Candida auris Real Time PCR (axilla/groin or nares)

Test Code: 33330

candida auris fungal

This assay is for determining the presence of C. auris, whether the patient is colonized or has an invasive infection. This assay is intended for screening of C auris colonization from external body sites and should not be used for patient monitoring, for therapy decisions, or as a test of cure.

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Clinical and Procedure
Clinical Utility

Candida Real-time PCR assay for C. auris, allowing for the appropriate anti-fungal therapy or modification of therapy with patients afflicted with the targeted organism- which has known drug resistance.
The Candida auris Real-time PCR assay is focused on creating a diagnostic qPCR assay for detection in skin swabs (nasal, axilla, and groin). This test should not be used to determine or to monitor response to therapy.

Candida auris is listed by the CDC as being an Urgent Threat and it is on the World Health Organization’s 2022 priority pathogen listing. Currently, there are Five (5) unique clades of C. auris around the globe, with Four (4) of the clades reported in the United States.

The Candida auris Real-time PCR assay has been designed to utilize flocked swab samples collected from the nasal, axilla, and groin areas of the patient. These swabs can be submitted in a single tube containing liquid Amies media and transported for testing at ambient temperature. The assay has been designed to demonstrate inclusivity and acceptable sensitivities for the Four (4) clades currently in circulation within the United States. Supplemental testing of any emerging “new” clade will occur when either samples are available, or their genetic sequences are known.

About Test

This assay detects C 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.

Procedure

Extraction of genomic acid from swab specimen followed by PCR amplification of targets using real-time PCR methods. An internal control is added to ensure that extraction was performed correctly and that the PCR reaction was not inhibited.

Specificity

No cross reactivity was observed with off target bacterial and fungal pathogens.  The following pathogens were evaluated for cross reactivity: B. cepacia, B. multivorans, E. cloacae, E. coli, E. faecalis, H. influenzae, H. parainfluenzae, K. pneumoniae, N. meningitides, P. aeruginosa, S. aureus, S. epidermidis, S. marcescens, S. pneumoniae, S. pyrogenes, A. altemata, A. corymbifera, A. fumigatus, A. niger, A terreus, C. Neoformans, F. Solani, I. lacteus, P. boydii, P. mameffei, R. microsporus, R. oryzae, T cutaneum, T. mutcoides, M. racemosus, M. flavus, M. hiemalis, C. albicans, C. glabrata,  C. haemulonii,  C. krusei, C. lusitaniae,  C. parapsilosis and C. tropicalis.  Inclusivity was demonstrated with multiple C. auris strains from the CDC FDA AR-Bank representing clades l, ll, lll, lV and V.

Turnaround Time

24 hours from receipt of specimen.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
skin swab 33330 87481 Yes

Minimal 1 (One) flocked swab in >0.4 mL liquid Amies transport media.

Detected/ Not Detected

Collect skin surface samples using a flocked type swab.

  1. Open the swab package by grasping the plastic at the opposite end from the soft tip. Leave the swab tip enclosed in the package to prevent contamination. Carefully remove the tube from its packaging.
  2. Pull the swab from its package, being careful not to touch the soft tip. Firmly rub the soft end of the collection swab as described in the next step. Swab both the axilla and groin with the same swab as described below. Use a seperate swab for nasal collection.

Nasal Swab collection:

  1. Inserting a swab into the nostril about 0.5-.75 inches deep.
  2. While touching the sides of the nasal wall, rotat for 10-15 seconds in one nostril, then with the same swab, collected the same way in the other nostril.

For axilla or groin swab collection:

  1. Rub all sides of the swab tip over the left axilla skin surface and then the right, targeting the crease in the skin where the arm meets the body (i.e., swab both armpits, swiping back and forth 5 times per armpit).
  2. With the same swab used on the axilla, rub both sides of the swab tip over the left groin skin surface, targeting the inguinal crease in the skin where the leg meets the pelvic region and repeat with the right side (i.e., swab the skin of both hip creases, swiping back and forth 5 times per hip crease).
  3. After collecting skin swap, remove the cap from the swab collection tube; then place the soft end of the collection swab into the tube. Be careful to keep the cap from touching any materials that may contaminate your sample.
  4. Snap off the end of the swab at the marked line by bending the plastic handle against the edge of the transport media container.
  5. Replace the tube cap. You may need to adjust it until the snapped end of the swab slides into place in the center of the cap.
  6. Write specimen information on the tube label or apply patient identification label.
  7. Send or ship immediately to a testing laboratory.
  8. Specimens should be tested within 4 days of collection, or as otherwise indicated.
Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with the patient’s name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste, #10 Ste. #10, Lenexa, KS 66219

Assay Limitations

A negative test result cannot rule out the diagnosis of candidiasis.

 

Causes for Rejection

Specimens beyond their acceptable length of time from collection as listed in the specimen handling.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

  1. The CPT codes provided are based on Eurofins Viracor’s interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
References
  1. Emerging fungal pathogen: Candida auris, Tyler M. Barrett1 and Clement K. M. Tsui
  2. So Many Diagnostic Tests, So Little Time: Review and Preview of Candida auris Testing in Clinical and Public Health Laboratories, Emily K. Dennis, Sudha Chaturvedi, and Vishnu Chaturved
  3. Candida auris outbreak involving liver transplant recipients in a surgical intensive care unit, Nicole M. Theodoropoulos
  4. Epidemiology, clinical characteristics, resistance, and treatment of infections by Candida auris, Andrea Cortegiani
  5. Donor-Derived Transmission of Candida auris During Lung Transplantation, Marwan M. Azar
  6. Forsberg K, Woodworth K, Walters M, et al. Candida auris: The recent emergence of a multidrug-resistant fungal pathogen. Med Mycol 2019; 57:1–12.
  7. CDC. Antibiotic Resistant Threats in The United States 2019. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf. Accessed 14 August 2022.
  8. Vallabhaneni S, Kallen A, Tsay S, et al. Investigation of the First Seven Reported Cases of 5 Candida auris, a Globally Emerging Invasive, Multidrug-Resistant Fungus-United States, May 2013-August 2016. Am J Transpl 2017; 17:296–299.
  9. Peter G. Pappas, Carol A. Kauffman, David R. Andes, Cornelius J. Clancy, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.
  10. Healthcare Cost and Utilization Project (HCUP)
  11. National Inpatient Sample (NIS)
  12. National Ambulatory Medical are Survey (NAMCS)
  13. National Hospital Ambulatory Medical Care Survey (NHAMCS)
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