1/n An overdue thread on #SalivaDirect...
No doubt many of you heard of it, either on this platform, or on the news. It generated a lot of buzz in the media, and not all of it is true. Lets walk through these, and how to get it set up in your lab.
covidtrackerct.com/about-salivadi…
No doubt many of you heard of it, either on this platform, or on the news. It generated a lot of buzz in the media, and not all of it is true. Lets walk through these, and how to get it set up in your lab.
covidtrackerct.com/about-salivadi…
2/n We apologize for the delay in getting information out on this. The FDA issued our EUA on a Saturday, and a media onslaught came before we could get ahead of it. This received much more attention than we ever imagined! We are working through our hundreds of emails...
3/n: Our mission is to remove capitalism from surveillance. We want to make available cheaper tests, and we believe that companies shouldn't overly profit from this. That is why we offer our protocol for free, and we are working with labs to implement cost and time saving steps.
4/n: What is SalivaDirect?
It is an RNA-extraction free, dualplex PCR for saliva to detect #SARS-CoV-2. It is meant to make sample collection and testing simpler and cheaper for large screening needs - like any "return-to" program.
It is an RNA-extraction free, dualplex PCR for saliva to detect #SARS-CoV-2. It is meant to make sample collection and testing simpler and cheaper for large screening needs - like any "return-to" program.
5/n We've validated different reagents and equipment for each step to make this easier to implement within labs, and we'll work with labs to do additional bridging studies to help implement. This also helps to alleviate supply chain issues and decrease costs by switching vendors.
6/n We've used this on inpatients, healthcare workers, and even NBA players & staff. The main concern that labs have with using saliva is that it is hard to work with (viscous) - but our protocols are optimized to collect for saliva collection help us to collect true saliva.
7/n What isn't SalivaDirect?
It isn't a point-of-care or an at-home rapid test. It uses PCR, and thus requires a high-complexity lab.
It isn't a point-of-care or an at-home rapid test. It uses PCR, and thus requires a high-complexity lab.
8/n What isn't SalivaDirect?
It's not a kit, it's a protocol – so we don't have products to distribute. Rather, for authorized labs, we can provide a protocol for doing inexpensive saliva-based RT-qPCR testing.
It's not a kit, it's a protocol – so we don't have products to distribute. Rather, for authorized labs, we can provide a protocol for doing inexpensive saliva-based RT-qPCR testing.
9/n @michaelmina_lab has a thread on some of the misconceptions of SalivaDirect in the media. While I agree with much of this, I don't agree with everything. But that is ok 😀
10/n SalivaDirect is a tool that will help improve the efficiency of testing for population screening, but it won’t solve everything. We still need faster, cheaper, and portable tests. We’ll use our experience here to help bring more of those tests to reality too.
11/n How will SalivaDirect be offered?
Only by authorized CLIA certified labs. At this moment we cannot help you to find or set up a lab to run SalivaDirect, as we are focused on authorizing labs that are currently CLIA certified.
Only by authorized CLIA certified labs. At this moment we cannot help you to find or set up a lab to run SalivaDirect, as we are focused on authorizing labs that are currently CLIA certified.
12/n Also, we are currently not able to offer testing to the public, although we are working to develop testing partnerships that may be of use to you or your organization.
13/n How to become an authorized lab to use SalivaDirect?
If you represent a high complexity CLIA certified lab within the United States and would like to become authorized, please follow the steps listed on our website:
covidtrackerct.com/about-salivadi…
If you represent a high complexity CLIA certified lab within the United States and would like to become authorized, please follow the steps listed on our website:
covidtrackerct.com/about-salivadi…
13/n We are currently working with Yale and FDA legal teams to draft the conditions of the authorization and to formalize regulatory oversight of the process. As this is the first time that the FDA has issued a protocol EUA, it will take us a bit to get the documents approved.
14/n Once we are set, we will prioritize authorizing labs that will test schools first.
15/n What's next?
Automation. We are working with several institutions to validate robotic systems to automate the sample processing and/or PCR. Once these are validated, we'll add the protocols to our EUA for others to use.
Automation. We are working with several institutions to validate robotic systems to automate the sample processing and/or PCR. Once these are validated, we'll add the protocols to our EUA for others to use.
16/n What's next?
Rapid detection. We are working on approaches to replace the PCR step with either LAMP or RPA. PCR will still have a role, but a simple rapid test has the ability to be point-of-care.
Rapid detection. We are working on approaches to replace the PCR step with either LAMP or RPA. PCR will still have a role, but a simple rapid test has the ability to be point-of-care.
17/n What's next?
Pooling. By combining saliva from many people and testing it all at once, we can increase the number of samples that can be tested per day and reduce the amount of each reagent used per person.
Pooling. By combining saliva from many people and testing it all at once, we can increase the number of samples that can be tested per day and reduce the amount of each reagent used per person.
18/n If you have questions, please direct them to salivadirect@gmail.com and not my DMs or my personal email. Thank you!
19/n If you are a postdoc and would like help develop the next generation of SalivaDirect, please let us know!
covidtrackerct.com/jobs/
covidtrackerct.com/jobs/
