NOVA BIOMEDICAL Stat Profile PRIME Instructions For Use Manual page 74

Prime CCS Instructions for Use Manual
Precision Study Results
Analytical Precision or Repeatability
Three Stat Profile Prime CCS Analyzers were assessed
for within run precision or repeatability within a laboratory
setting. The protocol consisted of within run precision, and
run–to-run precision studies using 3 different quality control
materials.
• Stat Profile Prime Quality Control Level 1
• Stat Profile Prime Quality Control Level 2
• Stat Profile Prime Quality Control Level 3
Within Run Precision Performance
The protocol consisted of 20 replicates per run for each QC
level on each of 3 Stat Profile Prime CCS Analyzers. The
average, SD, CV%, and N for each analyzer for each QC
level and parameter was calculated. The pooled average,
SD, CV%, and N from all 3 analyzers for each QC level and
parameter was calculated.
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