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cobas® MRSA/SA Test

Product image for cobas® MRSA/SA Test

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.

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)
View Full Table
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  MRSA* SA*
Sensitivity 93% 94%
Specificity 99% 97%
Positive Predictive Value 85% 96%
Negative Predictive Value 99% 96%
* Performance comparison in a study of 379 samples.

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 an automated, qualitative, in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), 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. Concomitant cultures are necessary only to recover organisms for epidemiology typing or for further susceptibility testing.

Registration status

CE-IVD

Package inserts

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

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