Test Catalog

Test Id : CAURP

Candida auris, Molecular Detection, PCR, Random, Urine

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

Detection of Candida auris in urine specimens

 

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

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (RT-PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Candida auris PCR, U

Aliases
Lists additional common names for a test, as an aid in searching

C. auris

Specimen Type
Describes the specimen type validated for testing

Urine

Additional Testing Requirements

This test should always be performed in conjunction with fungal culture, order FGEN / Fungal Culture, Routine.

Shipping Instructions

Specimen must arrive within 7 days of collection.

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRCAU Specimen Source

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Urine Tubes, 10 mL (T068)

Container/Tube: Plastic, 10-mL urine tube

Specimen Volume: 1 mL

Collection Instructions: Collect a random urine specimen.

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 7 days
Frozen 7 days

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

Detection of Candida auris in urine 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 U S 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.

 

Candidia 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 Center for Disease Control and Prevention (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 urine was 37 colony-forming units (CFU)/20 mcL reaction. To evaluate the accuracy of the assay, 30 urine 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. Centers for Disease Control and Prevention (CDC) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Foodborne, Waterborne, and Environmental Diseases (DFWED): Candida auris. CDC; Updated October 26, 2020. Accessed November 2, 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

Method Description
Describes how the test is performed and provides a method-specific reference

Genomic DNA is extracted. The extracted DNA is placed on the LightCycler 480 instrument, which amplifies and monitors by fluorescence, the development of target nucleotide sequences after each polymerase chain reaction (PCR) cycle. A specific 269 base pairs target sequence from a portion of the 28S rDNA gene from Candida auris is amplified and the resulting segment is detected by melt-curve analysis using sequence-specific fluorescence resonance energy transfer hybridization probes. An internal control is added to every sample to monitor for extraction and PCR inhibition in the specimen.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87481

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CAURP Candida auris PCR, U 95764-7
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
SRCAU Specimen Source 31208-2
CAURU C auris PCR, Result, U 95764-7

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports