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COVID-19 Challenge — Point of Care and Home Diagnostic Kit for COVID-19 (Canada)

COVID-19 Challenge — Point of Care and Home Diagnostic Kit for COVID-19 (Canada)

Deadline: 20 April 2020

The Public Health Agency of Canada (PHAC) and National Research Council (NRC) are seeking a solution that will diagnose individuals affected by COVID-19 within 3 days of the start of their symptoms using a sample, other than a nasopharyngeal swab, with a rapid single-use home testing kit analogous to a home pregnancy test.

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Currently, COVID-19 testing is being performed by molecular detection using RT-PCR technology. This is occurring in large hospital-based or public health laboratories. This introduces several challenges, including sample routing (from patient to lab), requires specialized equipment and reagents (which can be in short supply) and requires specialized work force (which is vulnerable to illness from the pandemic). While there has been a concerted effort to mitigate these risks, they are insufficient. For example, decentralization of the testing to front-line labs increases capacity but also strains reagent resources. Alternatively, the validation and implementation of point-of-care diagnostics can extend capacity, provide rapid accurate results, and lower technology needs, but still require specialized instrumentation. This limits the ability to disseminate testing as far as would be ideal.

Essential Outcomes
The proposed solution should:

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Phase 1 requirements:
Detect SARS-CoV-2 (the causative agent of COVID-19) within the first 72 hours of symptoms with an accuracy similar to molecular RNA detection.
Results should be available 20 minutes (at most) from sample collection to diagnosis.
The sample input must be one other than a nasopharyngeal swab.
The device must be single use the following section has been added as a new requirement. or reusable as long as decontamination following the usage is easy and there is no complex disposal procedure of the previous test (e.g., it does not result in toxic waste).
The device price cannot exceed $40.
The device must be usable by a lay person with no technical training (although an instruction sheet is allowable).
The interpretation of the result should be easy for a lay person (i.e. negative or positive).
Each device should possess a unique identifier (i.e serial code, QR or bar code).
Phase 2 requirements:
Demonstrate, at the end of Phase 2, clinical efficacy data derived from a clinical trial comparing the device to the performance of the current gold standard. The gold standard is molecular detection by nasopharyngeal swab collection using two gene targets (the E and RdRp genes). Gold standard testing can be performed by the National Microbiology Laboratory or an accredited lab provided the samples are submitted in a blinded and anonimised fashion. Trial design should follow a non-inferiority trial design.
Additional Outcomes

The proposed solution should:

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The result of the test should be easily uploaded to the public health system / network connected to enable monitoring and action. The result should also be easily uploaded as anonymous if desired.
Interpretation of the device result would benefit from assistance using commonly available technology, such as smart phone cameras, to facilitate interpretation of positive or negative results and record the result.
Funding Information

Funding of up to $300,000.00 CAD for up to 3 months could be available for any Phase 1 grant resulting from this Challenge.
Estimated number of Phase 1 grants to be awarded: 2
Funding of up to $2,000,000.00 CAD for up to 12 months could be available for any Phase 2 grant resulting from this Challenge. Only eligible businesses that received Phase 1 funding could be considered for Phase 2.
Estimated number of Phase 2 grants to be awarded: 1
This disclosure is made in good faith and does not commit Canada to award any grant for the total approximate funding. Final decisions on the number of Phase 1 and Phase 2 awards will be made by Canada on the basis of factors such as evaluation results, departmental priorities and availability of funds. Canada reserves the right to make partial awards and to negotiate project scope changes.
Eligibility Criteria

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Solution proposals can only be submitted by a small business that meets all of the following criteria:

for profit
incorporated in Canada (federally or provincially)
499 or fewer full-time equivalent (FTE) employees Footnote
research and development activities that take place in Canada
50% or more of its annual wages, salaries and fees are currently paid to employees and contractors who spend the majority of their time working in Canada Footnote
50% or more of its FTE employees have Canada as their ordinary place of work Footnote
50% or more of its senior executives (Vice President and above) have Canada as their principal residence
For more information, visit https://www.ic.gc.ca/eic/site/101.nsf/eng/00100.html

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