Table 3.
Concentration | Day | CN | Mean CN | SD | %CV | Instrument | ||||
1000 virus copies/mL | 1 | 33.48 | 33.0 | 0.5 | 1.50% | Alinity m #1 | ||||
2 | 33.10 | |||||||||
3 | 32.48 | |||||||||
200 virus copies/mL | 1 | 35.18 | 35.4 | 0.2 | 0.60% | |||||
2 | 35.48 | |||||||||
3 | 35.55 | |||||||||
Negative | 1 | NDET | N/a | N/a | N/a | |||||
2 | NDET | |||||||||
3 | NDET | |||||||||
1000 virus copies/mL | 1 | 33.41 | 33.1 | 0.3 | 0.80% | Alinity m #2 | ||||
2 | 33.07 | |||||||||
3 | 32.92 | |||||||||
200 virus copies/mL | 1 | 36.22 | 35.5 | 0.7 | 1.90% | |||||
2 | 34.99 | |||||||||
3 | 35.16 | |||||||||
Negative | 1 | NDET | N/a | N/a | N/a | |||||
2 | NDET | |||||||||
3 | NDET | |||||||||
Table 3B. UW LDT SARS-CoV-2 Assay Precision Comparison | ||||||||||
Concentration | Day | N1 CN | N2 CN | N1 Mean FCN | N2 Mean FCN | N1 SD | N2 SD | N1%CV | N2%CV | Extraction Instrument |
1000 virus copies/mL | 1 | 34.19 | 35.28 | 34.65 | 35.16 | 0.40 | 0.17 | 1.16 | 0.48 | MagNA Pure 96 #1 |
2 | 34.95 | 34.97 | ||||||||
3 | 34.80 | 35.23 | ||||||||
200 virus copies/mL | 1 | 36.81 | 38.02 | 36.36 | 37.34 | 1.82 | 0.96 | 5.00 | 2.57 | |
2 | 34.36 | 36.66 | ||||||||
3 | 37.91 | NDET | ||||||||
Negative | 1 | NDET | NDET | N/a | N/a | N/a | N/a | N/a | N/a | |
2 | NDET | NDET | ||||||||
3 | NDET | NDET | ||||||||
1000 virus copies/mL | 1 | 33.76 | 35.79 | 33.89 | 35.44 | 0.32 | 0.51 | 0.95 | 1.44 | MagNA Pure 96 #2 |
2 | 33.66 | 35.67 | ||||||||
3 | 34.26 | 34.86 | ||||||||
200 virus copies/mL | 1 | 36.42 | 36.70 | 37.07 | 37.41 | 0.63 | 0.97 | 1.70 | 2.59 | |
2 | 37.11 | 37.02 | ||||||||
3 | 37.68 | 38.51 | ||||||||
Negative | 1 | NDET | NDET | N/a | N/a | N/a | N/a | N/a | N/a | |
2 | NDET | NDET | ||||||||
3 | NDET | NDET |
Abbreviations: CN, cycle number; SD, standard deviation,%CV, percent coefficient of variance, NDET, not detected; N/a, not applicable.
Different sample concentrations and a negative control (He-La cells) were run in triplicate over 72 h to evaluate SARS-CoV-2 assay precision between two separate Alinity m instruments.
Abbreviations: UW, University of Washington; LDT, laboratory developed test; CN, cycle number; SD, standard deviation,%CV, percent coefficient of variance, NDET, not detected; N/a, not applicable.
Different sample concentrations and a negative control (He-La cells) were run in triplicate over 72 h to evaluate the Alinity m SARS-CoV-2 assay precision in comparison to UW's LDT.