Pre-Approval
| For Outbreak Investigations: Please email VRDL.submittal@cdph.ca.govā prior to sending any specimens. VRDL will accept up to 10 specimens per outbreak.
For Routine Surveillance: VRDL will accept up to 25 specimens every two weeks.
Pre-approval is required for submissions that exceed these specimen limits above.ā
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āSupplemental Information Requested
| - āSample must be positive for SARS-CoV-2
- Specimens must have a Ct value of ā¤30 or an RLU value of ā„1100
- Ct values or RLU values should be indicated on the submittal form when available
- Outbreak location should be indicated on the submittal form if applicable
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āSubmittal Forms
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Methodology
| Whole Genome Sequencing (LDT) (Surveillance use only)
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Reflex Testing
| āNot applicableā
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āAcceptable Specimen Type(s) and Collection Method
| Human Specimens: - āUpper Respiratory specimens :
- āA single nasopharyngeal (NP) swab is preferred.
- Acceptable alternatives include:
- āA nasal mid-turbinate swab
- An anterior nares swab
- An oropharyngeal (OP) swab
- āāSARS-CoV-2 positive nucleic acid extracts with original specimen if possible
Swabs must have a Dacron or synthetic tip with aluminum or plastic shaft (same type as the ones used for influenza testing).
If two sites are swabbed (e.g. nasopharyngeal and oropharyngeal combination swabs), place both swabs in the same sterile collection tube of Universal or Viral Transport Medium or sterile saline.
VRDL can accept swabs from some COVID-19 rapid antigen kits for whole genome sequencing; please contact VRDL.submittal@cdph.ca.gov for guidance and pre-approval if you are if planning to submit this type of specimen.
Other specimen types, including lower respiratory tract specimens may be considered on a case-by-case basis. Please contact VRDL.submittal@cdph.ca.gov for more information. |
āMinimum Volume Requested
| - āRespiratory swabs: 2-3 mL of Universal or Viral Transport Medium or sterile saline.
- Nucleic acid extracts: 25 ĀµL-40 ĀµL
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āTransport Medium (if using)
| Universal or Viral Transport Medium preferred. Molecular Transport Medium also acceptable: please indicated media on submittal form. ā
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āSpecimen Labeling
| āEach specimen tube must be labeled with at least two unique patient identifiers; e.g., patient full name and date of birth.
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āStorage & Preservation of Specimen / Shipping Conditions
| - Swabs and extracts: freeze or refrigerate specimens promptly after collection. Freezing is strongly recommended.ā
Ship refrigerated specimens to VRDL on cold packs. Ship frozen specimens to VRDL on dry ice. |
āShipping Instructions
| Work with your local public health department to ensure samples are packaged according to instructions for Biological Substance ā 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
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Turnaround Time
| - 30 business days for in-house sequencingā
- 90 business days for outsourced sequencing
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Interferences & āLimitations
| This service is provided for public health investigational needs only. This is not a validated, diagnostic test, and results shall not be used for clinical management. Results will only be conveyed to local public health āofficials.
Samples with low viral load (real-time PCR Cycle Threshold >30) or that have been improperly stored or subjected to conditions that negatively impact nucleic acid integrity may not provide interpretable results.
Results may not confirm or predict anti-viral resistance.ā
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āAdditional Information
| Noneā |
āVRDL Points of Contact
| Medical and Epidemiologāāāy Liaisons: (510) 307-8585 or VRDL.Submittal@cdph.ca.govā
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