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Test Catalog

Test ID: CAURB    
Candida auris, Molecular Detection, PCR, Whole Blood

Useful For Suggests clinical disorders or settings where the test may be helpful

Detection of Candida auris in whole blood specimens

 

This test should not be used to determine cure or to monitor response to therapy.

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Candida auris is a yeast that was first identified as causing disease in an individual in Japan in 2009. Since then, cases have been reported in more than 30 countries worldwide. The first case of Candida auris in the US was reported in 2015, and cases have been reported in a number of states. In addition to causing disease, Candida auris can colonize individuals without signs or symptoms of disease.

 

Candida auris can cause serious and sometimes fatal infections, is often resistant to one or more classes of antifungal drugs, and inappropriate treatment may occur as it can be misidentified in the laboratory. In addition, Candida auris appears to be more resistant to disinfection than other yeasts, leading to prolonged survival in the environment and increasing the possibility of transmission in hospitals and nursing homes.

 

In December 2018, the CDC recommended that health care facilities implement routine surveillance screening of patients who have had an overnight stay in a health care facility outside of the US over the past year, particularly if the hospitalization was in a country with confirmed cases of Candida auris. The CDC also recommended considering screening of patients who have been hospitalized outside of the US and have a documented infection or colonization with a carbapenamase-producing Gram negative bacteria. These patients have frequently been found to have Candida auris colonization as well. A second group of people for whom screening is recommended includes health care workers who have been in close contact with patients who have previously unrecognized Candida auris infection or colonization.

 

The Candida auris polymerase chain reaction (PCR) assay detects and identifies Candida auris from blood or urine specimens and also from swabs including combination groin/axilla surveillance swabs and nares surveillance swabs.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Not applicable

Interpretation Provides information to assist in interpretation of the test results

A positive result indicates the presence of Candida auris DNA.

 

A negative result indicates the absence of detectable Candida auris DNA.

 

An inhibited result indicates that inhibitors are present in the specimen that could prevent the detection of Candida auris DNA. A new specimen can be resubmitted under a new order, if desired.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

A negative result does not rule out the presence of Candida auris because the organism may be present at levels below the limit of detection for this assay.

 

This assay detects Candida auris nucleic acid and, therefore, does not distinguish between viable, disease-related organisms and nucleic acid persisting from prior or treated infection. Test results should be correlated with patient symptoms and clinical presentation before a definitive diagnosis is made.

Supportive Data

During test verification, 32 culture isolates of Candida auris previously identified using the Bruker matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometer were tested and all 32 were positively identified as Candida auris by this polymerase chain reaction (PCR) assay.

 

Verification studies indicated that the limit of detection (LOD) for Candida auris spiked into blood was 54 colony-forming units (CFU)/20 mcL reaction. To evaluate the accuracy of the assay, 30 blood specimens were spiked with Candida auris at 1 log above the LOD and 29/30 were positive (97%) by the PCR assay.

 

A specificity panel consisting of 78 common skin flora organisms or pathogens (bacteria, yeast, molds, viruses and parasites) and all were negative by the PCR assay. No positivity was found with any other species of Candida including the closely related Candida duobushaemulonii and Candida haemulonii.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Spivak ES, Hanson KE: Candida auris: An Emerging Fungal Pathogen. J Clin Microbiol. 2018;56:e01588-17

2. Candida auris. Accessed March 2020. Available at: www.cdc.gov/fungal/candida-auris/index.html

3. Navalkele BD, Revankar S, Chandrasekar P: Candida Auris: A Worrisome, Globally Emerging Pathogen. Expert Rev Anti Infect Ther. 2017 Sep;15(9):819-827