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For in vitro diagnostic use only. The extendSURE™ lyophilized hemoglobin A1c linearity controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.

The extendSURE™ Lyophilized Hemoglobin A1c Linearity Controls comprises one vial each of 5 equally spaced levels of HbA1c control, 1 vial of reconstitution fluid and a product information sheet. The product is provided in a lyophilized form and each vial is reconstituted with 0.25 mL of reconstitution fluid (0.09% sodium azide) prior to use.

The Liquid Stable Hemoglobin A1c Control is intended for use as a quality control material to monitor the performance of laboratory testing procedures for HbA1c quantitation. The control is designed for use with lon exchange HPLC assays, Immunoassay based analyses and Boronate Affinity based assays. The use of quality control materials is indicated as an objective assessment of the precision and bias of methods and techniques in use and is an integral part of good laboratory practices. The two levels of controls allow performance monitoring within the clinical range. The controls are for in vitro diagnostic use only and should not be used past the expiry date.

The Liquid Stable HbA1c Control is a bi-level liquid HbA1c control that is prepared from human red cells. The control should be treated the same as patient specimens and tested following the instructions included with the instrument, kit or reagent being used.

The Hemoglobin A1c Control contains both Normal and Abnormal level Controls. They are intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.

The Hemoglobin A1c Control contains both Normal and Abnormal level Controls. They are intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. They are prepared from normal adult human blood The source blood is tested and found to be non-reactive for Hepatitis B surface antigen, Hepatitis C antibody, antibodies against human immunodeficiency virus (HIV) types 1 & 2, and Syphilis (RPR and TPHA). The Abnormal Level Control is prepared by controlled glycation of normal non-diabetic hemolysate. The controls are reconstituted with distilled water or a reconstitution solution comprising the biocide sodium azide (0.09%). The reconstitution volume is between 0.25 mL and 0.5 mL. The controls reconstitute in 15 minutes with occasional swirling, and are stored at 2° - 8°C.