Test Catalog

Test Id : KPNDP

Order This Test

Klebsiella pneumoniae Carbapenemase (blaKPC) and New Delhi Metallo-beta-Lactamase (blaNDM) Surveillance, PCR, Varies

Download
Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identifying carriers of carbapenem-resistant gram-negative bacilli harboring Klebsiella pneumoniae carbapenemase or New Delhi metallo-beta-lactamase genes

Highlights

This test detects Klebsiella pneumoniae carbapenemase (blaKPC) and New Delhi metallo-beta-lactamase (blaNDM) DNA (associated with antimicrobial resistance) in perirectal/rectal/perianal/anal swabs or fecal specimens.

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR) using LightCycler and Fluorescent Resonance Energy Transfer (FRET)

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 Surveillance, PCR

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

This assay should be used for surveillance testing on perirectal/rectal/perianal, anal swabs, or fecal specimens only. If testing isolates from culture, order KPNRP / KPC (blaKPC) and NDM (blaNDM) in Gram-Negative Bacilli, Molecular Detection, PCR, Varies.

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
KNSS 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 or New Delhi metallo-beta-lactamase DNA is not likely.

 

Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Perianal, anal, perirectal, rectal

Supplies: Culturette (BBL Culture Swab) (T092)

Container/Tube: Culture transport swab (Dacron or rayon swab with aluminum or plastic shaft with either Stuart or Amies liquid medium)

Specimen Volume: Swab

Specimen Stability Information: Refrigerated (preferred)/Frozen

 

Acceptable:

Specimen Type: Preserved feces

Supplies: Culture and Sensitivity Stool Transport Vial (T058)

Container/Tube: Commercially available transport system specific for recovery of enteric pathogens from fecal specimens (15 mL of nonnutritive transport medium containing phenol red as a pH indicator, either Cary-Blair or Para-Pak C and S vial)

Specimen Volume: Representative portion of feces

Collection Instructions:

1. Collect fresh feces and submit 1 gram or 5 mL in container with transport medium.

2. Place feces in preservative within 2 hours of collection.

Specimen Stability Information: Ambient (preferred)/Refrigerated

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

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

E-swab
Calcium alginate swab
Cotton-tipped swab
Swab sent in gel transport medium
Swab sent in viral or universal transport medium 		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 Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identifying carriers of carbapenem-resistant gram-negative bacilli harboring Klebsiella pneumoniae carbapenemase or New Delhi metallo-beta-lactamase genes

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 carbapenem-resistant (drug-resistant) Enterobacteriaceae (CRE) transmission. Such surveillance testing may be focused on certain high-risk settings or patient groups (eg, intensive care units, 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 Klebsiella pneumoniae carbapenemase (KPC) or New Delhi metallo-beta-lactamase (NDM) is becoming more common. The genes blaKPC and blaNDM encode KPC and NDM enzyme production, respectively. Polymerase chain reaction testing 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.

Negative

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

This polymerase chain reaction (PCR) test detects and differentiates blaKPC and blaNDM in surveillance specimens (perirectal/rectal/perianal/anal swabs or feces). A positive Klebsiella pneumoniae carbapenemase (KPC) and/or New Delhi metallo-beta-lactamase (NDM) PCR result indicates that the patient is colonized by a gram-negative bacillus (or gram-negative bacilli) harboring a carbapenemase gene, blaKPC and/or blaNDM, respectively.

 

A negative result indicates the absence of detectable DNA.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

False-negative results may occur due to inhibition of polymerase chain reaction, sequence variability underlying primers and probes, or the presence of the blaKPC or blaNDM genes in quantities lower than the limit of detection of the assay.

Supportive Data

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 were 100% for both blaNDM and blaKPC; for perirectal swabs, the sensitivity and specificity were 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 (colony-forming unit)/microliter and blaNDM 1.9 and 1.9 CFU/microliter.

 

In addition, 33 rectal swab specimens previously characterized as containing isolates of Klebsiella pneumoniae carbapenemase (KPC) polymerase chain reaction (PCR)-positive Enterobacteriaceae using the method of Lolans(1) were tested by the Mayo Clinic KPC and New Delhi metallo-beta-lactamase (NDM) PCR assay. There was complete agreement with the expected results.

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

1. Lolans K, Calvert K, Won S, Clark J, Hayden MK: Direct ertapenem disk screening method for identification of KPC-producing Klebsiella pneumoniae and Escherichia coli in surveillance swab specimens J Clin Microbiol. 2010 Mar;48(3):836-841. doi: 10.1128/JCM.01988-09.

2. Centers for Disease Control and Prevention (CDC). New carbapenem-resistant Enterobacteriaceae warrant additional action by healthcare providers. Centers for Disease Control and Prevention Health Alert Network; February 14, 2013. Accessed October 10, 2022. Available at https://stacks.cdc.gov/view/cdc/25250

3. 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 polymerase chain reaction (PCR). This assay amplifies and detects a specific portion of the genes encoding the Klebsiella pneumoniae carbapenemase (KPC) and New Delhi metallo-beta-lactamase (NDM) 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, Woodford N, Patel R: 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 Apr;51(4):1269-1271. doi: 10.1128/JCM.03062-12)

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.

1 to 4 days

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, 7 days if received in C and S vial

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.

87798 x 2

87999 (if appropriate for government payers

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
KPNDP KPC and NDM Surveillance, 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.
KNSS Specimen Source 31208-2
618315 KPC PCR 49617-4
618316 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 | 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

Test Update Resources

Change Type Effective Date
New Test 2022-12-20