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

Product Code: 243295

This combination provides two ways to access the 7th edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards): print and digital. 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.

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.

Product Features

The 7th edition of MT Standards, effective January 1, 2025, details the latest standards of practice for facilities using molecular methods. The Standards Portal allows users to customize their profile based on the activities for which they are accredited and can be rearranged at any time. Standards that do not apply to a user’s profile will appear grayed out to ensure that purchasers are aware of the standards that apply to their facility and those that do not.

The Standards Portal is also fully searchable by key word, chapter, or standard number, allowing users to navigate quickly to the most relevant standards to them at that time. Guidance is provided on how to implement a standard, why it was created, or why a change was made from this edition to the last. Any relevant documentation that would assist users in implementing the standard in question is provided.

New Benefits to Users

All links to outside websites and cross references to other standards in the portal are live and appear in popup windows to allow users to be able to see both the standard in question and the linked post. The full edition of the MT Standards (not including any guidance) is printable at any time to ensure that users can take the MT Standards on the go.

Any interim or emergent standards will appear seamlessly in the portal once effective and highlighted.

By purchasing the Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens, 9th edition (“Standards”) through the AABB Standards Portal (“Portal”), users acknowledge and agree that they will access the Standards solely for their own personal and/or professional use and not distribute, copy, or provide access to the Standards for use by any third parties. Furthermore, users will securely maintain their login and password for the Portal. In the event that AABB or its authorized agents discover that users have not complied with these Terms and Conditions of Use, they understand that they will lose all rights to access the Standards and will not be entitled to any refund.

For more information or help, please contact:
AABB Customer Support
Phone: +1.866.222.2498, +1.301.215.6489
Email: sales@aabb.org

Effective date: January 1, 2025

BUNDLE: AABB, 2024

Product Code: 243295br/>AABB Member Price: $233
Nonmember Price: $267

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)

List Price: $267.00

Member Price: $233.00

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