Macherey-Nagel URYXXON 500, User Manual

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Instruction for use URYXXON
®
500
31 Instruction for use URYXXON ® 500 V 2.1 / 01.23
17.4 Disposal
NOTICE
Disposal using public waste disposal facilities is not permitted.
In case of disposal, contact your MACHEREY‑NAGEL
representative.
Waste disposal according to EU Directive
2012/19/EU. In compliance with national
legal regulations (EU Directive 2012/19/
EU), MACHEREY‑NAGEL disposes the old
instruments.
17.5 Analytical Performance Characteristics
17.5.1 Table of results
Param. CONV SI ARB
BLD NEG NEG NEG
10 Ery/µL 10 Ery/µL +
50 Ery/µL 50 Ery/µL ++
250 Ery/µL 250 Ery/µL +++
UBG NORM NORM NORM
2 mg/dL 35 µmol/L +
4 mg/dL 70 µmol/L ++
8 mg/dL 140 µmol/L +++
12 mg/dL 200 µmol/L ++++
BIL NEG NEG NEG
1 mg/dL 17 µmol/L +
2 mg/dL 35 µmol/L ++
4 mg/dL 70 µmol/L +++
PRO NEG NEG NEG
30 mg/dL 0.3 g/L +
100 mg/dL 1 g/L ++
500 mg/dL 5 g/L +++
NIT NEG NEG NEG
POS POS +
KET NEG NEG NEG
25 mg/dL 2.5 mmol/L +
100 mg/dL 10 mmol/L ++
300 mg/dL 30 mmol/L +++
GLU NEG NEG NEG
NORM NORM NORM
50 mg/dL 2.8 mmol/L +
150 mg/dL 8.3 mmol/L ++
≥ 500 mg/dL ≥ 27.8 mmol/L +++
pH 5 5 5
6 6 6
6.5 6.5 6.5
7 7 7
8 8 8
9 9 9
SG 1.000 1.000 1.000
1.005 1.005 1.005
Param. CONV SI ARB
1.010 1.010 1.010
1.015 1.015 1.015
1.020 1.020 1.020
1.025 1.025 1.025
1.030 1.030 1.030
LEU NEG NEG NEG
25 Leu/µL 25 Leu/µL +
75 Leu/µL 75 Leu/µL ++
500 Leu/µL 500 Leu/µL +++
Meaning of the used abbreviations:
BLD ‑ Blood, UBG ‑ Urobilinogen, BIL ‑ Bilirubin, PRO ‑ Protein,
NIT ‑ Nitrite, KET ‑ Ketone, GLU ‑ Glucose, SG ‑ specific gravity of
the urine (density), LEU – Leukocytes
17.5.2 Precision
The precision was evaluated by using the commercially
available control solution Medi‑Test Control, manufactured by
MACHEREY‑NAGEL, Dueren, Germany. This Control is used for
daily routine system check of the URYXXON
®
500 urinalysis system.
It is available as a 2 level set (Medi‑Test Control N = level 1 (N):
negative‑normal, Medi‑Test Control P = level 2 (P): positive values).
Repeatability and reproducibility amount to 100 % in all cases.
The results are summarized in the following table.
Precision / Repeatability within series
BIL BLD GLU KET LEU NIT PRO UBG pH SG
Total measurements 40 40 40 40 40 40 40 40 40 40
True positive 20 20 20 20 20 20 20 20 20* 20*
False positive 0 0 0 0 0 0 0 0 n/a n/a
False negative 0 0 0 0 0 0 0 0 n/a n/a
True negative 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
Total measurements 60 60 60 60 60 60 60 60 40 40
True positive 30 30 30 30 30 30 30 30 20* 20*
False positive 0 0 0 0 0 0 0 0 n/a n/a
False negative 0 0 0 0 0 0 0 0 n/a n/a
True negative 30 30 30 30 30 30 30 30 20* 20*
Precision / Reproducibility day-to-day
BIL BLD GLU KET LEU NIT PRO UBG pH SG
Total measurements 100 100 100 100 100 100 100 100 100 100
True positive 50 50 50 50 50 50 50 50 50* 50*
False positive 0 0 0 0 0 0 0 0 n/a n/a
False negative 0 0 0 0 0 0 0 0 n/a n/a
True negative 50 50 50 50 50 50 50 50 50* 50*
* pH and density do not provide negative / positive interpretation. Obtained
values were in accordance to target values of Control N and P.