Low Cost System for Hemoglobin A1c
- Principles & Features

Hemoglobin A1c Assay System - view as PDF

Hemoglobin A1C Testing Guide - view as PDF

The Scripps Laboratories
HbA1c System

Development Stage: Finalizing design based on partner input

Assay Principle: The Scripps assay is a boronate affinity method. Both total and glycated hemoglobin are measured on the same disposable assay device

Meter: Glucometer type reflectometer

Assay Range: 3 to 13% DCCT harmonized HbA1c

Patent Status: US patent issued; PCT patents pending

Stability: Assay contains no potentially labile components such as enzymes, antibodies or chromogenic markers. Preliminary studies indicate good stability at room temperature and 45°C with desiccation.

Advantages & Features:

1. Small sample size: 2 to 3 µl fingerstick
2. Technique independent
3. Whole blood capillary sample with no pre-treatment
4. Reports DCCT harmonized %HbA1c
5. All measurements are made on the same area of the matrix, minimizing system error
6. Short assay time: ~ 5 minutes
7. Low cost test strip and reflectance meter
8. Boronate affinity method - will not be affected by the labile fraction of glycated hemoglobin or by the presence of hemoglobin variants in the sample.