Abstract
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 that can be performed to stratify clinical biospecimens according to their biomolecular quality.
Highlights
Clinical biospecimens used in research are subject to two types of laboratory analyses
This review shows that many tools are already available and can be used for specimen qualification
Biospecimen: any biological specimen, which may be a: B Primary sample: specimen directly collected from the donor; B Simple derivative: sample prepared through a simple laboratory manipulation without the addition of chemical substances, and without cell disruption or cell selection as part of a multi-step process; or B Complex derivative: derivative whose isolation requires usage of multiple steps and/or addition of chemical substances
Summary
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). 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.[1] Results of these analyses are used to discover novel clinical endpoint correlates (biomarkers)
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