antigen testing playbook

Information contained in this document is preliminary | Working draft as of 4/26/2021.

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CDPH Testing Task Force

Antigen Testing

Playbook

DRAFT

4/26/2021

Version 2.0

All healthcare guidance contained in this manual is based on CDPH / CDC guidelines


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Table of Contents

Introduction ....................................................................................................................... 3

Roles and responsibilities for antigen testing ............................................................... 3

5 steps to conduct antigen testing ............................................................................... 4

1. Identify testing need and submit application form ............................................... 6

2. Sign MOU or Acknowledgment and receive antigen tests .................................. 8

3. Onboard to IT platform and prepare logistics for testing ..................................... 9

4. Train staff ...................................................................................................................... 13

5. Begin testing and deliver antigen test results ...................................................... 155

Appendix ......................................................................................................................... 23


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Introduction

In an effort to improve the equitable distribution of testing resources to

communities facing disproportionate effects of COVID-19, the State of California

has established a comprehensive testing program that provides antigen and

PCR testing resources (e.g., test kits, reporting platforms, and technical

assistance).

This document outlines how organizations can utilize antigen tests (available

through the state) and when needed, conduct confirmatory PCR tests (also

available through the state). Please note, all results must be reported in

accordance with state and federal requirements, and entities must have the

ability to conduct serial testing on a population (e.g., testing a person at least 2x

per week for multiple weeks) OR require rapid tests for entry into congregate

setting or large gathering. Given various nuances, a set of population-specific

antigen testing playbooks are also available:

• Schools playbook: please contact [email protected]

• Department of Social Services (DSS) playbook: please contact

[email protected]

Roles and responsibilities for antigen testing

State responsibilities

▪ Approve organizations, provide support and instructions for conducting

testing

▪ Provide an opportunity for organizations to do antigen testing under the

direction and oversight of a state-designated Ordering Physician and

Laboratory Director

▪ Provide options for IT platform solutions for antigen and PCR test

registration, delivering participant results, and reporting to the state, local,

and federal government

▪ Supply antigen tests to organizations who have undergone the training

▪ Supply PCR test kits for confirmatory testing for facilities interested in using

the Valencia Branch Laboratory for confirmatory PCR tests

▪ Conduct PCR test processing and provide results within 24-48 hours

through the Valencia Branch Laboratory

mailto:[email protected]



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Organization responsibilities

▪ Provide required information to CDPH for registration, attest to serial testing

of population, and adhere to all program requirements as outlined in the

MOU

▪ Provide staff and manage on-site logistics (e.g., obtain personal protective

equipment, provide physical space, supervise sample collection, order

test kits, onboard onto IT platform)

▪ Ensure that all staff supervising and performing the test are fully trained

▪ Report results to the participant with EUA Patient Fact Sheet, to the

ordering physician, and to local public health jurisdiction via IT platform

options

▪ Comply with governing CDPH policies and procedures regarding data

storage, confidentiality, and privacy protection

5 steps to conduct antigen testing

The state has partnered with Abbott to offer the BinaxNOW COVID-19 Ag Card,

enabling Local Health Jurisdictions (LHJs) and local organizations to provide

COVID-19 antigen testing efficiently and effectively to their communities. As an

organization, you can partner with the State to offer COVID-19 antigen tests by

following a 5-step process:

1. Identify testing need and submit application form

Identify the testing demand in your community or organization

Choose an IT platform for reporting (if using the state’s Ordering Physician

and Laboratory Director (i.e., CLIA waiver), the designated IT platform is

Primary)

Submit application form

Develop plans for confirmatory PCR testing

2. Sign MOU or Acknowledgment and receive antigen tests

Sign MOU or Acknowledgement

Receive antigen tests

3. Onboard to IT platform and prepare logistics for testing

Onboard to IT platform

Identify site Binax Lead and assemble Binax binder


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Identify staff to deliver reagent and read tests (recruit staff if needed)

Set up facility

4. Train staff

Ensure staff complete required self-serve trainings

Complete virtual hands-on training and competency quiz (requires

antigen tests on hand)

Complete initial quality control and product inventory log

Onboard to Valencia Branch Laboratory for PCR testing (If using the

state’s CLIA waiver or partnering with VBL for confirmatory PCR testing)

5. Begin testing and deliver antigen test results

Register and obtain consent from participants

Check-in participants on testing day

Supervise nasal swab sample collection

Perform the tests

Read tests, communicate results, and identify next steps

Distribute EUA Patient Fact Sheets (can be done via IT platform)

Conduct confirmatory PCR test (if applicable)

Dispose of cards appropriately

Report results via IT platform to state’s public health reporting system

(CalREDIE)

Report significant deviations of test performance (examples provided in

section 5)

