Analytical Specificity - NOVA BIOMEDICAL Stat Profile PRIME Instructions For Use Manual

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 , PCO
2
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 significant effect on test results:
Interfering
Substance
Acetaminophen
Acetylsalicylic acid
Ammonium Chloride
Ascorbic Acid
Benzylkonium Chloride 1.0 mg/dL
Calcium Chloride
D-Galactose
Dopamine
Hydrochloride
EDTA
Ethanol
Fluorescein
Fluoride
Glucose
Glycolic Acid
, Na, K, iCa, Cl, glucose and lactate at
2
Highest
Concentration Tested
20.0 mg/dL
3.62 mmol/L
107.0 µmol/L
50 mg/dL
2.0 mmol/L addition
10.0 mmol/L
5.87 µmol/L
3.4 umol/L
0.5%
1.0 mmol/L
105 µmol/L
1,000 mg/dL
160.0 mg/dL
80.0 mg/dL
Appendix A
Analyte(s)
Tested
Glu, Lac
Cl, Glu, Lac
Na, K, Cl
Cl, Glu, Lac
Na, K, Cl, iCa,
pH, PCO , PO ,
2 2
Na, K
Lac
Glu, Lac
Glu
Glu, Lac
PCO , PO
2 2
Glu Lac
Lac
Glu
Lac
A-3