Botulinum

Botulinum – Toxin Assay

Laboratory Fee Schedule

Procedure: BTA0201

CPT: 83789


Botulinum - Toxin Assay
Synonym(s): Clostridium botulinum toxin, Botulism
Requisition Form G-27A
Test Description Detection of Clostridium botulinum toxin
Pre-Approval Needed
  • DSHS Epidemiology consultation with physician required
  • Must notify BioThreat Team prior to sample submission: (512) 689-5537
Supplemental Information Required Patient history
Supplemental Form(s) N/A
Performed on Specimens from (sources)
  • Human
  • Environmental
  • Food (associated with a positive clinical sample)
Sample/Specimen Type for Testing
  • Anaerobic isolate
  • Stool
  • Gastric
  • Water enema
  • Serum (no serum on infants)
  • Wound swab
  • Tissue
  • Food (associated with a positive clinical sample)
Minimum Volume/Size Required

Feces

  • Infant 5-10 g or 5 mL enema
  • Adult 5-50 g or 5 ml enema

Vomitus or gastric aspirate 

  • 20 mL

Serum (no serum on infants)

  • 10 mL

Food

  • 50 g

Wound swab

  • 1 required, 2 preferred

Tissue

  • pea-sized sample
Storage/Preservation Prior to Shipping

Wound and tissue

  • maintain at ambient temperature

Serum

  • maintain at 2° to 8°C (refrigerated) unless >48 hours, ship at -20°C (frozen)

All others

  • maintain at 2° to 8°C (refrigerated)
Transport Medium Isolates sent in anaerobic transport media
Specimen Labeling

Human

  • Two patient-specific identifiers required (e.g., patient full name, date of birth, Medical record number)
  • Identifiers on specimen must exactly match submission form.

Environmental or Food

  • Sample identification must match submission form.
Shipping and Specimen Handling Requirements
  • Ship according to Dangerous Good Regulations, IATA, and/or CFR 49.
  • Handled as infectious agent using universal precautions. 
  • Triple contained in accordance with federal shipping regulations for infectious agents. 
  • See also Emergency Preparedness resources online.
  • Notify BioThreat Team prior to sample submission: (512) 689-5537
Method Mass spectrometry
Turn-around Time 7-14 days
Interferences/Limitations
  • Improper storage or shipping temperatures may affect toxin detection.
Common Causes for Rejection
  • insufficient quantity
  • unacceptable specimen type or source
  • improper shipping conditions
  • expired media or collection container
  • discrepancies between specimen label and submission form
  • incomplete or missing submission form
Additional Information May be paired with Culture:  Botulinum (human) and/or PCR – Botulinum toxin genes

Last updated June 3, 2021