Chimerism analysis after allogeneic hematopoietic stem cell transplantation: standardization and quality assurance

Abstract

Background: the European Federation of Immunogenetics excellence accreditation awarded to the Transfusion Medicine Complex Structure of the “SS. Antonio and Biagio e Cesare Arrigo” Hospital in the year 2000, requires all laboratories working in the field of hematopoietic stem cell transplantation to meet specific standards for guaranteeing a good level of service quality. Objectives: to evaluate the performance of the new Applied Biosystems™ SeqStudio™ Genetic Analyzer by validating the PowerPlex® 16 HS System kit (Promega Italia Srl, Milan, Italy), at the Transfusion Medicine Laboratory of the “SS. Antonio e Biagio and Cesare Arrigo” Hospital of Alessandria. Materials and Methods: three different studies were conducted: sensitivity, mixture, reproducibility, using DNA from hematology patients undergoing allogeneic hematopoietic stem cell transplantation and DNA from blood donors. Results: the sensitivity studies using the AB SeqStudio genetic analyzer proved to be more sensitive than those used previously (AB 3130), while the values obtained in the mixture studies overlapped with the expected values and the results obtained in the reproducibility studies were replicable and the same correlation exists in the tests performed on both instruments. Conclusions: the AB SeqStudio genetic analyzer through the PowerPlex® 16 HS System kit demonstrates excellent performance in accuracy and reproducibility of results and is a better performing instrument in sensitivity than the previous analyzer.

External proficiency testing for histocompatibility and immunogenetics in today and future

“…With this objective, various EPT programmes were established globally ( Table 1 ). Successful performance in EPT was accepted as a prerequisite for accreditation of a laboratory ( Doxiadis et al, 2000 ; Bogunia-Kubik et al, 2006 ; Bogunia-Kubik and Lange, 2008 ; Bogunia-Kubik and Lange, 2010 ; Balza et al, 2023 ; European Federation for Immunogenetics, 2023 ).…”