38
Performance Characteristics of Urinalysis Reagent Strips
The performance characteristics of the
AimStrip
®
and
Fisherbrand
®
Urinalysis Reagent Strips have
been determined in both laboratory and clinical tests. The following table indicates performance
characteristics for each parameter.
Reagent Composition
Sensitivity-
Visual Reading
Sensitivity –
AimStrip
®
and
Fisherbrand
®
Urine
Analyzer Reading
Glucose
(GLU)
glucose oxidase;
peroxidase; potassium
iodide; buffer;
non-reactive
ingredients
Detects glucose as low as
50-100 mg/dL (2.5-5
mmol/L).
Detects glucose as low as
80-100 mg/dL (4-5 mmol/L).
Bilirubin
(BIL)
2, 4-dichloroaniline
diazonium salt; buffer
and non-reactive
ingredients
Detects bilirubin as low as
0.4-1.0 mg/dL
(6.8-17 µmol/L).
Detects bilirubin as low as
0.8-1.0 mg/dL
(13.6-17 µmol/L).
Ketone
(KET)
sodium nitroprusside;
buffer
Detects acetoacetic acid as
low as 2.5-5 mg/dL (0.25-0.5
mmol/L).
Detects acetoacetic acid as
low as 4-5 mg/dL (0.4-0.5
mmol/L).
Specific
Gravity
(SG)
bromthymol blue
indicator; buffer and
non-reactive
ingredients; poly
(methyl vinyl
ether/maleic
anhydride); sodium
hydroxide
Determines urine specific
gravity between 1.000 and
1.030. Results correlate
with values obtained by
refractive index method
within ±0.005.
Determines urine specific
gravity between 1.000 and
1.030. Results correlate
with values obtained by
refractive index method
within ±0.005.
Blood
(BLO)
3,3’,5,5’-tetramethylben
zidine (TMB); cumene
hydroperoxide; buffer
and non-reactive
ingredients
Detects free hemoglobin as
low as 0.018-0.060 mg/dL or
5-10 Ery/µL in urine
specimens with ascorbic acid
content of
<50 mg/dL.
Detects free hemoglobin as
low as 0.018-0.030 mg/dL or
5-10 Ery/µL in urine
specimens with ascorbic acid
content of
<50 mg/dL.
pH
methyl red sodium salt;
bromthymol blue;
non-reactive
ingredients
Permits the quantitative
differentiation of pH values
within the range of 5-9.
Permits the quantitative
differentiation of pH values
within the range of 5-9.
Protein
(PRO)
tetrabromophenol blue;
buffer and non-reactive
ingredients
Detects albumin as low as
7.5-15 mg/dL (0.075-0.15
g/L).
Detects albumin as low as
12-15 mg/dL (0.12-0.15 g/L).
Urobilinogen
(URO)
p-diethylaminobenzald
ehyde; buffer and
non-reactive
ingredients
Detects urobilinogen as low
as 0.2-1.0 mg/dL (3.5-17
µmol/L).
Detects urobilinogen as low
as 0.8-1.0 mg/dL (13.6-17
µmol/L).
Nitrite
(NIT)
p
-
arsanilic acid;
N-(1-naphtyl)
ethylenediamine;
non-reactive
ingredients
Detects sodium nitrite as low
as 0.05-0.1 mg/dL in urine
with a low specific gravity and
less than 30 mg/dL ascorbic
acid.
Detects sodium nitrite as low
as 0.05 mg/dL in urine with a
low specific gravity and less
than 30 mg/dL ascorbic acid.
Leukocytes
(LEU)
derivatized pyrrole
amino acid ester;
diazonium salt; buffer;
non-reactive
ingredients
Detects leukocytes as low as
9-15 white blood cells
(Leu/
μ
L) in clinical urine.
Detects leukocytes as low as
12-15 white blood cells
(Leu/
μ
L) in clinical urine.