NOVA BIOMEDICAL Stat Profile PRIME, Instructions For Use Manual

Page: 65 / 102

A-5
Appendix A
Appendix A
The following table represents substances that were tested
that demonstrated a clinically significant effect on test results:
Glucose
Interfering
Substance
Concentration
of interfering
substance
Analyte (Glu)
concentration
Bias mg/dL
D-Galactose 10.0 mmol/L 94 mg/dL - 10.7 mg/dL
Glucosamine 30 µmol/L 99 mg/dL - 16.6 mg/dL
Hydroxyurea 0.8 mg/dL 112 mg/dL - 18.8 mg/dL
Lactate
Interfering
Substance
Concentration
of interfering
substance
Analyte (Lac)
concentration
Bias mmol/L
Glycolic acid 80 mg/dL 2.7 mmol/L (+) 3.6 mmol/L
A.2 Analytical Performance Studies
Three Stat Profile Prime CCS analyzers were compared to
2 Stat Profile pHOx Ultra Analyzers in a laboratory setting
by healthcare professionals. The protocol consisted of
within run precision runs, day-to-day precision runs, linearity
validation, and method comparison studies comparing the
performance of the Stat Profile Prime CCS Analyzers to the
Stat Profile pHOx Ultra Analyzers.
Method Comparison Study
Heparinized arterial whole blood discarded specimens
from hospital patients were analyzed in duplicate on the 3
Stat Profile Prime CCS Analyzers and 2 Stat Profile pHOx
Ultra reference analyzers. The number of samples per run
and the total number of runs each day depended upon the
availability of blood specimens on any given test day. Some