Test Order Name - Sin Nombre Virus (Hanta Virus Pulmonary Syndrome) Detection PCR
Synonym(s) - Hanta Virus, Sin Nombre Virus
Methodology - Real-time RT-PCR (LDT)(Diagnostic)
Acceptable Specimen Type(s) for Testing -
Human specimens:
- Serum:
- Plain Red-Top Tubes: Serum collected in plain, red-top tubes must be separated and transferred to sterile, screw-cap tubes for storage and transport.
- Serum Separator Tubes (SST): SST may be transported after centrifugation.
- Whole blood: EDTA (lavender top) tubes
- Plasma (Surveillance Use Only): Plasma must be separated from EDTA (lavender top) whole blood within 2 hours of collection and transferred to sterile, screw-cap tubes for storage and transport.
- Fresh Tissue (Surveillance Use Only)
- Formalin Fixed Paraffin Embedded Tissue (Surveillance Use Only)
Additional specimens may be tested if patient is deceased (Surveillance Use Only) please contact VRDL’s Medical and Epidemiology Liaisons at (510) 307-8585 or VRDL.Submittal@cdph.ca.gov for more information.
Transport / Collection Medium - Not Applicable
Storage and Preservation of Specimen -
Diagnostic Specimens:
- Serum:
- Keep serum refrigerated (> 0°C to ≤ 8°C) if sample will arrive at CDPH within 21 days of collection to shipping.
- If specimens cannot be sent within 21 days of collection, freeze at -30oC to < 0°C; specimens may be stored for up to 6 months from date of collection to shipping.
- If frozen at ≤ -70°C, specimens may be stored for up to 3 years from collection to shipping.
- Whole blood (EDTA):
- Keep whole blood (EDTA) refrigerated (> 0°C to ≤ 8°C); specimens may be stored for up to 14 days from date of collection to shipping.
- Whole blood should not be frozen (at or below 0°C).
- Plasma and Fresh Tissue:
- If refrigerated at > 0°C to ≤ 8°C, specimens may be stored for up to 21 days from collection to shipping.
- If frozen at > -30oC to < 0°C, specimens may be stored for up to 6 months from collection to shipping.
- If frozen at ≤ -70°C, specimens may be stored for up to 3 years from collection to shipping.
- FFPE Tissue:
- Formalin-fixed, paraffin-embedded (FFPE) tissue specimens may be stored at > 0°C.
Shipping Temperatures:
- Serum: ≤ 8°C Shipping serum specimens frozen is strongly recommended.
- Whole Blood (EDTA): > 0°C to ≤ 8°C
- Plasma: ≤ 8°C
- Fresh tissue: ≤ 8°C
- Formalin Fixed Paraffin Embedded tissue (FFPE): > 0°C
Frozen specimens should be sent with dry ice. Refrigerated specimens should be sent with frozen cold packs. Specimens should be received within 21 days of collection. Specimens received outside of acceptable temperature ranges and/or collection dates as noted above will be tested for public health surveillance purposes only; no diagnostic result will be issued.
Minimum Volume Required -
- Serum: 1 mL
- Whole Blood in EDTA tubes: 5 mL
- Plasma (Surveillance Use Only): 1 mL
- Fresh Tissue (Surveillance Use Only): 60 mg
- Formalin Fixed Paraffin Embedded Tissue (FFPE) (Surveillance Use Only): 1 Tissue block
Additional Collection Instructions -
Prior to submission please contact San Francisco Communicable Disease Control Unit (CDCU) for approval: (628) 217-6100
Submit specimens accompanied with both:
- A hard copy of the Hantavirus Submittal Instructions and Case Report Form (PDF)
- A hard copy of the completed VRDL General Purpose Specimen Submittal Form (PDF) or a form generated in the VRDL Lab Web Portal.
Please submit the Hantavirus Submittal Instructions and Case Report Form (PDF) to VRDL’s Medical and Epidemiology Liaisons at VRDL.Submittal@cdph.ca.gov for pre-approval.
Each specimen tube must be labeled with at least two unique patient identifiers, e.g., patient full name and date of birth.
Additional Required Information -
Contact VRDL’s Medical and Epidemiology Liaisons at (510) 307-8585 or VRDL.Submittal@cdph.ca.gov for requested supplemental information, including but not limited to animal or environmental exposure, disease onset date, clinical symptoms
After negative results, samples may be reflexed to additional respiratory PCR assays to test for other agents.
Detection of Sin Nombre virus RNA is most successful when samples are collected within 14 days of symptom onset.
Since the incidence of HPS is rare in California, we recommend that you also submit a respiratory specimen for viral isolation and/or respiratory PCR assays to test for other agents that may be causing your patient’s illness.
Send Out? - Yes
Turnaround Time - 10 Business Days
Limitations / Notes / Disclaimer -
Negative result does not preclude the possibility of infection.