The 4th edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards), effective October 1, 2018, 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:

• New to the 4^th edition, Standard 1.3.1 requires that all exceptions to policies, processes, and procedures be approved and justified by the medical director. This standard appears in many other sets of AABB Standards.
• Standard 3.4.2 has been edited to ensure that any device that has been repaired, retooled, or recalibrated has shown that an indication exits to perform lookback to determine when the previous acceptable check occurred.
• Standard 5.4.2 is new to the 4^th edition, and recognizes that many laboratories are using their own laboratory developed tests. Standard 5.4.2 ensures that laboratories maintain version control for the algorithms developed in genotype prediction.

(2018, AABB, soft cover, 57 pages, ISBN 9781563959837)

Effective date: October 1, 2018

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)