Evaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals.
Clin Biochem
; 47(16-17): 158-63, 2014 Nov.
Article
en En
| MEDLINE
| ID: mdl-25130957
ABSTRACT
OBJECTIVES:
We evaluated the analytical performance of 24 immunoassays using the Beckman Coulter DxI 800 immunoassay systems at Mayo Clinic, Rochester, MN for trueness, precision, detection limits, linearity, and consistency (across instruments and reagent lots).METHODS:
Clinically oriented performance goals were defined using the followingmethods:
trueness-published desirable accuracy limits, precision-published desirable biologic variation; detection limits - 0.1 percentile of patient test values, linearity - 50% of total error, and consistency-percentage test values crossing key decision points. Local data were collected for precision, linearity, and consistency. Data were provided by Beckman Coulter, Inc. for trueness and detection limits.RESULTS:
All evaluated assays except total thyroxine were within the proposed goals for trueness. Most of the assays met the proposed goals for precision (86% of intra-assay results and 75% of inter-assay results). Five assays had more than 15% of the test results below the minimum detection limits. Carcinoembryonic antigen, total thyroxine and free triiodothyronine exceeded the proposed goals of ±6.3%, ±5% and ±5.7% for dilution linearity. All evaluated assays were within the proposed goals for instrument consistency. Lot-to-lot consistency results for cortisol, ferritin and total thyroxine exceeded the proposed goals of 3.3%, 11.4% and 7% at one medical decision level, while vitamin B12 exceeded the proposed goals of 5.2% and 3.8% at two decision levels.CONCLUSIONS:
The Beckman Coulter DxI 800 immunoassay system meets most of these proposed goals, even though these clinically focused performance goals represent relatively stringent limits.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Inmunoensayo
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
Clin Biochem
Año:
2014
Tipo del documento:
Article
País de afiliación:
Estados Unidos