Specimen Collection Instructions

Attention!

Because specimen submission requirements for CLIA diagnostic testing are currently being updated, ALL submissions to CDC for diagnostic testing require pre-approval at this time. Please contact AFMLab@cdc.gov before submitting AFM specimens to CDC.

What You Need to Know, 2023

The single case of polio – identified in the United States in July 2022 – reinforces the importance of collecting stool from patients with suspected AFM to rule out polio.

Download the Specimen Collection Job Aid

Specimen Testing Protocols

  • CDC will conduct routine testing and typing of CSF, respiratory specimens and stool for enterovirus/rhinovirus, and poliovirus testing of stool specimens to rule out the presence of poliovirus.
  • Additional testing protocols are being developed to look for AFM biomarkers and studies to identify possible mechanisms for AFM are underway.
  • Pathogen-specific testing should continue at hospital or state public health laboratories and should include CSF, respiratory swab, serum, and stool specimens.

Early Specimen Collection is Critical

Clinicians should collect specimens from patients under investigation (PUIs) for AFM as early as possible in the course of illness, preferably on the day of onset of limb weakness. Early specimen collection has the best chance to yield a cause of AFM.

specimen collection tools

Clinicians should:

If specimens have not been collected or all of the available specimens have been used and no specimen remains, you should repeat specimen collection, when feasible.

Sharing Testing Results

  • Since the testing protocols include several assays that are not performed under the Clinical Laboratory Improvement Amendments (CLIA) nor intended for clinical diagnosis, CDC will be unable to provide patient-specific results for certain tests that are performed.
  • Results following testing of samples from multiple cases that may indicate a possible cause of AFM will be rapidly disseminated.
  • Results from certain tests, such as EV/RV testing and typing and stool testing, will be shared with the health department upon completion.

CDC appreciates your assistance and participation in this important endeavor. With your assistance, we hope to gain further insights into the nature of this condition.

Specimens to Collect and Send to CDC for Testing for Patients Under Investigation (PUIs) for AFM

Cerebrospinal fluid (CSF)
specimen collection tool - CSF

Spun and processed; collect at same time or within 24 hours of serum if feasible

Cerebrospinal fluid (CSF)
Minimum Amount 0.15 mL, 0.5-2 mL preferred
Tube Type Cryovial
Storage Freeze at <-20°C
Shipping Ship on dry ice
Results of Testing Results for EV/RV testing will be returned as testing completed (within 14 days); CSF will also be used for special studies
Respiratory - nasopharyngeal (NP) or oropharyngeal (OP) swab
specimen collection tool - NP Swab

Store in viral transport medium

Respiratory – nasopharyngeal (NP) or oropharyngeal (OP) swab
Minimum Amount 0.5 mL, 1 mL preferred
Tube Type N/A
Storage Freeze at <-20°C
Shipping Ship on dry ice
Results of Testing EV/RV testing and typing will be performed and results returned within 14 days of sample receipt
Serum*
specimen collection tool - Serum

Spun and processed; send aliquot; collect at same time or within 24 hours of CSF if feasible

Serum
Minimum Amount 0.5 mL, 1 mL preferred
Tube Type Tiger/red top for collection; separate tube for shipping
Storage Freeze at <-20°C
Shipping Ship on dry ice
Results of Testing Results for EV/RV testing will be returned as testing completed (within 14 days); Serum will also be used for special studies
Whole stool
specimen collection tool - stool

Two samples total, collected at least 24 hours apart, both collected as early in illness as possible and ideally within 14 days of illness onset

Whole stool
Minimum Amount 1 gram, 10 – 20 grams preferred
Tube Type Sterile container; Not a rectal swab†.
Storage Freeze at <-20°C
Shipping Ship on dry ice
Results of Testing Results for EV/RV and poliovirus testing will be returned as testing completed (within 14 days)

*If any of the serum samples that you are sending to CDC were collected after the patient had received intravenous immune globulin (IVIG), steroid treatments, or plasmapheresis/plasma exchange, please indicate the date of that therapy on the Patient Summary Form.

† The negative predictive value is very low for rectal swabs since the amount of fecal material collected is much less than for stool.

Reporting Job Aid for Clinicians: Reporting Patients Under Investigation for Acute Flaccid Myelitis (cdc.gov)

Handling and Shipping

Prior to shipping, send an email regarding what is being shipped and include the name, phone number and email address of the shipper.

