Test Methodology
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Carbapenemase genotypic detection: PCR based assay (Xpert Carba-R)
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Reflex Testing
Criteria
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Not Applicable.
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Pre-Approval
Required
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Yes, must be approved by CDPH Healthcare Associated Infections (HAI) Program and California Antimicrobial Resistance Laboratory (CARL) Program prior to submission. Please coordinate with
HAIProgram@cdph.ca.gov and
CARLProgram@cdph.ca.gov to ensure proper submission.
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Supplemental Information and Required Form(s)
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Please use MDL AST “Antimicrobial susceptibility testing” form for submission and select “CPO Colonization Screening” on Page 2. Submittal form and instructions for using the MDL Lab Web Portal (LWP can be found are on our website at:
Barcode Submission form and submission instructions.
Detailed instructions for filling out and submitting the AST form can be found here:
AST instructions.
For more information on the CPO Swab test, please reference our test announcement Carbapenemase-Producing Organism (CPO) Colonization Testing.
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Required Specimen Type(s)
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Rectal swabs collected using Cepheid dual-swab collection device.
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Minimum Volume Required
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Not Applicable
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Specimen Stability
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Swabs in the transport tubes can be stored up to 5 days from collection at room temperature (15-28⁰C).
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Rejection Criteria
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- Samples collected with unacceptable swab collection devices
- Samples that have not been preapproved for testing
- Samples with insufficient or conflicting labelling
- Leaking samples
- Specimens shipped or stored at other than room temperature
- Specimens received past 5 days from collection date
- Specimen/sample types not meeting acceptance criteria (see CPO colonization testing guide)
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Storage/Transport Conditions
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Swabs in the transport tubes can be stored up to 5 days from collection at room temperature (15-28⁰C).
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Transport Medium,
if applicable
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Liquid Stuart transport media included in Cepheid dual swab collection device.
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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 preferred, date of birth, medical record number).
- Collection date and time
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Shipping Instructions and Specimen Handling Requirements
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Ship at ambient temperature using appropriate DOT/IATA approved shipping procedures.
Shipping materials may be provided by CDPH’s California Antimicrobial Resistance Laboratory (CARL) Program prior to submission. Please coordinate with CARLProgram@cdph.ca.gov to ensure proper submission.
Ship to: California Department of Public Health
Microbial Diseases Laboratory
ATTN: Bacterial Diseases Section
850 Marina Bay Parkway, Specimen Receiving Room B106
Richmond, CA 94804
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Specimen Collection Instructions, if applicable
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Collection instructions available from Cepheid (Rectal/Perirectal Swab PDF)
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Turnaround Time
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7 business days
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Interferences & Limitations
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This test is intended for infection control purposes. 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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None
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MDL Point of Contact
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For questions regarding submissions, please email CARLProgram@cdph.ca.gov or MDL.Submissions@cdph.ca.gov or call the MDL Bacterial Diseases Section at 510-412-3903 Monday – Friday 8 AM to 5 PM PT
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