Antigen Testing Appendix

Appendix B: Software options for organizations not using the State’s CLIA waiver and Ordering Physician

Appendix C: Interpreting test results and next steps

This applies to BinaxNOW COVID-19 Ag Card antigen testing only

* A close contact is defined by CDPH and CDC as a person who is within 6 feet of a person with COVID-19 for at least 15 minutes over a 24-hour period starting from 2 days before symptoms appeared (or, for participants who do not have symptoms, 2 days prior to their test) until the time the participant is isolated. In some situations, it may be difficult to determine whether individuals have met this criterion and an entire stable worker cohort or other group may need to be considered exposed, particularly if the group has spent time together indoors for an extended period. For more information, see CDPH guidance here.

Appendix D: Setting up PCR testing through VBL for organizations using their own CLIA and ordering physician

Organizations using their own CLIA waiver and ordering provider who are interested in partnering with VBL for confirmatory PCR testing will need to take the following 5 steps. For detailed instructions, please refer to the this website.

Step 1: Register with Color and onboard onto the Color platform

Once your organization is approved, the Testing Task Force will provide the Color onboarding form to onboard to the Color platform. You will be asked to submit a list of the emails addresses for all staff who will be registering participants and/or collecting or monitoring self-administered samples for the confirmatory PCR.

The individual managing the collection site should alert each of these staff members that they will receive instructions to create individual Color accounts which allows them to access the system.

It is important that staff members complete this process and test their access to the site at least two business days before testing in order to avoid issues on the day of testing

For participants requiring confirmatory PCR testing, registration information must be loaded onto the Color platform online. Paper forms may be included but all information must be entered into the online platform. Samples cannot be shipped to the lab until this has been done.

Step 2: Order kits

Organizations can order kits through the Ordering Portal. As the state provides the ordering physician, test kit orders can be placed without the organization needing their own physician sign-off. Unless expedited shipping is used (at an additional cost), each order may take five or more business days to arrive at collection site. Color will provide appropriate materials to ship samples to the laboratory. Organizations must use the provided ship-back boxes to ship the samples to the lab.

Kits have a shelf life of 1-2 years. Before kits are used for testing, they should be stored somewhere secure with no direct exposure to sunlight or heat. The ideal environment to store test kits is at room temperature (between 72 and 76 degrees Fahrenheit).

NOTE: These collection kits use PrimeStore transport media (the small amount of liquid in each tube) to stabilize and inactivate the virus. This media contains guanidine thiocyanate, which produces a dangerous chemical reaction that releases cyanide gas when exposed to bleach (sodium hypochlorite). Do not use bleach products near collection kits.

Step 3: Supervise sample collection

In order to begin sample collection, organizations must register participants for testing. The swabs provided are anterior nares (nasal) swabs which can be self-administered. Individuals collecting their own samples must be supervised and each individual must follow the following steps as shown in the printable flyer here (Spanish version here).

Step 4: Ship collected samples

Collection sites are responsible for secure storage of samples prior to shipment and selecting and coordinating pick-up by a courier. Collection sites are responsible for properly packaging all samples appropriately for transportation. Test kits provided by the state, through Color, will come with specific packaging materials to help streamline the return process.

Color provides an electronic manifest and batch shipping tool to all collection sites to help track samples as they are transported from the collection site to VBL and ensure that VBL only receives activated samples that can be processed. Once the samples have been collected, an electronic manifest will need to be completed on the Batch Shipment tool for each shipment. A printout of the manifest will need to be included with every sample shipment sent to the lab. Paper manifest for your collection site are also provided (if needed).

