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Precision (ng/mL)
Within-Run
3
4
Mean
SD
1
0.60
0.01
2
1.5
0.03
3
3.1
0.07
4
5.2
0.11
5
11
0.20
6
13
0.30
Specificity
Compound
1
Amount Added
Insulin
200 µIU/mL
Glucagon
15,000 ng/mL
Secretin
15,000 ng/mL
Proinsulin
4
ND: not detectable.
Linearity (ng/mL)
1
Dilution
Observed
1
8 in 8
5
1.3
4 in 8
0.63
2 in 8
0.31
1 in 8
0.15
2
8 in 8
2.9
4 in 8
1.3
2 in 8
0.66
1 in 8
0.33
3
8 in 8
4.2
4 in 8
2.1
2 in 8
0.98
1 in 8
0.48
4
8 in 8
5.2
4 in 8
2.4
2 in 8
1.1
1 in 8
0.56
IMMULITE 2000 C-Peptide (PIL2KPEP-9, 2018-03-15)
1
2
Total
5
CV
SD
CV
1.7%
0.02
3.3%
2.0%
0.05
3.3%
2.3%
0.09
2.9%
2.1%
0.17
3.3%
1.8%
0.36
3.3%
2.3%
0.62
4.8%
% Cross-
2
reactivity
ND
ND
ND
10 ng/mL
10%
2
3
Expected
%O/E
─
0.67
94%
0.33
94%
0.17
88%
─
1.4
93%
0.72
92%
0.36
92%
2.1
100%
1.1
89%
0.52
92%
─
2.6
92%
1.3
85%
0.65
86%
Dilution
5
8 in 8
4 in 8
2 in 8
1 in 8
6
8 in 8
4 in 8
2 in 8
1 in 8
7
8 in 8
6 in 8
5 in 8
4 in 8
2 in 8
1 in 8
3
Bilirubin (Conjugated)
Unspiked
1
1.4
2
4.8
3
6.7
4
10
5
12
6
14
4
─
Bilirubin (Unconjugated)
Unspiked
1
1.4
─
2
4.8
3
6.7
4
10
5
12
6
14
─
1
Observed
2
Expected
7.5
─
3.6
3.80
1.7
1.9
0.81
0.94
15
─
7.2
7.3
3.3
3.7
1.6
1.8
> 15
─
>15
─
14
─
11
11
5.4
5.6
2.5
2.8
2
100 mg/L
200 mg/L
1.2
1.2
4.0
4.0
5.9
5.7
8.8
8.6
10
10
12
12
2
100 mg/L
200 mg/L
1.2
1.2
3.8
3.9
5.8
5.7
8.7
8.7
9.8
10
12
12
3
%O/E
4
─
95%
89%
86%
─
99%
89%
89%
─
─
─
100%
96%
89%
7
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