Publisher's Synopsis
The second edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards) contains requirements for facilities using molecular methods to predict blood group antigens on red cells, platelets, and neutrophils, as well as quality system requirements, operational stan dards, and a detailed list of inventory resources necessary for the identification of targeted nucleotides that encode these antigens. Organized according to the Quality System's Essentials quality template, the MT Standards addresses operational aspects such as test methods including Restriction Fragment Length Polymorphism Testing, DNA Testing for Nucleotide Sequence Determination or Single Nucleotide Polymorphism (SNP) Analysis, and DNA Array. The guiding principle of this document is to be consistent with avail able scientific information while focusing on patient advocacy and opti mal care for donors. These MT Standards represent the minimum requirements under which a laboratory specializing in molecular testing should operate. Included is a CD containing guidance intended to assist in the understanding and practical application of MT Standards. The guidance focuses on the quality concepts that provide the framework for the Standards. There is no guidance for some standards; the Molecular Testing Standards Program Unit has chosen to focus the guidance document on those issues that may be the least familiar to members of the molecular testing community.
