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MDL Candida auris Colonization Screening

MiCROBIAL DISEASES LABORATORY BRANCH

Test Name

Candida auris Colonization Screening

Test Methodology	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-Approval Required	Yes, must be approved by the CDPH’s HAI Program prior to submission. Please coordinate with HAIProgram@cdph.ca.gov to ensure proper submission.
Supplemental Information and Required Form(s)	Barcode submittal 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) Ship to: California Department 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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