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
RANDOX LABORATORIES

ORASURE TECHNOLOGIES

OraSure Technologies develops, manufactures and distributes oral fluid diagnostic and collection devices and other te... read more Featured Products: More products

Download Mobile App




Events

ATTENTION: Due to the COVID-19 PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event.

ORAcollect RNA Saliva Collection Device for SARS CoV-2 Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 04 Nov 2020
Print article
Image: The ORAcollect·RNA collection device (Photo courtesy of OraSure Technologies, Inc.)
Image: The ORAcollect·RNA collection device (Photo courtesy of OraSure Technologies, Inc.)
OraSure Technologies, Inc.’s (Bethlehem, PA, USA) subsidiary, DNA Genotek, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the use of the ORAcollect·RNA (OR/ORE-100) saliva collection device for the collection, stabilization and transport of saliva specimens suspected of containing SARS-CoV-2 RNA.

The ORAcollect·RNA collection device is an important component of molecular/PCR tests as laboratories are able to use it as the saliva sample collection method for their COVID-19 tests. This is the second FDA EUA received by DNA Genotek for its saliva collection devices. Similar to the EUA recently obtained by DNA Genotek for its OMNIgene·ORAL (OM/OME-505), the latest EUA allows for the unsupervised use of the device at-home or in a healthcare setting when used as a component of an authorized or cleared self-collection kit. This means it can be part of a kit that is authorized under its own EUA for use by an individual to collect saliva specimens at home.

“Accessible and accurate testing programs that include a non-invasive, saliva-based collection option will be essential throughout the duration of the COVID-19 pandemic,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. “This second EUA gives our customers additional non-invasive options for SARS CoV-2 sample collection. Saliva sample collection is quick, painless, non-invasive and requires less human contact both minimizing the need for PPE and reducing exposure to potentially infected patients.”



New
Gold Supplier
Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit
Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Prepacked)
New
COVID-19 RT-PCR Test
Quicknostics COVID-19 RT-PCR
New
SARS-CoV-2 / Influenza A+B Detection Kit
RealLine SARS-CoV-2 / Influenza A+B
New
Magnetic Induction Thermocycler
CoDx Box

Print article

Channels

Molecular Diagnostics

view channel
Image: The Lumipulse G β-amyloid 1-40 assay kit (Photo courtesy Fujirebio)

APOE Gene Influences Alzheimer's Symptoms, Biomarkers in Down Syndrome

Individuals with Down syndrome (DS) constitute a population at ultrahigh risk of developing Alzheimer disease (AD) because of trisomy of chromosome 21, which harbors the amyloid precursor protein (APP) gene.... Read more

Industry

view channel
Illustration

ELITechGroup Acquires Freezing Point Osmometry Provider GONOTEC

ELITechGroup (Puteaux, France) has acquired GONOTEC (Berlin, Germany), thus uniting two osmometry market leaders. The acquisition will also provides the industry with a full range of osmometry solutions... Read more
Copyright © 2000-2021 Globetech Media. All rights reserved.