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. 2024 Jul 16;62(7):e0052524.
doi: 10.1128/jcm.00525-24. Epub 2024 Jun 18.

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

Sukalyani Banik  1 , Burcu Ozay  2 , Marisol Trejo  3 , YanChun Zhu  4 , Charan Kanna  1 , Cynthia Santellan  3 , Bennett Shaw  3 , Sukantha Chandrasekaran  3 , Sudha Chaturvedi  4 , Lindy Vejar  2 , Soumitesh Chakravorty  1   2 , David Alland #  1 , Padmapriya Banada #  1
Affiliations

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

Sukalyani Banik et al. J Clin Microbiol. .

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.

Keywords: Candida auris; GeneXpert; assay; colonization; point of care; simple test; skin swabs; specific test; surveillance; test.

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Conflict of interest statement

D.A. receives research support and royalty payments from Cepheid. B.O. and S.C. are employees of Cepheid. The other authors do not declare any competing interests.

Figures

Fig 1
Fig 1
A simple three-step sample to result in testing protocol.
Fig 2
Fig 2
C. auris surveillance assay cartridge (CaurisSurV cartridge) performance is demonstrated analytically showing wide dynamic range of C. auris spiked from 1 to 107 CFU/mL in skin swab matrix (A, R2 = 0.9911); LoD with non-aggregative strain (AR0388, B) and an aggregative strain (AR0382, C) of C. auris spiked in clinical skin swab matrix.
Fig 3
Fig 3
Flow chart of the clinical evaluation study performed with C. auris surveillance assay cartridge (CaurisSurV cartridge).
See this image and copyright information in PMC

References

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