Access to the Abbot BinaxNOW™ antigen tests is currently being coordinated by the federal government through the California Department of Public Health (CDPH). The local Medical and Health Operational Area Coordinator (MHOAC) is responsible for test distribution. The California Recommended Distribution for BinaxNOWTM Antigen Tests guidance includes prioritizing underserved communities and geographic locations with testing positivity disparities. The LA County MHOAC, in collaboration with the LA County Department of Health Services and Public Health, is offering these test kits to facilities that fall within the CDPH recommendations and meet local criteria.
The BinaxNOW™ COVID-19 Antigen (Ag) Card is a rapid antigen test approved for Emergency Use Authorization (EUA) by the FDA. This diagnostic viral test can be administered on-site by a healthcare professional if the facility has a CLIA certificate of waiver Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The test is indicated for symptomatic individuals suspected to have COVID-19 by their healthcare provider within the first seven days of symptom onset. The test is performed directly on a nasal swab (no transport media). It provides a positive or negative result in 15 minutes. For more information about the test, visit the Abbott BinaxNOW™ Training webpage.
Test accuracy is dependent on many factors including the pretest probability of disease, timing of the test, specimen collection and handling, and the specific characteristics of the assay. Clinicians should review the EUA and supporting materials for any SARS-CoV-2 test(s) they are using to understand these issues and how to interpret negative and positive test results. False positive results have been reported with antigen tests when users do not follow the instructions for use and when testing in low prevalence settings. See FDA letter to Healthcare Providers Potential for False Positive Results with Antigen Tests.
Although antigen tests have demonstrated lower sensitivity compared with RT-PCR testing, when antigen tests are performed on symptomatic individuals within the appropriate window period (within the first 7 days of symptoms for BinaxNOW™), a positive result has strong positive percent agreement with PCR testing. For this reason, a positive antigen test generally confirms a SARS-CoV-2 infection. Negative antigen results are more likely to be falsely negative compared to PCR. For this reason, negative results in symptomatic patients are considered presumptive negative and should be confirmed with a RT-PCR test.
See the Healthcare providers LAC DPH COVID-19 Testing webpage for more information on currently available test types.
The BinaxNOW™ test must only be used to test symptomatic persons in first 7 days of illness. It is not to be used to test asymptomatic persons, including essential workers or asymptomatic contacts of COVID-19 cases.
It is critically important that testing sites observe best practices for handling and performing these tests and fully train all staff engaged in sampling and test operations.
How to perform the test
Good laboratory practices
All patients being tested
Per the FDA, patients being tested with BinaxNOW™ (or any assay under EUA) must be given a patient fact sheet (40 hard copies in English are included with the test kit, Spanish fact sheets can be downloaded from Binaxnow-navica.abbott).
Patients who test positive
Patients who test negative
Report results (positive, negative, or invalid) for each patient to Public Health using the online COVID-19 Medical Provider Point of Care Test (POCT) Result Report Form https://redcap.link/lacdphpoct. This reporting replaces the requirement to submit a Medical Provider Report Form for positive results. For reporting questions, email COVID19@ph.lacounty.gov.
Your site is ready to begin using the BinaxNOW COVID-19 tests once the steps below have been completed. You do not need any further approval/clearance from Public Health Laboratory.Training and Protocols
Ensure inventory of appropriate supplies, including: