PRINCIPLE
HbA1c Control L + H is intended to check the accuracy of assays using MANTech HbA1c reagent. It must be used to evaluate the performances of the assay procedure and to detect possible analytical deviations due to the reagents or the analysers used.
COMPOSITION
Controls are lyophilised hemolysates prepared from human erythrocytes. Concentration of HbA1c Control L is in the normal range, and concentration of HbA1c Control H in the pathological range.
TRACEABILITY
Concentration values for HbA1c Control L + H have been standardized from NGSP/DCCT(%) system. These values have been converted by calculation to traceable values from IFCC reference method (mmol/mol).
PRECAUTIONS
– Controls are prepared from human material found to be negative for HbsAg, anti-HCV antibody and anti-HIV1& 2 antibodies.
However, handle cautiously as potentially infectious.
– Use clean or single use laboratory equipment to avoid contaminations.
– Discard cloudy control.
WASTE MANAGEMENT
Disposal of all waste material should be in accordance with local and legal requirements.
PREPARATION
Reconstitute each controls with 0.5 mL deionized water. Gently mix for 10 minutes, or until all material has dissolved.
Note : As all samples, these controls should be hemolysed before use (except if hemolysis is done automaticcaly on-board).
STABILITY AND STORAGE
To store at 2-8 °C and protected from light.
Before opening :
Controls are stable until the expiry date stated on the label.
After reconstitution :
Controls are stable for 30 days when stored at 2-8 °C.
– After opening, the vials should be kept correctly and tightly capped to prevent contamination and evaporation.
– Do not freeze
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