The Nova Allegro Analyzer System (Allegro) Evaluation Study
Research type
Research Study
Full title
The evaluation of analytical performance and characteristic assessment of the Nova Biomedical Allegro Analyzer System
IRAS ID
290895
Contact name
Maurice O’Kane
Contact email
Sponsor organisation
Nova Biomedical
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Blood and urine tests are used in the assessment of diabetes, chronic kidney disease and hyperlipidaemia 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 analyser performs to a similar degree of accuracy to the laboratory analyses.
The aim of this research study is to use the Allegro system to take and record HbA1c, Total Cholesterol, Urine Creatinine, HDL Cholesterol, Urine Albumin, Triglycerides from 120 patients using a combination of capillary blood from finger pricks, venous blood and urine samples to assess the performance of the Allegro system at the Point-of-Care. Repeatability variance will be tested through laboratory discarded biological samples. All Allegro results will be compared for performance characteristics to other Point-of-Care methods and central laboratory reference methods available to clinicians. Reference testing will take place at Altnagelvin and in other reference labs worldwide. The Allegro machine operability will be assessed by healthcare staff trained by reading the operation guide rather than by face to face training.
Allegro results will not have any impact on the care pathway or patient management of any participants that may take part.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0274
Date of REC Opinion
17 Dec 2020
REC opinion
Further Information Favourable Opinion