MACHEREY-NAGEL URYXXON Relax Manual De Instrucciones página 105

Precision / Repeatability within series
Total measurements
True positive
False positive
False negative
True negative
Precision / Repeatability batch-to-batch
Total measurements
True positive
False positive
False negative
True negative
Precision / Reproducibility day-to-day
Total measurements
True positive
False positive
False negative
True negative
* 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).
URYXXON Relax (N=612)
®
1)
Albumin
2)
Albumin/creatinine ratio
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".
BIL BLD GLU
40 40 40
20 20 20
0 0 0
0 0 0
20 20 20
BIL BLD GLU
60 60 60
30 30 30
0 0 0
0 0 0
30 30 30
BIL BLD GLU
100 100 100
50 50 50
0 0 0
0 0 0
50 50 50
Negative percent
agreement
83.6 %
84.8 %
Manual URYXXON
KET LEU NIT
40 40 40
20 20 20
0 0 0
0 0 0
20 20 20
KET LEU NIT
60 60 60
30 30 30
0 0 0
0 0 0
30 30 30
KET LEU NIT
100 100 100
50 50 50
0 0 0
0 0 0
50 50 50
Positive percent
agreement
85.0 %
89.5 %
Relax EN, V 6.01 / 03.22
®
PRO UBG pH
40 40 40
20 20 20*
0 0 n/a
0 0 n/a
20 20 20*
PRO UBG pH
60 60 40
30 30 20*
0 0 n/a
0 0 n/a
30 30 20*
PRO UBG pH
100 100 100
50 50 50*
0 0 n/a
0 0 n/a
50 50 50*
Overall percent
agreement
84.2 %
86.4 %
SG ASC
40 40
20* 20
n/a 0
n/a 0
20* 20
SG ASC
40 60
20* 30
n/a 0
n/a 0
20* 30
SG ASC
100 200
50* 100
n/a 0
n/a 0
50* 100
105