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Test Order
Test Order
Botulism Laboratory Confirmation CDC-10132
Synonym(s)
Botulinum toxin, Clostridium botulinum
CDC Pre-Approval Needed
None
Supplemental Information Required
For clinical samples, provide patient name, date of birth, history of present illness, and treatment history, including date of BabyBIG or BAT administration.
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
None
Performed on Specimens from
Human and Food/Environmental/Medical Devices/Biologics
Acceptable Sample/ Specimen Type for Testing
Contact CDC POC prior to specimen submission for specimen acceptance, collection, storage and preservation requirements.
Minimum Volume Required
Adult patients: 5 mL serum, 10 g of stool.
Infant patients: 10 g of stool.
Note: Smaller quantities of stool (up to 0.5 - 1 g) may be tested; if needed, enema can be obtained with sterile non-bacteriostatic water. Minimum volume for serum is 1 mL.
Infant patients: 10 g of stool.
Note: Smaller quantities of stool (up to 0.5 - 1 g) may be tested; if needed, enema can be obtained with sterile non-bacteriostatic water. Minimum volume for serum is 1 mL.
Collection, Storage, and Preservation of Specimen Prior to Shipping
Serum must be collected before antitoxin treatment. Use tubes with no-additive and no anti-coagulant for serum collection. Collect raw stool in a sterile container. If enema is needed, use sterile non-bacteriostatic water.
Foods should be left in their original containers or placed in sterile unbreakable containers. Empty containers with remnants of foods can also be recovered and submitted for testing.
Refrigerate all specimens promptly after collection. Maintain specimen refrigerated (2-8°C) until shipment. Ship stool specimens to CDC within 2 days of collection.
Note: serum can be shipped within 20 days of collection date.
Foods should be left in their original containers or placed in sterile unbreakable containers. Empty containers with remnants of foods can also be recovered and submitted for testing.
Refrigerate all specimens promptly after collection. Maintain specimen refrigerated (2-8°C) until shipment. Ship stool specimens to CDC within 2 days of collection.
Note: serum can be shipped within 20 days of collection date.
Transport Medium
Submit cultures of suspected botulinum neurotoxin producing species of Clostridium in Chopped Meat Glucose Starch broth or Chopped Meat Glucose broth
Specimen Labeling
Test subject to CLIA regulations and 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 the test requisition.
Shipping Instructions which Include Specimen Handling Requirements
CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday – Friday. Ship refrigerated (refrigerated or frozen cold packs). Package must have proper labeling for biological hazards: UN3373 biological substance, Category B.
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. Upon shipment, submitter should send an email to the CDC POC providing shipping company, shipped date and package tracking number.
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. Upon shipment, submitter should send an email to the CDC POC providing shipping company, shipped date and package tracking number.
Methodology
Mass Spectrometry (MS)
Turnaround Time
12 Weeks
Interferences & Limitations
Incorrect storage and/or spoilage of food may affect results.
Additional Information
CDC pre-approval is not needed; however, hospitals must obtain approval from their state health department prior to submitting specimens to CDC. Turnaround Time: Preliminary results may be available within 48 hours of specimen receipt.
CDC Points of Contact
Version
2.4
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