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

Quotient Diagnostics

Status: Terminated

Conditions: Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT01829061

QDL Clinical Studies

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

360 participants in 1 patient group

No Treatment