Fig. 3: Clinical evaluation of RVP in a CLIA-certified laboratory. | Nature Medicine

Fig. 3: Clinical evaluation of RVP in a CLIA-certified laboratory.

From: Multiplexed CRISPR-based microfluidic platform for clinical testing of respiratory viruses and identification of SARS-CoV-2 variants

Fig. 3

a, Workflow for LOD studies according to the FDA guidelines for establishing assay sensitivity. b, Fluorescence values for SARS-CoV-2 target LOD at the indicated SARS-CoV-2 concentrations; 20 replicates were performed. c, Normalized fluorescence signal at 1 h post-reaction initiation for each virus on the RVP using the on-target sequence (should detect), closely related sequences (should not detect) and an NTC (see Supplementary Table 2 for sequence information). Should and should not detect activities were based on ADAPT design predictions (Methods). Closest to further relatives are based on percentage nucleotide homology to the corresponding on-target sequence. d, Positive and negative percentage agreement (PPA, NPA, respectively) for each virus on the RVP, calculated based on clinical data in Supplementary Table 5. Dashed line: FDA agreement cutoff for assay performance. e, Concordance of the performance of RVP to concurrent comparator assays for 166 retrospective patient specimens tested (left) and 150 contrived samples (right).

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