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BUNDLE Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 8th edition – Print and Guidance

Product Code: 264205

ISBN: 978-1-56395-565-5

This combination provides the 8th edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards) and the Guidance for Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards) for one great price. This edition of 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 8th edition

  • Addition to ensure that clear communication exists between AABB and all accredited laboratories in cases where an event has occurred that has impacted their accreditation status.
  • Reference Standard 2.2A has been expanded to include three new blood groups that have been added to the GenBank Database.
  • Addition to ensure that all laboratories monitor their critical technology infrastructure and that they function as expected. There must be defined checks to monitor that technology is working as intended and expected.
  • Addition requiring that facilities performing fetal cell-free DNA testing conduct additional validation studies before they implement.
  • Laboratories must have a plan to participate in the publication of novel alleles.

Guidance for Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens includes verbatim requirements from the 8th edition of 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.

Effective date: January 1, 2027

BUNDLE: AABB, 2026, 116 pages, ISBN 978-1-56395-565-5 and AABB, 2026, 94 pages

Product Code: 264205
Member Price: $245
Nonmember Price: $280

Item Details (Standards):

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)

Item Details (Guidance):

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)

List Price: $280.00

Member Price: $245.00

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