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MiCROBIAL DISEASES LABORATORY BRANCH

Tes​​t​​ Name 

Candida ​auris Colonization Screening​

​​Test ​​​​​​​​M​​​​e​th​o​​​​d​​​olog​y​​

​​Real-time​ PCR utilizes the BD MAX™ System for detection of Candida auris DNA directly from patient specimens. Culture-based C. auris screening is performed by enrichment of swab culture followed by colony screening on CHROMagar™ Candida Plus; culture identification is confirmed by MALDI-TOF mass spectrometry, ​Sanger sequencing, or other validated method.

Reflex Testing
Criteria

​​Culture-based testing will be performed on specimens for which Positive or Indeterminate PCR results were obtained. Confirmatory culture results will only be reported specimens with Indeterminate PCR results.

Pre-A​pproval Requi​red

​Ye​s, must be approved by the CDPH’s HAI Program prior to submission. Please coordinate with HAIProg​ram@cdph.ca.gov to ensure proper submission​​.

Supp​lemental Information and Required Form(s)​

​​Barcode subm​ittal form 449 “Candida auris Colonization Screening​​” or instructions for using the MDL Lab Web Portal (LWP​) can be found at: MDL Submission Instructions and Forms​.​​

​​Instructions on completing the form at MDL Form 449

Required Specimen Type(s)

​​Patient composite axilla/groin skin swabs collected using BD ESwab collection and transport system containing 1.0 mL Amies buffer

Minimum Volume Required

​1 mL (standard amount supplied with BD ESwab collection kit)​.


Specimen Stability

​Room Temperature: not acceptable.
​Refrigerated: up to 9 days.
Frozen: DO NOT freeze.

​Rejection Criteria
  • Samples with insufficient or conflicting labelling​​
  • ​Leaking samples
  • ​Specimens shipped without cold packs​
  • ​Specimens received past 9 days from collection date​
  • ​​Specimen/sample types not meeting acceptance criteria​
Storage/Transport Conditions ​​​

​​Ship with cold pack to the laboratory for processing within 9 days of collection.

Transport Medium,​
if applicable


​​​Transport medium included in the ESwab™ collection system.

Specimen Labeling

​- Two identifiers, including patient full name, and at least one other identifier (specimen accession number, date of birth, medical record number)
​- Collection date
Shipping Instructions and Specimen Handling Requirements

​Ship ESwab specimens with cold pack within 9 days of collection. Follow the appropriate DOT/IATA approved shipping procedures for a Biological Substance, Category B (UN3373)​

Sh​​ip to:

California Depart​ment of Public Health​
Microbial Diseases Laboratory ​
C/O ​Specimen Receiving Room B106​
​850 Marina Bay Parkway​
Richmond, CA  94804​​
Specimen Collection Instructions, if applicable

ESwab ​Instructions at Copan​ ESwab instructions​ (PDF)​.
Turnaround Time

​2–3 days (PCR)
​7–14 days (for PCR-indeterminate samples reflexed for culture-based confirmation)

Interferences & Limitations

​This test is intended for infection control purposes. Additional culture of swabs that are PCR-positive for C. auris will be performed for surveillance purposes only. The PCR assay cannot differentiate between viable and non-viable cells present in the sample.​

Reference Range

​Not Applicable

Additional Information

​Please contact the MDL Mycobacterial, Mycotic, and Parasitic Diseases Section for special consideration if any of the above criteria cannot be met.​

MDL Point of Contact

​For questions regarding submissions, please contact ARLN Coordinator via email CARLProgram@cdph.ca.gov. The MMPDS Section can be contacted at CDPHMDLMMP@cdph.ca.gov or (510) 412-3926.​


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