Linearity; Cut-Off Concentration - MACHEREY-NAGEL URYXXON Relax Manual De Instrucciones

Manual URYXXON

15.3.4. Linearity

Assay reportable range:
Bilirubin: neg. – 1 – 2 – 4 mg/dL
Blood: neg. – 10 – 50 - 250 erythrocytes/μL
Glucose: neg. - norm. – 50 – 100 – 150 – 500 – ≥1000 mg/dL
Ketones: neg. – 25 – 100 – 300 mg/dL
Leucocytes: neg. – 25 – 75 – 500 leucocytes/μL
Nitrite: neg. – pos.
pH: 5 – 6 – 7 – 8 – 9
Protein: neg. – 30 – 100 – 500 mg/dL
Ascorbic acid: neg - 10 - 20 mg/dL
Albumin: 10 - 30 - 80 -150 mg/L
Creatinin: 10 - 50 - 100 - 200 - 300 mg/dL
specific gravity: 1.000 – 1.005 – 1.010 – 1.015 – 1.020 – 1.025 – 1.030
Urobilinogen: norm. – 2 – 4 – 8 – 12 mg/dL

15.3.5. Cut-off concentration

The Cut-Off-Concentration (Medical decision point) has been defined as the
concentration, where minimum 50% of the results are positive.
Parameter
Ascorbic acid
3)
Albumin
Bilirubin
Blood
3)
Creatinin
Glucose
Ketones
Leucocytes
Nitrite
Protein
Urobilinogen
3)
For Performance data on these parameters, please refer to Chapter 15.3.3 "Mikroalbumin")
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Detection limit URYXXON
approx. 5 mg/dL
approx. 0.8 mg/dL
approx. 4 Ery/μL
approx. 35 mg/dL
approx. 10 mg/dL
approx. 15 Leu/μL
approx. 0.05 mg/dL
approx. 15 mg/dL
approx. 0.5 mg/dL
Manual URYXXON
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Relax EN, V6.00 / 11.20