Ordering Recommendation

Detect the presence of predominant carbapenemase genes (blaKPC, blaNDM, blaVIM, blaOXA-48, blaIMP) responsible for resistance to carbapenem and other beta-lactam antibiotics. Test is performed on rectal swab specimen.

New York DOH Approval Status

This test is not New York state approved. There are no New York state-approved laboratories available. Submit a Non-Permitted Laboratory Request Form (NPL) to the NYDOH prior to collection of specimen. If NPL is approved by NYDOH, and sample is received at ARUP, testing will be performed.

Specimen Required

Patient Preparation
Collect

Rectal eSwab. Refer to collection instructions at https://www.aruplab.com/Specimen-Handling/resources/pdf/rectal-eswab.pdf

Specimen Preparation

Transport rectal swab in eSwab transport media (ARUP Supply #45877) available online through eSupply using ARUP ConnectTM or contact ARUP Client Services at (800) 522-2787. Place each specimen in an individually sealed bag.

Storage/Transport Temperature

Refrigerated. Also acceptable: Frozen.

Unacceptable Conditions
Remarks

Specimen source required.

Stability

Ambient: 48 hours; Refrigerated: 6 days; Frozen: 6 days

Methodology

Qualitative Polymerase Chain Reaction

Performed

Sun-Sat

Reported

1-2 days

Reference Interval

Not Detected

Interpretive Data

This assay detects five carbapenemase gene families (blaKPC, blaNDM, blaOXA-48, blaVIM, blaIMP) encoding enzymes that may confer resistance to carbapenem and other beta-lactam antibiotics. This assay is intended for use as an aid to infection control in the detection of carbapenem-resistant bacteria and is not intended to guide or monitor treatment of infection. A negative result does not exclude the presence of other resistance mechanisms or assay-specific nucleic acid in concentrations below the level of detection.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Modified FDA

Note

This assay will generate a negative IMP result when testing samples containing IMP-7, IMP-13 or IMP-14 gene sequences, and may detect IMP-4 at reduced sensitivity. False-negative results may be encountered in rectal specimens with Pseudomonas aeruginosa containing the blaVIM gene and with Acinetobacter baumanii containing blaIMP gene.

Hotline History

N/A

CPT Codes

87798

Components

Component Test Code* Component Chart Name LOINC
2014278 KPC gene by PCR 49617-4
2014279 NDM gene by PCR 73982-1
2014280 OXA-48 gene by PCR 63368-5
2014281 VIM gene by PCR 63368-5
2014282 IMP gene by PCR 63368-5
2014283 CarbaR Interpretation 48767-8
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • carbapenem-resistance
  • carbapenemase
  • CRE
  • Enterobacteriaceae
  • IMP
  • Klebsiella pneumoniae carbapenemase
  • KPC
  • MDR
  • multi-drug resistance
  • NDM
  • NewDelhi metallo-B-lactamase
  • OXA-48
  • resistance mechanism
  • VIM
Antimicrobial Susceptibility - Surveillance Carbapenemase Gene Detection by PCR