Solutions Being Considered by CDC

A. Pre-Established collection processes, protocols, permits, and agreements

It will be more likely that difficult-to-obtain test materials will be available when needed with pre-established:

• Sample collection processes.
• Protocols.
• Shipping permits.
• Collaborative agreements.

Several processes could be developed and implemented to expedite the collection of appropriate patient samples. These include:

• The development of a sample collection protocol (including appropriate informed consent documents) that is approved by the Institutional Review Board (IRB).
• Obtaining provisional IRB approval for generic sample collection that can be minimally modified based on the circumstances of an outbreak.

Entities that are able to collect samples in different domestic and international locations, could be identified through Blanket Purchase Agreements (BPA).

Processes for collection of samples could be instituted to facilitate the sample collection processes, including:

• Pre-established sharing and material transfer agreements (MTA).
• Standardized patient and clinical data collection formats.
• Strategic positioning of prepaid shipping materials and labels.

Other processes that could also help to improve the ability to rapidly and efficiently ship samples:

• Negotiate pre-established contracts with national shippers.
• Secure proper import permits (CDC, USDA, and Department of Commerce).

CDC’s longstanding relationships could be leveraged to facilitate collection, characterization, and sharing of needed materials. These include:

• Many external public health organizations, such as the Association of Public Health Laboratories and the World Health Organization.
• Other U.S. governmental agencies, including the National Institutes of Health and Department of Defense.
• State public health laboratories.

Partnerships with governmental, commercial, and academic biorepositories are also explored to expand access to samples and materials during a response.

B. Procurement and proper storage of currently available materials

Identifying priority emerging disease threats, and procuring and storing available materials, would increase the speed that these could be distributed in an emergency. Blood, sera, plasma, and other materials collected from unaffected donors could be purchased from tissue supply companies. These could then be characterized and stored for use as matrices for test development and validation of contrived clinical samples.

Similarly, characterized stocks of viruses, bacteria, and common interfering substances could be created by CDC. They could be stored for production of samples to be used for both the analytical and clinical evaluation of diagnostic tests. Stability studies could be performed regularly to confirm sample integrity and the suitability of storage conditions. This could be used to establish expiration dates of the test materials.

Data collection could be standardized to establish a uniform presentation of information and data for all samples. A virtual catalog of available samples (both at CDC and other participating laboratories or repositories) could be created to facilitate:

• Searching.
• Identification.
• Requests for preparedness repository samples.

A web portal could be created to inform stakeholders, and to improve communication between laboratories and test developers both inside and outside of CDC.

C. Advanced preparation of standardized panels

Ways to allow comparison of newly developed diagnostic tests and identify the best test to address the needs of the public health response would be:

• Advance preparation of panels of clinical samples, contrived samples, and pathogens (where possible).
• Production plans and agreements to produce standardized panels on demand.

These panels could also be subsequently used for diagnostic test verification or proficiency testing by spiking them with the agent of interest.

Protocols for the manufacture of contrived specimens that are acceptable to FDA could be pre-positioned. Methods for pathogen inactivation could be validated so that materials could be shipped easily and provided to laboratories that do not have biosafety containment capabilities.

The creation of a preparedness repository that could serve as a centralized distributor of well-characterized clinical samples, organisms, and other materials. This would be a tremendous resource to clinical diagnostic test developers who work in public health (federal, state, local, and territories) and the commercial sector.

The CDC Biorepository (CBR), managed by the Division of Core Laboratory Services and Response (DCLSR), has over 20 years of experience with storage and management of collections. It could—with appropriate financial resources—provide the required expertise and infrastructure to support a repository of specimens and materials for emergency preparedness and response activities. The materials maintained and managed within this repository could include:

• Characterized individual clinical samples (both positive and negative).
• Pooled patient samples.
• Bulk material (e.g., blood, serum, urine, plasma) from unaffected donors.
• Characterized stocks of pathogens.
• Interfering substances or cross-reactivity organisms.

The CBR could establish mechanisms and partnerships for rapid acquisition and characterization of specimens and materials. It could distribute these products for test development, validation, optimization, and verification.

DCLSR has extensive experience and expertise with:

• Collecting and processing patient samples and other materials.
• Storing select agents.
• Creating validation and proficiency test panels.
• Manufacturing and shipping reagents and controls.

DCLSR also has a United States import permit and contracts in place to obtain blood products from sources outside the United States.