Analytic variability due to change of deficient plasma vials: application to one-stage clotting factor VIII assay.

Author(s): Nougier C, Sobas F, Nguyen TK, Carage ML, Lienhart A, Négrier C

Publication: Blood Coagul Fibrinolysis, 2011, Vol. 22, Page 151-4

PubMed ID: 21192255 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to assess the analytic variability on FVIII titered control plasmas associated with use of a new vial of freeze-dried or frozen FVIII deficient plasma without recalibration. FVIII deficient plasma specimens were purchased from six different manufacturers, and instrument calibration was performed only for the first of 30 vials from each manufacturer.

   Summary of Findings:

   All freeze-dried FVIII deficient plasmas including those from T-Coag, Siemens, Instrumentation Laboratory, and Stago showed greater analytic variability due to forgoing recalibration after vial changes on the C2 plasma than the frozen FVIII deficient plasmas from Precision Biologic and Affinity Biologicals did. The freeze-dried plasmas from Instrumentation Laboratory and Stago showed the greatest analytic variability associated with vial changes on the C1 plasma, while freeze-dried plasmas from T-Coag and Siemens and both the frozen FVIII deficient plasmas showed less analytic variability on the C1 plasma.

   Biospecimens

   • Bodily Fluid - Plasma

   Preservative Types

   • Frozen
   • Other Preservative

   Diagnoses:

   • Not specified
   • Normal

   Platform:

   Analyte	Technology Platform
   Protein	Hematology/ auto analyzer

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Biospecimen Preservation	Type of fixation/preservation	Frozen Lyophilized

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