Send site records to CDPH Laboratory Director at AntigenLabDirector-

[email protected] (if using the state’s CLIA waiver and Ordering

Provider)




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Detailed instructions to the 5 steps to conduct testing

1. Identify testing need and submit application form

Identify the testing demand in your organization or community

Choose an IT platform for reporting (if using the State’s Ordering Physician

and Laboratory Director (i.e., CLIA waiver), the designated IT platform is

Primary)



Identify the testing demand in your community or organization

Before proceeding with offering testing, organizations need to determine their

testing demand and make decisions on the following:

▪ Populations to be tested, e.g., all employees in an organization or in a given

building. Note: for the best results in preventing new infections or outbreaks,

the Testing Task Force recommends that all employees in a given facility be

tested regardless of job title or position

▪ Testing can be performed in people with COVID-19 symptoms or people

without symptoms. When testing people without COVID-19 symptoms, the

recommend testing frequency is at least 2 times per week

▪ Pre-entry testing: Testing can also be performed if rapid results are needed for

entry into a congregate setting (e.g., shelter) or an event (e.g., live

performance, sporting event)

▪ Determine location where testing will be performed in the facility

Choose an IT platform for reporting

Organizations using the state’s CLIA Certificate of Waiver (under its Laboratory

Director) and Ordering Physician will use the state’s contracted IT platform,

Primary, to help with participant registration, participant consent, test result

management, and mandated electronic reporting to public health (CalREDIE).

Primary will provide training related to use of its software.


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For organizations not using the state’s CLIA Certificate of Waiver and Ordering

Physician, the state recommends using an IT platform of the organization’s

choice to support registration and reporting. Contact information for potential

providers are located in Appendix B. Depending on the vendor, choosing an IT

platform may require contracting with the vendor. The preferred IT platform must

be specified in the application form.


After identifying the testing demand, if your organization is interested in

partnering with the state, please submit the antigen testing application form.

Note: entities without CLIA waivers who have existing stocks of BinaxNOW

COVID-19 Ag Card tests can now onboard to the Testing Task Force’s antigen

testing offering by submitting the application form. These entities can use the

state’s CLIA waiver, ordering physician, and IT platform, and their existing

antigen test supplies to test worker cohorts. At this time, the state’s CLIA waiver

may only be used for the BinaxNOW COVID-19 Ag Card tests, not with any other

COVID-19 tests, including other antigen tests.

Once submitted, a representative will reach out to you within 3-5 business days.


Confirmatory PCR testing is required when an individual receives a positive

antigen test result OR is symptomatic (e.g., fever or chills, cough, shortness of

breath or difficulty breathing, fatigue, muscle or body aches, headache, new

loss of taste or smell, sore throat) and receives a negative antigen test result. In

both these situations a confirmatory PCR test is required (see section Begin

testing and deliver antigen test results). Note: for organizations using the state’s

CLIA Certificate of Waiver under its Laboratory Director and Ordering Physician,

the CDPH Valencia Branch State Public Laboratory is the preferred laboratory for

performing molecular testing for SARS-CoV-2.

For organizations not using the statewide CLIA Certificate of Waiver and

Ordering Physician, CDPH strongly recommends setting up plans for confirmatory

PCR testing. There are 3 available options:

1) Partner with the Valencia Branch Laboratory (VBL) to set up PCR testing at

your organization. For more information on VBL, please see here.

Organizations can indicate interest in partnering with VBL for PCR testing on

the application form. Once approved, organizations will receive an email to

https://labsupport.powerappsportals.us/AntigenSurvey/


https://testing.covid19.ca.gov/pcr-resources/



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onboard to the state’s online platform for PCR testing. In addition,

organizations will be responsible for shipping and packaging samples to the

lab. For more details, please refer to Appendix D.

2) Continue using your existing PCR vendor. This option is only available to

organizations who are using their own CLIA waiver and ordering physician.

3) Find your own PCR solution. See the Testing Task Force’s Lab List for

laboratories in California ready to do COVID-19 testing here. This option is only

available to organizations who are using their own CLIA waiver and ordering

physician.

2. Sign MOU or Acknowledgment and receive antigen tests

Sign MOU or Acknowledgment


Sign MOU or Acknowledgment

Organizations using the State’s CLIA waiver and Ordering Physician for antigen

testing must also use VBL for any necessary confirmatory PCR testing. Once

approved to partner with the state, the site’s point-of-contact will receive via

DocuSign two MOUs (one for antigen testing and one for confirmatory PCR) to

sign and return to the state. Organizations using the state’s CLIA who already

partner with VBL will not need to sign a new MOU for confirmatory PCR testing.

Organizations who do not use the State’s CLIA waiver or Ordering Physician will

sign an Acknowledgment and Acceptance of Responsibility document in lieu of

an MOU.


