Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 7th edition – Print

The 7th 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.

Significant Changes to the 7th Edition

• The updated Quality Systems Essentials template has been incorporated into the 7th edition, including updated language and new sections on key concepts, key terms, and examples of objective evidence.
• New Standards 2.1.3.1 and 2.1.3.2 provide details on what training should include and the qualifications of the trainer providing the training.
• Reference Standard 2.2A, Minimum DNA Resources, has been expanded to include all 45 red blood cell systems available to accredited molecular testing laboratories.
• New Standard 5.3.2 requires that laboratories using laboratory developed tests or research use only kits follow specified requirements.
• New Standard 5.3.2.3 ensures that investigational products are labeled appropriately.
• New Standard 5.6.2 requires that laboratories have a plan in place for the implementation of ISBT nomenclature antigens and alleles.

Effective date: January 1, 2025

PRINT EDITION: AABB, 2024, 116 pages, ISBN 978-1-56395-516-7

Product Code: 243115
AABB Member Price: $146
Nonmember Price: $167

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)