IRIS iChemVelocity

11 Appendix
301-7146 English Rev B 11/02/2011 Operator’s Manual NA 216
Precision
Within Run Precision
Three levels of target analyte concentrations for each assay (negative,
first positive level and highest positive level) were tested 3 times each for
20 runs. The exact % agreement with expected results is shown.
Test
Analyte Concentration
% Exact Agreement
Bilirubin
<1 mg/dL bilirubin
100
2 mg/dL bilirubin
96.1
4 mg/dL bilirubin
100
Urobilinogen
<0.2 mg/dL urobilinogen
100
2 mg/dL urobilinogen
96.3
4 mg/dL urobilinogen
100
Ketones
<1 mg/dL acetoacetate
100
5 mg/dL acetoacetate
99.4
80 mg/dL acetoacetate
99.4
Ascorbic acid
<0.2 mg/dL ascorbic Acid
100
20 mg/dL ascorbic Acid
97.6
40 mg/dL ascorbic Acid
99.8
Glucose
<15 mg/dL glucose
100
50 mg/dL glucose
95.6
500 mg/dL glucose
100
Protein
<15 mg/dL albumin
100
30 mg/dL albumin
98.9
500 mg/dL albumin
100
Blood
No detectable Hb
100
0.03 mg/dL Hb
97.8
1 mg/dL Hb
98
pH
pH = 5
100
pH = 7
100
pH = 9
97.6
Nitrites
<0.03 mg/dL nitrite
100
0.15 mg/dL nitrite
99.4
Leukocytes
<1uL/mL subtilisin*
100
3.41 uL/mL subtilisin*
96.3
50 uL/mL subtilisin*
100
*Subtilisin is a surrogate for leukocyte esterase. 3.41 uL/mL subtilisin is
equivalent to 25 WBCs/mL and 50 μL/mL is equivalent to 500 WBCs/μL.