Candida auris
is a multidrug-resistant fungal pathogen with a propensity to colonize humans and persist on environmental surfaces.
C. auris
invasive fungal disease is being increasingly identified in acute and long-term care settings. We have developed a prototype cartridge-based
C. auris
surveillance assay (CaurisSurV cartridge; “research use only”) that includes integrated sample processing and nucleic acid amplification to detect
C. auris
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
C. auris
, respectively. All five known clades of
C. auris
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 (
C. auris
negative matrix,
N
= 31) and analytical (non-
C
.
auris
strains,
N
= 32) samples. An additional blinded study with
N
= 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
C. auris
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
Candida auris
infection and hence quicker response for any potential future outbreaks.