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NOVA BIOMEDICAL Stat Profile PRIME User Manual

NOVA BIOMEDICAL Stat Profile PRIME
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A-3
Appendix A
Appendix A
A.1.1 Analytical Specificity
An interference study was performed according to CLSI
guideline EP7-A2. The study used spiked and diluted
specimens containing potential interfering substances for
pH, PO
2
, PCO
2
, Na, K, iCa, Cl, glucose and lactate at
normal physiological levels. Each sample containing the
interfering substance was evaluated against a reference
specimen without the interfering substance. Potential
interfering substances were selected for test based upon a
known potential to interfere with the test methodology. The
following table represents substances that were tested without
demonstrating a clinically signicant effect on test results:
Interfering
Substance
Highest
Concentration Tested
Analyte(s)
Tested
Acetaminophen 20.0 mg/dL Glu, Lac
Acetylsalicylic acid 3.62 mmol/L Cl, Glu, Lac
Ammonium Chloride 107.0 µmol/L Na, K, Cl
Ascorbic Acid 50 mg/dL Cl, Glu, Lac
Benzylkonium Chloride
1.0 mg/dL Na, K, Cl, iCa,
Calcium Chloride 2.0 mmol/L addition
pH, PCO
2
, PO
2
,
Na, K
D-Galactose 10.0 mmol/L Lac
Dopamine
Hydrochloride
5.87 µmol/L Glu, Lac
EDTA 3.4 umol/L Glu
Ethanol 0.5% Glu, Lac
Fluorescein 1.0 mmol/L PCO
2
, PO
2
Fluoride 105 µmol/L Glu Lac
Glucose 1,000 mg/dL Lac
Glycolic Acid
160.0 mg/dL
80.0 mg/dL
Glu
Lac

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NOVA BIOMEDICAL Stat Profile PRIME Specifications

General IconGeneral
BrandNOVA BIOMEDICAL
ModelStat Profile PRIME
CategoryMeasuring Instruments
LanguageEnglish

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