104
Manual URYXXON
®
Relax EN, V 6.03 / 08.22
Precision / Repeatability within series
BIL
BLD
GLU
KET
LEU
NIT
PRO
UBG
pH
SG
ASC
Total measurements
40
40
40
40
40
40
40
40
40
40
40
True positive
20
20
20
20
20
20
20
20
20*
20*
20
False positive
0
0
0
0
0
0
0
0
n/a
n/a
0
False negative
0
0
0
0
0
0
0
0
n/a
n/a
0
True negative
20
20
20
20
20
20
20
20
20*
20*
20
Precision / Repeatability batch-to-batch
BIL
BLD
GLU
KET
LEU
NIT
PRO
UBG
pH
SG
ASC
Total measurements
60
60
60
60
60
60
60
60
40
40
60
True positive
30
30
30
30
30
30
30
30
20*
20*
30
False positive
0
0
0
0
0
0
0
0
n/a
n/a
0
False negative
0
0
0
0
0
0
0
0
n/a
n/a
0
True negative
30
30
30
30
30
30
30
30
20*
20*
30
Precision / Reproducibility day-to-day
BIL
BLD
GLU
KET
LEU
NIT
PRO
UBG
pH
SG
ASC
Total measurements
100
100
100
100
100
100
100
100
100
100
200
True positive
50
50
50
50
50
50
50
50
50*
50*
100
False positive
0
0
0
0
0
0
0
0
n/a
n/a
0
False negative
0
0
0
0
0
0
0
0
n/a
n/a
0
True negative
50
50
50
50
50
50
50
50
50*
50*
100
* pH and density do not provide negative / positive interpretation. Obtained values were in accordance to target values
of Control N and P.
15.3.3 Mikroalbumin
For determination of the performance data of Medi-Test Microalbumin, urine samples from
urological practice were used which had been obtained as part of daily routine urine control.
The measured albumin and creatinine values were compared with the results of the respective
reference method (immunoturbidimetric assay for albumin and colorimetric Jaffé method for
creatinine).
Negative percent
agreement
Positive percent
agreement
Overall percent
agreement
URYXXON
®
Relax (N=612)
Albumin
1)
83.6 %
85.0 %
84.2 %
Albumin/creatinine ratio
2)
84.8 %
89.5 %
86.4 %
1)
Here a negative assessment corresponds to the result 10 mg/L albumin, a positive assessment to the result 30, 80
or 150 mg/L albumin.
2)
Here a negative assessment corresponds to the result “Normal”, a positive assessment to the result “Abnormal” or
“High Abnormal”.
Содержание URYXXON Relax
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