IRIS iChemVelocity

11 Appendix
301-7146 English Rev B 11/02/2011 Operator’s Manual NA 219
Strip lot to strip lot precision
Three levels of target analyte concentrations for each assay (negative,
first positive level and highest positive level) were tested 20 times on
each of three iChemVELOCITY urine chemistry strip lots. The exact %
agreement with expected results is shown.
Test
Analyte Concentration
% Exact Agreement
Bilirubin
<1 mg/dL bilirubin
100
2 mg/dL bilirubin
91.7
4 mg/dL bilirubin
100
Urobilinogen
<0.2 mg/dL urobilinogen
100
2 mg/dL urobilinogen
96.7
4mg/dL urobilinogen
100
Ketones
<1 mg/dL acetoacetate
100
5 mg/dL acetoacetate
100
80 mg/dL acetoacetate
100
Ascorbic acid
<0.2 mg/dL ascorbic Acid
100
20 mg/dL ascorbic Acid
98.9
40 mg/dL ascorbic Acid
99.4
Glucose
<15 mg/dL glucose
100
50 mg/dL glucose
94.4
500 mg/dL glucose
100
Protein
<15 mg/dL albumin
100
30 mg/dL albumin
97.2
500 mg/dL albumin
100
Blood
No detectable Hb
100
0.03 mg/dL Hb
97.2
1 mg/dL Hb
96.7
pH
pH = 5
100
pH = 7
100
pH = 9
95
Nitrites
<0.03 mg/dL nitrite
100
0.15 mg/dL nitrite
98.3
Leukocytes
<1uL/mL subtilisin*
100
3.41 uL/mL subtilisin*
95
50 uL/mL subtilisin*
100
*Subtilisin is a surrogate for leukocyte esterase. 3.41 uL/mL subtilisin is
equivalent to 25 WBCs/mL qnd 50 μL/mL is equivalent to 500 WBCs/μL.