Abstract

ROMERO MARTINEZ, Kenia et al. Stability study of ELISA DAVIH-p24 Ag. Rev Cubana Med Trop [online]. 2009, vol.61, n.1, pp. 0-0. ISSN 1561-3054.

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 1^st, 4^th, 7^th and 9^th 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 9^th 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 9^th 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.

Keywords : stability studies; p24 antigen diagnosis; ELISA/methods.

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