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Companion App for At-Home Rapid Tests

by Eric Gastfriend | Nov 18, 2020 | in Introduce Your Idea or Solution

Tele-Lab: From Epidemic to Pandemic

DynamiCare Health was built to address the opioid epidemic. Instead of having patients do urine tests at a clinic, we empower our members to perform instant saliva tests at home, verified via selfie video through our app. Over 30,000 substance tests have been performed through our platform. Now, we have the opportunity to apply what we've built to address the COVID-19 pandemic.

DynamiCare's platform includes/will include the following functionality:
- Patients get step-by-step instructions on how to perform a test
- Patients can record themselves over selfie video to have a verified record of their test results
- The app can automatically read color changes on an immunoassay strip to analyze results
- Patients have a HIPAA-compliant platform to share test results with providers, employers, schools, etc.
- Patients can prove their COVID status to employers, schools, govt., etc.
- Patients are prompted to answer a demographic survey and AOE questions
- Testing device makers can pair the DynamiCare app with their device
- Employers/schools/hospitals can set a schedule to assign self-administered tests to their populations, get results automatically, and analyze data
- DynamiCare will automatically report de-identified test results to public health authorities

We are seeking feedback and expertise on:
- The future of at-home rapid tests (e.g. non-prescribed, OTC)
- Data reporting to public health databases

Also curious to hear feedback/ideas on how we can improve this offering.

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edited on Nov 20, 2020 by Eric Gastfriend
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Andrea Pitkus Nov 18, 2020

Trying to understand how your approach would address the following (In general) 1. How to collect AOEs, from ordering provider/patient/specimen collector. (Looks like this would be met from description, but how would LOINC and SNOMED CT coding aspects be applied to these data?)

2. Integrate into app/LIS or other information source for patient to be married to results of IVD test device/system (either lab performed or patient performed)

3. All data including PHI transmitted to public health jurisdiction (ELR), depending on where patient resides. May include meeting slightly different ELR requirements by different jurisdictions.

4. Deidentified data transmitted to HHS (may be met by 3 by the public health jurisdiction).

Also, is this designed to work with a specific IVD vendor test kit/device or a variety? If multiple, how would UDI information be supported?

Eric Gastfriend Nov 18, 2020

Thank you Andrea -- I sent you a message via LinkedIn because I'd love to discuss more.

Andrea Pitkus Nov 18, 2020

There seems to be quite a bit of similarity with the EUA just announced for the first patient performed home test, but it can be performed by health professionals in POCT settings too. See https://www.fda.gov/media/143810/download Note POCT requires reporting of public health/HHS data items. Hope this helps!

Andrea Pitkus Nov 20, 2020

Another setting your video approach may be helpful is long term care facility (LTC) COVID testing that's now required. Some of the reporting workflow is a bit different, but they are using POCT. The video would help to ensure adequate specimen collection especially if any patient collected specimens.

Eric Gastfriend Nov 20, 2020

Andrea, thank you for your comments and for speaking with me yesterday!
To sum up our conversation for the rest of the forum-watchers:
1. DynamiCare is focused on data collection, test performance, and verification of results on the side of the patient. We would ask the AOE questions directly to the patient in the app before they perform the test. You're right that this could also be useful in LTC POCT settings where verification of the testing procedure and results are important!
2. We now have a fully at-home test on the market, and there will likely be more coming soon. DynamiCare would make the perfect companion app for them.
3. Reporting to public health authorities (ELR) and providers (EHR/LIS) would happen on the back-end. This is not DynamiCare's area of expertise, but we are looking into partnering with software companies that can provide this functionality/integrations.
Thank you again for your interest and support!

mellisa123 Sep 30, 2022

Patients can record themselves over selfie video to have a verified record of their test results.
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johnjenniffer Sep 30, 2022

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The app can automatically read color changes on an immunoassay strip to analyze results.