Analyticon combi scan 500 User Manual

30
Appendix
Performance data
Detection Limit
Parameter Detection Limit *
Ascorbic acid 15 mg/dl
Bilirubin 0,6 mg/dl
Blood 6-8 Ery/µL (as Hb)
Glucose 40-50 mg/dl
Ketones 4-6 mg/dl
Leucocytes 10-15 Leu/ul
Nitrite 0,1 mg/dl
Protein 20 mg/dl
Urobilinogen 1,5 mg/dl
* Since the concentration of normal urine constituents may vary between different sam-
ples, the detection limit also may show variations.
Agreement to Reference
Comparison 1 Comparison 2 Comparison 3 Comparison 4
Parameter same
colour
block
+/–1
colour
block
same
colour
block
+/–1
colour
block
same
colour
block
+/–1
colour
block
same
colour
block
+/–1
colour
block
Ascorbic acid 84,8% 100% 84,8% 100% – – 100% 100%
Bilirubin 68,8% 100% 93,8% 100% 86,7% 99,6% 100% 100%
Blood 92,0% 100% 98,2% 100% 90,7% 100% 100% 100%
Glucose 86,6% 100% 89,3% 100% 90,7% 97,8% 93,6% 100%
Ketones 83,0% 100% 93,8% 99,1% 92,9% 99,1% 100% 100%
Leucocytes 83,0% 98,2% 91,1% 100% 84,1% 99,1% 98,4% 100%
Nitrite 99,1% 100% 96,4% 100% 94,7% 100% 100% 100%
pH 90,2% 100% 60,7% 99,1% 64,2% 100% 100% 100%
Protein 86,6% 100% 94,6% 100% 82,3% 97,8% 100% 100%
Spec. gravity 60,7% 96,4% 30,4% 82,1% 33,6% 81,4% 94,7% 100%
Urobilinogen 90,4% 97,6% 83,0% 100% 89,8% 99,1% 100% 100%
For clinical utility, test principles, expected values, limitations, reagent compositions of
he test pads, storage of test strips and special notes / instructions concerning test strips
pleaser refer to the package insert of the CombiScreen test strips.

Analyticon combi scan 500 Specifications

General

Brand	Analyticon
Model	combi scan 500
Category	Measuring Instruments
Language	English