10 years of IBBL publications (1/4) – Documenting preanalytics with the Standard PREanalytical Code

IBBL recently celebrated 10 years of service to the national and international scientific community through the publication of its 100th scientific paper, sharing its knowledge and expertise in biobanking and biospecimen research to promote the standardisation of biobanking practices and ultimately advance biomedical research. To facilitate the management and tracking of the most important preanalytical variations, IBBL contributed significantly to the development of the Standard PREanalytical Code, a tool conceived by the International Society for Biological and Environmental Repositories (ISBER) to foster effective and efficient interconnectivity and interoperability between biobanks.

The traceability and documentation of biospecimen preanalytics are key when evaluating the quality and fitness-for-purpose of biological samples. Indeed, unknown or uncontrolled preanalytical variables can have negative repercussions on the accuracy and reproducibility of downstream analytical results, thus potentially compromising the sample’s fitness for purpose. Therefore, the harmonisation of methods to trace preanalytical information is necessary for the development of large-scale research involving samples from different settings.

For this reason, the ISBER Biospecimen Science Working Group (ISBER BSWG), co-chaired by IBBL’s Chief Scientific Officer Dr. Fay Betsou, developed the Standard PREanalyticalCode (SPREC), a tool which provides detailed information about the preanalytical factors associated with each processed sample. The SPREC code, initially developed in 2009, consists of seven individual elements, corresponding to seven preanalytical variables, and contains eleven (for liquid samples) or thirteen (for solid tissues) letters in a defined order, separated by six hyphens. In the case of liquid samples, the preanalytical variables are biospecimen type, primary container type, pre-centrifugation conditions (i.e. the delay between collection and processing and the temperature), first centrifugation time/speed/temperature, second centrifugation time/speed/temperature, post-centrifugation and long-term storage conditions. For solid samples, the seven critical variables are sample type, collection type (e.g. autopsy, biopsy, etc.), warm ischemia time, cold ischemia time, fixation/stabilisation type, fixation time and long-term storage conditions.  The code can be linked to all aliquots of the corresponding sample and will allow immediate assessment of each preanalytical step. The SPREC 1.0 was published in the journal ‘Cancer Epidemiology, Biomarkers & Prevention’ and can be accessed here.

With the rise of new technologies for biospecimen collection (e.g. new anticoagulants), processing (e.g. new tissue stabilisation methods) and storage (e.g. new storage media), the ISBER BSWG revised and updated the original SPREC code in 2012 to include more options for some of the preanalytical variables covered. For liquid biospecimens, the SPREC 2.0 featured additional options for sample type, primary container type, centrifugation conditions and storage conditions, while further options for sample types, collection method, fixation type and fixation time were added for solid specimens. In addition, various support tools for the implementation of SPREC 2.0 were put in place, including SPRECware — developed by the San Raffaele Research Hospital (Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele – IRCCS) — and SPRECalc — developed by IBBL’s Quality Manager Dr. Sabine Lehmann. The former is a software which allows the selection from a drop-down menu of information related to the preanalytical processing of a given sample and the generation of a resulting SPREC code and corresponding barcode. The latter requires the input of the preanalytical variables themselves to perform an automatic calculation of the time-associated elements and generate the SPREC. The updated SPREC 2.0 was published in the journal ‘Biopreservation and Biobanking’, accessible here.

Finally, in 2018, the ISBER BSWG published the third updated version of the SPREC (SPREC 3.0), which introduces additional options under each of the seven variables, based on the latest technological developments and recently acquired knowledge on the critical ranges of preanalytical times, such as tissue ischemia times.

“The SPREC code provides a standardised format for biospecimen comparison and was developed to facilitate research collaborations across different laboratories and institutions handling similar samples. Indeed, it addresses the need for more detailed information on the preanalytical factors of specimens used for research activities and contributes to improving the overall quality of biomedical research”, explains Dr. Fay Betsou. “Moreover, the SPREC code is simple, straightforward, easy to implement and to integrate into biobank quality management systems”, adds Dr. Sabine Lehmann, Quality Manager at IBBL.

The SPREC 3.0 was published in the journal ‘Biopreservation and Biobanking’, accessible here.