Test Methodology
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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.
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Reflex Testing
Criteria
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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.
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Pre-Approval Required
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Yes, must be approved by the CDPH’s HAI Program prior to submission. Please coordinate with
HAIProgram@cdph.ca.gov to ensure proper submission.
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Supplemental Information and Required Form(s)
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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
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Required Specimen Type(s)
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Patient composite axilla/groin skin swabs collected using BD ESwab collection and transport system containing 1.0 mL Amies buffer
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Minimum Volume Required
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1 mL (standard amount supplied with BD ESwab collection kit).
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Specimen Stability
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Room Temperature: not acceptable.
Refrigerated: up to 9 days.
Frozen: DO NOT freeze. |
Rejection Criteria
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- 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
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Storage/Transport Conditions
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Ship with cold pack to the laboratory for processing within 9 days of collection.
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Transport Medium,
if applicable
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Transport medium included in the ESwab™ collection system.
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Specimen Labeling
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- Two identifiers, including patient full name, and at least one other identifier (specimen accession number, date of birth, medical record number)
- Collection date
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Shipping Instructions and Specimen Handling Requirements
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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
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Specimen Collection Instructions, if applicable
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ESwab Instructions at Copan ESwab instructions (PDF).
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Turnaround Time
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2–3 days (PCR)
7–14 days (for PCR-indeterminate samples reflexed for culture-based confirmation)
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Interferences & Limitations
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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.
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Reference Range
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Not Applicable
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Additional Information
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Please contact the MDL Mycobacterial, Mycotic, and Parasitic Diseases Section for special consideration if any of the above criteria cannot be met.
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MDL Point of Contact
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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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