Anti-D Immunoglobulin positive control

Specification

• Cat#: THP-0108-209
• Product Name: Anti-D Immunoglobulin positive control
• Description: This material is a positive control preparation for haemagglutination tests performed to control the level of anti-D in normal intravenous immunoglobulin (IVIG) products. This preparation has a nominal titre of 8 using direct haemagglutination of papain-treated OR2R2 erythrocytes. Preparation THP-0108-210 is the negative control. An international collaborative study has shown that use of the reference reagents would help overcome interlaboratory variability in haemagglutination tests and ensure that such tests are sufficiently sensitive to detect anti-D in IVIG products. It is also proposed that the level of anti-D in this material defines the maximum permissible titre of anti-D in IVIG products.
• Species: Human
• 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 inopening ampoules or vials, to avoid cuts.
• Formula: One ampoule contains the lyophilized residue of approximately 1 mL normal IVIG (5% IgG, w/v)
• Endotoxin: <0.001 EU/mg by the LAL method
• Storage: The product is shipped with ice packs. Use a manual defrost freezer and avoid repeated freeze-thaw cycles. 36 months from date of receipt for unopened vials, at -20 centigrade.
• 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 1 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. The reconstituted material is to be used in direct haemagglutination tests using papain-treated erythrocytes for anti-D activity in IVIG products.