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RADx webinar - Shared screen with speaker view
Jan Tang
34:05
You are fading in and out.
ibirn
34:25
your audio is going in and out
Jan Tang
34:59
We can't hear you.
Eric Evans
35:42
Seems to be getting worse rather than better.
Wendy Perrow
35:48
You are fading in and out on sound
Dr. Renu
35:54
Audio is not clear, choppy
Wendy Perrow
36:50
yes
James Burroughs
36:52
We can hear you perfectly
Dr. Renu
36:55
Yes
Schachter
37:03
Sorry about that.
Ruth Lipman
41:52
why has there not been a switch to testing using saliva?
Alexander Wimbush
42:49
Could you not consider targeting symptomatic individuals as a preliminary test performed before the true viral test? And then the 'whole' test is the combination fo the two, given the test characteristics of each step?
Chang Hee Kim
44:49
What should the Ct cut-off be for positives ?
Dr. Renu
45:03
A single platform mibrofluidic device to sense the virus and any antibody floating round in plasma
Anupam
46:16
Is there a point of care that can test for antigen, antibody for sarscov2 as well as flu a and flu b with one sample? available in 20 minutes
Dr. Renu
47:05
Yes we are struggling on such an integrated platform for CoV2 but not on flu
Josh Tolkoff
50:52
After exposure, State guidelines are often to quarantine for 14 days or get a Covid test. A single test might be premature of actual infection during the 14 day period. What tests and when should they be deployed to give a true "safe" alternative to 14 day quarantine?
BrendanWalker
52:02
Our company is developing an instrument-free, rapid SARS-CoV-2 diagnostic for self-administered testing at home. Will RADx have a program aimed at supporting decentralized testing solutions like ours?
Dino
53:48
Is there really a problem with “false” negatives - is it not a question of failure to detect. 1) Low sensitivity or 2) poor sample collection from individuals
Alexander Wimbush
54:53
They have the potential to erode trust if nothing else, if a true positive is reported as a negative and then develops sever symptoms that makes the communication of the benefits of testing ever more difficult.
JohnHaller
55:25
What is the timeline for deployment of tests developed in the RADx program? (Sorry, if this question was already addressed earlier).
Stephan Kang
55:28
We have developed a technology directly related with this discussion. Please take a look at https://www.junometabolomics.com/junocovid19
Yuka Manabe
55:40
@Dino I think that is a good way to frame the issue. Early reports of negative molecular testing were likely due to later disease, insensitive sample types (lower respiratory samples are more sensitive later in infection), and poor sample collection--agree
Anupam
57:54
2Dino @Yuka agreed, surprised not many people talk about this
Kingston Coats
59:23
There seems to be a lot of different Covid-19 solutions being developed. Will there be a close to diagnostic technologies that is being developed and approved for use or will it be up to state to state or agency approved?
Alexander Wimbush
59:49
But retrospectively determining that actually the test would have been fine were it not for these factors doesn't help in the instant the test is performed. If you aren't sure about these things when the test is deployed then surely they're still very much a concern?
Shelley Brunson
01:00:47
How does the pharmacy testing fit in to the research aspect? Walgreens is now offering free testing.
James Burroughs
01:02:04
As a scientist of color, I am concerned about the lack of centralized reporting federally, or at the state level, regarding positive cases. Also, looking at seroprevalence,projections vs. confirmed cases, what are plans to focus on African American and minority communities, who represent a disproportionate amount of SARS-CoV-2 positivity and clinical signs requiring hospitalization?
Anupam
01:02:06
Does anyone know if RADx still accepting new applications?
Alexander Wimbush
01:03:07
I've been trying to develop an algorithm which does just this, suggests the most appropriate combinations of testing and targeting given weighted values of economy, safety, intrusion etc.
Shelley Brunson
01:03:20
This sounds like a pregnancy test.
George Petropoulos MD
01:04:26
Does any one know how long is the period that IgG Levels, remain in a sufficient level ?
Elias Caro
01:04:51
The test should be paid and do not require a doctor's order for patients t decide to test themselves frequently
Shelley Brunson
01:07:12
If Walgreens can offer a free test to the insured, then a test should be able to be offered to those who cannot afford a test through Medicaid , Medicare and other agencies.
James Burroughs
01:08:05
Regarding molecular tests and specificity, there is sufficient evidence of significant mutational changes, what are our chances of that homologies will be so low for primers that we can't do proper RT-PCR? Is the polymerase that sloppy for SARS-CoV-2, and how are we accounting for this?
Jennifer Joe, MD
01:09:50
The ideal strategy has to encompass all of that, I think
Christine Hanson
01:09:50
Screening questions about symptoms can also be a hinderance to receiving a Covid test in a timely manner. Screening is an area in need of improvement for access to testing. For example, a local prominent health system in the midwest requires having at least one symptom in each of the two categories: (Category 1) respiratory and (Category 2) other symptoms such as new chills, headache, muscle pain, fatigue, load of taste or smell, etc. The second category does not include a rash.
Jennifer Joe, MD
01:11:04
Well said. That's true too.