Organizations can also use the State’s California COVID-19 Courier Network (CCN) to ship samples to VBL. Through the CCN, already-approved collection sites will be able to drop off samples at specified CCN drop-boxes (Please see the latest live and upcoming drop-box locations at the CCN Drop-Box Mapping Tool, but you must opt-in to the network and receive instructions before being able to use these drop-boxes). Samples will be picked up from the drop-boxes by CCN’s transportation courier, Mobile-Med, and delivered to the VBL. The majority of samples will have a 12-14-hour transit time from pick-up to delivery to the VBL. An organization can opt in to utilize CCN during the Color onboarding process. The collection site point-of-contact will be connected with the courier (Mobile Med) to gain instructions and access (i.e., keys) to the nearest drop-box

Step 5: Resulting, reporting and billing

VBL will be responsible for processing all samples within 48 hours of receipt. When results are available, Color will notify participants through SMS and/or email (using the mobile phone number and/or email provided through the registration process) that results are available. Participants can use their date of birth and the barcode number associated with their sample (which is provided on a take-away card for sites that will be provided kits by the state) to access their results through Color’s HIPAA compliant website. If the participant loses their Color barcode for their test, they can call the Color support hotline. Participants can also access their results by clicking on the link from their email or text notification.

Participants with positive test results will receive a follow-up call from the State’s clinical call center within 48 hours to ensure they receive their test results. Spanish and other languages are available on these calls through the language line
Organizations have two billing options*:

• Direct billing: The state directly bills organizations for the cost of each test conducted ($55/test). The state will invoice the organization monthly for the tests conducted. Please note, hospitals seeking temporary support to test healthcare workers must set-up direct billing.
• Insurance billing: The state bills an individual’s health insurance for the cost of each test ($55/test). This applies to both participants and employees. Participants and employees will never be balance billed by the state.
• *Schools have a separate billing structure

Appendix E: Consent protocol

For organizations using the state’s CLIA waiver and Ordering Physician, the state’s IT platform, Primary, will manage consent for participants. For organizations using their own CLIA waiver and Ordering Physician, a sample consent is provided below.
NOTE: Because SARS-CoV2 is recognized as a communicable disease, which is required to be reported, California state law provides that minors 12 years and older can consent to diagnosis and treatment of COVID-19. Minors ages 12-17 may consent on their own and receive results through their own contact information or through their parent’s contact information. For minors under the age of 12, the parent or legal guardian must provide consent, and use their email/phone to obtain results. Participants must sign consent form (either on printout or electronically through software platform).

Sample Consent

Organization is pleased to offer site-based screening for COVID-19 for the organization population. Organization will be using Abbott laboratories BinaxNOW COVID-19 Ag Card tests. These are rapid, point-of-care tests that deliver results in 15-30 minutes. This test is voluntary and will only be completed if this form is signed.

To collect the specimen, the participant will place a swab, similar to a cotton swab/Q-Tip, inside of the tip of the nose. A trained staff member will observe the specimen collection.

• I authorize Organization to conduct specimen collection and testing for COVID-19 via nasal swab.
• I acknowledge that a positive test results is an indication that I may have the COVID-19 virus. If I receive a positive test result, I acknowledge that I must self-isolate and continue to wear a face-covering to avoid infecting others.
• I understand that Organization is not acting as my medical provider; that this testing does not replace treatment by my medical provider; and I assume complete and full responsibility to take appropriate action concerning my test result. I agree to seek medical advice, care and treatment from my medical provider if I have questions or concerns, or if my condition worsens.
• I understand that, as with any medical test, there is the potential for incorrect test results. I understand that a confirmatory test may be required depending on the result.
• I have been informed about the test purpose, procedures, possible benefits and risks and I have received a copy of this informed consent. I have been given the opportunity to ask questions before I sign, and I may ask additional questions at any time.
• I understand that my test results will be shared with clinical and other staff at the collection site and the local Public Health Department.
• I have read, understand and agree to the above.
• Signature of Participant

Disclaimer: Your decision to consent to the screening test is completely voluntary. Organization will take reasonable precautions for the safety of the population. Neither the test administrator nor Organization nor any of its trustees, officers, employees, or organization sponsors are liable for any accident, injuries, or other damage that may occur to you arising out of or in any way connected to this consent or the administration, evaluation, or results of the BinaxNOW COVID-19 Ag Card rapid antigen test for the COVID-19 virus.

Appendix F: BinaxNOW COVID-19 Ag Card Training Materials

Training Requirements for Performing the Abbott BinaxNOW TM COVID-19 Ag Card Test for Organizations. Please NOTE: All organizations must complete the training before proceeding with testing

Overview

From the Abbott BINAXNOW COVID-19 AG CARD (PN 195-000) – INSTRUCTIONS FOR USE:
“The BinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in participant care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.”

