Test Id : CARBI
Carbapenem Resistance Genes, Molecular Detection, PCR, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting and differentiating blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem intermediate or resistant results
Aiding in infection control in the detection of gastrointestinal colonization of patients in healthcare settings with bacteria not susceptible to carbapenems using bacterial isolates from rectal or perirectal swabs
Method Name
A short description of the method used to perform the test
Real-Time Polymerase Chain Reaction (PCR)/Reverse Transcription (RT-PCR)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Carbapenem resistant CRE
Carbapenem resistant Enterobacteriaceae
Carbapenem resistant Enterobacterales
Carbapenem resistant Pseudomonas aeruginosa
Carbapenem resistant Acinetobacter species
Carbapenem resistant gram-negative bacilli
Carbapenem non-susceptible
Carbapenemase
CRO
CRE
OXA
OXA-48
VIM
IMP
KPC
NDM
CP-CRE
Specimen Type
Describes the specimen type validated for testing
Varies
Ordering Guidance
This assay should be used for testing of isolates of Enterobacterales, Pseudomonas aeruginosa and Acinetobacter baumannii. If testing directly from rectal swabs is desired, order CRPCR / Carbapenem Resistance Genes, Molecular Detection, PCR, Rectal Swab.
Other mechanisms of carbapenem resistance, including other carbapenemase not targeted by this assay, porin mutations, and hyperexpression of drug efflux pumps, may result in carbapenem resistance. These mechanisms are not detected by this assay.
Additional Testing Requirements
1. Organism identification must be provided. If organism identification is unknown, concomitantly order IDENT / Organism Referred for Identification, Aerobic Bacteria.
2. If susceptibility testing is needed, also order ZMMLS / Antimicrobial Susceptibility, Aerobic Bacteria, Varies.
Shipping Instructions
1. For shipping information, see Infectious Specimen Shipping Guidelines.
2. Place specimen in a large infectious container and label as an etiologic agent/infectious substance if appropriate.
Necessary Information
Organism identification and specimen source are required.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| CRORG | Organism Identified by Client |
ACINETOBACTER BAUMANNII ACINETOBACTER BAUMANNII COMPLEX CITROBACTER AMALONATICUS CITROBACTER FREUNDII CITROBACTER KOSERI CITROBACTER SPECIES KLEBSIELLA AEROGENES ENTEROBACTER CANCEROGENUS ENTEROBACTER CLOACAE ENTEROBACTER CLOACAE COMPLEX ENTEROBACTER GERGOVIAE ENTEROBACTER SPECIES ESCHERICHIA COLI KLEBSIELLA OXYTOCA KLEBSIELLA PNEUMONIAE KLEBSIELLA PNEUMONIAE COMPLEX KLEBSIELLA SPECIES MORGANELLA MORGANII MORGANELLA SPECIES PROTEUS MIRABILIS PROTEUS SPECIES PROTEUS VULGARIS PSEUDOMONAS AERUGINOSA SERRATIA MARCESCENS SERRATIA SPECIES |
| CRSRC | Specimen Source |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by Klebsiella pneumoniae carbapenemase (KPC), New Delhi metallo-beta-lactamase (NDM), Verona integron-encoded metallo-beta-lactamase (VIM), oxacillin-hydrolyzing beta-lactamase (OXA-48), and imipenemase-type metallo-beta-lactamase (IMP) DNA is not likely.
Supplies: Infectious Container, Large (T146)
Container/Tube: Slant
Specimen Volume: Isolate
Collection Instructions:
