Soleris® Automated System for the Rapid Detection of Burkholderia cepacia Complex in Cosmetic Products.

This article evaluates the Soleris VR automated system combined with a Burkholderia cepacia complex (Bcc) supplement (S2-BCC-S) for rapid detection of Bcc in cosmetic products, comparing its performance to the United States Pharmacopeia (USP) reference method USP <60>. The study demonstrated that the Soleris Bcc method is robust, sensitive, and specific, showing equivalent or better inclusivity and exclusivity results than the USP method across 28 cosmetic matrices, with a high agreement (Kappa index 0.96). The Soleris system provides real-time, automated detection within 48 hours post pre-enrichment, reducing time and labor compared to the 5–6 days required by the USP method. Additionally, the Soleris assay exhibited good repeatability, robustness to minor procedural variations, reagent lot consistency, and stability under simulated shipping conditions. This method offers a user-friendly, efficient alternative for detecting Bcc, an opportunistic pathogen of concern in nonsterile personal care products due to its antimicrobial resistance and association with infections in vulnerable populations.