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. 2021 May 14;140:104869. doi: 10.1016/j.jcv.2021.104869

Table 3.

A. Abbott Alinity m SARS-CoV-2 Assay Precision.

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.