We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
Sekisui Diagnostics

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




Rapid Strep A PCR Test Approved for Use Outside Traditional Clinical Labs

By LabMedica International staff writers
Posted on 01 Jun 2015
A 15-minute diagnostic test for the detection of Streptococcus A (Strep A) in throat cultures that was designed to be run on a user-friendly, automated PCR platform has been granted a CLIA (Clinical Laboratory Improvement Amendments) waiver from the [US] Food and Drug Administration.

The CLIA waiver allows use of the Roche (Basel, Switzerland) cobas Liat System Strep A test in nontraditional laboratory sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics, and other healthcare facilities.

The cobas Liat System is a rapid, easy-to-use, compact PCR platform designed for on-demand testing in point-of-care settings such as physician clinics, pharmacy, and hospital and satellite laboratories. More...
The system is fully-automated with touchscreen guided operation, requiring minimal training and hands-on time. The system includes the cobas Liat Analyzer—a small, benchtop analyzer safeguarded by an extensive array of instrument controls—plus a growing portfolio of assays, including cobas Influenza A/B, cobas Influenza A/B and RSV, and cobas Strep A.

“Today’s decision allows the cobas Strep A test to be utilized in clinical settings that previously relied on rapid antigen technology, which is less sensitive and often requires confirmatory testing,” said Roland Diggelmann, COO of Roche Diagnostics. “The approximately 15-minute turnaround time of the cobas Strep A test offers a much improved experience for both the patient and the health care professional when compared to culture testing, which can take several days for a result.”

Related Links:
Roche



Platinum Member
Automated Coagulation Analyzer
Hemolumi H6
Gold Member
Clinical Chemistry Assay
Sorbitol Dehydrogenase (SDH)
New
Gastrointestinal Panel
Xpert® GI Panel
Automated Clinical Chemistry Analyzer
Envoy 500+
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

Clinical Chemistry

view channel
Image Credit: 123RF

Screening After Pneumococcal Disease May Reveal Undiagnosed Blood Cancer or Immune Disorders

Severe pneumococcal disease requiring hospitalization often presents as pneumonia, particularly in older adults and people with cancer or compromised immune function. Because M protein testing and antibody... Read more

Technology

view channel
Image: The laser-based photoacoustic spectroscopy setup consists of a Mid-IR laser equipped with three QCL modules covering wavelengths from 5.6 μm to 12.9 μm, two silver coated mirrors (SCM), a dichroic mirror (DM) with a transmittance of 90%, a thermal power sensor head (PM) to monitor the output laser power, a mechanical chopper (MC) for frequency modulation and a CEPAS-detector with a self-designed swab holder (SH). (Credit: Graunke, T., Scholz, T., Pieniak, M. et al. Scientific Reports (2026). https://doi.org/10.1038/s41598-026-68298-9)

Laser-Based Swab Analysis Shows Promise for Detecting Disease-Linked Odor Patterns

Disease-related changes in volatile organic compounds can alter body odor, producing measurable patterns in exhaled breath and bodily fluids. Current analytical methods can be complex, time-consuming,... Read more

Industry

view channel
Image

Collaboration Combines AI Cognitive Assessment and RNA Blood Testing for Earlier Alzheimer’s Detection

Alzheimer’s disease is often identified only after substantial neurodegeneration, partly because current diagnostic pathways are fragmented and difficult to scale. As treatment shifts toward earlier intervention,... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.