HbA1c Linearity Controls
It is recommended that instruments used for HbA1c analysis are tested at 6monthly 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.
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|HB510||HbA1c Linearity Control kitset: 1 vial of each level , 5 levels|