March 17, 2015-SP
3/17/2015
“DIRECT” METHOD PERFORMANCE DATA (3 DAYS ACCURACY/PRECISION DATA) Day‐1 QC ‐ MDL QC ‐ Low QC ‐ Med QC ‐ High 1 135.1 84 77.7 77.8 2 134.7 115.2 85.5 79.5 3 132.2 71.6 72 77 4 147.4 80.9 82.6 81.6 5 157.8 88.9 72.8 71.6 Avg. %accuracy 141.4 88.1 78.1 77.5 SD 10 9 16 4 5 9 3 7 . . . .
Sample In powder (ug/g) In RTF liquid (ug/g)
%RSD
7.7
18.6
7.6
4.8
QC ‐ MDL
0.03
0.002 0.011 0.025 0.050
QC ‐ Low 0.15
Day‐2
QC ‐ MDL QC ‐ Low QC ‐ Med QC ‐ High
QC ‐ Med QC ‐ High
0.35 0.70
1 2 3 4 5
81.2 57.6 65.6 76.6 76.9 17.4 22.7 103.3 129.6 163.6 142.6 145.7 137.4 143.8
88.3
77.7 99.6 99.6 97.1 105 95.8 10.5 11.0
101 95.1
93
80.6
108.2
129.4
95.4
99.5 98.2 18.8 19.1
106.2 101.2
Avg. %accuracy
SD
6.0 5.9
%RSD
MDL Calculation
Day‐3
QC ‐ MDL QC ‐ Low QC ‐ Med QC ‐ High
1 2 3 4 5
Outlier
102.8
75.1
t-value, 99% CI, (N-1) = 13 degrees of freedom
2.624 0.012
118.7 107.5
82
101.1
SD
92.5
88
LOD
0.03 ug/g
75.7 96.9 99.7 18.3 18.4 95.0 17.2 18.2
109.6
110.8
89.1 95.2 11.0 11.6 89.7 12.2 13.6
94.6 93.9 13.5 14.3 90.9 13.1 14.4
Avg. %accuracy
SD
12.6
%RSD
8.8
3Day average
120.7
SD
34.6 28.7
%RSD
Proprietaryand confidential — do not distribute © 2015 Abbott Laboratories
19
MFA‐AOAC, 2015
March17,2015
METHOD PERFORMANCE DATA – LAB#2
•
Run QCs (precision/accuracy)
Standard Curve (accuracy)
# 1 2 3
QC ‐ MDL QC ‐ Low QC ‐ Med
STD Conc (ppb) %Accuracy (Set‐1) %Accuracy (Set‐2) 5 118.77 100.76
139 131 132
122
104 113
10 25 50
82
101.97
105.97 100.24
140
93
96.96 95.46 95.70
Avg. %accuracy
134.0 114.7 103.3
96.57 95.43 97.18
SD
100 200
4.4 3.3
29.7 25.9
10.0
%RSD
9.7
100.36
Calibration Curve
Proprietaryand confidential — do not distribute © 2015 Abbott Laboratories
20
MFA‐AOAC, 2015|
March17,2015
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