nal von minden Reactif Touch - Appendix 1 Urine Analyzer Specifi Cati Ons; Appendix 2 Performance Characteristi Cs of Urinalysis Reagent Strips

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Parameters Composi on
Sensi vity-
Visual Reading
Sensi vity-
Reac f Touch Urine Analyzer
Reading
Leukocytes
(LEU)
deriva zed pyrrole ami-
no acid ester; diazonium
salt; buff er; non-reac ve
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) ethylene-
diamine; non-reac ve
ingredients
Detects sodium nitrite as
low as 0.05-0.1 mg/dL in
urine with a low specifi c
gravity and less than 30
mg/dL ascorbic acid.
Detects sodium nitrite as low as 0.05
mg/dL in urine with a low specifi c
gravity and less than 30 mg/dL as-
corbic acid.
Urobilinogen
(URO)
p-diethylaminoben-
zaldehyde; buff er and
non-reac ve 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;
buff er and non-reac ve
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-reac ve ingredients
Permits the quan ta ve
diff eren a on of pH values
within the range of 5-9.
Permits the quan ta ve diff eren a on
of pH values within the range of 5-9.
Blood
(BLO)
3,3’,5,5’-tetramethylben-
zidine (TMB); cumene hy-
droperoxide; buff er and
non-reac ve 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.
Specifi c
Gravity
(SG)
bromthymol blue
indicator; buff er and
non-reac ve ingredients;
poly (methyl vinyl ether/
maleic anhydride); sodi-
um hydroxide
Determines urine specifi c
gravity between 1.000 and
1.030. Results correlate
with values obtained by
refrac ve index method
within ±0.005.
Determines urine specifi c gravity
between 1.000 and 1.030. Results
correlate with values obtained by re-
frac ve index method within ±0.005.
Ketone
(KET)
sodium nitroprusside;
buff er
Detects acetoace c acid as
low as 2.5-5 mg/dL (0.25-
0.5 mmol/L).
Detects acetoace c acid as low as 4-5
mg/dL (0.4-0.5 mmol/L).
Bilirubin
(BIL)
2, 4-dichloroaniline
diazonium salt; buff er and
non-reac ve 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).
Appendix 2 Performance Characteris cs of
Urinalysis Reagent Strips
The performance characteris cs of the Reac f Urinalysis Reagent Strips have been deter-
mined in both laboratory and clinical tests. The following table indicates performance
characteris cs for each parameter.