Pre-Approval
| Not Applicable
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āSupplemental Information Requested
| Previous test results: Sampled lesion must be positive for Monkeypox Virus (MPXV) using a generic MPXV or MPXV clade II-specific assay or a Non-variola orthoāpoxvirus assay. Samples that test negative for clade II MPXV but are positive in a generic MPXV-specific assay are not acceptable, since these may fall under Select Agent rules (See Additional Information). Ct values, lesion site, treatment with tecovirimat or other antiviral, vaccination status, and outbreak location (if applicable) should be indicated on the submittal form when available.ā
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āSubmittal Forms
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Methodology
| Whole Genome Sequencing (LDT) (Surveillance use only)
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Reflex Testing
| āMay be referred to CDC for additional testingā
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āAcceptable Specimen Type(s) and Collection Method
| Human Specimens: - Lesion swabs, in Viral Transport Medium (preferred) or dry
- Dāry lesion scabs or crusts
- Positive nucleic acid extracts
Lesion specimens or nucleic acid extracts only acceptable from clade II MPXV, MPXV (generic), or Non-variola orthopox virusāpositive persons.ā
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āMinimum Volume Requested
| - āLesion Swabs:
- ā200 ĀµL residual VTM or PBS from positive swab, or
- Duplicate swab from positive lesion placed in 1ā3 mL VTM, or
- Dry swab
- āāNucleic acid extracts: 25 ĀµL
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āTransport Medium (if using)
| Viral Transport Medium
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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
| - Freeze or refrigerate specimens promptly after collection. Freezing is strongly recommended.
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
| 60 business days
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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.
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.
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āAdditional Information
| āClade II MPXV or undifferentiated MPXV-positive samples or those that are non-variola virus-positive from suspected mpox cases are acceptable.
MPXV-positive samples tāhat are known not to be clade II are not acceptable. As a reminder, MPXV clade I is regulated as a select agent and must be reported to the CDC DSRC within 7 days.
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āVRDL Points of Contact
| Medical and Epidemiology Liaisons: (510) 307-8585 or VRDL.Submittal@cdph.ca.govā
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