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.
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.
Supporting Clinical Decision Making
Providing Laboratory Efficiency
Increasing Cost Effectiveness
| Attribute | Value |
|---|---|
| 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 |
| Sentosa SA Direct MRSA/SA PCR Test Flyer | CE-IVD | EN |
| Product | Pack Size | Item 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.