Specimen Collection and Transport Guidelines for Suspect Smallpox Vaccine Adverse Events

Effective communication and precautionary measures between specimen collection teams and laboratory staff is essential to maximizing safety in the manipulation of infectious specimens.

This is especially relevant in hospital settings, where laboratories routinely process specimens from patients with a variety of infectious and noninfectious conditions.

Laboratory exposures to poxviruses occur primarily through needle-stick injuries, direct contact with the specimen, or aerosols that may be generated by laboratory procedures. Sharps should not be included with any specimens, and should be disposed of in appropriate puncture-resistant containers for autoclave of infectious waste.

Collection of specimen can begin after appropriate consultations have been made. Procedures and materials used will vary depending on the suspected adverse event.

Diagnostic Testing

Real-time polymerase chain reaction (PCR) testing is available across the United States through reference level Laboratory Response Network (LRN) member laboratories. Detection of antibodies by enzyme-linked immunosorbent assay (ELISA) is performed only at the Centers for Disease Control and Prevention (CDC). Consultation with the state epidemiologist, state health laboratory, and CDC is necessary before sending specimens to CDC.

Collection of Specimens for Vaccinia Virus Diagnosis

Report possible human cases of vaccinia virus (smallpox vaccine) to your local hospital epidemiologist and/or infection control personnel, who will contact your local, state, or territorial health department. If appropriate, the state health department will contact the Centers for Disease Control and Prevention (CDC). Consultation with the state epidemiologist, state health laboratory, and CDC is necessary before sending specimens to CDC.

Personnel who collect specimens should use personal protective equipment (PPE) in accordance with recommendations for standard and contact precautions. Collect specimens in the manner outlined below. When possible, use plastic rather than glass materials for specimen collection.

The following types of specimens should be collected according to suspected vaccine adverse event:

*Cardiac adverse events related to vaccination are typically diagnosed by clinical evaluation; although the cause remains unknown (immune-mediated response versus direct viral infection), a cardiac tissue biopsy may be used to evaluate for the presence of virus or histological evidence of inflammation.

Packaging and Transporting Low or Moderate-Risk Specimens

Package, label, and ship low- or moderate-risk specimens as a Category B Infectious substance (UN 3373) in accordance with the U.S. Department of Transportation’s Hazardous Materials Regulations and the International Air Transport Association Dangerous Goods Regulations.