During the COVID-19 emergency, the State of California will allow the use of the BinaxNOWTM COVID-19 Ag Card (hereafter referred to as “Binax”) on asymptomatic individuals.

The Binax is a CLIA-waived test. As such, the test must be performed in a facility that holds a CLIA Certificate of Waiver. All personnel that will participate in Binax testing at sites require training. This document describes the training requirements for personnel performing testing with the Binax.

Qualifications of personnel performing the Binax tests

Organizations should identify one or two persons to be the “Binax Lead,” who will be responsible for ensuring that all personnel are properly trained. The Binax Lead will maintain a binder (“Binax Binder”) that holds the printed training material, training records, the quality control records, Instructions for Use (IFU) and product inserts, and other material. The Binax Lead will also be responsible for training additional personnel as needed.

Training

Training is required for all personnel who will participate in Binax testing. The Binax training requires reviewing the:

• Written Material and Training Videos
• Quality Control (QC) Procedure
• Workflow

In addition, the trainee will:

• Perform in-person hands-on training (or hands-on training conducted virtually by CDPH training group)
• Pass the CDPH competency quiz

Recommended Reading Material and Training Videos

Prior to the virtual training, trainees are recommended to review the following information:

1. Reading Material:

a.COVID-19 Antigen Testing Playbook

b. Training Requirements for Performing the Abbott BinaxNOW™ COVID-19 Ag Card Test

c. Abbott BinaxNOW COVID-19 Ag Card Instructions For Use (IFU)

2.Videos:

a. Abbott BinaxNOW COVID-19 Ag Card training modules

b. The following modules must be completed:

i. Module 1: Getting Started

ii. Module 2: Quality Control

iii. Module 3: Specimen Collection and Handling

iv. Module 4: Module 4: Participant (Individual) Test

c. Preparing for & Running the BinaxNOW™ COVID-19 Ag Card Test.

d. Reading the BinaxNOW COVID-19 Ag Card test video.

e. Video of children self-swabbing for reference.

f. Health Insurance Portability and Accountability Act (HIPAA) training

g. Family Educational Rights and Privacy Act (FERPA) training as provided by your organization

Quality Control (QC) Procedure

For every shipment that arrives, trained personnel must inspect the shipment and record date, number of tests, the Lot Number and Expiration date for the tests in the Inventory Quality Control log (Appendix G) in the Binax Binder (see picture below; expiration and lot number are in the red box). If the shipment contains multiple lots of the tests, all Lot Numbers must be entered. The Binax Lead can track each shipment in the Inventory Quality Control log (see Appendix G). Please note that the manufacturer may have updates on the expiration dates for the test kits including updates on extending the expiration date compared to what is printed on the label. Therefore, it is best to check with the statewide Laboratory Director or the manufacturer if there are questions about the test expiration date information.

QC must be performed on each lot of tests that arrives with the shipment. It is not necessary to perform QC on each box of 40 tests. QC involves running the positive control and negative control swabs. In each 40-test BinaxNOW COVID-19 Ag Card box there is one, foil-wrapped, external positive control. An unused swab can be used for a negative control. After running the control swabs, record the results in the QC log and record the date and name of the person who performed the QC. For sites operating under the statewide CLIA Certificate of Waiver and license, a negative QC test must be performed once per week for each site and recorded on the QC log. The Binax Lead should review the QC log at least once per two weeks. If the control swabs do not work as expected, contact Abbott Technical Services and CDPH for guidance. Abbott Technical Services can be reached at: 800-257-9525 8 AM – 8 PM EST or via email at ts.scr@abbott.com. CDPH can be reached at testing.taskforce@state.ca.gov.

Workflow

The protocol for performing the Binax test must follow the manufacturer’s IFU and CDPH guidelines. Each testing site is unique, and the workflow will be different depending upon the layout of the site, the number of testing personnel, the software platform, and other factors. Example roles for Binax testing personnel are described below.

