LightCycler® MRSA Advanced Test

Simple. Flexible. Reliable.

Provides accurate and reliable results for the effective prevention and control of MRSA infections

A simple, flexible and reliable way to incorporate molecular methicillin-resistant Staphylococcus aureus (MRSA)surveillance into hospital infection control programs for better care in healthcare settings.

The LightCycler® MRSA Advanced Test provides simple handling for sample preparation with ready-to-use reagents, and flexible, high-efficiency workflow whether running a single sample or a full run of 30 samples. Expect reliable results with both high relative sensitivity and high relative specificity compared to directly plated culture.

Features and Benefits

Simple

  • Ensures the safety and productivity of laboratory staff: Sample preparation without a single pipetting step minimizes the risk of repetitive strain injuries
  • Ready-to-use reagent format minimizes hands-on time and the need for specialized skills
  • Results in 2 hours for batches of 1 to 30 samples
  • Small LightCycler® footprint makes it easy to add more instruments as testing needs grow

Flexible

  • Improved turnaround time without reagent waste or significant cost increase
  • Increases throughput: Test 30 samples per run without exponentially increasing hands-on time and cost
  • Run up to 40,000 tests per year on a single instrument (1 shift, 5 days per week)
  • Validated for use with 3 swab transport media

Reliable

  • High diagnostic sensitivity and specificity*
  • Increased accuracy and reliability: the only rapid MRSA test containing Roche AmpErase enzymes, which reduces post-amplification contamination

Intended Use

The LightCycler® MRSA Advanced Test is a qualitative in vitro diagnostic test for the direct detection of nasal colonization with methicillin-resistant Staphylococcus aureus to aid in the prevention and control of MRSA infections in healthcare settings. The test, performed on the LightCycler® 2.0 Instrument with nasal swab specimens from patients suspected of colonization, uses swab extraction and mechanical lysis for specimen preparation followed by polymerase chain reaction (PCR) for the amplification of MRSA DNA, and fluorogenic target specific hybridization probes for the detection of the amplified DNA.

The LightCycler® MRSA Advanced Test is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiology typing or for further susceptibility testing.

*A 5-site, 1400-patient 2008/09 clinical trial in the United States compared LightCycler® MRSA Advanced Test performance to directly plated cultures on a chromogenic media as well as a second nucleic acid amplification technology (NAT)-based test. Preliminary analysis revealed that the LightCycler® MRSA Advanced Test is likely to deliver diagnostic sensitivity and specificity greater than 96% against chromogenic culture.