Poster Presentation ABNA - Biobanking: Shaping the Future Together

188.  Quality control for sample collection, processing, and biobanking in the multi-center Environment Determinants of Islet Autoimmunity (ENDIA) study (#2)

Dao Huynh 1 , Christopher M Hope 1 2 , Helena Oakey 1 , James D Brown 1 , Guinevere EN Martin 1 , Griffith B Perkins 1 , Kelly Watson 3 , Trung Nguyen 1 , Georget Reaiche-Miller 4 , Sabrina Binkowski 5 , Minh Bui 6 , Thao Tran 6 , Dexing Huang 7 , Ki Wook Kim 8 9 , Cynthia SA Yau 8 9 , Emily J Ward 8 9 , Ana Karceva 10 , William D Rawlinson 8 9 11 12 , Ying Y Wong 1 , Tim Sadlon 1 , Peter Colman 3 , Simon C Barry 1 2 , Jennifer J Couper 1 2 , Megan AS Penno 1 , ENDIA study Group 1
  1. Robinson Research Institute, Adelaide Medical School, University of Adelaide, Adelaide, SA, Australia
  2. Women’s and Children’s Hospital, Adelaide, SA, Australia
  3. Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Melbourne, VIC, Australia
  4. The University of Adelaide Biobank, Division of Research and Innovation, the University of Adelaide, Adelaide, SA, Australia
  5. Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, WA, Australia
  6. Child Health Research Unit, Barwon Health, Geelong, VIC, Australia
  7. Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC, Australia
  8. Discipline of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia
  9. Serology and Virology Division (SAViD), NSW Health Pathology, Virology Research Laboratory, Prince of Wales Hospital, Sydney, NSW, Australia
  10. Kids Research, The Children’s Hospital at Westmead, Sydney, NSW, Australia
  11. School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia
  12. School of Biotechnology and Biomolecular Sciences, Faculty of Science, University of New South Wales, Sydney, NSW, Australia

Introduction: Adherence to quality control in multi-center longitudinal research is crucial for maintaining sample integrity and enhancing research impact. The ENDIA Study Quality Control (QC) Team identified four critical "P-points" to evaluate and improve practices, focusing on the vulnerability of peripheral blood mononuclear cells (PBMC) to external variation.

Methods: The "P-points" included:

  1. Processing: Auditing sample processing times from collection to -80°C storage, including during COVID-19.
  2. Proficiency: Establishing a QC program for PBMC at each lab, with a central evaluation of post-thaw viability and functional quality. Annual participation in the IBBL PBMC isolation proficiency testing program.
  3. Primary Outcome (islet-autoantibody testing): Monitoring assay performance using inter-assay CVs of controls and standards, with biannual participation in IASP workshops.
  4. PBMC: Developing linear mixed-effect models using data from 1520 thawed PBMC samples to evaluate post-thaw viability concerning time and storage conditions between blood collection and PBMC isolation, total viable cell number, cell storage volume, inter-laboratory shipping, and LN2 biobank storage duration.

Results:

  1. Processing: Significant differences in processing times were observed across sites (p<0.001) and between pre-, intra-, and post-COVID periods (p<0.001).
  2. Proficiency: QC samples' storage viability and total viable cell numbers exceeded international CHAVI standards, achieving "very satisfactory/satisfactory" levels in IBBL metrics. Differences were noted in post-thaw viability, recovery, and IFN-γ release assays between sites.
  3. Primary Outcome: Intra-assay CVs were <33% for all islet antibody tests, with ENDIA consistently ranking among the highest in IASP sensitivity and specificity.
  4. PBMC: Post-thaw viability was significantly reduced by delays between blood collection and PBMC isolation (-23%), room temperature storage (-11.6%), reduced cell storage volume (-21%), and biobanking over 100 days (-2.4%). Improvements included higher total cell number at storage (23.4%) and LN2 versus dry-ice shipping (37.1%).

Conclusions: ENDIA's practices meet acceptable standards, ensuring reliable outcomes. External validation is underway to develop a predictive tool to estimate post-thaw cell yield and viability, aiding experimental planning.