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MiCROBIAL DISEASES LABORATORY BRANCH

ā€‹Tesā€‹ā€‹tā€‹ ā€‹ā€‹Name 

Candida ā€‹auris Colonization Screeningā€‹

ā€‹ā€‹Test ā€‹ā€‹ā€‹ā€‹ā€‹ā€‹ā€‹ā€‹Mā€‹ā€‹ā€‹ā€‹eā€‹thā€‹oā€‹ā€‹ā€‹ā€‹dā€‹ā€‹ā€‹ologā€‹yā€‹ā€‹ā€‹

ā€‹ā€‹Real-timeā€‹ PCR utilizes the BD MAXā„¢ 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 CHROMagarā„¢ Candida Plus; culture identification is confirmed by MALDI-TOF mass spectrometry, ā€‹Sanger sequencing, or other validated method.

ā€‹Reflex Testing
Criteria

ā€‹ā€‹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.

ā€‹Pre-Aā€‹pproval Requiā€‹redā€‹

ā€‹Yeā€‹s, must be approved by the CDPHā€™s HAI Program prior to submission. Please coordinate with HAIProgā€‹ram@cdph.ca.gov to ensure proper submissionā€‹ā€‹.

ā€‹Suppā€‹lemental Information and Required Form(s)ā€‹ā€‹

ā€‹ā€‹Barcode submā€‹ittal form 449 ā€œCandida auris Colonization Screeningā€‹ā€‹ā€ or instructions for using the MDL Lab Web Portal (LWPā€‹) can be found at: MDL Submission Instructions and Formsā€‹.ā€‹ā€‹

ā€‹ā€‹Instructions on completing the form at MDā€‹L Form 449

ā€‹Required Specimen Type(s)

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

ā€‹Minimum Volume Required

ā€‹1 mL (standard amount supplied with BD ESwab collection kit)ā€‹.


ā€‹Specimen Stability

ā€‹Room Temperature: not acceptable.
ā€‹Refrigerated: up to 9 days.
Frozen: DO NOT freeze.

ā€‹ā€‹Rejection Criteria
  • Samples with insufficient or conflicting labellingā€‹ā€‹
  • ā€‹Leaking samples
  • ā€‹Specimens shipped without cold packsā€‹
  • ā€‹Specimens received past 9 days from collection dateā€‹
  • ā€‹ā€‹Specimen/sample types not meeting acceptance criteriaā€‹
ā€‹Storage/Transport Conditions ā€‹ā€‹ā€‹

ā€‹ā€‹Ship with cold pack to the laboratory for processing within 9 days of collection.

ā€‹Transport Medium,ā€‹
if applicable


ā€‹ā€‹ā€‹Transport medium included in the ESwabā„¢ collection system.

ā€‹Specimen Labeling

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

ā€‹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)ā€‹

Shā€‹ā€‹ip to:

California Departā€‹ment of Public Healthā€‹
Microbial Diseases Laboratory ā€‹
C/O ā€‹Specimen Receiving Room B106ā€‹
ā€‹850 Marina Bay Parkwayā€‹
Richmond, CA  94804ā€‹ā€‹
ā€‹Specimen Collection Instructions, if applicable

ESwab ā€‹Instructions at Copanā€‹ ESwab instructionsā€‹ (PDF)ā€‹.
ā€‹Turnaround Time

ā€‹2ā€“3 days (PCR)
ā€‹7ā€“14 days (for PCR-indeterminate samples reflexed for culture-based confirmation)

ā€‹Interferences & Limitations

ā€‹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.ā€‹

ā€‹Reference Range

ā€‹Not Applicable

ā€‹Additional Information

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

ā€‹MDL Point of Contactā€‹

ā€‹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.ā€‹

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