Blood Routine Examination Clinical Trial
Official title:
Performance Evaluation of In-Vitro Diagnostic Device
| NCT number | NCT02894762 |
| Other study ID # | 201410068DSD |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | August 16, 2016 |
| Last updated | September 8, 2016 |
| Start date | January 2015 |
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
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Lite-On Technology Corporation H.S.P.B |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quantitative measurement of biochemical indicators in the blood of adult that include of Albumin (ALB), Blood urea nitrogen (BUN), Glucose (GLU), and Total Protein (TP). | Measured results will collected from the at least 120 individuals of adults for each biochemical indicator. | 6 months | No |