Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

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
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. More...
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


Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
Serological Pipet Controller
PIPETBOY GENIUS
New
Hand-Held Immunofluorescence Analyzer
WS-Si1500
New
Gold Member
Serological Pipets
INTEGRA Serological Pipets
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








DIASOURCE (A Biovendor Company)

Channels

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.