Check in: Participants will check in at the first station of a testing site. The state strongly suggests partnering with an IT platform provider. Organizations are responsible for identifying and contracting with such providers, as well as separately performing any training required to use those systems. The check-in person “associates” the participant taking the test with a Binax test card by marking the initials of the person taking the test on the Binax test card. The card should be returned to the foil pouch.

Swab supervisor: The swab supervisor will take the “associated” Binax test card and hand the participant a swab. The swab supervisor will observe the self-swabbing and escort the participant to the testing table where the swab supervisor drops off the test card with the tester

Tester: Prior to being handed the swab, the tester will prepare the Binax test by adding 6 drops of the reagent to the well on the card. The participant will hand the swab to the tester who will insert it into the Binax test card, rotate 3 times clockwise, peel off the adhesive liner, and securely seal the test card. The tester will write the start time and end time of the test and lay the test on a flat surface. At this point, the tester should sanitize their gloves or change gloves if the glove has become contaminated. Gloves must be changed after sanitizing 6 times or if a Covid-19-positive swab has been handled.

Reader: 15-30 minutes later, the reader will examine the Binax test card and first determine if the test is valid by examining the control band. Next the reader will examine the sample line and determine whether the test result is positive or negative. It is highly recommended that a second person (this could be the tester) review the card to confirm the interpretation of the reader. If in agreement, the reader should mark a “+” or “- “on the card to indicate the result.

Data Entry: The data entry staff will record the Binax result as “positive,” “negative,” or “ambiguous” in the data system. The names of the “tester” and “reader” should also be recorded. It is highly recommended to take a picture of the Binax cards and some software platforms (e.g. Primary) have the capability to do this. A picture of the card is important because it can help reduce recording errors. The picture can also be used to identify readers that require additional training in reading tests.

Hands-on Training

Hands-on training will occur under the guidance of a qualified CDPH Binax trainer. On the day of training, all trainees should have completed sections 1-3 of this document. The requirements for trainees to complete hands-on training are listed below.

Required Materials: each testing site should have following items available for hands-on Binax training and eventual testing.

• Box of BinaxNOW COVID-19 Ag Card tests for each trainee
• Tables (folding tables or desks, one for each trainee, placed 6 feet apart)
• Sign in sheet to keep track of who has been trained
• Trash cans with bags/trash containers
• Biohazard waste bags or containers for disposal of positive Binax cards or other potentially infectious material
• Gloves
• Face shield/goggles
• Gowns
• Hand sanitizer
• Paper towel/or table covering
• Face masks
• Sharpies and pens
• Large digital clock
• Optional: Timer (could be on your phone)
• Laminated reading materials: decision tree with graphics for evaluating Binax results; interpretation tree for follow-up procedures after receiving Binax results (see Appendix C)

Personal Protective Equipment (PPE): PPE is required for all personnel touching any part of the test kits. The PPE required are masks and gloves. Goggles or face shields and gowns are recommended but not required. Trainees should practice putting on and removing PPE. Those in the role of testers will need to change or clean their gloves after handling a swab. The CDC has issued guidelines for cleaning gloves using alcohol-based hand sanitizer. Gloves must be changed after a tester or reader handles a positive COVID-19 Binax test. Potentially contaminated PPE should be disposed of in the biohazardous waste container.

Familiarization with the Test Kit: The trainee should examine the outside of a Binax box (test kit) and note the sticker that has the expiration date and lot number of the test. The trainee should open the box and verify that it contains the test cards, nasal swabs, positive control swab, reagent bottle, product insert, and procedure card.

Performing the QC Procedures: The trainee should perform the QC procedure by running the positive and negative control swabs according to the instructions in the product insert. It is recommended that the trainee first run a negative control swab, which is an unused swab.

