Immunoglobulin (anti-A, anti-B antibodies test) positive control

Specification

• Cat#: THP-0108-310
• Product Name: Immunoglobulin (anti-A, anti-B antibodies test) positive control
• Description: This material is a reference preparation for standardising haemagglutination tests and specifications to control the levels of anti-A and anti-B in normal intravenous immunoglobulin (IVIG) products. Preparation defines the recommended maximum limits, where these are applicable, for those IVIG products having higher anti-A and anti-B titres than those in the 'Anti-A and Anti-B in IVIG: Positive control preparation'. Preparation is the negative control for use in the same assay. The preparations have been validated in an international collaborative study. The study showed that preparation has anti-A and anti-B titres in the 2-fold range 32-64 using direct haemagglutination of papain-treated A1 and B red cells.
• Species: Human
• Storage: Store unopened ampoules at -20 centigrade or below.
• Reconstitution: Reconstitute the ampoule contents with 0.5 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. Once reconstituted, users should determine the stability of the reconstituted material according to their own storage facilities. 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. Preparation THP-0108-310 defines the recommended maximum limits, where applicable, for those IVIG products having higher anti-A and anti-B titres than those in the 'Anti-A and Anti-B in IVIG: Positive control preparation', THP-0108+AB, in the direct 'spin' haemagglutination method using papain-treated red cells.