Revista Cubana de Endocrinología (Apr 2003)
Validación analítica de un juego de reactivos para cuantificar la tirotropina humana sérica Analytical validation of a reageant set for cuantification of human serum thyrotropin
Abstract
Se presentan los resultados de la evaluación analítica de un ensayo de segunda generación (IRMA-I125-hTSH-BGTâ) producido y comercializado por el Centro de Isótopos. Se determina la sensibilidad analítica y funcional, intervalo de referencia, imprecisión y exactitud del diagnosticador. El método presentó sensibilidad analítica de 0,014 mUI/ L y funcional de 0,11 mUI/L. La imprecisión intraensayo fue de 4,34; 4,04 y 1,60 % y la imprecisión interensayo de 12,96; 4,30; 5,98 y 10,21 % para 4 sueros controladores de la calidad con concentraciones de 0,42; 9,77; 27,03 y 1,31 mUI/L, respectivamente. Los estudios de exactitud mostraron en la prueba de linealidad y paralelismo, rectas y coeficientes de correlación muy cercanos a 1 (E1, m = 0,992; r = 0,998 -C2, m = 1,008; r = 0,998 - C3, m =1,013; r = 0,999), sin que existieran diferencias significativas (p The results of the analytical evaluation of a second-generation assay (IRMA-I125-hTSH-BGT®)) produced and commercialized by the Center of Isotopes are presented. Analytical and functional sensitivity, reference interval, imprecision and accuracy of the diagnostic method were determined. The method had an analytical and functional sensitivity of 0,014 mUI/ L and 0,11 mUI/L respectively. The intra-assay imprecision was 4,34; 4,04 y 1,60 % and the interassay imprecision was 12,96; 4,30; 5,98 y 10,21 % for 4 quality control sera at concentrations of 0,42; 9,77; 27,03 y 1,31 mUI/L respectively. The accuracy studies showed in the linearity and parallelism test straight lines and correlation coefficients very close to 1 (E1, m= 0,992; r= 0,998 -C2, m= 1,008; r=0,998 - C3, m=1,013; r=0,999), without significant differences (p<0,05) among the slopes or among the variances of the described straight lines; they were parallel to each other. The median recovery was 105,50% and average accuracy was 102,75%. The reference interval was 0.52-3,92 mUI/L; n=215; 95,33%. The method presents analytical and functional sensitivity rates that match those of the second-generation hTSH assays in addition to being precise and accurate. This diagnostic method complies with the analytical criteria for it being commercialized in the laboratory network that provides endocrinology and nuclear medicine services throughout the country.
