BinaxNOW

BinaxNOW
Name	BinaxNOW
Manufacturer	Abbott Laboratories
Type	Rapid diagnostic test
Used for	Detection of SARS-CoV-2 antigens
Sample type	Nasal swab
Analyte	Viral antigen
Read time	15 minutes

BinaxNOW. It is a rapid diagnostic test manufactured by Abbott Laboratories designed to detect proteins, or antigens, from the SARS-CoV-2 virus that causes COVID-19. The test is authorized for use in symptomatic individuals within the first seven days of symptom onset and for certain asymptomatic screening purposes. It provides results in approximately 15 minutes without the need for laboratory equipment, facilitating point-of-care testing.

Overview

The test utilizes lateral flow assay technology, similar to that used in home pregnancy tests, to identify the presence of viral nucleocapsid protein. It received an Emergency Use Authorization from the U.S. Food and Drug Administration during the COVID-19 pandemic, becoming a critical tool for expanding community testing capacity. The Centers for Disease Control and Prevention has incorporated its use into various testing strategies for schools, workplaces, and community settings. Its design allows for administration by healthcare professionals in clinics, pharmacies, and designated testing sites.

Development and authorization

Abbott Laboratories developed the test in response to the urgent global need for widespread, accessible testing during the COVID-19 pandemic. The company submitted data from clinical studies to the U.S. Food and Drug Administration, which granted an Emergency Use Authorization in August 2020. This authorization was later expanded to include over-the-counter, non-prescription use for self-testing by individuals at home. The development process involved collaboration with research institutions and was supported by initiatives like the National Institutes of Health's RADx program. Subsequent authorizations were granted for use in asymptomatic individuals and for serial testing protocols.

Performance and accuracy

Clinical performance studies submitted to the U.S. Food and Drug Administration demonstrated high specificity and sensitivity, particularly in individuals with high viral loads. The test's performance is most reliable when used on symptomatic individuals during the peak of infection. Comparative studies, such as those published in the Annals of Internal Medicine, have evaluated its accuracy against the gold standard of polymerase chain reaction testing conducted in laboratories like the Mayo Clinic. Factors such as proper sample collection technique and timing of infection can influence test results, leading to occasional false negatives.

Usage and procedure

The test procedure involves inserting a nasal swab approximately one inch into the nostril, swirling it several times, and then inserting the swab into a pre-filled extraction tube. After mixing, the extracted sample is applied to a credit-card-sized test card containing the lateral flow strip. Results are read from the card's window after 15 minutes, displaying lines to indicate positive, negative, or invalid results. Training for proper administration has been provided to personnel at organizations like the Walgreens pharmacy chain and various public health departments. The U.S. Department of Health and Human Services has distributed millions of tests for use in settings such as long-term care facilities overseen by the Centers for Medicare & Medicaid Services.

Availability and distribution

Following its authorization, the test was rapidly scaled for mass production at Abbott manufacturing facilities. The U.S. federal government purchased hundreds of millions of tests for national distribution, with shipments coordinated by the Department of Defense under Operation Warp Speed. Tests were allocated to states, territories, and tribal organizations, as well as to critical infrastructure sites like schools participating in the Project ACT program. They have also been made available for retail purchase at major chains like CVS Pharmacy and Walmart.

Impact and reception

The widespread deployment of BinaxNOW significantly increased testing accessibility across the United States, aiding in the isolation of infectious individuals and mitigation of community spread. Its use was endorsed by public health officials including those from the White House COVID-19 Response Team. The test played a notable role in reopening strategies for institutions from the National Basketball Association to university systems like the University of Illinois. While praised for its convenience and speed, some experts from the Infectious Diseases Society of America have emphasized its limitations compared to PCR tests, advocating for its appropriate use within a broader diagnostic framework.

Category:Medical tests Category:COVID-19 testing