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Test ID: KNSRP    
KPC (blaKPC) and NDM (blaNDM) Surveillance PCR

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

Identifying carriers of carbapenem-resistant Enterobactericeae harboring KPC (Klebsiella pneumoniae carbapenemase) or NDM (New Dehli 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 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.

Not applicable

Interpretation Provides information to assist in interpretation of the test results

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.

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 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