NOVA BIOMEDICAL Stat Profile PRIME, Instructions For Use Manual

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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.