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 how different factors in the Pre-Analytic phase can impact analytical results:

  • Donor related factors: fasting status impacts blood lipid profile, medications affect blood molecule concentrations
  • Collection factors: collection timing (morning vs afternoon) affects 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
  • Assess risks and any potential negative impact
  • Plan risk-control measures to reduce or control risk occurrence
  • Ensure that preventive measures remain effective and applicable. Adjust as applicable
  • Use a BIMS to document and monitor pre-analytical steps. Its system 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 of obtained 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

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

Publications PubMed

PMID: 18852848

  • Livesey et al. Preanalytical Requirements
  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • PMID – PubMed ID
  • SBP – Swiss Biobanking Platform
Basic ↦ Biobanking ↦ Definition ↦ Pre-Analytical Phase

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