Seventh Edition of Molecular Testing Standards Takes Effect Jan. 1

December 18, 2024

The seventh edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards) will take effect Jan. 1 and contains several notable changes from previous editions.

AABB’s MT Standards Committee highlighted the following updates in the new edition:

The seventh edition incorporates quality systems essentials template, 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.

The seventh edition is available in the AABB Store in an electronic format, print format or as a bundle of both versions. A bundle of seventh edition (in print) and Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens is also available.

Organizations interested in adopting the standards can participate in a complimentary two-week trial of the electronic version of the seventh edition in the Standards Portal.

AABB has published a document, “Significant Changes and Response to Comments to the Seventh edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens,” to assist users in their implementation of the edition.

Individuals with questions regarding the standards should contact standards@aabb.org.