Performance Evaluation of In-Vitro Diagnostic Device

Lite-On Technology

Status: Unknown

Conditions: Blood Routine Examination

Study type: Observational

Funder types: Industry

Identifiers

NCT02894762

201410068DSD

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• You must be an adult over 20 years of age and weigh over 50 kg to be eligible to participate in the study.

Exclusion criteria

• You may not participate in this study if you do not meet the above inclusion criteria.