CAN/CGSB-106.5-95

1. Scope 1.1 This standard provides minimum requirements for the potency and specificity of the following four main groupings of reagents to be used in Canada: ABO; Rh reagents, anti-D; Rh reagents, other than anti-D; and anti-human globulin reagents. 1.2 These reagents are biological fluids of human or animal origin. They may be chemically-modified or unmodified products or manufactured from monoclonal antibodies derived from cultured cell lines. 1.3 The tube, liquid phase microplate, column agglutination, gel, solid phase and automated techniques are considered in this standard where appropriate. The slide method is not recommended as a preferred technique for routine testing. 1.4 The Standards for Transfusion Medicine of the Canadian Society for Transfusion Medicine (CSTM) should be followed by consumers for assessing lots of reagents. It is recommended that consumers assess lots of reagents received by comparing their reactivity with those of reagents giving current satisfactory results in the laboratory's routine method. Appropriate controls must be used. Consumers' complaints regarding reagents may be directed to the Bureau of Medical Devices, Environmental Health Directorate, Health Canada, Block 1600, Main Statistics Building, Tunney's Pasture, Ottawa, Ontario, K1A 0L2. 1.5 The testing and evaluation of a product against this standard may require the use of materials and/or equipment that could be hazardous. This document does not purport to address all the safety aspects associated with its use. Anyone using this standard has the responsibility to consult the appropriate authorities and to establish appropriate health and safety practices in conjunction with any existing applicable regulatory requirements prior to its use, such as those parts of Medical Devices Regulations pertaining to medical devices that contain material of human or animal origin which is capable of transmitting hepatitis and/or human immunodeficiency virus (HIV).