IRIS iChemVelocity

11 Appendix
301-7146 English Rev B 11/02/2011 Operator’s Manual NA 218
Instrument to instrument precision
Three levels of target analyte concentrations for each assay (negative,
first positive level and highest positive level) were tested 60 times on
each of three iChemVELOCITY systems. The exact % agreement with
expected results is shown.
Test
Analyte Concentration
% Exact Agreement
Bilirubin
<1 mg/dL bilirubin
100
2 mg/dL bilirubin
97.8
2 mg/dL bilirubin
100
Urobilinogen
<0.2 mg/dL urobilinogen
100
2 mg/dL urobilinogen
100
4mg/dL urobilinogen
100
Ketones
<1 mg/dL acetoacetate
99.4
5 mg/dL acetoacetate
100
80 mg/dL acetoacetate
100
Ascorbic acid
<0.2 mg/dL ascorbic Acid
100
20 mg/dL ascorbic Acid
97.2
40 mg/dL ascorbic Acid
100
Glucose
<15 mg/dL glucose
100
50 mg/dL glucose
93.3
500 mg/dL glucose
100
Protein
<15 mg/dL albumin
100
30 mg/dL albumin
99.4
500 mg/dL albumin
100
Blood
No detectable Hb
100
0.03 mg/dL Hb
95
1 mg/dL Hb
94.4
pH
pH = 5
100
pH = 7
100
pH = 9
97.2
Nitrites
<0.03 mg/dL nitrite
100
0.15 mg/dL nitrite
100
Leukocytes
<1uL/mL subtilisin*
100
3.41 uL/mL subtilisin*
94.4
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.