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
Sign In
Advertise with Us
LGC Clinical 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




Events

09 Apr 2024 - 12 Apr 2024
15 Apr 2024 - 17 Apr 2024
23 Apr 2024 - 26 Apr 2024

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

By LabMedica International staff writers
Posted on 01 Jun 2015
Print article
Image: The cobas Liat System, a fast, easy-to-use, compact PCR system (Photo courtesy of Roche).
Image: The cobas Liat System, a fast, easy-to-use, compact PCR system (Photo courtesy of Roche).
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. 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
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
One Step HbA1c Measuring System
GREENCARE A1c
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
Magnetic Bead Separation Modules
MAG and HEATMAG

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: MOF materials efficiently enrich cfDNA and cfRNA in blood through simple operational process (Photo courtesy of Science China Press)

Blood Circulating Nucleic Acid Enrichment Technique Enables Non-Invasive Liver Cancer Diagnosis

The ability to diagnose diseases early can significantly enhance the effectiveness of clinical treatments and improve survival rates. One promising approach for non-invasive early diagnosis is the use... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more

Pathology

view channel
Image: The OvaCis Rapid Test discriminates benign from malignant epithelial ovarian cysts (Photo courtesy of INEX)

Intra-Operative POC Device Distinguishes Between Benign and Malignant Ovarian Cysts within 15 Minutes

Ovarian cysts represent a significant health issue for women globally, with up to 10% experiencing this condition at some point in their lives. These cysts form when fluid collects within a thin membrane... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.