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This work describes the validation of an enzyme-linked immunosorbent assay (ELISA) for detection of anti-Saccharomyces cerevisiae antibodies (ASCA) in diabetic patients with foot ulcers, after the treatment with Heberprot-P®. Validation followed regulatory guidelines of US FDA and European Medicine Agency. Minimum required dilution of samples and quality controls were defined using pools of sera from diabetic patients and from healthy donors. Parameters such as cut point, specificity, precision, selectivity, robustness and sample stability were analyzed. The repeatability and intermediate precision percent ranged between 7.93-10.61% and 7.93-11.43 %, respectively, indicating low intra- and inter-assay variation. The specificity was proved by background noise suppression, reaching 100% of inhibition as strong criterion for the specificity of the immunoassay. The validated ELISA is a reliable tool for ASCA detection in human serum after the administration of Heberprot-P®, in order to find immunological reactions associated with latent contamination by host cell proteins from Saccharomyces cerevisiae.

ELISA validation approach for the detection of anti-saccharomyces cerevisiae antibodies in patients treated with biopharmaceutical heberprot-P®