia.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 5 days |
| Frozen | 35 days |