Stability study of ELISA DAVIH-p24 Ag

[摘要] OBJECTIVE: extending useful lifetime of ELISA DAVIH-p24 Ag, an on shelf stability test was conducted.METHODS: three consecutive batches of the diagnostic kit were studied for 12 months. The applied protocol was to test the calibration curve of the positive control according to the manufacturer's instructions for the system operation. The quality requirements for each reagent, according to their specifications, were controlled. Normality in obtained values for each point of the curve in the analyzed period and also homogeneity of means and variances were studied by using Grubbs´ and Cochran´s tests, respectively. For the assay precision, each point of the curve was analyzed at 1st, 4th, 7th and 9th months by means of Levy-Jennings´ graphs, setting ± 2 standard deviations as limit values.RESULTS: the quality requirements of each component met the specifications up to 9th month; from that moment on, changes in the organoleptic characteristics of tetramethylbenzidine chromogen and deterioration in the operational characteristics of the system were observed due to substrate buffer. The remaining components did not change. The yielded values were accepted as normal up to the 9th month. Grubb´s and Cochran´s test values for the 6 points of the curve during the nine months were lower than the tabulated critical values for a= 5 %, so homogeneity between means and variances was confirmed. Levey-Jennings´s graphs showed values within the set limits.CONCLUSIONS: these results allowed extending the validity period of the system to six months, with 50 % coverage.

[学科分类] 传染病学

[关键词] Estudios de estabilidad;diagnóstico de AgP24;ELISA/métodos