| Pre-Approval | 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.
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Supplemental Information Requested
| 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
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Submittal Form
| Submit specimens accompanied with both: |
| Methodology (Commercial Test Name or Laboratory Developed Test (LDT)) | Real-time RT-PCR (LDT)(Diagnostic)
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| Reflex Testing | After negative results, samples may be reflexed to additional respiratory PCR assays to test for other agents.
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| Acceptable Specimen Type(s) and Collection Method | 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. |
| Minimum Volume Requested | - 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
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| Transport Medium (if using) | Not Applicable |
| Specimen Labeling | Each specimen tube must be labeled with at least two unique patient identifiers, e.g., patient full name and date of birth. |
| Storage & Preservation of Specimen / Shipping Conditions | Storage & 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).
Non-Diagnostic (Surveillance Use Only) Specimens: - 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.
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Shipping Instructions | Work with your local public health department to ensure samples are packaged according to instructions for Biological Substance – Category B (UN 3373) shipment. Ship specimens and a hard copy of the completed submittal forms to: CDPH VRDL ATTN: Specimen Receiving 850 Marina Bay Parkway Richmond, CA 94804 Phone: 510-307-8585 |
| Turnaround Time | 10 Business Days |
| Limitations | Negative result does not preclude the possibility of infection. |
| Additional Information | 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. |
| VRDL Points of Contact | Medical and Epidemiology Liaisons: (510) 307-8585 or VRDL.Submittal@cdph.ca.gov
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