Who can see your viewing activity?
what is definition of invalid, unsatisfactory and inconclusive in Broad testing?
Invalid = Control failure, UNSAT = issues with swabs (Upside down/goop etc), inconclusive = largely algorithm calling issue
Yuka: see Table 2 legend: https://www.medrxiv.org/content/10.1101/2021.05.03.21256560v1.full.pdf
fantastic and thanks to you both!
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
Is there concern about aerosolization given that swabs are being added to buffer at POC (rather than dry)?
What was the reference for the calculator?
If you save the original swab in transport media for the deconvulation there would not be a requirement for resampling
Pooling for STIs has been done since 1998
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.
How will we get the swabs to do these pooling validations with the declining rates?
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.
At schools, any idea how to overcome nervousness of nurses/admins to doing something that seems more complicated than single person test?
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.
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.
Multiplex question is on the docket for tomorrow morning with FDA. Will start the conversation Steve