Please send this information to the following mailboxes:

State and local health departments and clinicians treating PUIs may contact CDC for further laboratory and epidemiologic support by phone through the CDC Emergency Operations Center (770-488-7100), or by email at AFMinfo@cdc.gov (epidemiology information) or by email at AFMLab@cdc.gov (laboratory information).

  • Overnight shipping:  CDC advises overnight shipment of available clinical specimens from patients under investigation (PUIs) for AFM to CDC to optimize yield from specialized testing.
  • Arrive Tuesday through Friday:  Please ship specimens overnight so they arrive at CDC on Tuesday through Friday. Do not ship specimens on Friday or over the weekend.
  • For samples that should be frozen: Please freeze them at ≤-20°C and make arrangements to ship the samples overnight to CDC frozen on dry ice.
  • Include Patient Forms:  Samples from each patient should be shipped with completed hard copies of
  • If 10 or more patient specimens are submitted:  Please provide an electronic line listing by email. Use the following headers in this order: patient ID number; date of birth; sex; onset date; fatal y/n; specimen ID number; specimen collected date; specimen type; if culture isolate—cell line and passage number.

Shipping Address

Shannon Rogers
Centers for Disease Control and Prevention
RDSB/STAT Unit 76
ATTN: Polio and Picornavirus Laboratory Branch
1600 Clifton Road, NE
Atlanta, GA 30329
Office: +1-404-639-2677
Mobile: +1-678-520-6455
Email: AFMLab@cdc.gov

Specimens to Collect and Send to CDC for Testing in the Event of Death

In the event of death, please send the following specimens, if possible.

Formalin-fixed or formalin-fixed, paraffin-embedded tissue
Formalin-fixed or formalin-fixed, paraffin-embedded tissue
Pre-approval Required In the event of death, prior to shipping, please contact the Infectious Diseases Pathology Branch (IDPB) at pathology@cdc.gov for pre-approval to submit formalin-fixed tissues
Collection & Storage
  • Autopsy tissue blocks – Only acceptable if embedded within 2 weeks (or within 4 weeks for brain) after being placed in formalin
  • Autopsy wet tissue – Only acceptable if the duration of formalin-fixation has been within 2 weeks (or within 4 weeks for brain) or if tissues have been transferred to 70% ethanol within 2 weeks (or within 4 weeks for brain) after initial placement in formalin
  • Specimen Collection Recommendations for Pathologic Evaluation of Central Nervous System Infections, is available at: https://www.cdc.gov/ncezid/dhcpp/idpb/specimen-submission/cns.html
  • Blocks & wet tissue – Store at room-temperature
Shipping
Additional Information IDPB’s specimen requirements and specimen submission instructions, including shipment address, is available at: https://www.cdc.gov/laboratory/specimen-submission/detail.html?CDCTestCode=CDC-10365
Fresh-frozen tissue
Fresh-frozen tissue
Pre-approval Required Fresh-frozen tissues may be acceptable under limited circumstances. In the event of death, prior to shipping, please contact the Infectious Diseases Pathology Branch (IDPB) at pathology@cdc.gov for pre-approval to submit fresh-frozen tissues
Collection & Storage
  • Do not add any media to specimens
  • Freeze specimens (-20°C or lower) immediately and ship within 24 to 48 hours of collection
  • If specimens must be stored for more than 48 hours, freeze immediately at -70°C or lower and ship within 4 weeks of collection
Shipping
Additional Information IDPB’s specimen requirements and specimen submission instructions, including shipment address, is available at: https://www.cdc.gov/laboratory/specimen-submission/detail.html?CDCTestCode=CDC-10560

Handling and Shipping

Prior to shipping, please contact Infectious Diseases Pathology Branch (IDPB) at pathology@cdc.gov for pre-approval of specimen submission.

Additional information on IDPB’s specimen requirements and specimen submission instructions, including shipment address, is available at:  https://www.cdc.gov/laboratory/specimen-submission/detail.html?CDCTestCode=CDC-10365

Contact us with questions

State and local health departments and clinicians treating PUIs may contact CDC for further laboratory and epidemiologic support by:

  • Phone: CDC Emergency Operations Center (770-488-7100)
  • Email: AFMinfo@cdc.gov (epidemiologic support)
  • Email: AFMLab@cdc.gov (laboratory support)