What is it? Why is it important?
The Pre-Analytic phase encompasses all steps prior to the analysis of Biological Material (BM). It makes up the main part of Sample Workflow, and carries the highest risk regarding ways by which BM is handled, potentially affecting the quality, authenticity and reproducibility of analytical results.
Examples on how different factors in the Pre-Analytic phase can impact analytical results inlcude:
- Donor related factors: fasting status impacts blood lipid profile, medications affect blood molecule concentrations
- Collection factors: collection time (morning vs afternoon) can affect the level of blood molecules. Collection volume impacts the concentration between blood and additives in the collection tube
- BM processing factors: centrifugation conditions affect the separation and potential destruction of blood cells (haemolysis)
- Storage factors: time lapse between collection and freezing of BM affects the integrity/stability of molecules. The same applies for freeze-thaw cycles
What do I need to do?
Based on the steps included in your Pre-Analytical phase:
- Review the literature on how Pre-Analytic steps potentially affect the integrity and quality of your BM
- Make a list of defined risks affecting BM quality. Implement a risk-based approach
- Use a BIMS to document and monitor pre-analytical steps. A BIMS facilitates the ongoing documentation of quality control results and the recording and management of non-conformities
- Regularly note down applicable risk-control measures or guidelines and train applicable staff
The documentation of non-conformities during the Pre-Analytic phase can explain unexpected deviations in analytical results (e.g. ineffective risk prevention, novel unexpected risks, unintended mistakes during BM processing steps).
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
SOP, Forms and Templates – see in particular
- Biological material management SOP
- Livesey et al. Preanalytical Requirements