Rapid Strep A PCR Test Approved for Use Outside Traditional Clinical Labs
By LabMedica International staff writers Posted on 01 Jun 2015 |
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
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
Latest Technology News
- New Diagnostic System Achieves PCR Testing Accuracy
- DNA Biosensor Enables Early Diagnosis of Cervical Cancer
- Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples
- Breakthrough in Diagnostic Technology Could Make On-The-Spot Testing Widely Accessible
- First of Its Kind Technology Detects Glucose in Human Saliva
- Electrochemical Device Identifies People at Higher Risk for Osteoporosis Using Single Blood Drop
- Novel Noninvasive Test Detects Malaria Infection without Blood Sample
- Portable Optofluidic Sensing Devices Could Simultaneously Perform Variety of Medical Tests
- Point-of-Care Software Solution Helps Manage Disparate POCT Scenarios across Patient Testing Locations
- Electronic Biosensor Detects Biomarkers in Whole Blood Samples without Addition of Reagents
- Breakthrough Test Detects Biological Markers Related to Wider Variety of Cancers
- Rapid POC Sensing Kit to Determine Gut Health from Blood Serum and Stool Samples
- Device Converts Smartphone into Fluorescence Microscope for Just USD 50
- Wi-Fi Enabled Handheld Tube Reader Designed for Easy Portability