Serum biobank certification and the establishment of quality controls for biological fluids: examples of serum biomarker stability after temperature variation.

Author(s): Chaigneau C, Cabioch T, Beaumont K, Betsou F

Publication: Clin Chem Lab Med, 2007, Vol. 45, Page 1390-5

PubMed ID: 17635068 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to examine the effects of up to 100 freeze-thaw cycles and storage at 37 degrees C for up to 10 days on serum biomarkers.

   Summary of Findings:

   Little variation was observed in MMP-7, anti-HBS or TGF-beta1 for up to 10 freeze-thaw cycles, but freezing of serum led to an immediate decrease (18-43%) in PLA activity which remained below baseline until 10-15 freeze-thaw cycles. TGF-beta1 remained within 5% of baseline and anti-HBS within 30% of baseline for up to 100 freeze-thaw cycles. After 15 freeze-thaw cycles, PLA increased and stabilized at 359%-505% of baseline. In contrast, MMP-7 decreased rapidly after 10-20 freeze-thaw cycles and was completely degraded by 30 cycles. Storage of serum at 37 degrees C resulted in an immediate increase in PLA which remained at 260-400% of baseline for the 10 days studied. MMP-7 was relatively stable in both specimens for 3 days, at which point degradation occurred in one specimen while the other remained within 17% of baseline for the full 8 days studied. Both anti-HBS and TGF-beta1 were elevated with storage at 37 degrees C in one specimen, while the other specimen remained constant for the full 6 (anti-HBS) or 4 (TGF-beta1) days studied.

   Biospecimens

   • Bodily Fluid - Serum

   Preservative Types

   • Frozen
   • None (Fresh)

   Diagnoses:

   • Normal

   Platform:

   Analyte	Technology Platform
   Protein	Enzyme assay
   Protein	ELISA

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Storage	Storage duration	0 days 1 days 2 days 3 days 4 days 5 days 6 days 7 days 8 days 9 days 10 days
   Storage	Storage temperature	-80 degrees C 37 degrees C
   Storage	Freeze/thaw cycling	0 cycles 1 cycle 2 cycles 3 cycles 4 cycles 5 cycles 10 cycles 15 cycles 20 cycles 30 cycles 40 cycles 50 cycles 60 cycles 70 cycles 80 cycles 90 cycles 100 cycles
   ELISA Specific	Targeted peptide/protein	Secretory phospholipase A2 Matrix metalloprotease 7 Transforming growth factor beta 1 anti HBs immunoglobulin G
   Biospecimen Preservation	Type of fixation/preservation	Frozen None (fresh)

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