Accuracy-based proficiency testing for testosterone measurements with immunoassays and liquid chromatography-mass spectrometry.
Clin Chim Acta
; 469: 31-36, 2017 Jun.
Article
en En
| MEDLINE
| ID: mdl-28288785
ABSTRACT
BACKGROUND:
Accurate testosterone measurements are needed to correctly diagnose and treat patients. Proficiency Testing (PT) programs using modified specimens for testing can be limited because of matrix effects and usage of non-reference measurement procedure (RMP)-defined targets for evaluation. Accuracy-based PT can overcome such limitations; however, there is a lack of information on accuracy-based PT and feasibility of its implementation in evaluation for testosterone measurements.METHODS:
Unaltered, single-donor human serum from 2 male and 2 female adult donors were analyzed for testosterone by 142 NYSDH-certified clinical laboratories using 16 immunoassays and LC-MS/MS methods. Testosterone target values were determined using an RMP.RESULTS:
The testosterone target concentrations for the 4 specimens were 15.5, 30.0, 402 and 498ng/dl. The biases ranged from -17.8% to 73.1%, 3.1% to 21.3%, -24.8% to 8.6%, and -22.1% to 6.8% for the 4 specimens, respectively. Using a total error target of ±25.1%, which was calculated using the minimum allowable bias and imprecision, 73% of participating laboratories had ≥3 of the 4 results within these limits.CONCLUSIONS:
The variability in total testosterone measurements can affect clinical decisions. Accuracy-based PT can significantly contribute to improving testosterone testing by providing reliable data on accuracy in patient care to laboratories, assay manufacturers, and standardization programs.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Espectrometría de Masas
/
Testosterona
/
Análisis Químico de la Sangre
/
Inmunoensayo
/
Cromatografía Liquida
/
Límite de Detección
Tipo de estudio:
Prognostic_studies
Límite:
Adult
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Female
/
Humans
/
Male
Idioma:
En
Revista:
Clin Chim Acta
Año:
2017
Tipo del documento:
Article
País de afiliación:
Estados Unidos