Abstract
With the increasing demand of providing personalized medicine the need for biobanking of biological material from individual patients has increased. Such samples are essential for molecular research aimed at characterizing diseases at several levels ranging from epidemiology and diagnostic and prognostic classification to prediction of response to therapy. Clinically validated biomarkers may provide information to be used for diagnosis, screening, evaluation of risk/predisposition, assessment of prognosis, monitoring (recurrence of disease), and prediction of response to treatment and as a surrogate response marker. Many types of biological fluids or tissues can be collected and stored in biorepositories. Samples of blood can be further processed into plasma and serum, and tissue pieces can be either frozen or fixed in formalin and then embedded into paraffin. The present review focuses on biological fluids, especially serum and plasma, intended for study of protein biomarkers. In biomarker studies the process from the decision to take a sample from an individual to the moment the sample is safely placed in the biobank consists of several phases including collection of samples, transport of the samples, and handling and storage of samples. Critical points in each step important for high quality biomarker studies are described in this review. Failure to develop and adhere to robust standardized protocols may have significant consequences as the quality of the material stored in the biobank as well as conclusions and clinical recommendations based on analysis of such material may be severely affected.
Highlights
With the increasing demand of providing personalized medicine the need for biobanking of biological material from individual patients has increased
A protein biomarker can be defined as a protein or peptide that can be objectively quantitatively measured and evaluated as an indicator of normal biological processes, pathological processes, exposure to environmental factors, lifestyle, presence of pathogens, or responses to a therapeutic intervention
The process of biomarker development and application, from the decision to take a sample from a patient to dispatch of the final assay result to the physician or researcher, consists of three phases: preanalytical, analytical, and postanalytical
Summary
Specific aspects that should be included and described in any standard operating procedure for blood collection and handling (see text for details). Description of method of how the sample should be obtained from the patient, e.g. site of venipuncture, whether tourniquet should be applied Additional information such as whether patient should be fasted, any specific posture such as supine or sitting. In our view it is not possible to recommend one uniform standard operating procedure (SOP) for fluid collection for biomarker studies because the purpose of the sampling may differ between the clinical studies, if a specific analyte is being measured, as different biochemical and biophysical properties may require tailor-made processing. It will help others in designing a protocol from which they can independently reproduce the data
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