An immunoassay method for rapid detection of Staphylococcus aureus in cosmetics, pharmaceutical products, and raw materials.

The TECRA Staphylococcus aureus Visual Immunoassay allows a presumptive positive or negative result for the presence of S. aureus to be obtained within 26 h, in contrast to 4-5 days by traditional cultural methods. Presumptive positive immunoassay results are confirmed by streaking the enrichment broth onto conventional agar media. A validation study was undertaken to compare the TECRA assay with a cultural reference method based on the Bacteriological Analytical Manual (8th Ed.), which is also consistent with U.S. Pharmacopoeia requirements. The products tested included a range of cosmetics (toothpaste, shampoos, conditioners, sunscreens, moisturizers, lip and eye creams) and pharmaceuticals (cough mixtures, laxatives, ulcer treatments, infant formulae, antiseptic cream), as well as some pharmaceutical ingredients. Samples were inoculated with S. aureus at 10-20 cfu/g, and then enriched for 24 h at 35 degrees-37 degrees C at a product-to-sample ratio of 1:100. Two different enrichment broths were used for the study: Tryptone Soya Broth with 4% Tween 80 and Modified Letheen Broth. For both enrichment broths, results of the immunoassay and the reference method showed close correlation. The TECRA S. aureus Visual Immunoassay provides a rapid and convenient alternative to cultural methods and provides advantages to industry, such as greater speed of product and ingredient release and faster tracing of contamination problems. Because the immunoassay may be read either visually or with the aid of a plate reader, there is no need for an initial outlay on capital equipment. However, the assay can be automated if required.