Requirements for Submitting Diagnostic Specimens/Cases to IDPB

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For detailed information on acceptable specimens and specimen submission instructions, please refer to CDC’s Infectious Diseases Laboratory Test Directory: Pathologic or Molecular Evaluation of Fixed Tissues for Possible Infectious Etiologies (CDC-10365)

Acceptable specimens differ depending on the following factors:

  • Specimen type:
    • Formalin-fixed wet tissues
    • Formalin-fixed paraffin-embedded tissue blocks
    • Unstained slides only
  • Source:
    • Biopsies from living patient
    • Samples from autopsy
  • Anticipated type of testing:
    • Immunohistochemistry
    • PCR and Sequencing

Specimen Acceptance Criteria

Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are the preferred specimen type for histopathology, histochemistry (special stains), immunohistochemistry, PCR and sequencing and nucleic acid extraction for transfer to other CDC labs.

If an infectious etiology is suspected, tissues should demonstrate histopathologic evidence of a possible infectious process.

FFPE tissue blocks must be less than 10 years of age.

Biopsy and autopsy tissue specimens are only acceptable if embedded within 2 weeks after being placed in formalin.

Formalin-fixed wet tissue from biopsies is not acceptable for testing.

Autopsy tissue specimens are only acceptable if the duration of formalin-fixation has been within 2 weeks, or if tissues have been transferred to 70% ethanol within 2 weeks after initial placement in formalin.

  • Brain autopsy tissue may take longer than 2 weeks for full formalin-fixation, but fixation cannot exceed 4 weeks.

Unstained paraffinized tissue slides are acceptable for histopathology, histochemistry (special stains), and immunohistochemistry. These tissue slides are only acceptable if created 10 days prior to the submission of specimens to CDC. They are not acceptable for PCR testing and sequencing or nucleic extraction for transfer to other CDC laboratories.

Formalin-fixed paraffin-embedded (FFPE) tissue scrolls are not acceptable for testing.

Electron Microscopy (EM) specimens (see separate Test Order Code CDC-10559)

Glutaraldehyde-fixed biopsy, autopsy, or necropsy tissues from any organ or site are acceptable. However, tissue specimens should be submitted from the site(s) of the patient’s disease process.

Thin section EM such as glutaraldehyde-fixed wet tissues, epoxy-embedded tissues, and ultrathin sections from epoxy-embedded tissues are acceptable.

Negative stain EM such as paraformaldehyde-fixed cell culture supernatants and body fluids such as cerebral spinal fluid, saliva, urine, stool samples, and crusts to be evaluated for rash illness are acceptable.

Specimens may be rejected if specimen integrity is found to be compromised.

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Specimen Submission Instructions

U.S. healthcare professionals should first consult with their state health departments regarding any sample submissions.

Then, send an email to Pathology@cdc.gov with the following information:

  • A brief clinical history (including age, sex, patient initials, patient’s state and county of residence)
  • A copy of the surgical pathology report or autopsy report (prelim reports are acceptable)
  • A listing of available formalin-fixed specimen types (wet tissue, paraffin blocks, and/or slides), and a description of gross or histopathologic findings in the tissues to be submitted
  • Relevant clinical, gross pathology, or microscopic pathology digital images, as available
  • Documentation or statement indicating that specimens to be submitted meet IDPB’s specimen acceptance criteria

Please do not include patient identifiers such as name, date of birth, or medical record number. You must follow all applicable federal, state, tribal, local, and territorial regulations to adhere to patient confidentiality and privacy protections.

Once you receive CDC approval by email, follow these instructions for submitting samples to IDPB:

  • Electronically fill, save, and print both pages of the Specimen Submission Form CDC 50.34.
    • The form must be filled electronically to generate 3 barcodes required for accessioning
    • Select Test Order Code CDC-10365 (Pathologic or Molecular Evaluation of Fixed Tissues for Possible Infectious Etiologies)

Click on links below for specific syndrome-based tissue collection recommendations. Note that selected syndromes have additional syndrome-specific specimen submission guidance, as indicated below:

  1. Pathologic Evaluation of CNS Infections
  2. Pathologic Evaluation of Influenza Virus Infections
  3. Pathologic Evaluation of Myocarditis
  4. Pathologic Evaluation of Suspect Pneumonia Infections
  5. Pathologic Evaluation of Rash- and Eschar-Associated Illness
  6. Pathologic Evaluation of Hepatitis
  7. Pathologic Evaluation of Sudden Unexplained Infant Death with Pathologic or Clinical Suspicion of Infection
  8. Pathologic Evaluation of Unexplained Illness Due to Possible Infectious Etiology
  9. Pathologic Evaluation of Suspect Mycobacterium Cases (Note: includes additional syndrome-specific specimen submission guidance)
  10. Pathologic Evaluation of Unexplained Illness due to Possibly Infectious Etiology (International) (Note: includes additional syndrome-specific specimen submission guidance)

Mailing/Contact Info:

  • Ship to:
    Jana Ritter
    Centers for Disease Control and Prevention
    1600 Clifton Rd NE
    RDSB/STATT Unit 109
    Atlanta, GA 30329-4027
  • Mail in suitable packaging for delivery Monday–Friday, excluding Federal holidays
  • Send tracking number to Pathology@cdc.gov
  • Tel: 404-639-3132
    eFax: 404-638-5358
    Email: Pathology@cdc.gov
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Syndrome-Specific Tissue Collection Recommendations