• Set up a clean area with a paper towel or absorbent paper, a swab, a new Binax card, and the reagent bottle.
• Partially open the swab from the bottom end.
• Open a new Binax card pack, remove the card, and write “negative control” on the card.
• Open the Binax card and lay it flat.
• Making sure to hold the reagent bottle vertically, carefully add 8 drops of the reagent to the top hole. The control swabs require 8 drops of reagent while participant samples will use 6 drops.
• Insert the swab into bottom hole and rotate 3-times clockwise.
• Peel off the adhesive liner and close and securely seal the card.
• Write the start and end time on the card; leave the card on a flat surface for 15 minutes.
• After 15 minutes, read the test. Verify that the blue control line has turned pink/red.
• Read the sample line. Mark a “+” or “- “on the card to indicate the result of the test.
• Write the actual time that the test was read on the card. Note, this time could be between 15 and 30 minutes after inserting the swab.
• It is not necessary to record the results of the control into a computer system or to report results to CalREDIE.

The same procedure should be repeated for the positive control swab. After the trainee has run both the positive and negative swabs, the trainer should examine the cards and review the test results to ensure that the controls are performing as expected.

Observing and Instructing Anterior Nares (Nares) Self-Swabbing. The trainee will first observe the trainer describing the Anterior Nares self-swab procedure. From the Abbott BinaxNOWTM COVID-19 Ag Card IFU (January 2021), “Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall 5 times or more for a total of 15 seconds, then slowly remove from the nostril. Using the same swab, repeat sample collection in the other nostril.” The trainee will then practice guiding a volunteer in self-swabbing. The trainee should evaluate whether the person performing the self-swab is following the procedure correctly and if necessary, should instruct the person to make corrections to the self-swabbing procedure. Used swabs should be disposed of in the biohazard waste container.

Quiz

After completing the training sections of this document, trainees can take the online quiz located here. A passing score of 100% is required to complete the training. The quiz can be taken as many times as necessary to receive a passing score.

Checklist of training to complete before beginning testing

Reading Material

• COVID-19 Antigen Testing Playbook
• Training Requirements for Performing the Abbott BinaxNOWTM COVID-19 Ag Card Test
• Abbott BinaxNOW COVID-19 Ag Card IFU (Media Download)

Videos

Abbott BinaxNOW COVID-19 Ag Card training modules available here.

The following modules must be completed:

• • Module 1: Getting Started
  • Module 2: Quality Control
  • Module 3: Specimen Collection and Handling
  • Module 4: Participant (Individual) Test

• Preparing for & Running the BinaxNOW COVID-19 Ag Card Rapid Test. YouTube Video
• Reading the BinaxNOW COVID-19 Ag Card Covid-19 Ag card test.
• Video of self-swabbing
• HIPAA training
• FERPA training per your organization guidance
• Hands-on training
• Pass the quiz

Additional resources

1. Specimen collection

a. Train personnel how to guide participants in self-swabbing (see guidance here)
b. For the rare circumstance’s individuals are not able to perform self-collection additional consent may be needed to allow appropriate personnel to collect the specimen. See more information in the Recruit / train staff or volunteers section

2. Antigen BinaxNOW COVID-19 Ag Card test kit

a. Video of Susan Coffin overview of the BinaxNOW COVID-19 Ag Card test 

b. Interpret results

3. Personal Protective Equipment (PPE)

a. Proper methods for using PPE can be found here.

4. Training log: to print and store on site

Appendix G: Inventory quality control

Quality control

For information on external quality control, please refer to BinaxNOW COVID-19 Ag Card IFU

Ambiguous Tests

• If there is any doubt about the absence or presence of a line in the sample window, the BinaxNOW COVID-19 Ag Card test should be repeated (this will be uncommon)
• If the repeat test is still ambiguous, a confirmatory PCR test should be performed, and the tested individual should go home to isolate. Close contacts* may remain at work
• If the PCR test result is positive, the tested individual should be considered infected and continue to be isolated, and close contacts* should go home to quarantine
• If the PCR test result is negative, the tested individual may return to school if asymptomatic or return to school per school policy if symptomatic
• If there is a faint line in the sample window and it extends edge-to-edge on the sample window, this is a positive result (see several examples and note how faint the line can be and still be considered positive)
• If there is a faint line in the sample window but it does not extend edge-to-edge, the test result is most likely negative
• Other resources for reading the BinaxNOW COVID-19 Ag Card test results are available at: United Health: Binax Training
• Whenever possible, antigen test results should be read by two independent readers

