Analytical validation of an in-house method for adenosine deaminase determination

Autor: Flávia Martinello, Laís Fernanda Dos Santos, Camila Fontana Roman, Lisiê Silva Dalsasso Joaquim, Natalli Granzotto
Rok vydání: 2018
Předmět:
Zdroj: Journal of clinical laboratory analysis. 33(3)
ISSN: 1098-2825
Popis: BACKGROUND: The adenosine deaminase (ADA) enzyme is a marker of inflammatory processes whose activity can be measured through a colorimetric method developed as an in‐house assay. This validation can reduce costs and expand the alternatives for laboratory diagnosis. METHODS: The ADA analysis was achieved through a modified form of Giusti and Galanti's (1984) method. The following parameters were characterized: calibration curve, linearity, analytical sensitivity, limit of detection, limit of quantification, method working range, precision (within‐assay and between‐assay), bias, total analytical error, and sample stability. The results were statistically evaluated and compared with quality specifications based on biological variations and the performance of commercial tests. RESULTS: The analytical sensitivity and limit of detection (0.013 and 3.0 U/L, respectively) were lower than those of commercial tests. The method's working range was 3.2‐100.0 U/L. According to the quality specification, the method showed optimum performance with a bias
Databáze: OpenAIRE