Table 7.
An Overall Concordance Level of 91.89% Was Achieved When Comparing the SARS-CoV-2 Nucleocapsid LDT with the Wadsworth EUA
| Wadsworth EUA results | N1 nucleocapsid LDT | N1 Wadsworth EUA | N2 nucleocapsid LDT | N2 Wadsworth EUA | HRP nucleocapsid LDT | HRP Wadsworth EUA | Concordance between SARS-CoV-2 nucleocapsid LDT and Wadsworth EUA | Notes |
|---|---|---|---|---|---|---|---|---|
| Early Ct (<30) | 13.61 | 13.20 | 10.32 | 12.23 | 12.30 | 22.71 | Concordant | |
| Positives | 14.22 | 13.77 | 12.20 | 13.14 | 14.11 | 20.93 | Concordant | |
| 14.51 | 14.03 | 13.08 | 13.31 | 15.08 | 21.67 | Concordant | ||
| 16.16 | 16.53 | 14.85 | 15.02 | 19.86 | 25.95 | Concordant | ||
| 16.40 | 16.86 | 15.23 | 16.59 | 20.37 | 25.32 | Concordant | ||
| 17.93 | 18.14 | 17.58 | 17.57 | 19.60 | 22.22 | Concordant | ||
| 18.62 | 19.56 | 16.75 | 17.38 | 22.78 | 24.15 | Concordant | ||
| 20.71 | 22.52 | 20.79 | 21.06 | 20.21 | 22.12 | Concordant | ||
| 23.09 | 24.32 | 21.03 | 23.77 | 24.71 | 25.33 | Concordant | ||
| 24.01 | 24.61 | 21.97 | 23.00 | 25.66 | 26.02 | Concordant | ||
| 23.47 | 24.56 | 21.50 | 23.38 | 23.44 | 24.47 | Concordant | ||
| 26.63 | 25.63 | 24.82 | 24.16 | 27.46 | 25.28 | Concordant | ||
| 24.62 | 27.28 | 22.80 | 25.64 | 26.79 | 20.19 | Concordant | ||
| 25.01 | 29.63 | 23.26 | 28.24 | 27.52 | 25.86 | Concordant | ||
| 27.21 | 29.87 | 27.25 | 31.19 | 23.89 | 24.84 | Concordant | ||
| Late Ct (>30) | 31.10 | 30.76 | 28.52 | 32.09 | 28.45 | 26.93 | Concordant | |
| Positives | 31.20 | 30.81 | 32.82 | 30.67 | 20.43 | 19.69 | Concordant | |
| 27.37 | 31.35 | 27.60 | 30.01 | 27.02 | 26.07 | Concordant | ||
| 0.00 | 31.38 | 0.00 | 30.70 | 21.72 | 20.68 | Discordant | Negative in TaqPath EUA with KingFisher Flex Extraction | |
| 29.84 | 31.54 | 30.55 | 32.27 | 22.59 | 22.83 | Concordant | ||
| 29.45 | 31.82 | 29.22 | 31.14 | 28.22 | 27.37 | Concordant | ||
| 28.83 | 31.82 | 29.95 | 31.43 | 22.09 | 23.57 | Concordant | ||
| 32.17 | 32.03 | 31.41 | 30.25 | 20.42 | 22.13 | Concordant | ||
| 34.08 | 32.06 | 32.49 | 32.51 | 33.85 | 28.47 | Concordant | ||
| 30.43 | 32.44 | 31.42 | 34.39 | 22.82 | 22.30 | Concordant | ||
| 29.36 | 32.87 | 27.27 | 31.59 | 22.24 | 23.14 | Concordant | ||
| 34.50 | 32.89 | 34.94 | 35.17 | 24.30 | 26.15 | Concordant | ||
| 30.04 | 33.35 | 29.96 | 32.29 | 25.09 | 26.14 | Concordant | ||
| 0.00/0.00 | 34.00 | 0.00/0.00 | 35.89 | 22.24/21.62 | 21.77 | Discordant X2 | Negative in TaqPath EUA with KingFisher Flex Extraction | |
| 31.09 | 34.09 | 31.21 | 35.82 | 28.51 | 28.00 | Concordant | ||
| 33.87 | 34.58 | 0.00 | 33.62 | 22.92 | 24.19 | Discordant | Negative in TaqPath EUA with KingFisher Flex Extraction | |
| 32.95 | 35.05 | 36.34 | 35.12 | 25.81 | 27.29 | Concordant | ||
| 31.74 | 35.07 | 31.46 | 35.69 | 24.55 | 27.44 | Concordant | ||
| 33.84 | 35.11 | 31.65 | 34.78 | 28.27 | 30.11 | Concordant | ||
| 34.07 | 36.17 | 31.81 | 31.33 | 32.17 | 27.11 | Concordant | ||
| 32.87 | 35.52 | 36.40 | 34.41 | 22.23 | 24.22 | Concordant | ||
| 33.42 | 36.63 | 32.07 | 34.21 | 29.01 | 27.57 | Concordant |
A clinical evaluation was performed comparing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid laboratory-developed test (LDT) with the Wadsworth Emergency Use Authorization (EUA). RNA was extracted by using the KingFisher Flex Extraction instrument with the MagMAX Viral/Pathogen II kit for the SARS-CoV-2 nucleocapsid LDT. RNA extraction for the Wadsworth EUA was performed with the EZ1 Advanced XL instrument and the EZ1 Virus Mini Kit 2.0. CT values and concordance results are listed for each patient sample. Notes for discordant samples are provided in the last column.
HRP, human RNAse P.