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

Terminated

• Conditions: Diabetes

• Registration Number: NCT01829061
• Lead Sponsor: Quotient Diagnostics Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-11
• Status Verified: 2013-11
• Primary Completion: 2014-01
• Study Completion: 2014-04
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C	10 Days	The objective is to conduct a method comparison between both the Quo-Test and Quo-Lab investigational devices and the reference method \[Tosoh G8 (K071132)\]. The reference method also serves as the predicate for the premarket notifications for both investigational devices. Both capillary and venous samples will be tested on the Quo-Test A1C System and Quo-Lab A1C Test, while only venous samples will be tested on the reference method.

Secondary Outcome Measures

Name	Time	Method
Obtain CLIA Waiver Status for the Quo-Test	10 Days

Trial Locations

Locations (3)

AMCR Institute; 🇺🇸 Escondido, California, United States

Ridgeview Research; 🇺🇸 Chaska, Minnesota, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States