Request for access to PATH COVID-19 Resources

To expedite our process of sharing biospecimens for future research, please complete the following survey. Your answers will be used to inform the Material Transfer Agreement (MTA) required to ship samples, as well as ensure ethical and scientific considerations are aligned with our Biorepository Governance Plan. Due to limited availability of specimens, our scientific oversight committee will be reviewing requests and prioritizing those anticipated to be successful in meeting the needs of non-high-income economies. We will be in touch after reviewing your request form and will inform you of our appeals process if your application is not initially approved. We do not charge recipients for the specimens out of the repository, however recipients are required to pay for shipping and handling costs, as well as any importation fees, upon approval and MTA execution. Please let us know if you have any questions by emailing specimenrepository@path.org.

A. Organization overview

A1. Organization Name*

A2. Technical contact information*

Please provide the name, phone number, title, and department of the technical lead/principal investigator for this project.

A3. What is the technical contact's email address?*

A4. What country does the technical lead/principal investigator for this project live in?*

A5. Name and email of administrative contact*

Please provide the name and email of an administrative contact for your research project.

B. Research overview

B1. Primary Objective*

Please describe the primary goals of your request for samples and of the proposed study in the following format by replacing the information in <>: Samples will be used by <party conducting research> to evaluate/verify <characteristics of interest (e.g. sensitivity/specificity/LOD, usability) > of <product/prototype name>. The protocol or assay(s) used for testing are <testing protocol / assay types>. Data generated will include <types of data>.

B2. What is the proposed study(ies) and primary objective of this request?*

Please provide a summary of research to be conducted with these samples, including how the samples will be used for each proposed activity.

B3. Briefly, what is the research design for these activities?*

Please describe the type of study or evaluation you are conducting. Example: early R&D, validation, verification

B4. Briefly, what are the proposed research methods for these activities?*

Please describe what research methods you will use with the samples. Include what party will be performing the research.

C. Requested samples

Please indicate what samples you are requesting by answering the following questions. See below information for a list of specimens available to request and specific details on specimens. Longitudinal serum/plasma: these are extremely limited and prioritized based on review of applications Convalescent plasma Nasal eluate: these are deidentified clinical discard specimens; these specimens that have tested positive by FDA EUA assay; positive and negative status is available for recipients, but we do not have demographic or symptomatic data. Nasal eluate negative pool Clinical dilution panels: these are still under development, will be extremely limited upon production, and prioritized based on review of applications. COVID-19 Serology Control Panels (CSCP): 5 well-characterized dried tube specimens pooled from COVID-19 convalescent plasma donors, labeled and packaged with blinded coding for distribution to laboratories for use as a resource to help understand the performance of COVID-19 serology tests.

C1. What type(s) of specimens are you seeking?*

Check all that apply.

Select

C1a1. What type of longitudinal serum/plasma are you requesting?*

Note that these are extremely limited and prioritized based on review of application.

Select

C1a2. How many unique specimens of longitudinal serum/plasma are you requesting?*

C1a3. What volume (up to 200 uL) per specimen of longitudinal serum/plasma are you requesting?*

C1b1. What type of convalescent plasma are you requesting?*

Select

C1b2. How many unique specimens of convalescent plasma are you requesting?*

C1b3. What volume (between 200 uL and 1.5 mL) per specimen of convalescent plasma are you requesting?*

C1c1. What type(s) of transport media and associated data for nasal eluate is acceptable?*

Select

C1c1a. What type of "other" transport media are you requesting?

C1c2. How many unique specimens of nasal eluate are you requesting?*

C1c3. What volume (up to 250 uL) per specimen of nasal eluate are you requesting?*

C1d1. What type of transport media for pooled negative nasal eluate are you requesting?*

Select

C1d2. What volume (up tp 50 mL) of pooled negative nasal eluate are you requesting?*

C1e1. How many COVID-19 serology control panels (CSCPs) are you requesting?*

Note: We recommend 1 CSCP kit per test being evaluated. It is not recommended to evaluate more than 1 test per CSCP kit.

D. Scientific and Ethical Review Questions

Answers to the following questions will help ensure scientific and ethical alignment between your study and our Biorepository Governance Plan.

D1. Will the data generated be shared with the FDA?*

Note: FDA regulated research requires ethical review; if you have further questions, please reach out and PATH will assist.

Yes

D2. Does your organization have policies to provide ethical oversight on secondary use of biospecimens?*

Note: PATH can support if needed.

Yes

D3. Are your laboratory staff trained in working with blood borne pathogens?*

Yes

D4. Do you have a minimum of a biosafety level 2 laboratory?*

If yes, please complete this biosafety lab level 2 checklist and attach at end of document. Link to checklist: https://path.box.com/s/uc3g9dwqhkz5y7f12re134ydnup7jl8e

Yes

E. About your technology

E1. What type of technology are you developing (select all that apply)?*

Select

E2. Please describe your "other" technology type.

E3. For each technology you are developing indicate whether it is currently under development and indicate its Technology Readiness Level (TRL).*

See link for description of NIH TRLs: https://ncai.nhlbi.nih.gov/ncai/resources/techreadylevels If you have more than one technology, please answer for each of your technologies.

E4. For each of your technologies, indicate whether it is commercially available.*

E5. For each of your technologies, indicate the regulatory approval or emergency use authorization (EUA).*

E6. Please describe your each technologies' regulatory approval or EUA, or plans to obtain regulatory approval.*

E7. What evidence have you generated on the performance of your technology(ies)?*

E8. What is the analytical sensitivity and specificity of your technology(ies)?*

E9. What clinical specimens have you evaluated with your technology(ies)?*

E10. Please provide references to product instructions and peer-reviewed literature for your technology(ies).*

In addition to this field, you may upload documentation at the end of the form.

F. Commercialization Questions

F1. Do you currently have manufacturing capacity for your COVID-19 product(s) in any low- or middle-income countries, as defined by the World Bank?*

See here for the World Bank's current economy classifications by income level: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups

Yes

F2. If you answered yes to F1, please describe the manufacturing capacity for each technology/product.

F3. Recipients of samples from the Biorepository will be expected to make commercially reasonable efforts to make final technologies available outside of high-income economies. Please explain if you foresee any challenges with this.*

For more information, see the Bill & Melinda Gates Foundation Global Access Statement: https://www.gatesfoundation.org/How-We-Work/General-Information/Global-Access-Statement

F4. Would you be willing to grant a license to your technology(ies) to a manufacture who would be responsible for filling regional demands in low-and middle-income countries?*

F5. Please describe your regulatory and commercialization plans to make proposed technologies available outside of high-income economies.*

See here for the World Bank's current economy classifications by income level: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups

G. Document upload and additional information.

1. Upload supporting documentation, including BSL-2 checklist, product instructions, and peer-reviewed literature.*

You may upload up to 10 documents and 30 MB.

Drag and drop files here or

G2. Which of the following documents have you uploaded (select multiple)?*

Select or enter value

G3. Is there any additional information you would like to provide us on your technology, organization, or aims?

I confirm that I am aware of and take responsibility for ensuring the samples I may receive are in compliance with local/country shipping and importation regulations and my organization's biosafety regulations.*

Checking this box acknowledges that you will ensure the samples shipped to you meet your country's and organization's regulatory and biosafety requirements PRIOR to sample shipment.

Send me a copy of my responses

Privacy Notice|Report Abuse