BUNDLE: Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 6th edition – Print and Guidance

The 6th 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 standards, 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 available scientific information while focusing on patient advocacy and optimal care for donors. These MT Standards represent the minimum requirements under which a laboratory specializing in molecular testing should operate.

Significant changes to the 6th edition:

• New Standard 1.9 requires that all laboratories have processes in place to perform risk assessments for all critical activities in the facility at defined intervals.
• Reference Standards 2.2A, 2.2B, and 2.2C have been expanded to include a third column to the tables focused on "Chromosome Position" which relates to the chromosome position for the current human reference genome assembly.
• New Standard 3.6.6 requires that laboratories have processes in place to minimize the risk and impact of internal and external data breach.
• New Standard 5.1.2.1 was created for facilities outside the United States that perform proficiency testing through programs in their region.

Guidance for Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens includes verbatim requirements from the 6th edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards) interspersed with guidance. Language from the MT Standards is presented; when there is appropriate guidance for that standard, the guidance language follows the standard with the heading “Guidance.” This format allows the reader to see both the requirement and the associated guidance side by side.

Please note that there is no guidance for some standards. The Molecular Testing Standards Committee has chosen to focus MT Standards on those issues that may require additional context and/or examples to assist in attaining compliance with the Standards.

(2022, AABB, softcover, 59 pages, and 2020, AABB, softcover, 64 pages)
Effective date: January 1, 2023
Nonmember price: $254
Member price: $222

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages - Standards (pdf)

View Sample Pages - Guidance (pdf)