Appendix H: Binax Antigen Test Product Issues Log

State of California – Health and Human Services Agency California Department of Public Health

Appendix I: CDC Guidelines

CDC Guidelines for Specimen Collection

For information on collecting, handling, and testing clinical specimens, please refer to the CDC’s guidelines

Appendix J: Sample registration fields

Appendix K: BinaxNOW™ COVID-19 Ag Card Fact Sheets

BinaxNOW™ COVID-19 Ag CARD EUA FACT SHEET FOR PATIENTSCDC’s guideline

Abbott Diagnostics Scarborough, Inc. Updated: April 6, 2021 BinaxNOW™ COVID-19 Ag Card
You are being given this Fact Sheet because your sample(s) was tested for the Coronavirus Disease 2019 (COVID-19) using the BinaxNOW COVID-19 Ag Card.

This Fact Sheet contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19. After reading this Fact Sheet, if you have questions or would like to discuss the information provided, please talk to your healthcare provider.

For the most up to date information on COVID-19 please visit the CDC Coronavirus Disease 2019 (COVID-19) webpage: www.cdc.gov/COVID19

What is COVID-19?

COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms of COVID-19 can be found here.

What is the BinaxNOW COVID-19 Ag Card?

The BinaxNOW COVID-19 Ag Card is a type of test called an antigen test. Antigen tests are designed to detect proteins from the virus that causes COVID-19 in respiratory specimens, for example nasal swabs.

Why was my sample tested?

You were tested because your healthcare provider believes you may have been exposed to the virus that causes COVID-19 based on your signs and symptoms (e.g., fever, cough, difficulty breathing), and/or other risk factors and you are within the first seven days of the onset of symptoms.

What are the known and potential risks and benefits of the test?

Potential risks include:

• Possible discomfort or other complications that can happen during sample collection.
• Possible incorrect test result (see below for more information).

Potential benefits include:

• The results, along with other information, can help your healthcare provider make informed recommendations about your care.
• The results of this test may help limit the spread of COVID-19 to your family and others in your community.

What does it mean if I have a positive test result?

If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive result). Your healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms.

What does it mean if I have a negative test result?

A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19

Note: For the purpose of the California Department of Public Health Antigen Testing Program: If you are symptomatic and test negative, repeat testing with a PCR test should be performed within 24 hours of your initial antigen test. You should isolate until your PCR test result is returned.

This means that you could possibly still have COVID-19 even though the test is negative. If your test result is negative, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. The amount of antigen in a sample may decrease the longer you have symptoms of infection. Specimens collected after you have had symptoms for more than seven days may be more likely to be negative compared to a molecular assay.

It is important that you work with your healthcare provider to help you understand the next steps you should take.

What are the differences between antigen tests and other COVID-19 tests?

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests.

This means that a positive result is highly accurate, but a negative result does not rule out infection.

If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation. If you will not have an additional test to determine if you are contagious, the CDC currently recommends that you should stay home until three things have happened:

• You have had no fever for at least 24 hours (that is one full day of no fever without the use of medicine that reduces fevers)

AND

• Other symptoms of COVID-19 are improving
• Note: Loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation

AND

• At least 10 days have passed since your symptoms first appeared.

For more information, the CDC has provided guidelines on how to prevent the spread of COVID-19 if you are sick.

Is this test FDA-approved or cleared?

No. This test is not yet approved or cleared by the United States FDA. FDA may issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test 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 for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

What are the approved alternatives?

There are no approved available antigen alternative tests. Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA, by FDA can be found by searching the medical device databases.

A cleared or approved test should be used instead of a test made available under an EUA, when appropriate and available. FDA has issued EUAs for other tests.

Where can I go for updates and more information?

The most up-to-date information on COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19. In addition, please also contact your healthcare provider with any questions/concerns.

BinaxNOW™ COVID-19 Ag CARD EUA FACT SHEET FOR HEALTHCARE PROVIDERS

Abbott Diagnostics Scarborough, Inc. Updated: April 6, 2021 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 anterior nasal (nares) 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.

