Check-Direct CPE

Rapidly identify CPE carriers and confirm suspected CPE

Covers the clinically most prevalent carbapenemases - KPC, OXA-48, VIM and NDM - including the emerging OXA-181 variant.

  • Accurate results in 2 hours directly from rectal swabs or cultures
  • Detect KPC, OXA-48, VIM and NDM, including OXA-181
  • Enables batch testing

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An accurate and rapid method to detect KPC, OXA-48, VIM and NDM genes directly from a rectal screening swab.

- Nijhuis et al. Diagn Microbiol Infect Dis. 2013 Dec;77(4):316-20.
  • Specimen: Rectal swab

    Sample preparation: NucliSENS® easyMAG®
    Amplification and detection: ABI 7500, LightCycler® 480 system I & II

  • Specimen: Culture

    Sample preparation: crude extraction
    Amplification and detection: ABI 7500, CFX96TM, LightCycler® 480 system I & II, Rotor-Gene Q

  • Carbapenemase target genes*KPC, OXA-48, VIM, NDM
  • Controls included

    Positive controls: KPC, OXA-48, VIM, NDM
    Negative control
    Internal control

  • Limit of detection

    < 5 copies/PCR reaction for KPC, OXA-48, VIM and NDM

  • Analytical reactivity

    Tested with:
    • 19 different strains of KPC
    • 25 different strains of OXA-48
    • 17 different strains of NDM
    • 34 different strains of VIM

  • Analytical specificity

    No positive results when tested against 87 non-carbapenemase producers

  • Result

    • KPC
    • OXA-48
    • VIM/NDM

*KPC-2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 21, 22, 23, 24, 25; OXA-48, 48b, 162, 163, 181, 204, 232, 244, 245, 370; VIM-1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47; NDM-1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16.

Sample preparation - DNA extraction from rectal swabs

  • Extract DNA with NucliSENS® easyMAG® using 200 μl rectal swab fluid and 5 μl internal control solution

Sample preparation - DNA extraction from cultures

  • Prepare a 0.5 McFarland bacterial cell suspension using PCR-grade water
  • Transfer 200 μl cell suspension and 10 μl internal control solution to an Eppendorf tube
  • Heat at 98°C for 10 min
  • Vortex for 30 seconds
  • Spin down for 2 min

Real-time PCR reaction setup

  • Prepare the qPCR reaction mix using the CPE PCR Mastermix and CPE solution provided with the kit
  • To each well/tube add: 15 μl qPCR reaction mix + 10 μl DNA sample
  • Seal plate/close tubes, mix and spin down briefly
  • Start the run, using the parameters specified in the user manual


Please refer to the full protocol in the user manual when performing this assay.

Accurate results in 2 hours directly from rectal swabs or cultures

Identify CPE carriers in specific risk groups or confirm CPE in routine suspected isolates. Check-Direct CPE can be performed directly from rectal swabs or culture specimens.

The most clinically prevalent carbapenemases, including OXA-181

Detect the most clinically prevalent carbapenemases, including emerging variants such as OXA-181. Information on the type of carbapenemase present – KPC, OXA-48-like and VIM/NDM – yields extra information for epidemiology.

Enables batch testing

Easily scale up to accommodate for higher testing volumes e.g. when investigating a suspected outbreak. The most common real-time PCR systems are compatible for use with the Check-Direct CPE.

End unnecessary patient isolation sooner

Rapid and accurate results help you end unnecessary patient isolation sooner. Stay up-to-date, stay in control.

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Technology

Learn more about the technology behind our Check-Direct multiplex real-time PCR products here

Posters


Publications

  • Huang TD, Bogaerts P, Ghilani E, Heinrichs A, Gavage P, Roisin S, Willems E, Verbruggen AM, Francart H, Denis O, Senterre JM, Glupczynski Y. Multicentre evaluation of the Check-Direct CPE® assay for direct screening of carbapenemase-producing Enterobacteriaceae from rectal swabs. J Antimicrob Chemother. 2015 Jun;70(6):1669-73.
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  • Findlay J, Hopkins KL, Meunier D, Woodford N. Evaluation of three commercial assays for rapid detection of genes encoding clinically relevant carbapenemases in cultured bacteria. J Antimicrob Chemother. 2015 May;70(5):1338-42.
    Learn more
  • Lau AF, Fahle GA, Kemp MA, Jassem AN, Dekker JP, Frank KM. Clinical Performance of Check-Direct CPE, a Multiplex PCR for Direct Detection of blaKPC, blaNDM/VIM, and blaOXA48 from Perirectal Swabs. J Clin Microbiol. 2015 Dec;53(12):3729-37.
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  • Saegeman V, Van den Eynde J, Niclaes L, De Ridder D, Schuermans A, Glupczynski Y. Performance of different culture methods and of a commercial molecular assay for the detection of carbapenemase-producing Enterobacteriaceae in nursing homes and rehabilitation centers. Eur J Clin Microbiol Infect Dis. Published online ahead of print 2015 Jan 21.
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  • Nijhuis R, Samuelsen Ø, Savelkoul P, van Zwet A. Evaluation of a new real-time PCR assay (Check-Direct CPE) for rapid detection of KPC, OXA-48, VIM and NDM carbapenemases using spiked rectal swabs. Diagn Microbiol Infect Dis. 2013 Dec;77(4):316-20.
    Learn more
  • Österblad M, Lindholm L, Jalava J. Evaluation of two commercial carbapenemase gene assays, the Rapidec Carba NP test and the in-house Rapid Carba NP test, on bacterial cultures. J Antimicrob Chemother. 2016 Mar 31. Published online ahead of print Learn more
Catalog number Description
18-0080 Check-Direct CPE kit, 48 reactions*
Accessories  
18-0070 4-Color Compensation Set for Check-Direct CPE, for 1 color compensation run**

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For information about further supplies needed to run the assay, please refer to the "Materials required but not supplied" section of the respective product's user manual.

*Screening: for ABI 7500, LightCycler® 480 system I & II; Confirmation: for ABI 7500, CFX96TM, LightCycler® 480 system I & II, Rotor-Gene Q.
**for use on the LightCycler® 480 system I & II.