Validating processing methods

Two new scientific papers by IBBL’s researchers have been published in the Biopreservation & Biobanking journal, as part of a set of biospecimen processing method validations. The published results show the optimisation and validation of methods for preparing serum/plasma and urine samples for downstream analysis of proteins and/or metabolites.

Although international guidelines exist for the processing of different types of biological samples, including serum, plasma and urine, most of them have not been formally validated with regards to whether they are fit for a specific downstream application. Beyond optimisation, method validation is an essential tool for the quality management of many laboratories, as it accounts for all major variables of the method that may impact the quality of the sample and its fitness-for-purpose. It allows biobanks and researchers to assure the quality of their biological samples and it is a key requirement for laboratory accreditation. As an alternative to carrying out their own method validation, biobanks looking for accreditation may use published validations, such as these two publications, as references when they apply the same protocol. Moreover, these publications can be used as a guide on how to approach and carry out processing method validation in biobanks.

To validate their biospecimen processing methods for specific, commonly-used downstream applications, IBBL got together with the Metabolomics Group at the Luxembourg Centre for Systems Biomedicine (LCSB), as well as the Department of Genetic and Laboratory Medicine at the Geneva University Hospitals. The scientists first optimized their methods for processing urine, plasma and serum for proteomic, metabolomic and/or circulating nucleic acid-based analyses. They then tested how reproducible their protocol is and how robust it is to common variables, like temperature, centrifugation speed or a delay in sample processing after collection.

For the validation of urine processing, the team assessed the concentration of cystatin C and creatinine, the amount of microparticles, and the profile of some metabolites. Their optimized method was reproducible and robust for centrifugation parameters, but was affected by the temperature and centrifugation brake speed. For the validation of serum and plasma processing, the researchers assessed microparticles, the yield of circulating DNA, haemoglobin contamination, as well as the profiles of proteins and metabolites. Here the results show that, while the method is robust for centrifugation brake speed, both the temperature and a delay pre-centrifugation can influence the analytical results. To conclude, the authors underline the need for biobanks to systematically control and record these parameters and suggest using the Standard PREanalytical Code (SPREC).