BD Receives FDA EUA for Asymptomatic Screening for SARS-CoV-2 Through Serial Rapid Antigen Testing
By LabMedica International staff writers Posted on 02 Apr 2021 |
Image: The BD Veritor Plus System for Rapid Detection of SARS-CoV-2 (Photo courtesy of Becton, Dickinson and Company)
Becton, Dickinson and Company (BD Franklin Lakes, NJ, USA) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its rapid antigen test to be used for SARS-CoV-2 screening through serial testing of asymptomatic individuals.
The BD Veritor Plus System for Rapid Detection of SARS-CoV-2 is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in direct anterior nasal swabs from individuals who are either suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. The EUA for the BD Veritor Plus System includes SARS-CoV-2 screening through serial testing of asymptomatic individuals when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Serial testing on the BD Veritor Plus System can be performed in any setting with a CLIA certificate of waiver.
"BD is supporting the global efforts to return to normalcy as soon as possible, and this additional authorization for the BD Veritor System to be used in screening through serial testing of asymptomatic individuals is a large step forward," said Dave Hickey, president of Life Sciences for BD. "Frequent testing of individuals without symptoms will enable those with negative results to resume their normal school or work routines and will help to identify and isolate positive cases of COVID-19 as early as possible to prevent further spread. Screening through serial testing is an important part of any back-to-school or back-to-work program, along with additional measures such as mask wearing and social distancing."
Related Links:
Becton, Dickinson and Company
The BD Veritor Plus System for Rapid Detection of SARS-CoV-2 is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in direct anterior nasal swabs from individuals who are either suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. The EUA for the BD Veritor Plus System includes SARS-CoV-2 screening through serial testing of asymptomatic individuals when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Serial testing on the BD Veritor Plus System can be performed in any setting with a CLIA certificate of waiver.
"BD is supporting the global efforts to return to normalcy as soon as possible, and this additional authorization for the BD Veritor System to be used in screening through serial testing of asymptomatic individuals is a large step forward," said Dave Hickey, president of Life Sciences for BD. "Frequent testing of individuals without symptoms will enable those with negative results to resume their normal school or work routines and will help to identify and isolate positive cases of COVID-19 as early as possible to prevent further spread. Screening through serial testing is an important part of any back-to-school or back-to-work program, along with additional measures such as mask wearing and social distancing."
Related Links:
Becton, Dickinson and Company
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants