Serum and Plasma Collection: Preanalytical Variables and Standard Operating Procedures in Biomarker Research - Proteomic and Metabolomic Approaches to Biomarker Discovery - page 76

INTRODUCTION

based biomarkers. There are basic considera-
tions common to any research project using
human specimens. Clinical laboratory medicine
requirements provide valuable resources to iden-
tify considerations when utilizing human bio-
specimens. 3 Standard operating procedures,
including signi

Transition in methodologies from one gene e
one protein to -omics has brought many changes
to biomedical research. 1 As translational

(or

“ ) research is becoming the

new paradigm, the importance of detailing
the human specimen collection steps cannot be
understated. The challenges of using human
specimens are complex and the analytic plat-
forms are quickly changing. Issues range from
(a) informed consent for collection and use of
the specimens, (b) legal and ethical implications
of discoveries using human samples, (c) HIPAA
(Health Insurance Portability and Accountability
Act of 1996) and future uses of banked materials
to (d) collection, management, storage, and ship-
ment of human biospecimens for current and
emerging technologies. Many journals have
adopted standards for reporting compliance
with human subject regulations requiring docu-
mentation of regulatory approvals to use human
specimens. 2 Standards have been proposed for
documenting preanalytical parameters in addi-
tion to analytical methodologies in order to
provide consistent and standardized informa-
tion for interpretation, comparison, and evalua-
tion of research results. 3
Signi

bench-to-bedside ”

cant documentation of numer-
ous preanalytical and analytical variables, are
required for regulatory approval of diagnostic
tests. Although not all candidate biomarkers or
proteomic platforms are intended for future use
as a diagnostic tool, this clinical laboratory medi-
cine paradigm provides good guidelines and
practices for ensuring high-quality specimens
and the research dependent upon them.

IMPORTANCE OF PREANALYTICAL
VARIABLES

Preanalytical variables are factors that affect
a sample before analysis, such as patient/subject
characteristics and specimen collection,
handling, and processing steps. 4 To assess
whether a biomarker of interest is truly discrim-
inating between disease state (case) and non-
disease state (control), the starting specimens
need to be characterized d i.e., their source and
variables of collection, handling, and storage.
These variables have an impact on the analysis
(positively or negatively) of a particular bio-
specimen. The literature is

cant resources exist to help researchers
consider and identify the parameters most
important to their platforms. This chapter does
not provide standard operating procedures
(SOPs), but rather presents considerations for
establishing SOPs or evaluating potential
samples available to you from various biobanks,
researchers, or clinical trials.
Blood and its components (serum, plasma,
cells, etc.) provide systemic information about
an organism. Blood samples are the most
common clinical specimen used routinely to
provide diagnostic and prognostic information
to clinicians. Many of the current laboratory
medicine tests used clinically, such as albumin,
hemoglobin, or C-reactive protein, are protein-

filled with examples
of promising biomarkers that were not ulti-
mately validated, often due to issues around
the preanalytical sample handling steps. 5 e 7
Obtaining high-quality, well-annotated speci-
mens, either locally within a single institution
or from external repositories and biobanks,
can be challenging. Well-annotated biosamples
are necessary in order to ascertain that quality
samples are used for initial discovery of -omic
pro les. High-quality biosamples will reduce

the possibility of false signals from variability in
analytical substrates d for example, instability