Blood Routine Examination Clinical Trial
Official title:
Performance Evaluation of In-Vitro Diagnostic Device
This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four
skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical
Chemistry Analyzer.
Analyte Principle:
Albumin (ALB) - Dye-Binding BCG
Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme)
Glucose (GLU) - Hexokinase, Colorimetry
Total Protein (TP) - Biuret
n/a
Observational Model: Case-Only, Time Perspective: Prospective