A simple and sensitive test for colonization, surveillance, and infection control suitable for near patient use.

Unlabelled: is a multidrug-resistant fungal pathogen with a propensity to colonize humans and persist on environmental surfaces. invasive fungal disease is being increasingly identified in acute and long-term care settings. We have developed a prototype cartridge-based surveillance assay (CaurisSurV cartridge; "research use only") that includes integrated sample processing and nucleic acid amplification to detect from surveillance skin swabs in the GeneXpert instrument and is designed for point-of-care use. The assay limit of detection (LoD) in the skin swab matrix was 10.5 and 14.8 CFU/mL for non-aggregative (AR0388) and aggregative (AR0382) strains of , respectively. All five known clades of were detected at 2-3-5× (31.5-52.5 CFU/mL) the LoD. The assay was validated using a total of 85 clinical swab samples banked at two different institutions (University of California Los Angeles, CA and Wadsworth Center, NY). Compared to culture, sensitivity was 96.8% (30/31) and 100% (10/10) in the UCLA and Wadsworth cohorts, respectively, providing a combined sensitivity of 97.5% (40/41), and compared to PCR, the combined sensitivity was 92% (46/50). Specificity was 100% with both clinical ( negative matrix, = 31) and analytical (non-. strains, = 32) samples. An additional blinded study with = 60 samples from Wadsworth Center, NY yielded 97% (29/30) sensitivity and 100% (28/28) specificity. We have developed a completely integrated, sensitive, specific, and 58-min prototype test, which can be used for routine surveillance of and might help prevent colonization and outbreaks in acute and chronic healthcare settings.

Importance: This study has the potential to offer a better solution to healthcare providers at hospitals and long-term care facilities in their ongoing efforts for effective and timely control of infection and hence quicker response for any potential future outbreaks.