Abstract

Objective: Evaluate the homogeneity, short-term stability, long-term stability, and stability after reconstitution of a lyophilized serum samples containing anti-Fasciola antibodies. Method: Experimental study on lyophilized serum samples containing anti-Fasciola antibodies. Homogeneity and stability of the lyophilized samples were assessed using the “Human Fasciola IgG ELISA Test Kit” from Cortez Diagnostics, Inc., according to the ISO 13528:2022 standard. The data were statistically analyzed using one-way ANOVA and t-test. Results: According to one-way ANOVA, the lyophilized serum samples containing anti-Fasciola antibodies demonstrated homogeneity with a p-value of 0.739. The t-test results indicated that the samples achieved short-term stability at evaluation times of 1, 3, 5, and 7 days with p-values of 0.058; 0.180; 0.278 and 0.129. Long-term stability was confirmed at 2 and 4 months with p-values of 0.328 and 0.444. After reconstitution, the samples remained stable for up to 7 days at all three temperatures: -20°C, 2 - 8°C, and 20 - 24°C. Conclusion: The lyophilized serum product containing anti-Fasciola antibodies meets quality standards for use in external quality assessment programs