HbA1c 24-Vial 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 24 vial kit contains 12 normal and 12 abnormal level controls and 4 vials 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.