Assays

Targeted screening tests
for detection & prevention of HA-MRSA and S. aureus infections

The burden of Surgical Site Infections (SSIs)

  • SSIs are the most common healthcare-associated infections (HAIs) in Europe – the rate of SSIs varies from 0.5% to 10.1%1
  • S. aureus can cause community-acquired and healthcare-acquired infections ranging from skin and soft tissue infections to sepsis and death
  • Patients with an SSI have a 2 to 11 times higher rate of mortality as compared to surgical patients without an SSI2
  • Asymptomatic nasal carriers of S. aureus have a risk of HAI three to six times higher than among non-carriers3-5
  • Most infections in carriers are endogenous infections6
  • The number of surgical-site S. aureus infections acquired in the hospital can be reduced by rapid PCR screening and decolonisation of nasal carriers of S. aureus upon admission7
  • Patients asymptomatically colonised with MRSA are a substantial reservoir for person-to-person spread in the hospital8
  • BD MAX™ MRSA XT detects 11 MREJ genotypes plus mecA drop-out mutants and the mecC gene9
  • BD MAX™ StaphSR detects both S. aureus and MRSA with the same Extended Detection Technology as the BD MAX™ MRSA XT assay10
  • Results for up to 24 patients in just over 2 hours to allow institutions to implement effective infection control procedures, thus avoiding transmission and subsequent infections9,10
  • Fully integrated on the BD MAX™ System with ready to use reagents stored at room temperature on a fully automated platform

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™ MRSA XT and StaphSR assays

HAI, healthcare-associated infections; MREJ, mec(SCCmec)-orfX right-extremity junction; MRSA, Methicillin-Resistant Staphylococcus aureus; KPC, Klebsiella pneumoniae carbapenemase; MSSA, Methicillin-Susceptible Staphylococcus aureus; PCR, polymerase chain reaction; SSI, surgical site intervention.

 

1. European Centre for Disease Prevention and Control. Healthcare-associated infections: surgical site infections. Annual epidemiological report for 2017. Accessed March 2020. 2. Nelson and Williams. Infectious Disease Epidemiology. Burlington, MA, Jones and Bartlett Publishers. 2014:Chapter 14;383. 3. Luzar MA et al. N Engl J Med 1990. 4. Kluytmans JA. J Infec Dis 1995. 5. Nouwen J et al. JCM 2006. 6. Bode LGM, Prevention of Healthcare associated Staphylococcus aureus infections 2014 thesis. 7. Bode, L. G. et al (2010). N Engl J Med 362(1): 9-17. 8. Sydnor E et al 2011 Clin Microbiol Rev. 9. BD MAX™ MRSA XT [Package Insert]. Sparks, MD: Becton, Dickinson and Company. 10. BD MAX™ StaphSR [Package Insert]. Sparks, MD: Becton, Dickinson and Company.