A standardized test to assess the impact of different organic challenges on the antimicrobial activity of antiseptics.

This paper presents a suggestion for determining the antimicrobial efficacy of antiseptics in a phase 2/step 1 assay. Emphasis is placed on specific organic challenges to evaluate the efficacy of antiseptics used to rinse the oral cavity, mucous membranes, or wounds for either prophylactic or therapeutic reasons. Basic data are given concerning ready-to-use products based on Poly(1-vinyl-2-pyrrolidone-)iodine-complex (PVP-iodine), chlorhexidine, octenidine, or cetylpyridinium chloride. Hydrogen peroxide (3.0%) was included to assess a product with known limited efficacy only. Using Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Enterococcus faecium, and Candida albicans, a 10(5)-fold reduction can be achieved in 10 min without interfering substances. In the presence of 10% albumin, 10% sheep blood, or 1% mucin, a 10(3)-fold reduction is yielded using products based on PVP-iodine, octenidine, or chlorhexidine. The combination of 4.5% albumin, 4.5% sheep blood, and 1% mucin was the most difficult organic challenge and only the products based on PVP-iodine, octenidine, or chlorhexidine remained active. The cetylpyridinium-based product and hydrogen peroxide were less effective. Based on these data, a proposal for a phase 2/step 1 assay for antiseptics is presented to promote the standardization efforts.