Long- and short-term in vitro D-dimer stability measured with INNOVANCE D-Dimer.

Author(s): Böhm-Weigert M, Wissel T, Muth H, Kemkes-Matthes B, Peetz D

Publication: Thromb Haemost, 2010, Vol. 103, Page 461-5

PubMed ID: 20126827 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to determine the effects of storage at room temperature, refrigerated storage, long-term frozen storage, and freeze-thaw cycling on D-dimer stability in plasma specimens with a range of normal and pathological D-dimer levels. Blood specimens were centrifuged within 2 hours of collection, stored in original tubes for an additional 4 hours at room temperature, and then transferred to 2-8 degrees C for 24 h. Alternatively, plasma specimens were transferred to new tubes after centrifugation and frozen at -60 degrees C or below for the evaluation of freeze-thaw cycling effects (4 cycles over 14 days) and long-term stability.

   Summary of Findings:

   D-dimer remained stable when plasma was stored in the original collection tube at room temperature for 4 hours after centrifugation and after an additional 24 h of storage at 2-8 degrees C. Up to 4 freeze thaw cycles over the course of 14 days did not significantly affect D-dimer stability in citrated plasma, compared to measurements taken within 8 hours of collection. While one out of 49 specimens would have shifted classification from possible deep vein thrombosis (DVT) or pulmonary embolism (PE) (0.47-0.49 mg/L fibrinogen equivalent units (FEU)) to normal (0.51 mg/L FEU) after freeze-thaw cycling, this variation was within assay imprecision. D-dimer decreased by an average of 5.1%, 11.7%, 4.8%, and 9.3% after 14 h, 19 months, 25 months, and 36 months of frozen storage, respectively, when baseline measurements were obtained within 12 hours of blood draw. The authors determined a clinically relevant change in D-dimer to be a deviation of greater than 10% from baseline, thus after 19 months of storage, the average change was clinically relevant, however with further storage the clinical relevance was not present. The authors conclude that there was a small decline in D-dimer values after freezing but the decline was not time dependent.

   Biospecimens

   • Bodily Fluid - Plasma

   Preservative Types

   • Frozen
   • None (Fresh)

   Diagnoses:

   • Not specified

   Platform:

   Analyte	Technology Platform
   Peptide	Hematology/ auto analyzer

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Storage	Time at room temperature	Less than 2 h 4-6 h Less than 8 h Less than 12 h
   Biospecimen Preservation	Type of fixation/preservation	Frozen None (fresh)
   Storage	Storage temperature	2-8 degrees C -60 degrees C or lower
   Storage	Freeze/thaw cycling	0 cycles 1 cycle 2 cycles 3 cycles 4 cycles
   Storage	Storage duration	14 h 24 h 19 months 25 months 36 months
   Preaquisition	Biomarker level	< 0.5 mg/L FEU > 0.5 mg/L FEU
   Storage	Type of storage container	Original collection tube New tube

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