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Test Id : KPNRP
KPC (blaKPC) and NDM (blaNDM) in Gram-Negative Bacilli, Molecular Detection, PCR, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Assessing pure isolates of gram-negative bacilli for mechanism of carbapenem resistance
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
Method Name
A short description of the method used to perform the test
A short description of the method used to perform the test
Real-Time Polymerase Chain Reaction (PCR) Using LightCycler with Amplified Product Detection Using Fluorescent Resonance Energy Transfer (FRET) Hybridization Probes
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Yes
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Lists a shorter or abbreviated version of the Published Name for a test
KPC and NDM PCR
Specimen Type
Describes the specimen type validated for testing
Describes the specimen type validated for testing
Varies
Shipping Instructions
1. See Infectious Specimen Shipping Guidelines in Special Instructions for shipping information.
Necessary Information
Organism identification and specimen source are required.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| SRC53 | Specimen source |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
The high sensitivity of amplification by PCR requires the specimen to be processed in an environment in which contamination of the specimen by Klebsiella pneumoniae (KPC) or New Dehli metallo-beta-lactamase (NDM) DNA is unlikely.
Supplies: Infectious Container, Large (T146)
Specimen Volume: Isolate
Collection Instructions:
1. Isolate the bacteria.
2. Bacterial organism must be in pure culture, actively growing. Do not submit mixed cultures.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
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
Identifies specimen types and conditions that may cause the specimen to be rejected
| Other | Agar plate, mixed cultures |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
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
Suggests clinical disorders or settings where the test may be helpful
Assessing pure isolates of gram-negative bacilli for mechanism of carbapenem resistance
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Nonsusceptibility to carbapenems in gram-negative bacilli by means of the enzyme KPC (Klebsiella pneumoniae carbapenemase) or NDM (New Dehli metallo-beta-lactamase) is becoming more common. The genes blaKPC and blaNDM encode KPC and NDM enzyme production, respectively. In addition to KPC and NDM production, there are other mechanisms of resistance to carbapenems in gram-negative bacilli, including production of other carbapenemases, or plasmid-encoded AmpC, or extended beta-lactamase production combined with decreased membrane permeability. Detection of carbapenemases by the modified Hodge test may be subjective and is not rapid. Testing for the minimum inhibitory concentration (MIC) determines the level but not the mechanism of resistance. PCR is a sensitive, specific, and rapid means of detecting of a specific portion of the genes encoding KPC and NDM production.
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.
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 applicable
Interpretation
Provides information to assist in interpretation of the test results
Provides information to assist in interpretation of the test results
This PCR detects and differentiates both blaKPC and blaNDM. A positive KPC (Klebsiella pneumoniae carbapenemase) PCR indicates that the isolate carries blaKPC. A positive NDM (New Dehli metallo-beta-lactamase) PCR indicates the isolate carries blaNDM.
A negative result indicates the absence of detectable blaKPC or blaNDM DNA; however, false-negative results may occur due to inhibition of PCR, sequence variability underlying primers and, or loss of a plasmid carrying blaKPC and blaNDM.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This assay should be used for testing of isolates of gram-negative bacilli. Request KNSRP / KPC (blaKPC) and NDM (blaNDM) Surveillance PCR, if testing directly from rectal or perirectal swabs is desired.
Supportive Data
The assay was validated using 159 gram-negative bacillus isolates, including 135 carbapenemase-producers (105 blaNDM positive and 30 blaKPC positive). The assay had 100% sensitivity and specificity for isolate testing compared with reference methods, including the modified Hodge test, testing for blaKPC using KPC (Klebsiella pneumoniae carbapenemase) PCR and testing for blaNDM by NDM (New Dehli metallo-beta-lactamase) PCR at the Health Protection Agency (HPA), London, UK.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
Recommendations for in-depth reading of a clinical nature
1. Cunningham SA, Noorie T, Meunier D, et al: Rapid and simultaneous detection of genes encoding Klebsiella pneumoniae carbapenemase (blaKPC) and New Delhi metallo-beta-lactamase (blaNDM) in Gram-Negative Bacilli. J Clin Microbiol 2013;51:66-69
2. Multiplex Real-Time PCR Detection of Klebsiella pneumoniae Carbapenemase (KPC) and New Delhi Metallo-beta-lactamase (NDM-1) genes. Centers for Disease Control and Prevention 2011 (unpublished)
3. CLSI Document M100-S23, Vol.33 No.1, 2013. CLSI, Wayne, PA
4. New Carbapenem-Resistant Enterobacteriaceae Warrant Additional Action by Healthcare Providers. Centers for Disease Control and Prevention Health Alert Network, February 14, 2013
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Library of PDFs including pertinent information and forms related to the test
Method Description
Describes how the test is performed and provides a method-specific reference
Describes how the test is performed and provides a method-specific reference
Isolates are lysed in buffer to release their DNA. This assay amplifies and detects a specific portion of the genes encoding the KPC (Klebsiella pneumoniae carbapenemase) and NDM (New Dehli metallo-beta-lactamase) enzymes. The LightCycler instrument amplifies and monitors target nucleic acid sequences by fluorescence during PCR cycling. This is an automated PCR system that can rapidly detect amplified product development through stringent air-controlled temperature cycling and capillary cuvettes. The detection of amplified products is based on the fluorescent-resonance energy transfer (FRET) principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3' end is excited by an external light source, which emits light that is absorbed by a second hybridization probed with an acceptor fluorophore LC-Led 610 (blaKPC specific) and LC-red 670 (blaNDM specific), on the 5' end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product. The detection process is completed in less than 1 hour using a closed tube system.(Cunningham SA, Noorie T, Meunier D, et al: Rapid and simultaneous detection of genes encoding Klebsiella pneumoniae carbapenemase (blaKPC) and New Delhi metallo-beta-lactamase (blaNDM) in gram-negative bacilli. J Clin Microbiol 2013;51:66-69)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Indicates whether the report includes an additional document with charts, images or other enriched information
No
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.
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.
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.
2 days
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
30 days
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Indicates the location of the laboratory that performs the test
Rochester
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.
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 Regional Manager. 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.
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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.
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.
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 x2
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.
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 |
|---|---|---|
| KPNRP | KPC and NDM 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.
|
|---|---|---|
| SRC53 | Specimen source | 31208-2 |
| 35168 | KPC PCR | 49617-4 |
| 35169 | NDM PCR | 73982-1 |
Test Setup Resources
Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
Normal and Abnormal sample reports are provided as references for report appearance.
SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.