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