KPC (blaKPC) and NDM (blaNDM) Surveillance PCR
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Identifying carriers of carbapenem-resistant Enterobactericeae harboring KPC (Klebsiella pneumoniae carbapenemase) or NDM (New Dehli metallo-beta-lactamase) genes
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Real-Time Polymerase Chain Reaction (PCR) Using LightCycler and Fluorescent Resonance Energy Transfer (FRET)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
KPC and NDM Surveillance PCR
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Submit only 1 of the following specimens:
Specimen Type: Perianal, perirectal, rectal
Collection Container/Tube: Culture transport swab
Specimen Volume: Swab
Additional Information: Specimen source is required.
Specimen Type: Preserved Stool
Container/Tube: Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of non-nutritive transport medium containing phenol red as a pH indicator, either Cary-Blair or Para-Pak C and S)
Specimen Volume: Representative portion of stool
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
E-swab (pink cap), calcium alginate swab, cotton-tipped swab, swab sent in gel transport medium, swab send in viral or universal transport medium, frozen swab
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The Centers for Disease Control and Prevention recommends active surveillance to detect unrecognized colonized patients who may be a potential source for carbapenemase-resistant Enterobacteriaceae (CRE) transmission. Such surveillance testing may be focused in certain high-risk settings or patient groups (eg, ICUs, long-term acute care, patients transferred from areas or facilities with high CRE prevalence) or by infection control to investigate an outbreak. 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. PCR is a sensitive, specific, and rapid means identifying patients colonized by CRE harboring blaKPC or blaNDM.
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.
This PCR detects and differentiates blaKPC and blaNDM in surveillance specimens (perirectal/rectal swabs or stool). A positive KPC (Klebsiella pneumoniae carbapenemase) and/or NDM (New Dehli metallo-beta-lactamase) PCR indicates that the patient is colonized by carbapenemase-resistant Enterobacteriaceae harboring blaKPC and/or blaNDM,, respectively.
A negative result indicates the absence of detectable DNA, however false-negative results may occur due to inhibition of PCR, sequence variability underlying primers and/or probes, or the presence of the blaKPC or blaNDM genes in quantities less than the limit of detection of the assay.
Cautions 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 surveillance testing on perirectal/rectal swabs or stool specimens. Request KPNRP KPC (blaKPC) and NDM (blaNDM) in Gram-negative bacilli, Molecular Detection, PCR if testing isolates from culture.
The performance of this assay was demonstrated by spiking perirectal swab and stool specimens (30 positive and 30 negative for each specimen type) with quantified heat-killed bacteria carrying blaNDM or blaKPC. The sensitivity and specificity in spiked stool specimens was 100% for both blaNDM and blaKPC; for perirectal swabs the sensitivity and specificity was 93% and 100%, respectively, for blaKPC and 100% and 100%, respectively, for blaNDM. The assay had the following limits of detection in perirectal swabs and stool, respectively: blaKPC, 9 and 90 CFU/microliter and blaNDM 1.9 and 1.9 CFU/microliter.
In addition, 33 rectal swab specimens previously characterized as containing isolates of KPC PCR positive Enterobacteriaceae using the method of Lolans (2) were tested by the Mayo Clinic KPC and NDM PCR assay. There was complete agreement with the expected results.
Clinical Reference Provides recommendations for further 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. Lolans K, Calvert K, Won S, et al: Direct ertapenem disk screening method for identification of KPC-producing Klebsiella pneumoniae and Escherichia coli in surveillance swab specimens J Clin Microbiol 2010;48:836-841
3. New carbapenem-resistant Enterobacteriaceae warrant additional action by healthcare providers. Centers for Disease Control and Prevention Health Alert Network, February 14, 2013
4. Vasoo S, Cunningham SA, Kohner PC, et al: Comparison of a direct and broth-enriched PCR, HardyCHROM ESBL and the CDC method for detection of Klebsiella pneumoniae carbapenemase carriage in surveillance rectal swabs. Abstracts of the Ninth International Symposium on Antimicrobial Agents and Resistance, Kuala Lumpur, Malaysia, March 13-15, 2013
Method Description Describes how the test is performed and provides a method-specific reference
Perirectal swabs are processed in neutralization buffer tubes and organisms are lysed to release their genomic material. Stool specimens undergo DNA extraction prior to PCR. 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)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
3 days if received in a swab transport
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) 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 U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87798 x 2
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
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