1. Perform isolation of infecting bacteria.
2. Bacterial organism must be submitted in pure culture, actively growing. Do not submit mixed cultures.
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Agar plate Mixed culture | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | ||
| Refrigerated | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting and differentiating blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem intermediate or resistant results
Aiding in infection control in the detection of gastrointestinal colonization of patients in healthcare settings with bacteria not susceptible to carbapenems using bacterial isolates from rectal or perirectal swabs
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The global spread of carbapenemase-producing Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii (organisms not-susceptible to carbapenem antimicrobials) is a critical public health issue. These bacteria are often resistant to all beta-lactam agents and frequently also resistant to multiple classes of other antimicrobial agents, leaving very few treatment options. Tracing the spread of organisms not-susceptible to carbapenems is complicated by the diversity of carbapenem-hydrolyzing enzymes that have emerged and the ability of the genes to spread among multiple bacterial species.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Not Detected
Interpretation
Provides information to assist in interpretation of the test results
A detected result is when blaKPC, blaNDM, blaVIM, blaOXA-48, or blaIMP target DNA is detected. This indicates the presence of gene sequences associated with carbapenem intermediate or resistant results.
A not detected result is when blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP target DNA is not detected.
A not detected Xpert Carba-R Assay result does not preclude the presence of other carbapenem-resistance mechanisms.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The Xpert Carba-R Assay detects blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP from pure colonies and is not for bacterial identification. Detection of these gene sequences does not indicate the presence of viable organisms.
The Xpert Carba-R Assay is not a genetic relatedness subtyping tool and does not report variants of the blaKPC, blaNDM, blaVIM, blaOXA-48, or blaIMP genes.
IMP types detected by this assay include only IMP-1, 2, 4, 6, 10 and 11.
Certain bacterial species, such as Pseudomonas aeruginosa and Acinetobacter baumannii have been shown to exhibit resistance to the carbapenem antimicrobial ertapenem due to intrinsic resistance mechanisms.
The detection of other OXA-carbapenemase genes besides blaOXA-48 and blaOXA-181 has not been evaluated with this assay.
Variants or alterations in primer or probe binding regions may affect detection of current, new, or unknown blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP variants, resulting in a false-negative result.
Testing with the Xpert Carba-R Assay should be used as an adjunct to other available methods.
Carbapenem-resistant anaerobes potentially present in fecal specimens have not been evaluated by the Xpert Carba-R Assay.
Erroneous test results might occur from improper culture techniques, failure to follow recommended procedure to prepare the 0.5 McFarland suspension, handling and storage procedures, technical error, sample mix-up, or because the number of organisms in the specimen is too low to be detected by the test. Careful compliance with the instructions in the test instructions for use is necessary to avoid erroneous results.
Supportive Data
The Xpert Carba-R Assay is an FDA-cleared test. The Xpert Carba-R was further verified for use with a Zeptometrix verification panel and organisms (Enterobacterales, Pseudomonas, and Acinetobacter bacteria) with known carbapenem antimicrobial susceptibility test results. The verification passed and is acceptable for use with patient testing.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Bush K, Bradford PA. Epidemiology of beta-lactamase-producing pathogens. Clin Microbiol Rev. 2020;33(2): e00047-19
2. Tenover FC, Nicolau DP, Gill CM. Carbapenemase-producing Pseudomonas aeruginosa - an emerging challenge. Emerg Microbes Infect. 2022;11(1):811-814
3. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. 11th ed. CLSI standard M07. CLSI; 2018
Method Description
Describes how the test is performed and provides a method-specific reference
The GeneXpert Dx System automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in simple or complex specimens using a real-time polymerase chain reaction (PCR) assay. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is eliminated. The primers and probes in the Xpert Carba-R Assay detect proprietary sequences for the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem intermediate or resistant results in gram-negative bacteria.(Package insert: Xpert Carba-R. Cepheid; 301-2438, Rev. G, 7/2020)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
87150
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| CARBI | Carbapenem Resistance Genes, Varies | 85502-3 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| IMPCB | IMP Resistance Gene | 85498-4 |
| VIMCB | VIM Resistance Gene | 85501-5 |
| NDMCB | NDM Resistance Gene | 73982-1 |
| KPPCB | KPC Resistance Gene | 49617-4 |
| OXACB | OXA-48-like Resistance Gene | 85503-1 |
| CRORG | Organism Identified by Client | In Process |
| CRSRC | Specimen Source | 31208-2 |