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Thinking about a low cost easy to manufacture home test kit for #Coronavirus. Outline: #Nasal_swab (Q-tip) w/ freeze dried reagents for isothermal #DNA amplification with #COVID19 primers. Colorimetric readout by #iOS or #Android #App w/ #geolocation & #HIPPA compliant reporting.
Read-out would be in minutes - timer in App - read by camera in your smart phone. No other machines. Links to telemedicine groups for positive results. Built in positive control - e.g. no color = improper test, green NEGATIVE, red POSITIVE.
I’ve done my best creating when faced by a challenge. Next gen sequencing when my son went to new born intensive care - #454 @iontorrent. Ultrasound on a chip @ButterflyNetInc when wanted to monitor my daughter’s kidneys.
So, this really has to be the last #pandemic without inexpensive home #test kits. With near instant results. Thinking today how to do for #COVID. We know we can do with a specialized machine (RTQPCR). So we just need to do an isothermal amplification and use phone for readout.
It’s clear you could do a test with a nosal swab, and then dip in a series of 3 tubes: 1) Lyse the virus and release its unique generic code - in this case an RNA molecule. 2) recognize the COVID-19 unique code with a DNA primer specific for this dangerous strain.
Still in tube 2, reverse transcribe the COVID-19 generic material into DNA. DNA is super stable and easy to amplify so we can detect it. Move swab to 3) and use an isothermal amplification method that doesn’t need a machine and produces a color change. Use camera to read color.
Ok. Now that we can do it with a swab and 3 tubes and a smart phone. Review each step and see how we can have the reagents already on the swab, and activated my moisture so we don’t need all the tubes, complexity and chance for failure.
To make it more robust let’s add a second DNA primer and second color for a positive control. That way we can have no color if we messed up the test. Green for just positive control, and red for the #COVID virus. And in #App links get proper #medical support and follow up test.
Would go for approval as a “risk assessment” NOT #diagnostic for faster regulatory clearance. And work with regulatory agencies to validate the PROCESS so for the next TEST and NEXT #pandemic we could update without going back to regulators as long as we followed same process.
Ok, got email from a great manufacturer. They have the manufacturing technologies ready to go. Time to work out the details. Let’s see if we can develop a point-of-care “risk” assessment for #covid19 that can be done at home by anyone, and read by an #App on their phone.
Home test for #covid19 is a thought experiment at this time. Assume I’d have to do as a “research use only product” at first. Even if “risk assessment”. Which means I need to work with a university that would provide an institutional review board to approve the study. #IRB
I’ve made some general progress on the sample collection, and #Coronavirus detection side, and have a potential manufacturer that wants to make. Would need to work out test details today. And start bench experiments.
Trying to figure out how to do #COVID19 test in one tube, so people at home don’t “mess” it up. But I also just figured out how to do an internal control and get two colors, so it’s clear when test is done right.
Ok, so should I work to quickly develop and deploy a simple & rapid home use test for #Coronavirus #COVID19? Realize all the issues with regulatory approvals I’ll face in many countries. And that any test will have BOTH false negative and FALSE POSITIVES. @gatesfoundation
Please DM me protocols & papers that you think would help make this a ONE tube colorimetric test suitable for at home self-testing, or a “paper strip” test. Love to test this week, kit, and get to academic medical centers to compare to gold standard RTQPCR #coronavirus #COVID19.
Ok. Here is an assay we can adopt for #coronavirus #COVID19 #test that can be read by comparing to color strips on the side of the spit tube, or read using an #iPhone App. Please focus suggestions on how to make it work in ONE tube from spit or on a paper strip. @gatesfoundation
Yes. I will need help. Would be great to have an #iOS and #android app that used the camera to read the color. And collected data in #HIPAA (medical record legal complaint way) and with #geotags produced real time map. I still need to work out how to do #COVID19 TEST in one tube!
Background: The gold standard test for #coronavirus is a RTQPCR reaction (that just means exponential amplification of #COVID19 specific target on this case) to see if the virus was “there”. ~$25,000 machine + dozen steps by technician and ~two hours to run tests and get results.
What I’m suggesting is replacing the specialized “lab only” #PCR machine and #kit (that just heats and cools to amplify the #coronavirus genetics sequence) with a “chain reaction” that runs at room temperature and uses your eye or #smartphone camera for the read out.
For clarity: Low cost #Coronavirus home test kit that gives the results at home in 20 minutes. No instrument. Not a home “collection” mailed back to central lab (great to compare #COVID19 tests). It would be “gene” test not antibody. Simple. Early. Sensitive. Working on it now.
Was asked about my “home” lab: my dad had a #chemistry #lab in our basement. I love having a lab- especially now with #coronavirus #pandemic. I need brilliant #interns, so DM me if you are a gifted #molecular_biologist with how you would make a “one tube” #COVID19 home RNA test.
Wish me luck. Doing kick off call with team for #coronavirus home test kit. Want to model our efforts after #Wuhan #hospital. Get it done in 10 days. And out to academics to compare against #RTQPCR standard-of-care. #COVID19 #TESTVIRUSNOW
Update on rapid simple home #covid19 test. We have reliable, simple, super scalable, ultra low price for detection method. Need everyone focused on the initial isothermal “amplification” from spit. Ideal short DNA fragment with distinct ends. #Coronavirus. One tube.
Break problem into two parts: 1) amplify genetic material unique to #covid19. 2) detect the amplified product. 2 ✅ Rules: no machines. Optional phone app to record and share. Please post drawings of the features the #App should have and how it should work with other efforts.
Kickoff - team working on companion #iphone #android #app to our “at home” #coronavirus #diagnostic kit. Software efforts complement molecular biology efforts now working out method to go from spit to diagnosis in 20 minutes. #COVID19 - sharing project in real time. @HomodeusInc
Just got off #googlehangout with our team developing companion #app for “at home” #covid19 diagnostic. @YaleMed @yale @penn we will need help soon comparing our results w/ gold-standard. Please work with our teams now to start #IRB (paperwork!) so ready to go! #corronavirus
Design spec for our home #coronavirus test. We’ve mobilized across @4Catalyzer & @HomodeusInc, collaborating w/ medical @yale @upenn. Have specific molecular biology, supply chain, programming skills to volunteer email: #COVD19 #COVID19 #Findyourmotivation
Looking for a talented illustrator to pro bono help make super simple instructions for our coronavirus home test kit on the compatible app. Email #COVID19 #ios #android @YaleMed @PennHealthTech @HomodeusInc @4Catalyzer
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