Yuka Manabe
01:11:31
Access is unlikely to improve with home testing, so having high throughput, sensitive, rapid turnaround testing that can be obtained without a doctor's order will be key.
Shelley Brunson
01:11:43
There are plenty of pregnancy tests that are not accurate, sold to the public. Either way you will still need to go to your physician to confirm any result you get. Not understanding why this is so different aside from isolation.
Alexander Wimbush
01:12:45
But the impact on an individual of a positive result can be huge if they rely on being able to travel to work. Mass testing will likely result in huge economic harm to a lot of vulnerable people, surely? Hence the need for pre-screening or targeting strategies based on visible symptoms.
Jennifer Joe, MD
01:13:07
False positives have downsides too. I think PSA was the big recent example of that.
Jennifer Joe, MD
01:14:15
Very well said. Matching the timing with the need is important.
AMartin
01:14:57
Thoughts on pooled testing with recent EUA approvals
Dilip Kumar Agarwal
01:15:08
If a person has infected with COVID-19 then what is the possibility him to getting infected again in near future? Would antibody created against the virus save the person from getting infected again?
Jennifer Joe, MD
01:15:25
Respect to Baltimore. Very difficult place to deliver healthcare.
Dino
01:15:26
Antigen testing surely has almost negligible false positives - could only be the result of misuse !
Shelley Brunson
01:15:53
I don't agree on mass testing unless we have treatment plans on a mass level to back it up.
Alexander Wimbush
01:15:56
@Dino but that's still a false positive, whether it's down to the test or the delivery
Ranga Sampath
01:17:21
@Shelly First step is tracing and isolation
Jennifer Joe, MD
01:17:36
Yes. The concept and importance of infrastructure is often underestimate.
Dino
01:17:41
@Alexander, that’s true but I mean deliberate misuse as opposed to suddenly getting and analyte signal for something that’s not there. It doesn’t happen in those tests.
Shelley Brunson
01:17:51
Don't tell a person they have a positive test and then tell them, "Well there is nothing we can do."'We are just letting you know you have it. What? Mass hysteria.
Ranga Sampath
01:18:07
So while specific Tx and Vx is important Testing is hugely important even without those two measures today
Yuka Manabe
01:18:33
@Dilip - COVID patients have a >99% likelihood of developing antibody, only ~80% of those will develop neutralizing immunity, so re-infection is possible and has been documented.
Jennifer Joe, MD
01:18:36
Oh no... I'll hold back on snarky remarks. =)
Anupam
01:18:58
How is it that China almost eliminate the infection or the numbers are all fake?
Anupam
01:19:05
eliminated
Alexander Wimbush
01:19:58
I've got an algorithm that'll spit out an optimised diagnostic algorithm for combinations of several available tests with different characteristics
Dino
01:20:21
That’s a very good point Bruce. We have been investigating the possibility of multiple Ags in the same sample i.e. multiple Ags from CoV2
Yuka Manabe
01:20:49
I am not advocating mas testing per se, but I do think that all people with symptoms and all contacts of those patients should be tested
Alexander Wimbush
01:21:38
@Yuka track and trace is almost itself a form of testing isn't it? You could calculate the sens/spec of test and trace and how that impacts subsequent testing strategies with actual tests
BrendanWalker
01:22:22
Bruce mentions "bridging the gap" between PCR and lateral flow with a novel technology that provides the performance (sensitivity/specificity) with the convenience of decentralized testing. What efforts are being made there to support the development of such technology?
JohnHaller
01:22:26
What are the metrics of success for the RADx program? For example, do metrics include time to deploy, use by the subgroups you have discussed (home, schools, office, travelers, etc.), number of available tests, etc.?
Eugene Rogers
01:23:04
eg. matching test sensitivity to utilization:.. ‘A (use)case for less sensitive Covid-19 tests’ https://www.nejm.org/doi/full/10.1056/NEJMp2025631
Anita Penkova
01:23:36
Is RADx still accepting new applications?
Eric Miller
01:24:06
I'm curious to what extent there are a) curated, biobanked samples from asymptomatic/presymptomatic/symptomatic patients for assay validation, and b) known correlations between RT-PCR Ct values and antigen concentrations in different patient specimens? Is it known what these analytical benchmarks are, and the proportion of patients that could be identified for a test with a given analytical performance?
Jennifer Joe, MD
01:24:08
Yes!
Jennifer Joe, MD
01:24:10
Agreed!
Jennifer Joe, MD
01:24:29
It's a rare opportunity to bring in impressive innovation
Jennifer Joe, MD
01:24:33
It's hard to do that in medicine
Shelley Hossenlopp
01:24:41
Great question Eric, I have been wondering the same… would be interesting to know.
Charlotte Gaydos
01:25:26
Pretest-probability of being positive is very important. When and where to test and with what test is recommended is very important. Multiple tests can be have a place too. Contract tracing is very important and will eventually help us
Jennifer Joe, MD
01:26:09
ER testing is designed around the concept of pre-test and post-test, and important in deciding to test, clinical management and recommendations
Dino
01:27:25
@Eric -I think Ray Biotech may have serum samples for -ve +ve that they sell.
