HbA1c Lyophilized Controls

The lyophilized Hemoglobin A1c control is a two level control with defined levels between 4.5% - 6.0% (Normal, Level 1) and between 9.0% - 14.0% (Abnormal, Level 2). They are intended as a quality control material for analytical methods including ion exchange HPLC, immunoassay and boronate affinity for quantitation of HbA1c. The controls are in glass vials with screw top caps.

Our 4 vial kit contains 2 normal and 2 abnormal level controls and 1 vial of reconstitution fluid. Each vial is reconstituted with 0.25ml to give a typical hemoglobin concentration of 14g/dL. The lyophilized product is stable for 3 years from manufacture with 3 months for the reconstituted control stored at 2° to 8°C.

The Level 2 Control is produced by In Vitro Glycation

The Level 2 extendSURE™ HbA1c control is produced by a process of controlled in vitro glycation of non-diabetic blood. This means there is not a reliance on sourcing blood from diabetic subjects with high HbA1c levels, and it also means that levels of up to over 20% can be produced in significant quantities. It also avoids the potential ethical issues relating to obtaining blood from a patient with a clinical condition.