EVALUATION OF THE TECRA™ VISUAL IMMUNOASSAY FOR DETECTING STAPHYLOCOCCUS AUREUS IN COSMETIC/PHARMACEUTICAL RAW MATERIALS AND FINISHED PRODUCTS

Abstract An assessment of the new TECRA™ Staphylococcus aureus Visual Immunoassay (VIA) was conducted to detect the presence of Staphylococcus aureus in cosmetic/pharmaceutical raw materials and finished products. Samples were inoculated with pure cultures of Staphylococcus aureus. In addition, a mixed bacterial inoculum of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, and Pseudomonas aeruginosa was used to inoculate samples of raw materials and finished products. After a 24 h incubation period at 35C, each enrichment broth was analyzed for the presence of Staphylococcus aureus by the standard conventional method and the TECRA™ VIA. The following preenrichment broths were analyzed: the TECRA™ Staphylococcus Growth Medium, a modified version of the TECRA™ Staphylococcus Growth Medium with 4% Tween 20. Tryptic Soy Broth (TSB), and TSB with 4% Tween 20. Uninoculated enrichment broth samples were used as negative test controls. There was a 100% correlation between the visual immunoassay and the standard method in both pure and mixed culture studies for the detection of Staphylococcus aureus in preenrichment samples of the modified TECRA™ Staphylococcus Growth Medium and TSB. However, the TECRA™ VIA detected Staphylococcus aureus in 26 h while standard USP detection method required 4–5 days to be completed. These test results indicate that the TECRA™ Staphylococcus aureus VIA is equivalent to the conventional method for detecting the presence of Staphylococcus aureus contamination in cosmetic/pharmaceutical finished products and raw materials, but in a considerably shorter period of time. Furthermore, the TECRA™ Staphylococcus aureus VIA provides a user-friendly alternative to the standard conventional method for the detection of Staphylococcus aureus contamination.