Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

Roche Diagnostics

Develops, manufactures, and markets a wide range of in vitro diagnostic systems, instruments, reagents, and tests read more Featured Products: More products

Download Mobile App




Automated MRSA/SA Test Receives US FDA Approval

By LabMedica International staff writers
Posted on 09 Feb 2015
An automated real-time polymerase chain reaction (PCR) assay for the detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA directly from nasal swabs has been certified for diagnostic use in the United States.

The [US] Food and Drug Administration (FDA) has issued 510(k) clearance, which allows marketing as a diagnostic tool, for the Roche (Basel, Switzerland) cobas MRSA/SA Test for the early, simultaneous detection of MRSA and SA directly from nasal specimens.

The cobas MRSA/SA assay was developed for use on the cobas 4800 system. More...
This system was designed to automatically perform real-time PCR for medium- to high-throughput laboratories (up to 384 samples a day). The system incorporates fully automated sample preparation from primary vials with ready-to-use, load-and-go reagents. No thawing or mixing is required and a full run of 94 samples can be set up in less than 20 minutes.

The cobas MRSA/SA Test joins the expanding US system menu that currently includes the cobas CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600 Mutation Test, and the cobas EGFR Mutation Test.

"Healthcare-associated infections continue to be a leading cause of mortality in US medical settings," said Paul Brown, head of Roche Molecular Diagnostics. "With the addition of the cobas MRSA/SA Test to our expanding menu of tests for the cobas 4800 System, Roche offers laboratories and clinicians a highly efficient molecular solution to aid in the overall management and prevention of healthcare-associated infections, leading to lower costs for hospitals and optimal patient care."

Related Links:

Roche 



Gold Member
Fibrinolysis Assay
HemosIL Fibrinolysis Assay Panel
POC Helicobacter Pylori Test Kit
Hepy Urease Test
Clinical Chemistry System
P780
Rapid Molecular Testing Device
FlashDetect Flash10
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: The diagnostic device can tell how deadly brain tumors respond to treatment from a simple blood test (Photo courtesy of UQ)

Diagnostic Device Predicts Treatment Response for Brain Tumors Via Blood Test

Glioblastoma is one of the deadliest forms of brain cancer, largely because doctors have no reliable way to determine whether treatments are working in real time. Assessing therapeutic response currently... Read more

Immunology

view channel
Image: Circulating tumor cells isolated from blood samples could help guide immunotherapy decisions (Photo courtesy of Shutterstock)

Blood Test Identifies Lung Cancer Patients Who Can Benefit from Immunotherapy Drug

Small cell lung cancer (SCLC) is an aggressive disease with limited treatment options, and even newly approved immunotherapies do not benefit all patients. While immunotherapy can extend survival for some,... Read more

Technology

view channel
Image: Vitestro has shared a detailed visual explanation of its Autonomous Robotic Phlebotomy Device (photo courtesy of Vitestro)

Robotic Technology Unveiled for Automated Diagnostic Blood Draws

Routine diagnostic blood collection is a high‑volume task that can strain staffing and introduce human‑dependent variability, with downstream implications for sample quality and patient experience.... Read more

Industry

view channel
Image: Roche’s cobas® Mass Spec solution enables fully automated mass spectrometry in routine clinical laboratories (Photo courtesy of Roche)

New Collaboration Brings Automated Mass Spectrometry to Routine Laboratory Testing

Mass spectrometry is a powerful analytical technique that identifies and quantifies molecules based on their mass and electrical charge. Its high selectivity, sensitivity, and accuracy make it indispensable... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.