Evaluation of the Analytical Performance of ALLEGRO™ Instrument

Study Overview
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Brief Summary
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To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods. To assess the Ease of Use of the Allegro in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package insert sheets, a Quick Reference Guide poster and Instructions for Use. No training, coaching, or prompting will be provided other than clarifying the protocol.

Detailed Description
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Blood and urine tests are used in the assessment of diabetes and to guide clinical management. In the traditional model of care, blood samples are taken from patients at the clinic and are sent to the laboratory for analysis and the results may not be available for a number of hours/days after the clinic visit. A new analyser has been developed (Allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. This means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. It is obviously important that this analyzer performs to a similar degree of accuracy to the laboratory analyses. The aim of this research study is to assess the accuracy of the Allegro™ analyzer compared to laboratory analyses on capillary and venous whole blood samples and urine samples. Three hundred sixty (360) patients with diabetes will be invited to give a venous blood sample, finger prick capillary blood sample and urine sample. The venous blood sample, finger prick capillary blood sample and urine sample will be analysed by both the Allegro™ analyser and laboratory analyses and the results compared. The Allegro™ results will not be used in the management of the patients' diabetes.

Official Title
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Allegro Evaluation Study for FDA Submission

Conditions
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Diabetes Mellitus, Kidney Diseases, Metabolic Disease

Intervention / Treatment
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* Diagnostic Test: HbA1c, Lipids, UACR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with ordered HbA1c, lipid profile, and UACr Exclusion Criteria: pediatric

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: HbA1c, Lipids, UACR|compare diagnostic tests to reference methods|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analytical verification of Allegro - HbA1c comparison | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HbA1c blood results in % (percentage) | 10 minutes | 
| Analytical verification of Allegro - Cholesterol comparison | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Cholesterol blood results in mg/dL | 10 minutes | 
| Analytical verification of Allegro - HDL comparison | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for HDL Cholesterol blood results in mg/dL | 10 minutes | 
| Analytical verification of Allegro - Triglycerides comparison | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Triglycerides blood results in mg/dL | 10 minutes | 
| Analytical verification of Allegro - Urine creatinine comparison | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Creatinine urine results in mg/dL | 10 minutes | 
| Analytical verification of Allegro - Urine Albumin comparison | Allegro™, a point of care testing instrument is as effective as a reference laboratory method for Albumin urine results in g/L | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HbA1c, Lipids, UACR