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Hepatitis E Serology, NAT and Genotyping CDC-10329

Synonym(s)
HEV, Hepatitis E virus
CDC Pre-Approval Needed
Saleem Kamili
(404) 639-4431
sek6@cdc.gov
Lilia Ganova
(404) 639-1158
lkg7@cdc.gov
Supplemental Information Required
None
Supplemental Form
Performed on Specimens from
Human
Acceptable Sample/ Specimen Type for Testing
This test order is currently not accepting any specimens until further notice.
Minimum Volume Required
2 mL
Collection, Storage, and Preservation of Specimen Prior to Shipping
Specimens should be kept frozen at -20 °C.  Specimens can be kept refrigerated at 4 °C if shipped in less than 72 hours of collection.
Transport Medium
Not Applicable
Specimen Labeling
Research or surveillance specimens may be labeled according to protocol. Labels should not include personally identifiable information. The results reported should NOT be used for diagnosis, treatment, assessment of health or management of the individual patient.
Shipping Instructions which Include Specimen Handling Requirements
CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday - Friday.
 
Ship to:
<Insert CDC Point of Contact>
Centers for Disease Control and Prevention
RDSB/STATT Unit 90
1600 Clifton Road, NE
Atlanta, GA 30329
<Insert CDC Point of Contact's Telephone Number>
 
All samples must be shipped in accordance with all applicable local, state and federal regulations.
Methodology
Hepatitis E Virus (HEV) Ribonucleic Acid (RNA) by Real Time quantitative Real Time Polymerase Chain Reaction (qRT-PCR), HEV Genotyping, Immunoglobulin G (IgG) Anti-HEV by ELISA, Immunoglobulin M (IgM) antibody to hepatitis E virus (anti-HEV) by enzyme-linked immunosorbent assay (ELISA)
Turnaround Time
3 Weeks
Interferences & Limitations
Hemolyzed specimen are not accepted
Additional Information
The tests used have not been cleared or approved by the FDA and the performance characteristics have not been fully established by CDC.  The results reported should NOT be used for diagnosis, treatment, or assessment of patient health or management.
CDC Points of Contact
Amanda Poe
(404) 639-0723
anp0@cdc.gov
Jan Drobeniuc
(404) 639-3790
DVHLabTesting@cdc.gov




Version
3.1