Test Id : CRPCR
Carbapenem Resistance Genes, Molecular Detection, PCR, Rectal Swab
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting and differentiating the 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 rectal or perirectal swabs
Method Name
A short description of the method used to perform the test
Real-Time Polymerase Chain Reaction (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
Swab
Ordering Guidance
This test is performed on rectal and perirectal swab specimens from patients at risk for intestinal colonization with bacteria not susceptible to carbapenem antimicrobials.
Other mechanisms of carbapenem resistance, including carbapenemases 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.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Specimen Type: Rectal/perirectal swab
Supplies: Culturette (BBL Culture Swab) (T092)
Container/Tube: Culture transport swab
Specimen Volume: Entire collection
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
See Specimen Required
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross lipemia | Reject |
| Incorrect swab used | 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 |
|---|---|---|---|
| Swab | Ambient | 5 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting and differentiating the 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 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 species (organisms not susceptible to carbapenem antimicrobials) is a critical public health issue. These bacteria are often resistant to all beta-lactam agents and, frequently, are 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 rectal and perirectal specimens 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.
Imipenemase-type metallo-beta-lactamase (IMP) types detected by this assay include only IMP-1, 2, 4, 6, 10, and 11.
Rectal and perirectal specimens from pediatric patients have not been evaluated.
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 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.
Cocolonization with 2 or more carbapenemase-producing organisms has been reported with the Xpert Carba-R Assay, but it is rare.
Carbapenem-resistant anaerobes potentially present in fecal specimens have not been evaluated by the Xpert Carba-R assay.
Supportive Data
The Xpert Carba-R Assay is a US Food and Drug Administration-cleared test. The Xpert Carba-R was further verified for use with a Zeptometrix verification panel and organisms (Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter bacteria) with known carbapenem antimicrobial susceptibility test results. The verification passed, and this test is acceptable for patient testing.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. McConville TH, Sullivan SB, Gomez-Simmonds A, Whittier S, Uhlemann AC. Carbapenem-resistant Enterobacteriaceae colonization (CRE) and subsequent risk of infection and 90-day mortality in critically ill patients, an observational study. PLoS One. 2017;12(10):e0186195
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; 01/2018)
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 Sunday
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.
87798
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 |
|---|---|---|
| CRPCR | Carbapenem Resistance Genes, PCR | 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.
|
|---|---|---|
| IMPCR | IMP Resistance Gene | 85498-4 |
| VIMCR | VIM Resistance Gene | 85501-5 |
| NDMCR | NDM Resistance Gene | 73982-1 |
| KPPCR | KPC Resistance Gene | 49617-4 |
| OXACR | OXA-48-like Resistance Gene | 85503-1 |