Fig. 6: Clinical validation of NISDA assay in oropharyngeal RNA extract specimens.
a Plotting the NISDA assay data points obtained in the laboratory for 127 clinical oropharyngeal RNA extracts (65 validated CoV-19 negatives and 62 validated CoV-19 positives) together with the corresponding C t values of the positive samples; blue solid circles indicate samples considered positive by NISDA and red hollow circles indicate samples considered negative by NISDA; mean value difference between the two populations was statistically significant (P < 0.001; calculated based on the unpaired two-tailed t test). b Reproducibility test of the NISDA assay showing the fluorescence kinetics of three identical measurements on a CoV-19-positive sample (C t = 30). CI denotes for the confidence interval. Error bars represent mean ± SD. c On-site performance of the NISDA assay at Bispebjerg Hospital using Real-Time PCR System (CFX96) for monitoring the fluorescence kinetics of 37 clinical oropharyngeal RNA extracts (31 validated CoV-19 negatives (gray solid lines under the cutoff value) and 6 validated CoV-19 positives (blue solid lines above the cutoff value)). d Numbers of false-negative and positive rates for two clinical validations in the laboratory and the hospital (on-site). Source data are provided as a source data file.
