Table 1.
QC Level | Intra - Assay Precision and Accuracya
|
Inter - Assay Precision and Accuracyb
|
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---|---|---|---|---|---|---|---|---|---|---|---|
Mean [ng/ml] |
SD [ng/ml] |
%CV | %DEV | Mean [ng/ml] |
SD [ng/ml] |
%CV | %DEV | ||||
TAF
|
|||||||||||
LLOQ [0.030 ng/mL] |
0.0307 | 0.00410 | 13.3 | 2.39 | 0.0321 | 0.00450 | 13.9 | 7.04 | |||
Low [0.090 ng/mL] |
0.0846 | 0.00850 | 10.0 | -5.96 | 0.0881 | 0.0127 | 14.4 | -2.07 | |||
Mid [3.00 ng/mL] |
3.11 | 0.230 | 7.38 | 3.56 | 3.22 | 0.200 | 6.15 | 7.43 | |||
High [130 ng/mL] |
120 | 8.60 | 7.20 | -7.95 | 123 | 10.7 | 8.65 | -5.13 | |||
|
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TFV
|
|||||||||||
LLOQ [1.00 ng/mL] |
1.03 | 0.100 | 9.64 | 3.27 | 1.01 | 0.107 | 10.6 | 0.680 | |||
Low [3.00 ng/mL] |
2.91 | 0.320 | 11.0 | -3.00 | 2.80 | 0.269 | 9.58 | -6.52 | |||
Mid [20.0 ng/mL] |
18.6 | 1.10 | 5.93 | -7.25 | 18.5 | 1.05 | 5.68 | -7.50 | |||
High [170 ng/mL] |
174 | 5.06 | 2.91 | 2.35 | 172 | 7.99 | 4.66 | 0.980 | |||
|
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CMX157
|
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LLOQ [0.25 ng/mL] |
0.265 | 0.0290 | 11.1 | 6.07 | 0.269 | 0.0310 | 11.4 | 7.76 | |||
Low [0.75 ng/mL] |
0.735 | 0.0480 | 6.54 | -1.98 | 0.734 | 0.0540 | 7.42 | -2.13 | |||
Mid [50.0 ng/mL] |
52.1 | 2.34 | 4.50 | 4.17 | 50.1 | 2.39 | 4.76 | 0.211 | |||
High [160 ng/mL] |
171 | 5.32 | 3.10 | 7.08 | 167 | 5.87 | 3.52 | 4.31 |
n=6 for each level of QC; representative data from a single analytical run
n=18 for all QC levels; complex precision and accuracy from three analytical runs