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
INTEGRA BIOSCIENCES AG

Download Mobile App





First Instrument-Free COVID-19 RT-PCR Test Granted FDA EUA for Pooled Samples

By LabMedica International staff writers
Posted on 27 Oct 2021
Print article
Image: First Instrument-Free COVID-19 RT-PCR Test Granted FDA EUA for Pooled Samples (Photo courtesy of Visby Medical)
Image: First Instrument-Free COVID-19 RT-PCR Test Granted FDA EUA for Pooled Samples (Photo courtesy of Visby Medical)
The first instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test.

Visby Medical’s (San Jose, CA, USA) instrument-free Reverse Transcription (RT)-Polymerase Chain Reaction (PCR) COVID-19 test has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for testing pooled patient samples in high-complexity Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories.

This authorization extends the previous EUA for single patient sample testing at the point of care. Furthermore, this validates the flexibility and adaptability of the Visby Medical innovative, palm-sized PCR technology by expanding its proven capabilities from individual, single-use testing to pooled testing of up to five patient samples at once. Pooling patient samples with the Visby test can help increase overall lab testing capacity without additional tools or resources, while maintaining both accuracy and speed by returning results in less than 30 minutes.

The company's COVID-19 test pooling protocol enables high-complexity clinical laboratories to combine up to five patient samples into a single device for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. A positive result triggers all five samples to be re-tested individually to determine which patient or patients are infected. By shrinking PCR technology to palm-sized dimensions, the Visby platform provides fast, accurate results. This single-use, instrument-free device quickly identifies COVID-19 infections, which is especially useful in communities with limited access to testing.

"With the SARS-CoV-2 virus ravaging the country, Visby remains steadfast in meeting the urgent needs of the community, its partners, and the changing market dynamics with our instrument-free PCR COVID-19 test," said Teresa Abraham, PhD, Director, Medical Affairs at Visby Medical. "Thanks to this EUA, laboratories can meet increasing testing demand by analyzing up to five patient samples at once, allowing for significantly increased efficiency and significantly decreased testing costs, particularly in low prevalence settings."

Related Links:
Visby Medical

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
Anti-Cyclic Citrullinated Peptide Test
GPP-100 Anti-CCP Kit
Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)

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: The study showed the blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% (Photo courtesy of Guardant Health)

Blood Test Shows 83% Accuracy for Detecting Colorectal Cancer

Colorectal cancer is the second biggest cause of cancer deaths among adults in the U.S., with forecasts suggesting 53,010 people might die from it in 2024. While fewer older adults are dying from this... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read more

Microbiology

view channel
Image: The new platform is designed to perform blood-based diagnoses of nontuberculosis mycobacteria (Photo courtesy of 123RF)

New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don't cause any problems.... Read more

Industry

view channel
Image: These new assays are being developed for use on the recently introduced DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics (Brea, CA, USA) and Fujirebio Diagnostics (Tokyo, Japan) have expanded their partnership focused on the development, manufacturing and clinical adoption of neurodegenerative... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.