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CSTE National ELR Workgroup

Welcome to the CSTE National ELR Workgroup Basecamp! We hope you will utilize the space to share resources with colleagues, start discussion threads, and identify topics for the workgroup to tackle on future calls. All workgroup members will have the opportunity to join. Please note that you may edit your notification preferences to suit your needs (and your email inbox). If you are not already on the ELR distribution list and would like to receive call communications, please enroll using this subscription form (copy and paste in browser): https://app.smartsheet.com/b/form/5a91a4579952496682084796b82112e6
Becky Lampkins, Manager, Surveillance/Informatics Program at CSTEMegan Toe, CSTEScott Troppy, Surveillance Epidemiologist at MA DPHMeredith Lichtenstein, CSTEAmy Drake, NMJohn RobertsNancy Barrett, Epi 4/PH Informatics SpecialistErin Holt, TDHRita Altamore, EpidemiologistDavid DiCesareJason HallWalter Kemper, ELR Coordinator, NC DHHS Div of Public HealthJulie LuepkeCarmen Pugh, Labcorp Manager State Reporting at LabCorpTom Safranek +399 others
Posted by Nancy Barrett ·

Pooled testing

Hi all, not sure if someone asked this before, but has anyone worked with a lab that is using pooled testing? I see on the FDA website that only 6 molecular methods were approved for pooling.
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

So if a lab or testing location indicates they are dong pooled testing, and it is not on the list, I'm going to ask for a copy of the EUA that indicates that they can use their test for pooled testing. Wondering if anyone else had these same concerns and what you were doing.

thanks!

Comments & Events

Sita Smith Sita Smith
We are live with Amazon, and they send us pooled negatives
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Emily Roberts Emily Roberts
Here in Utah, we also are live with Amazon. They are the only ones for now that are sending us pooled results.
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Nancy Barrett, Epi 4/PH Informatics Specialist Nancy Barrett, Epi 4/PH Informatics Specialist
Hi - Amazon is why I asked. They have not gotten FDA EUA for their testing - they have notified and are waiting for review. Because this is a newer process just wanted to be sure we are using an approved method. The exact message is: We have applied for EUA with the FDA and if you follow the link below, it indicates we have notified FDA that we have validated the pooling protocol and intend to begin testing while they review our EUA request, as FDA’s guidance permits (under the second FAQ, search for “STS Lab Holdco,” which is the corporate parent of STS Lab 2 LLC (KY lab):
 
Nancy Barrett, Epi 4/PH Informatics Specialist 😊
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