Product Manual

40
Performance Characteristics of Urinalysis Reagent Strips
The performance characteristics of the Clarity 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 –
Clarity Urocheck 120C Urine
Analyzer Reading
Leukocytes
(LEU)
derivatized pyrrole amino
acid ester; diazonium salt;
buffer; non-reactive
ingredients
Detects leukocytes as low as
9-15 white blood cells (Leu/μL) in
clinical urine.
Detects leukocytes as low as
12-15 white blood cells (Leu/μL)
in clinical urine.
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.
Urobilinogen
(URO)
p-diethylaminobenzaldehy
de; 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).
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).
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.
Blood
(BLO)
3,3’,5,5’-tetramethylbenzidi
ne (TMB);
diisopropylbenzene
dihydroperoxide; 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 0.018-0.060 mg/dL or
5-10 Ery/µL in urine specimens
with ascorbic acid content of <50
mg/dL.
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.
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).
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).
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).