Selected article for: "assay performance and clinical testing"

Author: Jennifer A. Doudna
Title: Blueprint for a Pop-up SARS-CoV-2 Testing Lab
  • Document date: 2020_4_12
  • ID: modtthxx_71
    Snippet: To ensure that diagnostic tests are clinically valid, the FDA recommends "that laboratories confirm performance of their assay with a series of contrived clinical specimens by testing a minimum of 30 contrived reactive specimens and 30 non-reactive specimens." These reactive specimens can be created by spiking . The dilution range was chosen to span the LoD we had established above (Fig. 2 )......
    Document: To ensure that diagnostic tests are clinically valid, the FDA recommends "that laboratories confirm performance of their assay with a series of contrived clinical specimens by testing a minimum of 30 contrived reactive specimens and 30 non-reactive specimens." These reactive specimens can be created by spiking . The dilution range was chosen to span the LoD we had established above (Fig. 2 ).

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