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VIRAL AND RICKETTSIAL DISEASE LABORATORY​​

Test Order
Monkeypox Virus Detection - Whole Genome Sequencing​​​​​

Information Category
​Information Detail
Pre-Approval

Not Applicable

​Supplemental Information Required
Previous t​​est results: Sampled lesion must be positive for Monkeypox Virus (MPXV) using a generic MPXV or MPXV clade II-specific assay or a Non-variola orthopoxvirus assay. Samples that test negative for clade II MPXV but are positive in a generic MPXV-specific assay are not acceptable, si​nce 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.​
​Submittal Forms
Specimens must be accompanied with a hard copy of the completed VRDL General Purpose Specimen Submittal Form (PDF) or a form generated in the VRDL Lab Web Portal

Mpox group submittal form available on request from  VRDL.Submittal@cdph.ca.gov.
Methodology 

Whole Genome Sequencing (LDT) (Surveillance use only)

Reflex Testing
​May be referred to CDC for additional testing
​Acceptable Specimen Type(s) and Collection Method
Human Specimens:
  • Lesion swabs, in Viral Transport Medium (preferred) or dry
  • Dry 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 virus–positive persons.​
​Minimum Volume Required
  • ​Lesion Swabs: 
    • ​200 µL residual VTM or PBS from positive swab, or
    • Duplicate swab from positive lesion placed in 1-3 mL VTM, or
    • Dry swab
  • ​​Nucleic acid extracts: 25 µL
​Transport Medium (if using)
Viral Transport Medium
​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

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.

​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
60 business days
Interferences & ​Limitations
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.
​Additional Information
​Clade II MPXV or undifferentiated MPXV-positive samples or those that are non-variola virus-positive from suspected mpox cases are acceptable. 

MPXV-positive samples t​hat 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.


​VRDL Points of Contact
Medical and Epidemiolog​​​y Liaisons: (510) 307-8585 or VRDL.Submittal@cdph.ca.gov​ 

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