Performance Evaluation of In-Vitro Diagnostic Device

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02894762

Enrollment

120

Registered

2016-09-09

Start date

2015-01-31

Completion date

Unknown

Last updated

2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Routine Examination

Brief 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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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).	6 months	Measured results will collected from the at least 120 individuals of adults for each biochemical indicator.

Countries

Taiwan

Contacts

Primary ContactAudrey Lin

Audrey.lin@liteon.com886-3-5787722

Outcome results