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External Quality Assurance programs for processing methods provide evidence on impact of preanalytical variables.
Paolo Verderio1, Chiara Maura Ciniselli1, Amélie Gaignaux2
1Unit of Bioinformatics and Biostatistics, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Italy.
New Biotechnology
|September 1, 2022
Summary
External Quality Assurance programs help labs assess processing methods like nucleic acid extraction and cell isolation. Analysis of over 1000 data points reveals critical preanalytical factors impacting specimen quality and shows laboratory performance improvements over time.
Area of Science:
- Biotechnology
- Laboratory Medicine
- Quality Assurance
Background:
- An annual External Quality Assurance (EQA) program has supported processing laboratories for a decade.
- EQA assesses methods including nucleic acid extraction and peripheral blood mononuclear cell (PBMC) isolation and cryopreservation.
Purpose of the Study:
- To globally analyze nearly 1000 EQA scheme/participant data points.
- To assess the impact of preanalytical factors on specimen attributes.
- To evaluate laboratory performance trends over time.
Main Methods:
- Statistical analysis of EQA scheme data, including preanalytical factors and quality attributes (z-scores).
- Evaluated DNA, cell-free DNA (cfDNA), RNA extraction from various tissues and fluids.
- Assessed viable PBMC isolation and cryopreservation.
Main Results:
- Identified critical preanalytical factors: extraction method/kit, elution buffer, enzymes, input material, and storage temperature.
- Observed indications of laboratory performance improvement over time.
- Provided insights into specimen quality based on preanalytical variables.
Conclusions:
- EQA for processing methods offers evidence-based insights into preanalytical factor impact.
- EQA facilitates comparative performance assessment of different methods and kits.
- EQA supports laboratories in validating their processing methods.
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