Treponema pallidum Requests by Commercial Entities

Details on Cultures

CDC provides Treponema pallidum subspecies pallidum (T. pallidum) strains propagated in rabbits or in vitro for research and development purposes. The bacterial cultures are intended solely for commercial entities developing syphilis diagnostic tests in the United States, including companies seeking FDA clearance or authorization.

• T. pallidum cultures are provided as crude preparations in frozen aliquots of approximately 0.5-1.0 mL, with concentrations typically ranging from 10⁴ to 10⁷ treponemes/mL.
• CDC may provide up to 5 vials per request.
  
• CDC will assign a CDC Unique Identifier (CUID) to each vial. The CUID should be referenced in any future correspondence regarding the material.
• A Material Transfer Agreement (MTA) between CDC and the requestor is required before cultures will be shipped.
• CDC assesses a fee of $350 per vial to recover a portion of the costs associated with strain propagation, storage and shipping.

How to Request Cultures

To inquire about T. pallidum culture availability, email the CDC STD Laboratory Reference & Research Branch at stdlaboratoryspecim@cdc.gov.
Attention: Drs. Allan Pillay or Weiping Medlin

After CDC confirms availability, submit a letter on company letterhead that includes the following information:

1. The purpose of the request and intended use of the culture.
2. A statement confirming agreement to pay the $350 per vial fee.
3. Confirmation that the receiving facility has appropriate biosafety practices, BSL-2 facilities, and approvals to handle the requested material.
4. Whether live or heat-inactivated culture is requested.
5. The requestor's organizational affiliation and complete contact information.
6. Payment must be received before cultures are shipped.
   

Disclaimer: CDC is not responsible for loss of culture viability due to shipping conditions or delivery delays.