HbA1c Linearity Controls

It is recommended that instruments used for HbA1c analysis are tested at 6 monthly intervals for linearity of readings over a range that extends beyond that typically found in patient samples. This can be achieved using the extendSURE™ Linearity Control Kitset which comprises 5 levels, evenly spaced between 3% - 17% HbA1c. They are intended as aquality control material for analytical methods including ion exchange HPLC, immunoassay and boronate affinity. *

The standard product has a reconstituted volume of 0.25mL with total hemoglobin of 14g/L and is supplied in a kitset containing 1 vial of each level with 1 vial reconstitution fluid. The lyophilized product is stable for 3 years from manufacture stored at 2° - 8°C, with 2 weeks for the reconstituted controls stored at 2° - 8°C.

The higher level extendSURE™ Linearity controls are produced by a process of controlled in vitro glycation of non-diabetic blood.

* See technical note on boronate affinity where high levels will not necessarily correspond with other methods. (This link will take you within the Technical Info page.)