Abbott Mass Distributes Rapid COVID-19 Tests, Offers App So Consumers Can Display Test Results
Source : 'HBW Insight'
The scope of the need for COVID-19 tests in the US is seen in Abbott Laboratories Ltd’s announcement of distributing 150m through the Department of Health and Human Services as it also makes available a smartphone app for consumers to display negative test results with a digital certificate.
The firm on 12 January said its BinaxNOW COVID-19 Ag rapid tests, the size of a credit card and with no other equipment required, will be sold directly to organizations conducting testing at $5 each and an at-home version, with use virtually guided through digital links, is available at $25 per test.
It says BinaxNOW is the most widely available and mass-produced rapid test in the US and provides results in 15 minutes and detects the virus when people are most infectious and at the greatest risk of spreading it to others.
BinaxNOW can be paired with the NAVICA app, available at no costs and developed by Abbott to allow consumers who test negative for COVID-19 to display the results through a temporary digital health certificate. They can receive QR codes, similar to mobile boarding passes airlines use, and organizations can scan and verify the information to manage entry into facilities that accept NAVICA.
Consumer demand for home-use COVID-19 tests points to a growing market for OTC diagnostic products following the end of the novel coronavirus pandemic. Regulatory approval for direct-to-consumer sales of sample-collection kits can be as complicated as the technology behind their products – the first at-home test for SARS-CoV-2, the virus that causes COVID-19, allowed for OTC distribution was cleared in the US nearly a year after national health emergency was declared due to the pandemic (see related story).
Mary Moreland, Abbot’s human resources executive vice president, said the Abbott Park, IL-based firm in October began been providing testing for US employees using BinaxNOW and the NAVICA platform. Results from the thousands of tests provided Abbott insights on managing workflow and on using NAVICA to allow consumers to store, access and display test results.
"Our experience shows that large organizations can effectively manage a high-throughput, rapid testing program across multiple sites and in different occupational settings," said Moreland in the firm’s release.
abbott's NAVICA app allows consumers to display negative test results from BinaxNOW COVID-19 Ag rapid tests, which are the size of a credit card.
BinaxNOW is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A nasal swab is used to collect specimens from people suspected of having an active infection.
Under an Emergency Use Authorization by the Food and Drug Administration, BinaxNOW is for use by health care professionals and can be used in point-of-care settings qualified to have the test performed and are operating under a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, compliance or accreditation.
While making at-home tests available, Abbott says its EUA for BinaxNOW is for use by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists and more with minimal training and a patient prescription.
The firm will continue supplying HHS with 30m BinaxNOW tests through March 2021 and already has provided 150m through HHS around the 50 states, between 18.7m to California and 151,500 to Vermont; and around US territories and other holdings, from 317,240 to Washington, DC, to 13,440 for the Northern Mariana Islands. Some also went to nursing homes, assisted living facilities, home health and hospice agencies, historically black colleges and universities and the Indian Health Service.
Abbott is near completion of its “self-funded investment in US manufacturing capacity” and is “ready to make tens of millions of BinaxNOW tests available per month for direct purchase to organizations including schools, workplaces and pharmacies.”
The University of Wisconsin System will be the first US customer to secure BinaxNOW at scale – 480,000 tests over six months for use at its universities and branch campuses.
The FDA’s first EUA for a rapid antigen test to diagnose COVID-19 went Quidel Corp.’s Sofia 2 SARS Antigen FIA test in May. Samples collected for the test can be analyzed by CLIA-authorized, high- and moderate-complexity laboratories but also used for point-of-care testing by facilities operating under a CLIA waiver certificate, facilitating a faster turnaround for results. ()
By Malcolm Spicer