Comparative Study - Macherey-Nagel URYXXON Relax User Manual

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
Blood
Urobilinogen
Bilirubin
Protein
Nitrite
Ketones
Glucose
pH
Density
Leukocytes
overall average
* 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
®
is 100 % in all cases.
Parameter
Ascorbic acid
Manual URYXXON
106
Comparison
®
URYXXON Relax – Competitor 1***
exact agreement agreement ± 1 bin
80 % 99 %
88 % 100 %
95 % 100 %
95 % 100 %
96 % N/A
98 % 98 %
92 % 100 %
84 % 100 %
96 %* 100 %**
88 % 99 %
91 % 100 %
Comparison
URYXXON Relax – QUANTOFIX
®
exact agreement
100 %
Relax EN, V 6.03 / 08.22
®
Comparison
URYXXON
exact agreement
87 %
91 %
95 %
88 %
96 %
91 %
92 %
88 %
65 %*
85 %
88 %
Relax is shown in the following table. Agreement
®
Relax
®
agreement ± 1 bin
100 %
®
Relax - Competitor 2***
agreement ± 1 bin
100 %
100 %
100 %
100 %
N/A
98 %
100 %
98 %
90 %**
100 %
98 %