CAP distributive model and Proficiency Testing

CAP QC documents refer to handling of reference tests under "distributed model"

 https://documents.cap.org/documents/2022-molecular-pt-recommendations.pdf

see also a deck at pierian on cap distributive model from 2018.

https://www.pieriandx.com/cap-distributive-model

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Issues like this were on the agenda of CLIAC (CLIA AD COMM) in Nov 2021

https://www.cdc.gov/cliac/docs/april-2022/cliac_recommendationstable_apr2022.pdf

See a 2018 CDC deck on NGS validation

https://www.aphl.org/conferences/proceedings/Documents/2018/04-CDC%20QAQC%20CLIA-MacCannell.pdf

See a 2020 Nature article on analytical validation of WGS, Marschall et al.

https://www.nature.com/articles/s41525-020-00154-9

See HELIX get FDA authorization for a WES platform

https://www.prnewswire.com/news-releases/helix-laboratory-platform-granted-the-first-and-only-fda-authorization-for-a-whole-exome-sequencing-platform-301204899.html

Helix Letter here

https://www.accessdata.fda.gov/cdrh_docs/pdf19/DEN190035.pdf

As of June 2023, only the reclass order (7p) and not the "decision summary" are published.

Few devices like a "decision summary."