Test Catalog

Test Id : KPNRP

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KPC (blaKPC) and NDM (blaNDM) in Gram-Negative Bacilli, Molecular Detection, PCR, Varies

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Overview

Test Catalog

Useful For
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

Method Name
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.

Yes

Reporting Name
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

Varies

Ordering Guidance

This assay is for testing of isolates of gram-negative bacilli. If testing directly from rectal or perirectal swabs is desired, order KPNDP / Klebsiella pneumoniae Carbapenemase (blaKPC) and New Delhi Metallo-beta-Lactamase (blaNDM) Surveillance, PCR, 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.

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

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 or New Delhi metallo-beta-lactamase DNA is unlikely.

 

Supplies: Infectious Container, Large (T146)

Container/Tube: Slant

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

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 cultures 		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

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

Nonsusceptibility to carbapenems in gram-negative bacilli by means of the enzyme KPC (Klebsiella pneumoniae carbapenemase) or NDM (New Delhi 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 determines the level but not the mechanism of resistance. Polymerase chain reaction testing 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.

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

This polymerase chain reaction (PCR) test detects and differentiates both blaKPC and blaNDM. A positive KPC (Klebsiella pneumoniae carbapenemase) PCR result indicates the isolate carries blaKPC. A positive NDM (New Delhi metallo-beta-lactamase) PCR result 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, 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

No significant cautionary statements

Supportive Data

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP): Multiplex real-time PCR detection of Klebsiella pneumoniae carbapenemase (KPC) and New Delhi metallo-beta-lactamase (NDM-1) genes. CDC; 2011. Accessed February 14, 2023. Available at www.cdc.gov/hai/settings/lab/kpc-ndm1-lab-protocol.html

2. Clinical Laboratory Standards Institute (CLSI): Performance Standards for Antimicrobial Susceptability Testing. 32nd ed. CLSI Document M100. CLSI; 2022

3. Centers for Disease Control and Prevention: New carbapenem-resistant Enterobacteriaceae warrant additional action by healthcare providers. CDC; February 14, 2013. Accessed February 14, 2023. Available at https://stacks.cdc.gov/view/cdc/25250

4. Bialvaei AZ, Kafil HS, Asgharzadeh M, Yousef Memar M, Yousefi M: Current methods for the identification of carbapenemases. J Chemother. 2016;28(1):1-19

Special Instructions
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

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 Delhi metallo-beta-lactamase) enzymes. The LightCycler instrument amplifies and monitors target nucleic acid sequences by fluorescence during polymerase chain reaction (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, Woodford N, Patel R. Rapid and simultaneous detection of genes encoding Klebsiella pneumoniae carbapenemase (blaKPC) and New Delhi metallo-ß-lactamase (blaNDM) in Gram-negative bacilli. J Clin Microbiol. 2013 Apr;51(4):1269-71. doi: 10.1128/JCM.03062-12. Erratum in: J Clin Microbiol. 2013 Oct;51(10):3472)

PDF Report
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.

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.

2 days

Specimen Retention Time
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

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.

  • 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 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.

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.

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.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

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.

SI Normal Reports | SI Abnormal Reports