Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System

Stopped early

Conditions studied: Diabetes

In brief

The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing devices should be used with this system.

Key facts

Study ID

NCT01829061

Run by

Quotient Diagnostics Limited

People needed

360

Starts

2013-04-01

Expected to finish

2014-04-01

Last updated by the study team

2016-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 18 years or over
• Able to read English
• Read, understood and signed the Informed Consent Form
• Agrees to participate and does not withdraw\\
• Either healthy (without diabetes) or has Type 1 or Type 2 diabetes
• Exlcusion Criteria:
• Declines participation or withdraws before study completion

Where it is running

• AMCR Institute — Escondido, California, United States
• Ridgeview Research — Chaska, Minnesota, United States
• University of Missouri — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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