Sentosa® SA Direct MRSA/SA PCR Test

Fast detection and differentiation of MRSA targets

RELEVANCE

Staphylococcus aureus is a major cause of nosocomial infections with clinical manifestations ranging from pustules to sepsis and death.1 The pathogen is usually transmitted through the contaminated hands of a person carrying S. aureus. Treatment of S. aureus infections has become a real challenge with the emergence of strains resistant to previously effective antimicrobial agents.

Methicillin-resistant S. aureus (MRSA) is a bacterium responsible for several difficult-to-treat infections in humans. MRSA is a strain of S. aureus that has developed resistance to beta-lactam antibiotics, including penicillins (methicillin, dicloxacillin, nafcillin, oxacillin, etc.) and cephalosporins. MRSA infections are associated with high mortality, morbidity, and costs. Thus, preventing and control of MRSA infection is a high priority in many hospitals. Conventional techniques used for detection of S. aureus and MRSA require culturing and isolation of pure colonies, which are time-consuming and labour-intensive.2

Using real-time polymerase chain reaction (PCR)-based assays for S. aureus and MRSA screening and diagnosis provides faster results than conventional techniques and can lead to appropriate control and prevention of S. aureus and MRSA infections.

References:

1) Centers for Disease Control and Prevention. Methicillin-resistant Staphylococcus aureus skin or soft tissue infection in the state prison-Mississippi. MMWR Morb Mortal Wkly Rep. 2000;50:919– 922.

2) Brown, D.F. et al. Guidelines for the laboratory diagnosis and susceptibility testing of methicillin-resistant Staphylococcus aureus (MRSA). J Antimicrob Chemother. 2005;56, 1000–1018. 

INTENDED USE

The Sentosa SA Direct MRSA/SA PCR Test is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test for qualitative detection of Staphylococcus aureus (SA) and methicillin-resistant S. aureus (MRSA) from nasal swabs in patients at risk for nasal colonization.

This test is validated for use with Sentosa SX Lysis Beads, followed by manual PCR set-up, in conjunction with PCR on the Rotor-Gene MDx 5plex HRM instrument and automated result calling and report generation with Sentosa SA Reporter.

The Sentosa SA Direct MRSA/SA PCR Test is intended to aid in the prevention and control of MRSA/SA infections in healthcare settings. It is not intended to diagnose, guide or monitor treatment for MRSA/SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

FEATURES AND BENEFITS

Supporting Clinical Decision Making

  • Sensitive and robust
  • Differentially detects MRSA and SA
  • Detects type I to VII and XI SCCmec/orfX cassettes
  • Detects new MRSA strain mecC

Providing Laboratory Efficiency

  • Very short turn-around time: 2 hours and 26 minutes for 24 samples 
  • Only 40 minutes of hands-on work
  • Automatic result call-out within 2 minutes
  • Tests up to 216 reactions/day (3 runs per day).

Increasing Cost Effectiveness

  • Three targets in one test to save reagents and consumables
  • Flexibility to test 1 – 72 reactions per run
  • Comprehensive and fast result call-out to reduce patient management cost

WORKFLOW

SPECIFICATIONS

AttributeValue
Analytical Sensitivity

SA: 50 CFU/swab (95% CI: 20.02 – 124.89 CFU/swab)

MRSA: 200 CFU/swab (95% CI: 84.59 – 472.85 CFU/swab)

Analytical Reactivity

9 SCCmec types (I, II, III, IV, V, VI, VII, VIII and XI)

11 PFGE types (USA100, USA200, USA300, USA400, USA500, USA600, USA700, USA800, USA900, USA1000 and USA1200)
Analytical Specificity No cross-reactivity with 138 other microorganisms tested
Clinical Sensitivity

SA: 100% (95% CI: 95.91 – 100%);

MRSA: 95.56% (95% CI: 89.12 - 98.26%)

Clinical Specificity

SA: 100% (95% CI: 95.91 - 100%)

MRSA: 100% (95% CI: 95.91 - 100%)

Reproducibility

99.77% (95% CI: 98.70 - 99.96%)

Sample Type(s) Nasal swabs

PRODUCT FLYERS

Sentosa SA Direct MRSA/SA PCR Test Flyer CE-IVD EN

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SA Direct MRSA/SA PCR Test (4x24) CE-IVD 4x24 300247
Sentosa SA Direct MRSA/SA PCR Test (4x24) RUO 4x24 300244
Sentosa SX Lysis Beads (96) RUO 96 tubes 300141
Sentosa SX Lysis Beads (CE-IVD) 96 tubes 300291

For availability in your country, please contact your Vela Diagnostics sales representative.