Botulinum – Toxin Assay

Laboratory Fee Schedule

Procedure: BTA0200

CPT: 87001

Botulinum - Toxin Assay
Synonym(s): Clostridium botulinum toxin, Botulism, Mouse Bioassay
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: >10 g or 5 mL

•   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: if >48 hours, ship at -20°C (frozen)

•   All others: maintain at 2.0° to 8.0°C (refrigerated)

Transport Medium Isolates sent in anaerobic transport media
Specimen Labeling


•   At least 2 patient specific identifiers: First and last name as one identifier and a DOB or a unique patient specific identifier (e.g. Medical record number).

•   Specimen identification must 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 Mouse Bioassay and/or ELISA
Turn-around Time 7-14 days
Interferences/Limitations Material must be viable. Improper storage or shipping temperatures may limit organism recovery.
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, and/or incomplete or missing submission form
Additional Information May be paired with Culture:  Botulinum (human) and/or PCR – Botulinum toxin genes

Last updated November 28, 2018