Zoonoses and Select Agent Laboratory (ZSAL)

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Specimen submission requirements for CDC Infectious Diseases Clinical Laboratory Improvement Amendments (CLIA) diagnostic testing are being updated.

All submissions to CDC for CLIA diagnostic testing require pre-approval by the CDC Infectious Diseases Laboratory point of contact (POC) for the testing being requested. Updates could affect the acceptable specimen types, storage conditions, shipping conditions, and documentation. Unfortunately, submissions not meeting the updated requirements cannot be accepted.

For general questions, please contact the Infectious Diseases Specimen Submission (IDSS) Help Desk at CDC_ID_lab_info@cdc.gov. Questions regarding the detailed information for a test should be addressed to the CDC POC for that test as listed in the CDC Test Directory.

Laboratory Activities

The Zoonoses and Select Agent Laboratory (ZSAL) of the Bacterial Special Pathogens Branch (BSPB) provides a variety of reference activities for the following bacteria:

  • Bacillus anthracis
    • Detection and isolation
    • Culture identification and genotyping
    • Serology
  • Leptospira spp. (including but not limited to L. interrogans)
    • Molecular Detection
    • Isolation
    • Culture identification and genotyping
    • Serology
  • Brucella spp. (including but not limited to B. abortus, B. canis, B. melitensis, B. suis)
    • Detection and isolation
    • Culture identification and genotyping
    • Serology (B. canis and B. abortus RB51 serology currently not available)
  • Burkholderia spp. (including B. mallei, B. pseudomallei and other members of the B. pseudomallei complex such as B. thailandensis)
    • Detection and isolation
    • Culture identification and genotyping
    • Serology (limited to B. pseudomallei)

Those working with Burkholderia spp. specimens should follow recommendations for management of accidental laboratory exposure to B. psuedomallei and B. mallei.

ZSAL accepts specimens from state public health laboratories and other federal agencies for analysis. Private healthcare providers and institutions should contact their local or state health department laboratory (state, county, city) to ensure appropriate processing.

Specimens for Testing

State public health laboratories may request testing using the test order codes found in the CDC Test Directory.

Click the relevant test code below for a link to the CDC Test Directory with detailed submission requirements.
Test Name Test Code Approval Needed
Bacillus anthracis detection in clinical specimens CDC-10204 Yes
Bacillus anthracis genotyping and AST CDC-10203 Yes
Bacillus anthracis serology CDC-10196 Yes
Bacillus anthracis study CDC-10205 Yes
Bacillus cereus genotyping CDC-10206 No
Brucella species identification, genotyping, and AST CDC-10207 No
Brucella species molecular detection CDC-10208 No
Brucella species serology CDC-10197 No
Brucella species study CDC-10209 Yes
Burkholderia mallei/pseudomallei identification, genotyping, and AST CDC-10210 No
Burkholderia mallei/pseudomallei molecular detection CDC-10211 No
Burkholderia mallei/pseudomallei study CDC-10212 Yes
Burkholderia pseudomallei serology CDC-10198 No
Leptospira species identification and genotyping CDC-10199 No
Leptospira species molecular detection CDC-10200 No
Leptospira species serology CDC-10201 No
Leptospira species study CDC-10202 Yes

Specimen Rejection Criteria

Please review the rejection criteria below prior to submission. ZSAL may reject specimens that are improperly labeled or submitted, or that are in unacceptable condition.

Unacceptable specimen labeling:

  • No labeling
  • Only one unique primary identifier on the specimen container (requirement is two unique identifiers on the specimen). Acceptable primary identifiers include:
    • Full first and last name
    • Date of birth OR age AND gender
    • Unique patient ID from time of collection (e.g. medical record number)
    • No submission form (50.34)
  • Unique identifiers on the specimen container do not match the form
  • Multiple labels on container with conflicting patient identifiers

Unacceptable specimen submission process:

  • Submitter is not authorized by state law (i.e. submitter is not on the state’s list of authorized persons)
  • Test requested is not performed at CDC
  • Specimen was sent to CDC in error

Unacceptable specimen or condition:

  • Specimen has leaked
  • Specimen is of poor quality
  • The volume of the specimen submitted was insufficient
  • The specimen type/site of collection is unacceptable for the testing requested
  • Specimen collection device or transport media are unacceptable
  • Specimen is improperly processed (e.g. serum collection tube not spun down)
  • Specimen is received in an expired specimen collection device
  • Specimen was shipped using unacceptable transport condition
  • Specimen is submitted in an unacceptable timeframe

In addition to the criteria above, the CDC CLIA Technical Supervisor may determine that a specimen should be rejected based on the following:

  • Required submission information not provided as specified according to the CDC Test Directory
  • Improperly completed 50.34 form
  • Specimens submitted directly to CDC without authorization by the jurisdictional Public Health Laboratory
  • Specimen is submitted in an inappropriate manner


All isolates and specimens for analysis by ZSAL should be sent and processed through the state public health laboratory. All bacterial isolates being sent for culture identification, except Leptospira spp., should be grown on solid media in tightly sealed containers (e.g. slants). Leptospira spp. should be grown in semi-solid EMJH and shipped at room temperature tightly sealed.

Serum samples for serological testing should ideally be sent in pairs, including an acute (≤7 days after symptom onset) and a convalescent-phase (14–35 days after symptom onset) specimen. It is recommended that the convalescent-phase specimen be taken 2 weeks after the acute specimen. Serum samples should be sent in a Sarstedt 2 ml microtube with an O-ring in the lid (Catalog Number #72.694.006) or the equivalent. Sera should be sent frozen. Whole blood samples should NOT be sent for serological testing.

PCR samples for Leptospira should be acute whole blood (≤4 days post symptom onset) collected in tubes containing any anticoagulant EXCEPT heparin, or urine collected in a sterile specimen container ≥7 days post symptom onset. Samples for PCR should be frozen and shipped on dry ice as soon as possible after collection.

Specimens submitted for testing must be accompanied by CDC Form 50.34. Samples sent for serology or Leptospira spp. testing should be addressed to unit 91. Samples sent for culture, identification, or PCR testing of B. anthracis, Burkholderia spp., and Brucella spp. should be addressed to unit 91. Select Agent forms may be required for these samples; see below for select agent shipping and reporting requirements.

More information is available on Recommended Specimens Needed for Testing for Anthrax and for Collecting, Preparing, and Shipping Serum Samples.

Follow specific shipping instructions indicated in the relevant CDC Test Directory entry. CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday–Friday. All samples must be shipped in accordance with all applicable local, state and federal regulations.

Shipping address for specimens is:

[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
ZSAL/STATT [Unit # 91]
1600 Clifton Road, NE
Atlanta, GA 30329
[Insert CDC Point of Contact’s Telephone Number]

Select Agents

Confirmed isolates of select agents sent for further characterization require an approved Form 2 from the Federal Select Agent Program (FSAP) prior to shipping. Also, confirmed isolates of select agents identified in a clinical or diagnostic lab must be reported via Form 4. See the FSAPexternal icon for the rules, regulations, and forms for transferring and reporting select agents.

Additional Information

If additional information is needed about the reference activities performed at ZSAL, please call 1-800-CDC-INFO (1-800-232-4636).