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

Specification

• Cat#: THP-0108-AB
• Product Name: Immunoglobulin (anti-A, anti-B antibodies test) negative control
• Source: Human Plasma. The preparation contains material of human origin, and either the final product or the source materials, from which it is derived, have been tested and found negative for HBsAg, anti-HIV and HCV RNA. As with all materials of biological origin, this preparation should be regarded as potentially hazardous to health. It should be used and discarded according to your own laboratory's safety procedures. Such safety procedures should include the wearing of protective gloves and avoiding the generation of aerosols. Care should be exercised in opening ampoules or vials, to avoid cuts.
• Storage: Use a manual defrost freezer and avoid repeated freeze-thaw cycles. 36 months from date of receipt for unopened vials, at -20°C.
• Usage: No attempt should be made to weigh out any portion of the freeze-dried material prior to reconstitution. RECONSTITUTE THE CONTENTS OF THE AMPOULE 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°C. 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. This preparation is intended to be used as a negative control along with THP-0108+AB in the direct 'spin' haemagglutination method using papain-treated red cells for testing anti-A and anti-B titres in batches of IVIG products. IVIG products with anti-A and/or anti-B titres that are higher than those obtained with THP-0108+AB should be compared with the 'Anti-A and anti-B in IVIG: Limit Reference Preparation', THP-0108-310, if applicable.
• Endotoxin Level: <0.001 EU per 1 mg by the LAL method
• Formulation: One ampoule contains the lyophilised residue of approximately 0.5 mL of a 5% IVIG preparation, diluted from 10% with a sterile buffer (250mM glycine and 0.4% NaCl). The 10% IVIG preparation was manufactured exclusively from plasma collected from blood group AB donors. Group AB plasma does not contain antibodies against the A and B blood group antigens. Anti-A and anti-B activities were not detected in direct haemagglutination assays carried out at Creative Biomart.