BUNDLE: Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 5th edition – Print and Guidance

Product Code: 204205

The 5th 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 5th edition:

Reference Standard 2.2A has been expanded to encapsulate currently available DNA resources while also including internationally applicable HGVS nomenclature to the reference standard to allow for ease in reporting.
New Standards 3.5 – 3.5.2 have been included requiring molecular testing laboratories to have alarm systems and that they activate when appropriate.
New Standard 5.1.4.3 requires that laboratories have methods in place to ensure that results received from another laboratory, but in a different format, are comparable.

Guidance for Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens includes verbatim requirements from the 5th 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.

(2020, AABB, softcover, 59 pages, and 2020, AABB, softcover, 64 pages)

Effective date: Effective date: October 1, 2020