Author: Jennifer A. Doudna
Title: Blueprint for a Pop-up SARS-CoV-2 Testing Lab Document date: 2020_4_12
ID: modtthxx_60
Snippet: The March 16th FDA guidance recommends identifying the LOD of a molecular diagnostic by conducting a dilution series of SARS-CoV-2 RNA (or inactivated virus) in an artificial or real clinical matrix. The FDA recommends that "laboratories test a dilution series of three replicates per concentration, and then confirm the final concentration with 20 replicates." For the purposes of an EUA, the FDA defines the limit of detection as "the lowest concen.....
Document: The March 16th FDA guidance recommends identifying the LOD of a molecular diagnostic by conducting a dilution series of SARS-CoV-2 RNA (or inactivated virus) in an artificial or real clinical matrix. The FDA recommends that "laboratories test a dilution series of three replicates per concentration, and then confirm the final concentration with 20 replicates." For the purposes of an EUA, the FDA defines the limit of detection as "the lowest concentration at which 19/20 replicates are positive." In this section we describe the experimental data that establish the LOD of our LDT.
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