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

An assessment of the new TECRA(TM) 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(TM) VIA. The following preenrichment broths were analyzed: the TECRA(TM) Staphylococcus Growth Medium, a modified version of the TECRA(TM) 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(TM) Staphylococcus Growth Medium and TSB. However, the TECRA(TM) 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(TM) 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(TM) Staphylococcus aureus VIA provides a user-friendly alternative to the standard conventional method for the detection of Staphylococcus aureus contamination.