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 anterior nasal (nares) 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.

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 “links provided in “Where can I go for updates and more information?”)

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. Negative results 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).

The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between July 2020 and October 2020. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARSCoV-2 and their prevalence, which change over time.

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).

What are the approved available alternatives?

There are no approved available antigen alternative tests. Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA, by FDA can be found by searching the medical device databases here.

A cleared or approved test should be used instead of a test made available under an EUA, when appropriate and available. FDA has issued EUAs for other tests that can be found here.

Where can I go for updates and more information?

CDC webpages:

General

Symptoms

Healthcare Professionals

Information for Laboratories

Laboratory Biosafety

Isolation Precautions in Healthcare Settings

Specimen Collection

Infection Control

Discontinuation of Isolation

FDA webpages:

General: www.fda.gov/novelcoronavirus EUAs: (includes links to patient fact sheet and manufacturer’s instructions)

Abbott Diagnostics Scarborough, Inc.:
10 Southgate Road Scarborough, Maine 04074
Technical Support:
Telephone: (800) 257 9525
ts.scr@abbott.com

Appendix L: Guidelines for self-swabbing

This is a guide to teaching participants how to self-swab. Sites may wish to print and display the infographics below where individuals will queue for self-swabbing.

Steps for self-swabbing (images below)

1. Take a small group of participants outside to the testing site
2. Have the participants space out at least 6 feet apart or guide them individually
3. Have the participants wash their hands or use hand sanitizer prior to testing
4. Open the swabs and hand out swabs to the participants and let participants know not to touch the soft cotton end of the swab
5. Have the participants slide their masks below their noses, keeping the mask over their mouths (while maintaining a 6-foot distance from them)
6. Have the participants place their swabs about a ½-inch (about the depth of 2 pencil erasers or the length of the soft part of the swab) into one of their nostrils and twist the swab and circle around, rubbing the inside surface of the nose at least 5 times slowly for 15 seconds, then have the participants place the swab in the second nostril and twist the swab around at least 5 times slowly for 15 seconds
7. Have the participant pull their masks back above their noses and carefully take the swabs back from the participants
8. Perform the test according to manufacturer’s instructions

Video demonstration

Language considerations for children: When guiding children in self-swabbing, be aware of the language you are using.

• Children may not know typical references such as “half an inch.” Consider using a different reference such as “put the swab in just the front part your nose, about 2 pencil erasers in depth, like you are picking your nose.”
• Use comforting terms, as children might be anxious about this new experience, especially if they have previously been tested by someone else. Using phrases like “this test might tickle a little bit or cause you to sneeze” can be comforting. Avoid negative phrases such as “this may feel uncomfortable” or “this won’t hurt.”

Prepare participants for the test: Preparing participants for testing beforehand will make the testing process smoother.

• Encourage participants to watch the video and practice with soft cotton swabs (Q-tips) at home
• Talk about the testing to prepare participants in the days prior to the first test and prepare them for how often testing will occur
• Consider showing the video on the day of testing
• Consider showing the images below or using a model of a nose (or a paper image of a nose), to demonstrate how far the swab is inserted in the nose
• Place posters of how to do the test in the area where participants will be waiting for their turn

Appendix M: Useful Links

Abbott BinaxNOW COVID-19 Ag Card

• Review the package insert
• The following directions are highlights on performing the BinaxNOW COVID-19 Ag Card test collection and processing. Detailed directions can be found in the BinaxNOW COVID-19 Ag Card EUA available here.
• UCSF brief video on interpreting BinaxNOW COVID-19 Ag Card results
• BinaxNOW COVID-19 Ag Card safety data sheet included in the following link

HIPAA Training:

• For those who do not have a HIPAA certificate, there are online course. Here is an example.

Staff:

• Personnel who are observing individuals performing self-collection should be trained on proper technique.

Liability information:

• DHS forms: Public Readiness and Emergency Preparedness Act (PREP Act) Overview

• Public Readiness and Emergency Preparedness Act

CDC Isolation Guidance:

• CDC Duration Isolation