Table 1. Operator Reproducibility. Three different operator tested 3 different concentrations in triplicate (n=3) from the 3 SARS-CoV-2 nucleocapsid target genes and the RNase P internal Control using Norgen’s 2019-nCoV TaqMan RT-PCR Kit to assess operator reproducibility. For each test the same kit Lot# and the same PCR instrument was used. The data in Table 1 showing the average Ct. values for the 3 SARS-CoV-2 nucleocapsid targets combined from the 3 different operators.

Table 2. Inter-instrument Reproducibility. Inter-instrument reproducibility was determined by running 3 different concentrations in triplicate (n=3) from the 3 SARS-CoV-2 nucleocapsid target genes and the RNase P internal Control using Norgen’s 2019-nCoV TaqMan RT-PCR Kit across 2 different qPCR instruments. For each test the same kit Lot# was used. The data in Table 2 showing the average Ct. values for the 3 SARS-CoV-2 nucleocapsid targets combined.

Table 3. Diagnostic Accuracy. Clinical evaluation for Norgen’s 2019-nCoV TaqMan RT-PCR kit was assessed by conducting a blind test with 10 different samples being either spiked or non-spiked with Norgen’s 2019-nCoV RT-PCR Positive Control (Cat. PC67102) to determine the Positive Predictive Value (PPV), Negative Predictive Value (NPV), Sensitivity, Specificity and the overall Diagnostic Accuracy.