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. Author manuscript; available in PMC: 2019 Apr 15.
Published in final edited form as: J Pharm Biomed Anal. 2018 Feb 8;152:248–256. doi: 10.1016/j.jpba.2018.02.011

Table 1.

Intra- and Inter- Precision and Accuracy

QC Level Intra - Assay Precision and Accuracya
Inter - Assay Precision and Accuracyb
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

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

CMX157
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
a

n=6 for each level of QC; representative data from a single analytical run

b

n=18 for all QC levels; complex precision and accuracy from three analytical runs