Multicenter evaluation of a bilayer polymer blood collection tube for coagulation testing: effect on routine hemostasis test results and on plasma levels of coagulation activation markers.

Author(s): Toulon P, Aillaud MF, Arnoux D, Boissier E, Borg JY, Gourmel C

Publication: Blood Coagul Fibrinolysis, 2006, Vol. 17, Page 625-31

PubMed ID: 17102648 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 tube type, anticoagulant concentration, post-centrifugation delays to analysis, and tube age on routine hemostasis assays and coagulation activation markers in plasma. Routine hemostasis assays were performed immediately but plasma was stored at -70 degrees C until analysis of coagulation activation markers. Analysis was completed in 5 different centers using their own analyzers and reagents.

   Summary of Findings:

   Collection of specimens in plastic Vacuette versus siliconized glass Vacutainer tubes, with 0.109 mol/L versus 0.129 mol/L citrate, in Vacuette tubes at the beginning or end of their shelf life, and 6 h post-centrifugation delays to analysis at room temperature did not result in clinically relevant differences in PT, FV, APTT, or anti-FXa activities. Statistically significant variations were seen for these analytes with the different collection and processing conditions that were also dependent on type of anticoagulant therapy. Levels of F1+2 and TAT in plasma were statistically significantly lower in specimens collected in plastic tubes than in glass tubes, but the difference was not clinically relevant.

   Biospecimens

   • Bodily Fluid - Plasma
   • Bodily Fluid - Blood

   Preservative Types

   • None (Fresh)
   • Frozen

   Diagnoses:

   • Not specified

   Platform:

   Analyte	Technology Platform
   Protein	Hematology/ auto analyzer
   Morphology	Hematology/ auto analyzer
   Protein	ELISA

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Preaquisition	Other drugs	No anticoagulant drugs Oral anticoagulants Unfractionated heparin Low molecular weight heparin derivative
   Biospecimen Acquisition	Anticoagulant	Sodium citrate Multiple concentrations evaluated
   Biospecimen Preservation	Type of fixation/preservation	Frozen None (fresh)
   Storage	Time at room temperature	0 h 6 h
   Biospecimen Acquisition	Type of collection container/solution	Vacuette (plastic) 11 months from expiration Vacuette (plastic) 1 month from expiration Vacutainer (glass)

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