A new publication by IBBL’s Chief Scientific Officer, Dr Fay Betsou, discusses how clinical biospecimen may be certified for nominal properties, such as diagnosis, to become Reference Materials.
Across different sectors, from pharmacology to environmental science, Certified Reference Materials (CRMs) are used to verify the quality of products, assays or instruments. These materials are produced by accredited laboratories according to ISO (International Organization for Standardization) guidelines. By definition, CRMs are certified for specific properties and need to be homogeneous and stable with respect to those properties. Since reference materials are commonly used in analytical chemistry, in most cases the certified properties are numerical. For example, a chemical compound may be certified for its percentage of purity or a solution may be certified for its concentration of different analytes. Some certified microorganisms have also become available. But since biological material is harder to characterise and standardise so far clinical biospecimens, such as blood or tissue, have not really been used as Reference Materials. Yet, the biomedical research, diagnostics and pharmaceutical sectors could benefit tremendously from well-characterised and standardised clinical biospecimens, especially in light of laboratory accreditation, regulatory submissions and tighter regulations.
In a paper published in Biopreservation and Biobanking, IBBL’s Chief Scientific Officer, Dr Fay Betsou, made the case for clinical biospecimens to be certified for nominal properties and ultimately achieve the level of CRMs. Unlike for chemicals, a Reference Material certification process for biospecimens would not be focussed on the material’s characteristic, but rather its clinical origin, as this is what is really needed for the development and validation of diagnostic tests or drugs. Through examples, the paper illustrates how clinical biospecimens may be certified for nominal properties, e.g. how DNA may be certified to originate from lung adenocarcinoma tissue or how cerebrospinal fluid may be certified to originate from a patient with Parkinson’s disease. In addition, to the diagnosis certification, biospecimen Reference Materials should include detailed information about the method of collection and processing, purity, stability and suitability for downstream applications. Dr Betsou concludes that biobanks certified and accredited for immunological, molecular biology and histopathological assays can become CRM producers for clinical biospecimens.
The full publication is available here