IVIG + anti-D

Specification

• Cat#: THP-0108-228
• Product Name: IVIG + anti-D
• Description: These materials are reference preparations for haemagglutination tests performed to control the level of anti-D in normal intravenous immunoglobulin (IVIG) products. Preparation THP-0108-228 has a nominal titre of 8 using direct haemagglutination of papain-treated OR2R2 erythrocytes. Preparation THP-0108-226 is the negative control. It is also proposed that the level of anti-D in THP-0108-228 defines the maximum permissible titre of anti-D in IVIG products.
• Species: Human
• Storage: Store unopened ampoules at -20 centigrade or below.
• Reconstitution: Reconstitute the ampoule contents with 1.0 mL distilled or deionised water containing 0.02% sodium azide. Allow several minutes, with occasional vortexing, for reconstitution. Transfer the reconstituted contents to a capped tube and store at 4 centigrade. Users should determine the stability of the reconstituted material according to their own storage facilities but tests indicate that the reconstituted material is stable for at least 1 week at 4 centigrade. The reconstituted contents are 5% (w/v) IgG.
• Usage: No attempt should be made to weigh out any portion of the freeze-dried material prior to reconstitution.