||Each sample is the lyophilized of Apo AI solution without additives. The material is kept under nitrogen gas in sealed glass ampoules.
||The material is intended to be used as a pure calibrant to establish traceability of serum-based reference materials which in turn will be employed in routine laboratory assays. If the material is used for calibration of in vitro diagnostic devices the commutability has to be assessed by the user.To make the material ready for use, it has to be reconstituted according to the following procedure:Reconstitution buffer0.15 mol/L NaCl in 0.1 mol/L Na2HPO4/NaH2PO4, pH=7.4Reconstitution procedure1. Allow ampoule to equilibrate for 1 hour at room temperature prior to opening.2. After ensuring that the contents are entirely in the body of the ampoule, break the snap top.3. Slowly add 1.0 mL of the reconstitution buffer to the ampoule using a calibrated dilutor. The accuracy of the dispenser is required to be better than ± 0.5% as assessed by multiple weighings of water.4. Swirl the ampoule gently and intermittently for five minutes to ensure complete dissoulution of the contents.Fllowing reconstitution, cover the ampoule with an airtight seal and store for no longer than three days at -20 °C prior to its use.
|Quality Control Test:
||Quantitative amino acid analysis
||The material has been tested for the presence of Hepatitis B surface Antigen and for HIV1/HIV2 antibodies and found negative. However, the material is of human origin and must be handled with adequate care. It is intended for in vitro analysis only.
||Upon arrival, the material shall be stored at -20 °C for not more than 12 months until use. However, the European Commission cannot be held responsible for changes that happen during storage of the material at the customer's premises, especially of opened samples.
||Amount of substance concertration: 37.7 μmol/LMass concentration: 1.06 g/L