Analytic variability due to change of deficient plasma vials: application to one-stage clotting factor VIII assay.
Blood Coagul Fibrinolysis
; 22(2): 151-4, 2011 Mar.
Article
en En
| MEDLINE
| ID: mdl-21192255
The statistical process control required under International Organization for Standardization 15189 as well as economic considerations necessitates having robust methods that do not need systematic recalibration for each series of analyses. Using the concrete example of one-stage clotting factor VIII assay, we assessed the analytic variability specifically linked to changing factor VIII deficient plasma vials. The study used freeze-dried (Instrumentation Laboratory, Siemens, Stago and T-Coag) and frozen (Affinity Biologicals and Precision Biologic) factor VIII deficient plasmas. On the most widely recognized acceptability criteria and methods (i.e. those of Kallner et al. and Kasper et al.), the Stago and Instrumentation Laboratory plasmas require systematic recalibration at each vial changeover.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Bioensayo
/
Pruebas de Coagulación Sanguínea
/
Factor VIII
Tipo de estudio:
Diagnostic_studies
/
Evaluation_studies
/
Guideline
Límite:
Humans
Idioma:
En
Revista:
Blood Coagul Fibrinolysis
Asunto de la revista:
ANGIOLOGIA
/
HEMATOLOGIA
Año:
2011
Tipo del documento:
Article
País de afiliación:
Francia
Pais de publicación:
Reino Unido