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cobas® MRSA/SA Test

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Effective surveillance that enables time-saving efficiencies and lifesaving answers

The need for an effective screening program
 

Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) infections represent a critical threat to public health.

  • Conventional culture-based screening methods require sample incubation which can delay the implementation of infection control measures.
  • More general infection control measures that apply to all patients may provide increased opportunity for transmission.
  • Active surveillance to identify MRSA/SA carriers is helping to mitigate the potential consequences of disease, providing relief to patients and health care institutions facing the challenges of escalating costs.

The cobas® MRSA/SA Test for use on the cobas® 4800 System uses a single nasal swab specimen to detect both MRSA and SA targets in a single sample run to deliver high quality results in a matter of hours.

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Powered by PCR

cobas® MRSA/SA lets you quickly and confidently identify colonized patients for timely implementation of appropriate barrier precautions.

  • Polymerase chain reaction (PCR) technology ensures exceptional performance, enabling decisive action.
  • High sensitivity and specificity demonstrated compared to a CE-marked and FDA-cleared nucleic acid amplification test (NAAT).

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  Sensitivity Specificity Positive Predictive Value Negative Predictive Value
MRSA* 93.1% 97.5% 71.6% 99.5%
SA* 93.9% 94.2%
 85.3% 97.7%
2,504 evaluable results.

High-quality results when they’re needed most

Less hands-on time means more walk-away time and reduced chance of error

Save time with first-of-its-kind primary vial loading using the MSwab™ system.

  • Specimens are collected on a FLOQSwab™ and transferred directly into the primary vial for testing
  • Simplify data interpretation with patented, state-of-the-art software algorithms
  • Flexibility to run 4 to 5 small runs or 2 high-volume runs for up to 194 results/day
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Run specimens with automated efficiency on the cobas® 4800 System

Process specimens using one of the fastest, most advanced real-time PCR amplification and detection methods available today.

  • cobas® MRSA/SA requires up to 93% less hands-on time compared to other molecular tests for 94 samples
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Increased testing flexibility

Parallel sample processing capabilities for the cobas® 4800 System allow you to run different tests and sample types in one run for a streamlined testing portfolio.

  • Nasal (cobas® MRSA/SA)
  • Stool (cobas® Cdiff)
  • Anogenital lesions (cobas® HSV 1 and 2)

Intended use

 

The cobas® MRSA/SA Test on the cobas® 4800 system is a qualitative in vitro diagnostic real-time PCR assay, for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA from nasal swabs to aid in the prevention and control of MRSA and SA infections in healthcare settings. The cobas® MRSA/SA Test is not intended to diagnose, guide or monitor treatment for MRSA or SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary only to recover organisms for epidemiology typing or for further susceptibility testing.

 

Registration status

US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

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