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'SMART' Facemask/Saliva At-Home or Anywhere COVID-19 Test-kit

by Charleson Bell | Nov 24, 2020 | in Introduce Your Idea or Solution

SMART (S-protein Molecular Assay enabling Real-time Tracing).  An easy-to-use, smartphone-compatible, at-home, rapid detection kit can be developed which detects SARS-Cov-2 virus in saliva, via spit collection, or expirate, following respiratory/aerosol capture via a PVDF nanofiber membrane, utilized as a breathable facemask insert.

Innovation: This kit consists of three reagent bottles with a single capture wand.  Briefly, following ~1-2 hrs of use, the PVDF facemask insert is placed into Bottle A, which contains viral eluting solution and anti-SARS-Cov-2 enzyme-like immuno-nanoconstructs.  Alternatively, the user could simply spit a 1-3 mL volume of saliva into the Bottle A.  A polystyrene capture wand, loaded with anti-SARS-Cov-2 antibody-labeled polystyrene beads, may be placed into Bottle A and incubated for ~1 hr.  During this incubation step, SARS-Cov-2 will be sandwiched between the immuno-nanoconstructs and the beads on the wand.  The wand will be removed and rinsed in Bottle B.  Subsequently, the wand will be added to Bottle C which contains the colorimetric catalyst.  Bottle C also has a proprietary QR-code printed to the bottom of the opaque bottle with transparent windows at the reference boxes of the pattern.  After ~2-60 min, depending on the viral concentration, the color of the solution will change to a blue-green and fill the reference boxes with color.  Upon imaging by a smartphone of the pattern at the bottom of Bottle C, our app will (1) determine if the viral protein has been detected, (2) inform the user that they should seek clinical diagnostic testing, and (3) send secure, HIPAA compliant test results, metadata, and location data for geospatial contact tracing.  We welcome collaboration and partnership from all innovative parties to bring this product to a market which desperately needs it.

Background: Smartphones can be utilized to collect, analyze and transmit images, and leveraged to provide geospatial and demographic data, in near real-time.  Smartphone-compatible (SC) technology such as QR codes/barcodes and image analysis are in widespread use among the public worldwide.  Rapid diagnostic tests (RDTs) are field-deployable, medical point-of-care assays that are easily operated. Most RDTs employ sandwich assay technology where an antigen is captured between an antibody-labeled substrate and an antibody-labeled nanoprobe.  Electrospun polyvinylidene fluoride (PVDF) nanofibers have been shown to readily capture aerosols/respiratory droplets and were demonstrated to provide personal protection against airborne SARS-Cov-2 virus on the N98 standard.  Further, they were reported to be at least 10X more breathable than a conventional N95 respirator. 

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edited on Nov 24, 2020 by Charleson Bell
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keyur Patel Nov 24, 2020

What is the Specificity and Sensitivity, as well as LOD for the testing method described above.

Charleson Bell Nov 25, 2020

We have not launched this method above, as it is in idea phase, so the following is supposition. We presume the specificity and sensitivity will approach or exceed that of lateral flow rapid tests that have 77% specificity overall (95% specificity in high viral load) and 58% sensitivity. We believe we can increase these metrics due to the catalytic amplification aspect of our colorimetric probe. We believe this amplification will also lower our LOD from previously described (in smartphone compatible viral testing) 0.055–20 μg/mL concentrations. I believe our test will easily detect the virus in high viral load persons, who - if pre or asymptomatic - have a high likelihood to spread the virus. I surmise if we are able to optimize the colorimetric enhancement, provided by our catalyst, simultaneously with optimizing the software algorithms/scripts which collects the QR image, we can achieve specificity and sensitivity which could allow our product to be used to provide the user some assurance of their status. Any positive test would, of course, require a PCR test to confirm.

keyur Patel Nov 26, 2020

We have seen much higher numbers seen in new antigen tests with Saliva and Sputum. Are there any research papers published for the proposed idea/

Charleson Bell Dec 1, 2020

We have not yet published papers for the proposed idea as we are currently transitioning from ideation phase to development phase.

Andrea Pitkus Dec 3, 2020

How would COVID test reporting requirements be met with your test system? How would AOEs be collected, results transmitted to public health etc as required for all non surveillance COVID testing? Or is this designed to be a surveillance test?

How do you ensure the patient performed the test correctly and has valid results (i.e. they didn't give it to their dog, drop it into the toilet or put it in their ear?) Such approaches may be accidental or intentional (i.e. to get a neg result to go back to work or school).

Charleson Bell Dec 4, 2020

Hey Andrea! We deliberately designed this test to be smartphone compatible such that telemedical approaches could be implemented, with real-time metadata collection. Through a telemedical app the required test data, as prescribed by the CDC (https://www.cdc.gov/coronavirus/2019-ncov/lab...-lab-data.html) could be obtained and reported in real-time to surveillance networks.

My philosophy is that all testing results, with geospatial metadata included, should be reported to surveillance networks to enhance the precision of contact tracing and enable predictive modeling.

Tests would be performed in front of technicians or healthcare professionals remotely/virtually through the smartphone telemedical platform. This is not a novel concept, as specimen collection for testing is performed in this remote fashion commercially today. I think the use of the smartphone and telemedical platform will streamline both the specimen collection, test performance (minimizing user error), and result transmission (surveillance) while providing users/patients access to resources and next steps immediately.

Improving these four aspects, with regard to testing, immediately improves our situation in the pandemic, if deployed in a widespread fashion.

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shara hall Aug 5, 2022

Smart is a test-kit that can be used to test your saliva for glucose levels. It’s especially subway surfers helpful if you’re trying to watch your glucose levels, as it is much easier to do so at home rather than quordle when you’re in the doctor’s office. Smart works by combining your saliva with a small drop of blood.

virgenwitham765 Sep 28, 2022

Background: Smartphones can be utilized to collect, analyze and transmit images, and leveraged to provide geospatial and demographic data, in near real-time.
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virgenwitham765 Sep 28, 2022

Background: Smartphones can be utilized to collect, analyze and transmit images, and leveraged to provide geospatial and demographic data, in near real-time.
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brunotan32 Sep 30, 2022

Electrospun polyvinylidene fluoride (PVDF) nanofibers have been shown to readily capture aerosols/respiratory droplets and were demonstrated to provide personal protection against airborne SARS-Cov-2 virus on the N98 standard.
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