Performance Evaluation of In-Vitro Diagnostic Device

Blood Routine Examination Clinical Trial

Official title: Performance Evaluation of In-Vitro Diagnostic Device

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Routine Examination

• NCT number: NCT02894762
• Study type: Observational
• Source: Lite-On Technology Corporation H.S.P.B
• Contact: Audrey Lin
• Phone: 886-3-5787722
• Email: Audrey.lin@liteon.com
• Status: Recruiting
• Phase: N/A
• Start date: January 2015