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Test Order
Test Order
Botulism Special Study
CDC-10133
Synonym(s)
Botulinum toxin, Clostridium botulinum
CDC Pre-Approval Needed
Supplemental Information Required
If specimen contains botulinum neurotoxin and/or botulinum neurotoxin producing species of Clostridium, the transfer must be approved by APHIS/CDC Federal Select Agents Program.
Complete one CDC Specimen Submission Form (50.34) per specimen and include in shipment. Include the following information within the CDC 50.34 Specimen Submission Form: point of contact name, phone number and email address for State Department of Health and Hospital.
Supplemental Form
Request to Transfer Select Agents and Toxins (APHIS/CDC FORM 2). https://www.selectagents.gov/resources/APHIS-CDC_Form_2_English_Fillable.pdf
Performed on Specimens from
Human and Food/Environmental/Medical Devices/Biologics
Acceptable Sample/ Specimen Type for Testing
Serum, stool, isolates
Minimum Volume Required
5 mL (serum), 10 g (stool)
Collection, Storage, and Preservation of Specimen Prior to Shipping
Refrigerate all specimens promptly after collection. Maintain specimen refrigerated (2-8 °C) until shipment.
Transport Medium
For isolates: Chopped Meat Glucose Starch
Specimen Labeling
This test order can accommodate diagnostic and non-diagnostic specimens. Testing subject to CLIA regulations requires two primary patient identifiers (e.g., patient first and last name, date of birth, unique patient identifier from time of collection, such as medical record number) on the specimen container and on the test requisition.
Research or surveillance specimens may be labeled according to protocol. Labels should not include personally identifiable information. All submitted specimens should include two unique identifies. The results should NOT be used for diagnosis, treatment, or assessment of patient health or management.
Research or surveillance specimens may be labeled according to protocol. Labels should not include personally identifiable information. All submitted specimens should include two unique identifies. The results should NOT be used for diagnosis, treatment, or assessment of patient health or management.
Shipping Instructions which Include Specimen Handling Requirements
Ship refrigerated specimens (2-8 °C) with cold packs.
CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday - Friday.
Ship to:
<Insert CDC Point of Contact>
Centers for Disease Control and Prevention
RDSB/STATT Unit 26
1600 Clifton Road, NE
Atlanta, GA 30329
<Insert CDC Point of Contact's Telephone Number>
All samples must be shipped in accordance with all applicable local, state and federal regulations.
Methodology
Mass Spectrometry (MS), Mouse Bioassay, Polymerase Chain Reaction (PCR), Whole Genome Sequencing
Turnaround Time
24 Weeks
Interferences & Limitations
To be determined
Additional Information
None
CDC Points of Contact
Version
2.0
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