Assays for Qualification and Quality Stratification of Clinical Biospecimens Used in Research

Dr. Fay Betsou Contact, Integrated BioBank of Luxembourg (IBBL)

Alexandre Bulla, University Hospital of Geneva

This technical report presents quality control (QC) assays that can be performed in order to qualify clinical biospecimens that have been biobanked for use in research.Some QC assays are specific to a disease area.Some QC assays are specific to a particular downstream analytical platform. When such a qualification is not possible, QC assays are presented thatcan be performed to stratify clinical biospecimens according to their biomolecular quality.

Clinical biospecimens used in research are subject to two types of laboratory analyses. The first of these is the analysis of established clinical biology / pathology parameters where reference ranges are usually known and methods are validated (e.g., CLIA or ISO15189 accreditation). Results of these analyses are necessary to support any research on novel clinically relevant biomarkers (definition of true positive and negative cases, use as a reference method).

The second type is analysis of research parameters where there are usually no established reference ranges, and often methods are not validated by the laboratory as extensively as clinical biology / pathology methods. Results of these analyses are used to discover novel clinical endpoint correlates (biomarkers).

In vivo and in vitro pre-analytical variations have a more or less significant impact on the output of analyses, depending on the biospecimen type, the pre-analytical variable, and the analyte of interest. According to the type of analysis above, the word ''significant'' has a different meaning. In the first type - the analysis of clinical biology/pathology parameters - ''significant'' means clinically consequential at the diagnostic level. In the second type - analysis of research parameters - ''significant'' means statistically significant.

In some cases, the impact may be molecule- and even epitope-specific, for example tissue ischemia time may influence specific phosphoepitopes differently. A standard biospecimen research experimental protocol has been proposed for this type of research.

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