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

Author:

Banik Sukalyani1,Ozay Burcu2,Trejo Marisol3,Zhu YanChun4,Kanna Charan1,Santellan Cynthia3,Shaw Bennett3,Chandrasekaran Sukantha3ORCID,Chaturvedi Sudha4ORCID,Vejar Lindy2,Chakravorty Soumitesh12,Alland David1ORCID,Banada Padmapriya1ORCID

Affiliation:

1. Center for Emerging Pathogens, Department of Medicine, Public Health Research Institute, Rutgers New Jersey Medical School, Newark, New Jersey, USA

2. Research and Development, Cepheid, Sunnyvale, California, USA

3. UCLA DGSOM Pathology & Lab Medicine, UCLA, Los Angeles, California, USA

4. Mycology laboratory, Wadsworth Center, Albany, New York, USA

Abstract

ABSTRACT 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.

Funder

HHS | NIH | National Institute of Allergy and Infectious Diseases

Publisher

American Society for Microbiology

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