Award Information
Award Amount
- Direct Costs: Up to $100,000
- Indirect Costs: Federally negotiated rate or 10% if not applicable
Grant Term
- 12 months. No-cost extensions may be awarded at the discretion of NIH/CAPCaT
Grant Requirements
- Timely just-in-time updates upon selection
- Monthly progress reports
- Participation in CAPCaT kickoff and showcase events
Grant Recommendations
- Participation in abbreviated I-Corp I-Corps Program at the UMCCTS | UMass Chan Medical School, Worcester MA (umassmed.edu)
- Pitch coaching from CAPCaT
- Participation in POCTRN national meeting
Point of Care Technologies Performance Criteria
Applicants are advised to consider the following criteria when developing and submitting proposals:
- Voice of the End User – Patients: Accuracy, immediate result availability, and out-of-pocket cost were identified as important POC characteristics by patients who participated in our needs assessment surveys. Applicants must understand the use case of the technology in the context of where the product will be used.
- Voice of the End User – Healthcare providers: Accuracy, cost, and ease with which the technology could be incorporated into existing workflows were identified as important POC characteristics by surveyed healthcare providers.
- Ease of Use: Ease of use is essential to successful implementation of POC test devices. In the case of instrumented devices, the user interface with the device should be designed to ensure regulatory compliance under the Clinical Laboratory Improvement Amendment (CLIA-88) with minimal requirements for intervention by the operator. Results readout must not be subjective but easy to read using color change, readout, digital, or graphic formats.
- Analytic Performance: As a rule, the performance of POC devices should be equivalent to central laboratory instruments regarding analytical accuracy, reportable range, and precision. Analytical time should be kept to a minimum (less than 5 minutes for common chemistry analytes and less than 15 minutes for immunoassays). Should a predicate device not exist, published preliminary data can be used to evaluate performance.
- Workflow: The POC technology should not require clinicians or staff to significantly alter the way they care for and treat patients in their practice setting and should ideally integrate into existing electronic systems. However, technologies can (and should) consider novel care paradigms, including hospital at home and remote monitoring, as these are 2026 areas of focus.
- Workforce scope: Use of technologies, including AI, holds promise for “up-skilling” medical professionals. Technology developers should therefore detail how new provider types (e.g., a community health worker) would be trained to utilize novel technologies that expand their scope of practice. Regulatory and other reimbursement considerations (including loss of reimbursement for other providers) should be considered and addressed, where appropriate.
- Result Availability: Results must be available in the home, at the hospital bedside, or during an office visit (typically 10 to 20-minute result availability), so that decisions can be made in a timely fashion based on the test results. Technologies should consider the education level (and training) of the intended user when deciding how to report results.
- Reducing Operator Errors: The device should have built-in software safeguards to ensure proper operation and reduce common errors such as lock-out of untrained or minimally trained operators, lock-out for failed quality control (or failure to perform quality control), and lock-out of expired reagents.
- Sample Types: Samples that do not require a trained phlebotomist should be used, such as capillary finger-stick whole blood or saliva.
- Storage of Consumables: All consumables, including reagents, calibrators, and quality control materials, should be stored at room temperature. The minimal shelf life should be 6 months to 1 year.
- Device Footprint: POC devices should be designed to have as small a footprint as possible. Small benchtops or handheld devices are optimal.
- Information Connectivity: All instrumented POC devices should be capable of being interfaced to the electronic medical record system. The ability to transmit data using a bidirectional wireless interface is most optimal.
- Security of intellectual property: Clearly articulated security of intellectual property will be considered most strongly (maybe issued or pending patents, or, for software, trademarks, or copyrights).
- Cost: Solutions that significantly reduce the cost of testing relative to the existing standard of care are encouraged.