Yuka Manabe
01:27:28
@Eric - RADx cores are developing such resources in asymptomatics--very important
Alexander Wimbush
01:28:25
@Eric A colleague of mine is developing an approach to characterising the uncertainty in diagnostic tests given an uncertain 'gold standard', it's a very interesting approach to try and resolve this.
Jennifer Joe, MD
01:28:40
Yes, to the IT infrastructure point and also how America approaches public health and its importance
Jennifer Joe, MD
01:29:16
If done well, it's an unusual opportunity to address known healthcare disparities
Eric Miller
01:30:31
Thanks @Yuka, glad to hear those resources are being put in place. Seems like a critical need to address, given that asymptomatic patients are the population that ubiquitous, low-cost tests would need to be developed for, for frequent, presumptive testing
Anthony Samir
01:30:45
The NIH transformative R01 research R01 has an emergency COVID grant. Unfortunately the review for these emergency awards is only in April 2021. For highly innovative testing technologies ubsmitted to this emergency mechanism this is problematic. Is there a way to speed this up?
Charlotte Gaydos
01:31:07
Excellent point Sara! Public health infrastructure will hopefully be strengthened as a result of this pandemic to help preparations for the next pandemic or public health problem.
Jennifer Joe, MD
01:31:18
Yeah, depending on phones is risky in high risk populations. I agree on pushing back on the dependency of the phone.
Alexander Wimbush
01:31:57
I know the NHS app in the UK has an option for reporting any test available, not sure what restrictions there are on ensuring factual information etc.
Jennifer Joe, MD
01:32:18
Yes, agree with the call out to strengthen the public health infrastructure as a greater good to the American population as a country.
Alexander Wimbush
01:32:24
Whether anyone uses that functionality though is another question
Jennifer Joe, MD
01:32:57
I think we just have to be careful around technology, and its potential to increase health disparities versus decrease them
Alexander Wimbush
01:35:03
Yeah, the effect on an individual of being forced to isolate or requiring care can be incredibly damaging if they are struggling and require access to work in order to survive. The NHS app was mocked because without it, you can't be told to isolate, so there's a massive incentive for working classes to just not use it in case their income stream gets cut off.
Tanya Kanigan
01:35:15
@Eric In response to your earlier question regarding curated biobanked samples, BioIVT offers serum with confirmed serology results from COVID-19 symptomatic and recovered donors https://bioivt.com/human-coronavirus-related-biofluid.
Shelley Hossenlopp
01:35:32
I have to vent my frustration as someone in the Dx IVD industry for 33 yrs and how hard funding has been to get for development and regulatory. Now, the globe/US is screaming why do we not have more Dx…
Dino
01:36:18
@Shelley - absolutely agree
BrendanWalker
01:36:33
Absolutely agreed Shelley. There is so much talk about all of this funding. Funny as someone looking for it to develop tech as it's nowhere to be found.
Jennifer Joe, MD
01:38:44
Agreed. Technology can improve health disparities. And the students are very inspirational to work with.
Schachter
01:39:23
Kudos and thanks to Bruce, Ranga, Sara, Nancy and Yuka for a wonderful, comprehensive, forward-looking and thought-provoking webinar, and thanks to Richard Creager and his committee for organizing this webinar and the preceding two webinars in this series.
Ranga Sampath
01:39:33
@shelley Hossenlopp: having spent my lifetime in this industry, I agree. However, there’s definitely more awareness and more opportunities now
Alexander Wimbush
01:39:53
But that can't be taken as a given, technology also has great potential to exacerbate inequality.
Jennifer Joe, MD
01:40:17
It's really a transformational opportunity of creating greater good for all of healthcare. Appreciate everyone's willingness and dedication to working together towards a greater cause.
Andrew Ahn
01:40:19
Data integration will require Interoperability and robust privacy/security protection; but as long as data is owned by large healthcare organizations or siloed into specific tech companies (Google or Apple), data integration will still be difficult. Hope there is some focus at the federal level about enabling patients/citizens themselves to own their own data.
Jennifer Joe, MD
01:40:30
I have to say that I adore and appreciate CIMIT
Lynn
01:40:41
Excellent session
Charlotte Gaydos
01:40:45
Excellent discussion to today for all thing great and small. Thanks to the psrticipants.
JohnHaller
01:40:47
Congrats to NIBIB and POCTRN and all investigators working on RADx
George Petropoulos MD
01:40:47
CONGRATULATIONS!
Alexander Wimbush
01:40:49
Thanks very much!
James Burroughs
01:40:50
Thanks to everyone
Anupam
01:40:52
thank you
Dino
01:40:52
Thank you to the panel -
Jennifer Joe, MD
01:40:56
Thank you!
Shelley Brunson
01:40:57
Thank you
Jennifer Joe, MD
01:41:08
And shout out to Julian Goldman, if he's around
Jennifer Joe, MD
01:41:09
=)