Serum biobank certification and the establishment of quality controls for biological fluids: examples of serum biomarker stability after temperature variation.
BACKGROUND
One of the main issues in biobanking is the establishment of standard operating procedures for specimen collection, preparation and storage to control for pre-analytical variation. For biological fluids such as serum, there is currently a lack of sensitive biomarkers for the quality control of cryopreservation conditions.


METHODS
The process approach was used to establish an ISO 9001:2000 quality management system. Immunoenzymatic and functional assays were used to assess the stability of the following candidate quality control biomarkers: secretory phospholipase A2, matrix metalloprotease 7, transforming growth factor beta1 and anti-HBs immunoglobulin.


RESULTS
Five product processes and their corresponding indicators were identified. In the preparation-aliquoting-storage process, no quality control indicator for serum was identified. Only matrix metalloprotease 7 showed moderate susceptibility to freeze-thaw cycles.


CONCLUSIONS
Biomarkers that have an on-off response to temperature variation could serve as quality indicators for the core processes of biobanking, which are the preparation and storage of biological fluids. The identification of such biomarkers is needed.
Chaigneau
Christine
C
Biobanque de Picardie, Centre Hospitalier Universitaire d'Amiens, Salouel, France.
Cabioch
Thomas
T
Beaumont
Katy
K
Betsou
Fotini
F
D015415:Biomarkers / Q000097:blood*; D001826:Body Fluids; D019411:Clinical Laboratory Techniques; D015925:Cryopreservation / Q000379:methods / Q000592:standards; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D006801:Humans; D008297:Male; D020783:Matrix Metalloproteinase 7 / Q000097:blood; D054497:Phospholipases A2, Secretory / Q000097:blood; D011786:Quality Control; D013048:Specimen Handling / Q000379:methods / Q000592:standards; D013696:Temperature; D013997:Time Factors; D053773:Transforming Growth Factor beta1 / Q000097:blood
D015415:Biomarkers; D006510:Hepatitis B Antibodies; D053773:Transforming Growth Factor beta1; D054497:Phospholipases A2, Secretory; D020783:Matrix Metalloproteinase 7