Once your MOU or Acknowledgment is received, the state will send you

instructions on receiving your first 6-week supply. All orders will be placed with a

1-week lead time. For organizations using the State’s CLIA waiver and Ordering

Physician, testing is not to be initiated until all training and onboarding

requirements are met.

https://testing.covid19.ca.gov/covid-19-testing-task-force-laboratory-list/


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3. Onboard to IT platform and prepare logistics for testing



Identify staff to deliver reagent and read tests (recruit staff if needed)

Set up facility


For organizations using the state’s CLIA Certificate of Waiver and Ordering

Physician, the state’s contracted IT platform, Primary, will send an email to

complete the onboarding process. Primary helps manage testing day operations

including participant registration, consent, and results, as well as reporting to

public health (via CalREDIE).

The organization lead will receive information from Primary after being approved

as a testing partner and receiving an approval email from the Testing Task Force.

The organization lead will need to provide details about staff members for each

site to Primary to onboard individually to the Primary platform. Each staff

member will also be required to complete self-serve trainings on the Primary

platform including on conducting antigen tests and using the Primary platform.

Organizations not using the state’s CLIA waiver and Ordering Physician should

follow-up with their chosen IT platform vendor for steps for onboarding to the

platform and training staff on how to register participants and report results to

participants. Contact information for potential providers are located in Appendix

B.

Paper forms can be printed as a back-up in case of internet problems. If paper

forms are used, all information collected must be entered in the online platform

once internet is available. As participant data are collected on these paper

forms, the testing site is responsible for securely shredding these documents. This

is necessary because the data are considered personal health information (PHI),

which is protected by HIPAA.


Organizations should identify one or two persons to be the “Binax Lead” who will

be responsible for ensuring that all procedures are being properly followed and


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all personnel are properly trained. The Binax Lead will maintain a binder with the

printed training material, training records, the quality control records, product

inserts, and other material. The Binax Lead will also be responsible for training

additional personnel as needed.

The Binax binder should include the following:

▪ Copy of the prescribing order

▪ Copy of the CA State Clinical Laboratory Registration with CLIA ID

▪ Name of Binax Lead(s) for site

▪ Copy of signed MOU (i.e., signed both by site and state)

▪ Copy of the Emergency Use Authorization (EUA)

▪ Current Manufacturer’s Instructions for Use (IFU)

▪ Current EUA Fact Sheets

▪ Product Insert information

▪ BinaxNOW COVID-19 Ag Card safety data sheet

▪ Site roles and responsibilities list including names of testing personnel at site

▪ Antigen testing playbook

▪ Training documentation and logs (Appendix F)

▪ Inventory Quality Control log (Appendix G)

▪ Binax Antigen Test Product issues log (Appendix H)

▪ Additional manufacturer’s information including test kit expiration date

extensions

▪ Shipment records that accompany delivered tests

Identify staff to deliver reagent and read tests (recruit staff if

necessary)

Organizations must have trained staff on site to oversee all aspects of testing.

Testing involves several roles. Number of staff required will vary based on size and

organization, and one person can perform multiple roles if necessary.

Roles:


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▪ Check-in: Performs check-in and associates the BinaxNOW COVID-19 Ag

Card individual test card with the staff member or student

▪ Swab Supervisor: Monitors self-collection

▪ Tester: Performs the BinaxNOW COVID-19 Ag Card test

▪ Reader: Tracks the time of the test and reads the results

▪ Data Entry: Enters the data into the software platform

Set up facility

Identify appropriate facility

Designate a secure place to store the BinaxNOW COVID-19 Ag Card tests where

temperature does not fall below 36°F or above 86°F. BinaxNOW COVID-19 Ag

Card tests have a shelf life between 6-9 months. Expiration date can be found

on the outside of the boxes near the lot number. Please also store any

manufacturer updates regarding test kit expiration date extensions with the tests

for ease of reference and include in Binax Binder.

Ensure that your site has a designated space in which you can register

participants and conduct testing. Outdoor locations are ideal to reduce COVID-

19 transmission. If you choose an outdoor location, have contingency plans for

inclement weather such as wind/rain or extreme temperatures, have supplies to

cover electronics and paperwork, and an alternative indoor location such as a

gymnasium. If an outdoor location is not feasible, then indoor spaces should

offer space for proper social distancing measures. Whatever the testing location,

you will need flat areas to lay the cards on when performing the test, such as

tables.

Procure necessary Personal Protective Equipment (PPE)

It is your responsibility as an organization to ensure all staff/volunteers have

appropriate PPE. PPE needs may vary based on the sample collection situation

(observing self-collection versus collection by trained provider). Most individuals

can self-collect.

