HbA1c controls, linearity sets and calibrators
for diabetes testing
The Hemoglobin A1c control is available in lyophilised or
liquid form, and is a two level control with defined levels between 4.5% – 6.0% (Normal, Level 1) and between 9.0% – 13.0% (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 source blood is tested as non-reactive for Hepatitis B surface antigen, Hepatitis C antibody, antibodies against human immunodeficiency virus (HIV) types 1 & 2, HIV-1 antigen, and Syphilis (RPR or TPHA).
The controls are in glass vials with screw top caps. Each vial is reconstituted with 0.25ml (lyophilised) or 1.0mL (liquid) to give
a typical hemoglobin concentration of 14g/dL. The lyophilised product is stable for 3 years from manufacture with 3 months
for the reconstituted control stored at 2° to 8°C. The liquid product has a closed vial life of 30 months and an open vial life of 30 days when stored at 2° – 8°C. There is no need to
aliquot and freeze in order to extend the shelf life.
These controls are listed with US FDA and are CE-Marked.
Available in 4 Vial, 24 Vial and bulk kits.
Contact us for more information.
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 a quality control material for analytical methods including ion exchange HPLC, immuno assay and boronate affinity.
(See the technical note on boronate affinity where high levels will not necessarily correspond with other methods.)
The standard product has a reconstituted volume of 0.25mL with total hemoglobin of 14g/dL and is supplied in a kitset containing 1 vial of each level with 1 vial reconstitution fluid. The lyophilised 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.
These controls are listed with US FDA.
Contact us for more information.