Assays

Identify, control, and prevent the spread of CPO

  • The European CDC states that pathogens resistant to carbapenems are one of the biggest threats to patient safety1
  • A large proportion of carbapenem-resistant Enterobacteriaceae (CRE) infections currently lack effective and relatively safe antibiotic treatment options2
  • CRE patients are 3 times more likely to receive inappropriate empiric therapy than non-CRE patients (46.5% vs 11.8%) resulting in longer hospital stays and increased system cost3
  • Carbapenemase genes KPC and OXA-48 were found most frequently in carbapenemase resistant Klebsiella pneumoniae and Escherichia coli4

Screening for colonisation is a key component of CPO control5

<strong>Screening for colonisation is a key component of CPO control<sup>5</sup></strong>
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Active surveillance can reduce transmission of CPO in healthcare settings6,7
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Screening hospital inpatients for CPO can be cost-effective and even cost-saving7
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Hospitals in the Netherlands and UK have estimated the economic impact of an out-break in their facilities to be approximately €1,000,0008,9
The European Centre for Disease Prevention and Control recommends investing while prevalence is low, as once an endemic situation is reached, it is more costly and less effective10

BD MAX™ Check-Points CPO assay is an integrated molecular screening solution

  • Provides results for the five most common carbapenemase genes in Gram-negative bacteria
  • Test can be processed from rectal swabs
KPC
OXA-48*
NDM
VIM/IMP
* OXA-48 and OXA-48 like
  • Results in <2.5 hours compared to culture which can take up to 48 hours
  • Fully integrated on the BD MAX™ System, a fully automated molecular system capable of running BD and partner developed assays as well as laboratory-developed tests
Improved patient management

Improved patient
management

Workflow efficiency

Workflow
efficiency

Fast screening results

Fast screening
results

The BD MAXTM Cdiff assay provides rapid detection of the C. difficile toxin B gene (tcdB),
the gene essential for CDI1, including infections caused by hypervirulent strains

  • CDI is the most important (preventable) infective cause of healthcare-associated diarrhoea in Europe and is associated with high morbidity and mortality2
  • The BD MAX™ Cdiff assay is a real time polymerase chain reaction (PCR) assay offering diagnostic speed and accuracy to allow fast treatment decisions and prevent transmission of infection3
  • Traditional diagnostic methods can be time-consuming (toxigenic culture or cell cytotoxicity neutralization assay) or may have poor sensitivity (glutamate dehydrogenase assays)4-5
  • PCR is recommended by ESCMID guidelines as a primary test in a 2-step algorithm for diagnosis of CDI2
  • The BD MAX™ Cdiff assay is integrated on the fully automated BD MAX™ System and is run compatible with
    other healthcare associated infection (HAI) assays3
  • Results are available in approximately 2 hours with only 1 minute of hands-on time per specimen3
Improved patient management

Improved patient
management

Improved workflow

Workflow
efficiency

Increased accuracy of detection

Diagnostic
accuracy


Characteristics of the BD MAX™ Cdiff assay

Test Sample type2 Storage and Stability2 Target
BD MAX™ Cdiff
  • Unpreserved stool
  • Specimens can be stored for up to 120 hours (5 days) at 2–8°C or for up to 48 hours at 2–25°C before testing
  • Transport should occur at 2–25°C
  • Clostridioides difficile* toxin B gene (tcdB)
Test BD MAX™ Cdiff
Sample type2
  • Unpreserved stool
Storage and Stability2
  • Specimens can be stored for up to 120 hours (5 days) at 2–8°C or for up to 48 hours at 2–25°C before testing
  • Transport should occur at 2–25°C
Target
  • Clostridioides difficile* toxin B gene (tcdB)
BD MAX™ Check-Points CPO assay

CPO, Carbapenemase-Producing Organisms; CRE, carbapenem-resistant Enterobacteriaceae; IMP, imipenemase; KPC, Klebsiella pneumoniae carbapenemase; NDM, New Delhi metallo-β-lactamase; OXA, oxacillinase; VIM, Verona integron-encoded metallo-β-lactamase.

 

1. World Health Organization. Infection prevention and control; 2017. Available at: http://www.who.int/infection-prevention/publications/guidelines-cre/en/. Updated 2017, Accessed May 2020. 2. David S et al. Nat Microbiol. 2019;4:1919–29. 3. Grundmann H et al. Lancet Infect Dis. 2017;17:153–63. 4. Zilberberg M et al. BMC Infect Dis. 2017;17(1):279. 5. Banerjee R, Humphries R. Virulence. 2017;8(4):427-439. 6. Antonelli A et al. Diagn Microbiol Infect Dis. 2016;86(1):30-34. 7. Lapointe-Shaw L, et al. Eur J Clin Microbiol Infect Dis. 2017;36(6):1047-1055. 8. Mollers M et al. Emerg Infect Dis. 2017;23(9):1574-1576. 9. Otter JA et al. Clin Microbiol Infect. 2017;23(3):188-196. 10. European Centre for Disease Prevention and Control. Carbapenem-resistant Enterobacteriaceae; 2006. Available at: https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/carbapenem-resistant-enterobacteriaceae-risk-assessment-april-2016.pdf. Updated April 2016, Accessed May 2020.