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Chart 3: Laboratory Testing for Suspect Smallpox Vaccine Adverse Event (Vaccinia)

Flow-chart depicting laboratory testing for suspect smallpox vaccine adverse event (vaccinia).
  1. A patient presents with suspect smallpox vaccine rash illness and is evaluated by healthcare practitioner, infectious disease or dermatology specialist
    1. Take digital photos of the rash presentation for clinical consultation
  2. Consult with local and/or state health department
  3. Laboratory testing occurs in a LRN Reference Laboratory with Orthopoxvirus PCR capacity. All other laboratories refer.
  4. LRN Reference Laboratory with Orthopoxvirus PCR capabilities must use BSL-2 facilities to perform the following tests:
    1. Non-variola Orthopoxvirus PCR
    2. Orthopoxvirus PCR
    3. Electron microscopy (if available)
  5. If the Non-variola Orthopoxvirus PCR is negative and the Orthopoxvirus PCR is negative, Orthopoxvirus is ruled out. The risk is low.
    1. Re-evaluate the patient’s condition and assess the need for dermatologic consultation and/or other diagnostic testing.
    2. Consider histologic testing for erythema multiforme, immune or drug reactions.
  6. If the Non-variola Orthopoxvirus PCR is positive and the Orthopoxvirus PCR is positive, the patient has a possible Orthopoxvirus infection other than variola virus (e.g., vaccinia, monkeypox, or cowpox virus).
    1. If needed, contact CDC to submit specimen(s) for confirmatory testing and species typing. The CDC Emergency Operations Center is available 24/7 at 770-488-7100.
  7. If the Non-variola Orthopoxvirus PCR is negative and the Orthopoxvirus PCR is positive, the patient has a possible smallpox infection. The results could also represent differential sensitives of the assays.
    1. Contact CDC immediately PRIOR to release of results. The CDC Emergency Operations Center is available 24/7 at 770-488-7100.

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