BinaxNOW COVID-19 Ag Healthcare Provider Fact Sheet

: June 2, 2024
: Abbot

Table of Contents

FACT SHEET FOR HEALTH PROVIDERS
What are the symptoms of COVID-19?
What do I need to know about COVID-19 testing?
What does it mean if the specimen tests positive for the virus that
What does it mean if the specimen tests negative for the virus that
What is an EUA?
Where can I go for updates and more information?
CDC webpages:
Read User Manual Online (PDF format)
Download This Manual (PDF format)

FACT SHEET FOR HEALTH PROVIDERS

Abbott Diagnostics Scarborough, Inc. August 26, 2020
BinaxNOW™ COVID-19 Ag Card

This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the BinaxNOW COVID-19 Ag Card. The BinaxNOW COVID-19 Ag Card is authorized for use using nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.

All patients whose specimens are tested with this assay will receive the Fact Sheet for Patients: Abbott Diagnostics Scarborough, Inc. – BinaxNOW COVID-19 Ag Card.

What are the symptoms of COVID-19?

Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea). The current information available to characterize
the spectrum of clinical illness associated with COVID-19 suggests that symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat or
new loss of taste or smell, nausea or vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the median time to symptom
onset is approximately 5 days. For further information on the symptoms of COVID-19 please see the link provided in “Where can I go for updates and more information?” section.
Public health officials have identified cases of COVID-19 infection throughout the world, including the United States. Please check the CDC COVID-19 webpage (see link provided in “Where can I go for updates and more information?” section at the end of this document) or your local jurisdictions website for the most up to date information.

What do I need to know about COVID-19 testing?

Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for
updates and more information?” section).

The BinaxNOW COVID-19 Ag Card can be used to test nasal swab samples directly using a dual nares collection (swab inserted in both nares).
The BinaxNOW COVID-19 Ag Card should be ordered for the detection of COVID-19 in individuals who are suspected of COVID-19 by their healthcare provider and
who are within the first seven days of onset of symptoms.
The BinaxNOW COVID-19 Ag Card is only authorized for use in laboratories in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate, high and waived complexity tests. This test is authorized for use at the point of care (POC), i.e., in patient care settings operating under a CLIA certificate of Waiver, certificate of compliance, or certificate of accreditation.

This test is to be performed only using nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.

Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in “Where can I go for updates and more information?” section). When collecting and handling specimens from individuals suspected of being infected with COVID-19, appropriate personal protective equipment should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information?” section).

What does it mean if the specimen tests positive for the virus that

causes COVID-19?

A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines. The BinaxNOW COVID-19 Ag Card has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects. All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

What does it mean if the specimen tests negative for the virus that

causes COVID-19?

A negative test result for this test means that antigens from SARS-CoV-2 were not present in the specimen above the limit of detection. However, a negative result does not rule
out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 7 of illness
may be more likely to be negative compared to a RT-PCR assay. Therefore, negative results from patients with symptom onset beyond 7 days should be treated as presumptive and
confirmed with a molecular assay, if necessary, for patient management.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs
and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative.
If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing or testing with molecular methods should be considered by healthcare
providers in consultation with public health authorities. Risks from a false negative result include: delay or lack of supportive treatment, lack of monitoring of infected individuals
and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events. A negative antigen test should not be the sole basis used to determine if a patient can end isolation precautions. For additional recommendations regarding infection control, refer to
CDC’s Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (Interim Guidance) (see links provided in “Where can I go for updates and more information” section).

What is an EUA?

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19.
The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).