Serum and Plasma Collection: Preanalytical Variables and Standard Operating Procedures in Biomarker Research - Proteomic and Metabolomic Approaches to Biomarker Discovery - page 83

These considerations are often new for discovery-
oriented scientists. Recognition of and compli-
ance with these regulations and requirements
are prerequisites for initiating research using
human biosamples.
Specimen labeling is subject to HIPAA regula-
tions requiring the protection of all protected
health information (PHI) from inappropriate
disclosure, including the use of PHI on specimen
labels or in analytical data sets. Links to some
website resources are provided in Table 4 .

studies and biobanks. Journal of Biomolecular NMR 2011;
49(3 e 4):231 e 43.
5. Ransohoff DF, Gourlay ML. Sources of bias in speci-
mens for research about molecular markers for cancer.
Journal of Clinical Oncology 2010;28(4):698 e 704.
6. Vaught JB, Caboux E, Hainaut P. International efforts to
develop biospecimen best practices. Cancer epidemiology
biomarkers & prevention 2010;19(4):912 e 5.
7. Moore HM, Kelly AB, Jewell SD, McShane LM,
Clark DP, Greenspan R, et al. Biospecimen reporting for
improved study quality (BRISQ). Journal of Proteome
Research 2011;10(8):3429 e 38.
8. Tuck MK, Chan DW, Chia D, Godwin AK, Grizzle WE,
Krueger KE, et al. Standard operating procedures for
serum and plasma collection: Early Detection Research
Network Consensus Statement Standard Operating
Procedure Integration Working Group.

CONCLUSIONS

Journal of

Proteome Research 2008/2009;8(1):113 e 7.
9. Ezzelle J, Rodriguez-Chavez IR, Darden JM,
Stirewalt M, Kunwar N, Hitchcock R, et al. Guidelines
on good clinical laboratory practice: bridging opera-
tions between research and clinical research laborato-
ries. Journal of Pharmaceutical and Biomedical Analysis
2008;46(1):18 e 29.
10. Elliott P, Peakman TC. The UK Biobank sample
handling and storage protocol for the collection,
processing and archiving of human blood and urine.
International Journal of Epidemiology 2008;37(2):234 e 44.
11. Meng Z, Veenstra TD. Proteomic analysis of serum,
plasma, and lymph for the identi

There are numerous considerations when
undertaking research projects that use human
biosamples. The resources listed in this chapter
are intended to provide guidance to researchers
using human biospecimens, highlighting
a number of issues, considerations, pitfalls, and
problems. Awareness of the complexities of
using human biospecimens, despite the relative
abundance, availability, and ease of collection,
is critical to the success of biomarker research. cation of biomarkers.

ProteomicsdClinical Applications 2007;1(8):747 e 57.
12. Jackson DH, Banks RE. Banking of clinical samples for
proteomic biomarker studies: a consideration of logis-
tical issues with a focus on preanalytical variation.
ProteomicsdClinical Applications 2010;4(3):250 e 70.
13. Bush V, Cohen R. The evolution of evacuated blood
collection tubes. LabNotes, BD: 2009. p. 19.
14. Rai AJ, Gelfand CA, Haywood BC, Warunek DJ, Yi J,
Schuchard MD, et al. HUPO Plasma Proteome Project
specimen collection and handling: towards the stan-
dardization of parameters for plasma proteome
samples. Proteomics 2005;5(13):3262 e 77.
15. Betsou F, Barnes R, Burke T, Coppola D, DeSouza Y,
Eliason J, et al. Human biospecimen research: experi-
mental protocol and quality control tools. Cancer
epidemiology biomarkers & prevention 2009;18(4):1017 e 25.

References
1. Xu X, Veenstra TD. Analysis of bio uids for biomarker

research. ProteomicsdClinical Applications 2008;2(10-11):
1403 e 12.
2. ICMJE. Uniform requirements for manuscripts submitted to
biomedical journals: writing and editing for biomedical
publication , http://icmje.org ; August 2012.
3. Moore HM, Kelly A, McShane LM, Vaught J. Bio-
specimen reporting for improved study quality
(BRISQ). Clinica Chimica Acta 2012;413(15 e 16):1305.
4. Bernini P, Bertini I, Luchinat C, Nincheri P, Staderini S,
Turano P. Standard operating procedures for pre-
analytical handling of blood and urine for metabolomic