Performance Evaluation of In-Vitro Diagnostic Device

NCT ID: NCT02894762

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Blood Routine Examination

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lite-On Technology Corporation H.S.P.B

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Audrey Lin

Role: CONTACT

886-3-5787722 ext. 5800

Facility Contacts

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YUE E Wu

Role: primary

886-913-772-512

Other Identifiers

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201410068DSD

Identifier Type: -

Identifier Source: org_study_id

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