106
Manual URYXXON
®
Relax EN, V 6.03 / 08.22
15.3.6 Comparative study
In a comparative study 240 urine samples were evaluated with urine test strips on the
URYXXON
®
Relax instrument and similar competitor instruments.
The results of the study are summarized in the following table:
Parameter
Comparison
URYXXON
®
Relax – Competitor 1***
Comparison
URYXXON
®
Relax - Competitor 2***
exact agreement
agreement ± 1 bin
exact agreement
agreement ± 1 bin
Blood
80 %
99 %
87 %
100 %
Urobilinogen
88 %
100 %
91 %
100 %
Bilirubin
95 %
100 %
95 %
100 %
Protein
95 %
100 %
88 %
100 %
Nitrite
96 %
N/A
96 %
N/A
Ketones
98 %
98 %
91 %
98 %
Glucose
92 %
100 %
92 %
100 %
pH
84 %
100 %
88 %
98 %
Density
96 %*
100 %**
65 %*
90 %**
Leukocytes
88 %
99 %
85 %
100 %
overall average
91 %
100 %
88 %
98 %
* this value represents agreement ± 1 bin
** this value represents agreement ± 2 bins
*** similar competitor devices with similar intended purpose (reflectometric device for automatic read-out of urine test
strips)
The exact agreement for parameters blood, urobilinogen, bilirubin, protein, nitrite, ketones,
glucose, pH and leukocytes amounts to ≥ 80 % in every case. For parameter density
agreement ± 1 bin amounts to 96 % and 65 % compared to two different competitor products.
Agreement ± 2 bins amounts to 100 % and 90 %, respectively.
Overall average exact agreement is 91 % and 88 % when compared to competitor products.
Overall agreement ± 1 bin amounts to 100 % and 98 %.
A summary of the comparative measurements for ascorbic acid with comparative product
QUANTOFIX
®
Ascorbic acid on QUANTOFIX
®
Relax is shown in the following table. Agreement
is 100 % in all cases.
Parameter
Comparison
URYXXON
®
Relax – QUANTOFIX
®
Relax
exact agreement
agreement ± 1 bin
Ascorbic acid
100 %
100 %