BIOTHREAT RULE OUT AND CONFIRMATORY TESTING

Laboratory: Biological Threat Emergency Response (BTER)

Test Description: Rule out and confirmatory testing for possible select agents including:

• Anthrax (Bacillus anthracis)
• Botulism (Clostridium botulinum)
• Brucellosis (Brucella species)
• Burkholderia mallei
• Burkholderia pseudomallei
• Plague (Yersinia pestis)
• Q fever (Coxiella burnetii)
• Tularemia (Francisella tularensis)
• Bacillus cereus biovar anthracis

Order Approval Required? Yes

• Possible Select Agent - Notification and consultation with DCLS is required prior to submission
• Not required for routine rule out testing of Bacillus species

Specimen Type:

• Pure bacterial isolate
• Some clinical specimens may be acceptable after consultation with Laboratory

Collection Container:

• Isolate - Slant (i.e. TSA slant) or plate media (i.e. blood agar plate)
• Clinical Specimens - Consult Laboratory for appropriate collection container

Optimal Volume: Clinical Specimens - Consult Laboratory for appropriate volume

Collection Guidelines: Clinical Specimens - Consult Laboratory for guidelines

Storage Container: Not Applicable

Storage Instructions:

• Isolates - Store isolates at 2-30°C, send to DCLS as soon as possible and within 7 days of identification
• Clinical Specimens - Consult Laboratory for instructions

Transportation Instructions:

• Isolates - Transport at 2-30°C
• Clinical Specimens - Consult Laboratory for instructions

Test Methodology: LRN conventional microbiological methods and Polymerase Chain Reaction (PCR)

Additional Information:

• Isolate/clinical specimen may be forwarded to the Centers for Disease Control and Prevention (CDC) for further testing if necessary
• Indicate on test request form whether full identification is requested if isolate is negative for Select Agents
• Identification/confirmation of Select Agent(s) will require the submitting lab to complete additional forms to submit to the CDC

Causes for Rejection:

• Samples may only be rejected at the discretion of the Lead Scientist or above
• Evidence of exposure to temperature extremes during transport
• Sample lacks two patient identifiers
• Sample submitted with no test request form or mismatched sample and test request form
• Media that has expired prior to inoculation
• Incorrect or broken transport media
• True duplicate specimens (same collection date, source, and patient identifiers) may be rejected
• Specimen received out of the appropriate temperature range.

Possible Results:

• Rule out of Select Agent(s)
• Full isolate identification of non-Select Agents if requested
• Identification/confirmation of Select Agent(s)