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Coronavirus Disease 2019

County BinaxNOW™ COVID-19 Antigen Card Program


Introduction

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.

BinaxNOW™ Antigen Card

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.

Antigen test accuracy

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.

County BinaxNOW™ COVID-19 Antigen Card Program Guidance
Who to test

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.

How to perform the test and good laboratory practices

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

  • Read and follow the Instructions for use - FDA (IFU)
  • Watch the demonstration videos
    1. Abbot BinaxNOWTM videos provide a step by step overview of the BinaxNOW™ COVID-19 Ag CARD kit.
      • Test overview video
      • Training videos #1-6
      • Customer training presentation
      • FAQ document
      • Assay procedure card
      • Nasal swab tech tips
    2. LAC DPH Training video provides supplemental tips for successful use of these tests including best laboratory practices and key points regarding pre-analytical, analytical, and post-analytical steps.
  • Review the testing summary on the Procedure summary sheet - BinaxNOW™ COVID-19 Ag Procedure Card which is included in the test kit and available on the Abbott BinaxNOW™ Training webpage.
  • Be familiar with other resources on the Abbott BinaxNOW™ Training webpage and Binaxnow-navica.abbott including the CLSI guidance, package insert, reagent and test device safety data sheets, patient and provider fact sheets (in English and Spanish).

Good laboratory practices

  • CDC Training Course on CLIA Waived Testing Ready? Set? Test! Patient Testing is Important : self study web-based training with CEs or PDF
  • COVID-19 antigen proficiency test program for quality assurance purposes
    • College of American Pathologists CAP catalog #COVAG website
    • American College of Physicians Medical Laboratory Evaluation MLE module #688 website
    • American Academy of Family Physicians AAFP-PT module #928) website
Information for patients

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

Information summary sheet for patints with COVID-19

ISOLATION: ph.lacounty.gov/covidisolation and ph.lacounty.gov/covidaislamiento

QUARANTINE: ph.lacounty.gov/covidquarantine and ph.lacounty.gov/covidcuarentena

Patients who test negative

Information sheet for symptomatic patients with negative antigen tests
  • Provide the information sheet for patients with symptoms and negative antigen tests. English  Spanish. The sheet instructs the patient to stay home and act like they have COVID-10 until their PCR result is ready. It also explains what to do if the PCR test comes back positive (isolate and tell close contacts to quarantine) or negative (stay home until fever free for 24 hours and symptoms have improved).
How to report results to Public Health

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.

Site Readiness

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 staff are trained on infectious material disposal per California Medical Waste Management Act
  • Develop standard operating protocol for test and obtain Laboratory Director signature
  • Develop clinic workflow; Train staff on workflow
  • Document and track staff competency for performing COVID-19 testing
  • Fax the BinaxNOW™ Laboratory Site Readiness Form and the documents listed below to the Public Health Laboratory, Attn: Dr. Nicole Green, Director at FAX 562-401-5999 
    • CLIA waived certificate (or Laboratory Field Services (LFS) acknowledgment of Clinical Laboratory Registration)
    • California Medical Waste Generator permit
    • Site Readiness Checklist (recommended) - on page 2 of the Laboratory Site Readiness Form

Supplies

Ensure inventory of appropriate supplies, including:

  • Transport tubes for bringing nasal swabs to waived testing area if applicable
  • PCR swab collection sets for confirmatory testing
  • Timers (and calibrated if not digital)
  • Red medical waste receptacle
  • Appropriate personal protective equipment
  • BinaxNOW™ COVID-19 test kits (640 tests/case) - see ordering information
Contact information
Criteria to participate in the County Program
Below are the requirements for entities that receive BinaxNOW™ tests through the County BinaxNOW™ COVID-19 Antigen (Ag) Card Program.
The entity must:
  1. Only use the antigen tests in symptomatic individuals within 7 days of symptom onset – per FDA EUA guidance. Testing symptomatic employees is acceptable, DO NOT used in asymptomatic individuals
  2. Agree to reflex ALL NEGATIVE antigen tests to PCR on the SAME DAY the negative antigen test is performed
  3. Have reasonable volume of symptomatic individuals presenting for care – e.g. active urgent care – with an average volume of 20 symptomatic patients/week
  4. Report all antigen test results within one business day.
  5. Follow all Abbot BinaxNOW™ Instructions for Use and watch the demonstration videos.
  6. Have a CLIA waiver in place for their facility laboratory (Note: Laboratory Field Services (LFS) acknowledgment of Clinical Laboratory Registration is now acceptable as per CDPH Temporary Allowance for Waived SARS-CoV-2 Antigen Testing)
  7. Have a California Medical Waste Generator permit
  8. NOT charge for the test – the patient should incur no out of pocket costs
  9. Provide information to patients as instructed


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  • Public Health has made reasonable efforts to provide accurate translation. However, no computerized translation is perfect and is not intended to replace traditional translation methods. If questions arise concerning the accuracy of the information, please refer to the English edition of the website, which is the official version.

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