Hospital-Acquired Infections

Hospital-acquired infections may prolong institutional stays, create long-term disability, and place a tremendous financial burden on health systems. Roche Molecular Diagnostics offers both diagnostic and research-oriented assays to accurately and reliably detect these potentially deadly infections.

In developed and developing countries, 7–10% of hospitalized patients will acquire an HAI.1

Rapid diagnostic techniques, like the cobas® MRSA/SA Test, enable the early detection of methicillin-resistant Staphylococcus aureus (MRSA) in colonized patients, supporting the timely implementation of appropriate barrier precautions.

Reference:

1. World Health Organization (WHO). Health care-associated infections Fact Sheet. http://www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf. Accessed May 11, 2016.

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cobas® 4800 system

For reliable real-time PCR for medium- to high-throughput labs, the cobas® 4800 system was engineered to inspire confidence. It uses the latest generation of LightCycler Technology to deliver reproducible results and represents a new standard in innovation.

For more information, visit: https://www.rochemicrobiologytests.com/cobas-4800-system-test-menu.html

TESTS:

cobas® MRSA/SA Test,

cobas® Cdiff Test,

LightCycler® VRE Research Use Only Detection Kit

cobas® MRSA/SA Test

cobas-4800-mrsa

Faster than a spreading infection 

The cobas® MRSA/SA Test detects both targets in a single sample run to deliver high quality results in a matter of hours.

Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) infections represent a critical threat to public health. The cobas® MRSA/SA Test provides innovative solutions for detecting both organism variances from a single nasal swab specimen, providing time-saving efficiencies and lifesaving answers.

Features and Benefits

Performance

  • Quickly identify colonized patients and take decisive action
  • Get the sensitivity and specificity that only PCR technology can deliver

Workflow

  • Save time with first-of-its-kind primary sample vial loading
  • Run MRSA/SA and HSV 1 and 2 samples at the same time, on the same system
  • Simplify data interpretation with patented, state-of-the-art software algorithms

Efficiency

  • Run 6 to 94 specimens using the fastest, most advanced real-time PCR amplification and detection available today

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. 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.

Learn more at: https://www.rochemicrobiologytests.com/healthcare-associated-infections/mrsa-sa-testing.html

cobas® Cdiff Test

Molecular detection moves C. difficile testing forward 

Traditional methods for identification of Clostridium difficile (C.difficile) include toxigenic culture, which is labor intensive and slow, and enzyme immunoassays (EIA), which have limited sensitivity. Algorithms have been developed using combinations of EIA testing to overcome shortcomings of individual assays. However, these algorithms may introduce delays in reporting results to physicians, which adversely impacts patient management. 

Molecular technologies (including nucleic acid amplification tests [NAAT]) offer better sensitivity and turnaround time in identifying toxigenic C. difficile when compared to several other approaches (glutamate dehydrogenase [GDH] assay, toxin A and B immunoassay, cell culture cytotoxicity neutralization assay), either alone or in combination.

In recent years, the frequency and severity of C. difficile-associated disease has continued to increase, prompting a need for rapid and reliable C. difficile testing, particularly in vulnerable elderly populations. By rapidly detecting C. difficile in patient stool samples, the cobas® Cdiff Test combines high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps, to facilitate earlier intervention of patients suffering from C. difficile-associated disease.

Workflow

  • Accuracy delivered efficiently 
    • The cobas® Cdiff Test requires only 3 simple steps for sample prep
    • Requires minimum sample handling
  • Less hands-on time means more walk-away time 
    • Requires up to 74% less hands-on time than competitor platforms

Performance

The cobas® Cdiff Test samples can be run with different tests and sample types in one run.

Run mixed batch assays of: 

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

Intended Use 

The cobas® Cdiff 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 the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having a C. difficile infection (CDI). The cobas® Cdiff Test is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

For more information, visit:

https://www.rochemicrobiologytests.com/healthcare-associated-infections/clostridium-difficile-testing.html

LightCycler® VRE Research Use Only Detection Kit

Detection of vancomycin resistance genes (vanA/vanB) in Enterococcus spp. in research samples only.

This kit provides the necessary amplification and detection reagents required for the detection and differentiation of vancomycin resistance genes in Enterococcus spp. (vanA, vanB, vanB2/3) on the LightCycler® 2.0 Instrument.

Features and Benefits

  • Internal Control (IC) identifies specimens with inhibitors of the amplification process to maximize kit reliability
  • IC is amplified with the same primers as the target DNA but detected in a separate fluorescence channel
  • Allows detection and differentiation of vancomycin resistance genes with minimal handling
  • Enzyme components and buffers are supplied as ready-to-use mixes, standards are predispensed
  • Analyzes 48 samples/56 reactions
  • Can be used with the High Pure PCR Template Preparation Kit or MagNA Pure LC Total Nucleic Acid Isolation Kit for sample preparation

Speed

  • Automated extraction and amplification on the MagNA Pure LC System and LightCycler® 2.0 Instrument deliver results within 3 hours

Convenience

  • All kit components are provided in ready-to-use solutions

• Detection and differentiation by melting curve within one run

Safety

• IC identifies specimens containing factors causing inhibition of the amplification process

Flexibility

• Can be combined with the LightCycler® MRSA Research Use Only Detection Kit in one run due to a common thermal profile