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RADx Webinar Series - Shared screen with speaker view
Yuka Manabe
58:00
what is definition of invalid, unsatisfactory and inconclusive in Broad testing?
Clair O’Donovan
59:48
Invalid = Control failure, UNSAT = issues with swabs (Upside down/goop etc), inconclusive = largely algorithm calling issue
Nira Pollock
01:00:05
Yuka: see Table 2 legend: https://www.medrxiv.org/content/10.1101/2021.05.03.21256560v1.full.pdf
Yuka Manabe
01:00:50
fantastic and thanks to you both!
cgaydos1
01:00:55
Blood Banks have been doing pooling of blood donation units for HIV for many years with regulatory approval. Regulatory approval is required for Labs to adopt. Great cooperation from the FDA
Nira Pollock
01:03:22
Is there concern about aerosolization given that swabs are being added to buffer at POC (rather than dry)?
Michael Patz
01:04:10
What was the reference for the calculator?
cgaydos1
01:04:52
If you save the original swab in transport media for the deconvulation there would not be a requirement for resampling
Ethan Berke
01:04:53
https://calculator.unitedinresearch.com/
Wolfgang Krull-
01:05:12
Also: https://whentotest.org
cgaydos1
01:14:01
Pooling for STIs has been done since 1998
cgaydos1
01:15:04
Kacena KA, Quinn SB, Howell MR, Madico GE, Quinn TC, Gaydos CA. Pooling urine samples for ligase chain reaction screening for genital Chlamydia trachomatis infection in asymptomatic women. J Clin Microbiol 36:481-5, 1998. PMCID: PMC104564.
Yuka Manabe
01:16:39
How will we get the swabs to do these pooling validations with the declining rates?
cgaydos1
01:18:32
67. Kacena KA, Quinn SB, Hartman SC, Quinn TC, Gaydos CA. Pooling of urine samples for screening for Neisseria gonorrhoeae by ligase chain reaction: accuracy and application. J Clin Microbiol 36:3624-8, 1998. PMCID: PMC105252.
Josh Tolkoff
01:19:08
At schools, any idea how to overcome nervousness of nurses/admins to doing something that seems more complicated than single person test?
Nira Pollock
01:22:28
It was much more challenging to get participation rates up in public schools (e.g.MA DESE/DPH program)—hard to set up as opt out, and can’t mandate in most cases. Re: nurses—school districts needed a LOT of support to stand up in-school pooling. Including hired hands, in many cases.
Erika Tyburski
01:27:13
Hello all, I need to jump for a meeting with FDA right now. Thank you for tuning in and please let me know if I can answer any follow up questions.
Erika Tyburski
01:27:48
Multiplex question is on the docket for tomorrow morning with FDA. Will start the conversation Steve
cgaydos1
01:29:22
Great presentations
Sam Geragonis
01:29:49
Thank uoi