Situation Personnel requirement PPE requirement/recommendations

Observation

of self-

collection

anterior

nares swabs

Personnel observing

individuals performing self-

collection should be trained

on proper technique:

https://www.cdc.gov/corona

virus/2019-

ncov/downloads/community/

All staff should follow Standard

Precautions. Face mask and gloves

required, eye protection (goggles

or face shield) also recommended

since participants may sneeze

when they swab.

https://www.cdc.gov/coronavirus/2019-ncov/downloads/community/COVID-19-anterior-self-swab-testing-center.pdf



https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html

https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html


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Situation Personnel requirement PPE requirement/recommendations

COVID-19-anterior-self-swab-

testing-center.pdf

Collection

of anterior

nares swabs

(for

individuals

who cannot

self-collect)

In clinical settings, trained

health care providers:

Allopathic and osteopathic

physicians, physician

assistants1, medical assistants2,

EMTs and paramedics3,

registered nurses4, licensed

vocational nurses5, and

respiratory care practitioners6

Staff should maintain proper

infection control. N95 or higher-

level respirator (or facemask if a

respirator is not available), eye

protection, gloves, and a gown,

when collecting specimens.

Manage crowd sizes

Certain measures must be used when testing large groups of people to avoid

people congregating in the same area and to ensure appropriate physical

distancing:

▪ Develop signage that directs participants where to check-in and line up

▪ Place markers on the ground to help participants maintain distance when

waiting in line and at the different stations

1. Physician assistants can perform collections of specimens for COVID-19 testing using nasal swabs as long as they

meet the current waiver requirements of DCA Waiver 02-04 in the following circumstances: a) A physician

assistant moves to a practice site or organized health care system to assist with the COVID-19 response, but

does not have a practice agreement in place with any authorized physician of the site or system; or b) As a

result of the COVID-19 response, no supervising physician with whom a physician assistant has an enforceable

practice agreement is available to supervise the physician assistant. Please note that the waiver keeps in place

the current law that all physician assistants must be supervised by licensed physicians, must be competent to

perform the services they provide, and must be educated, trained and experienced to perform services. For

more information please see Order Extending Three April 14, 2020, Orders Relating to Physician Assistant, Nurse

Practitioner, and Nurse-Midwife Supervision By 60 Days and Guidance on Physician Assistant Supervision

Requirements Waiver Under DCA Waiver-02-04.

2. Medical assistants can collect using nasal swabs, but front of the nose only. They may not collect using

nasopharyngeal or oropharyngeal swabs

3. EMTs and paramedics are authorized by the Director of the California Emergency Medical Services Authority to

collect nasopharyngeal swabs only for COVID-19 testing and only for the duration of the COVID-19 emergency.

Additional information about the local option scope of practice allowing them to do this is available on

the California Emergency Medical Services Authority webpage

4. Registered nurses can collect specimens using nasopharyngeal or oropharyngeal swabs

5. Nasopharyngeal or oropharyngeal swab collection is within the scope of practice for a licensed vocational

nurse (LVN) and psychiatric technician (PT) as long as the LVN or PT: a) Receives specialized instruction in the

proper procedure from a registered nurse or licensed physician; b) Demonstrates the requisite knowledge, skills

and ability prior to performance of the procedure; and; c) Performs the procedure in accordance with a

licensed physician’s order.

6. Respiratory care practitioners are authorized under their scope of practice to collect specimens using swabs,

including nasopharyngeal and oropharyngeal swabs

https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html

https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html

https://urldefense.com/v3/__https:/www.dca.ca.gov/licensees/dca_20_44.pdf__;!!EIXh2HjOrYMV!PvpeYaNeMlK-K1e0lz4WeRpWxrkxf9NI7OCPRfhlykrwG1kf6ggfbvNjiGmPZnYCmPuH1Q$

https://urldefense.com/v3/__https:/www.dca.ca.gov/licensees/dca_20_44.pdf__;!!EIXh2HjOrYMV!PvpeYaNeMlK-K1e0lz4WeRpWxrkxf9NI7OCPRfhlykrwG1kf6ggfbvNjiGmPZnYCmPuH1Q$

https://urldefense.com/v3/__https:/www.dca.ca.gov/licensees/physician_assistant_supervision_guidance.pdf__;!!EIXh2HjOrYMV!PvpeYaNeMlK-K1e0lz4WeRpWxrkxf9NI7OCPRfhlykrwG1kf6ggfbvNjiGmPZnaOulBClA$

https://urldefense.com/v3/__https:/www.dca.ca.gov/licensees/physician_assistant_supervision_guidance.pdf__;!!EIXh2HjOrYMV!PvpeYaNeMlK-K1e0lz4WeRpWxrkxf9NI7OCPRfhlykrwG1kf6ggfbvNjiGmPZnaOulBClA$

https://urldefense.com/v3/__https:/emsa.ca.gov/covid19/__;!!EIXh2HjOrYMV!PvpeYaNeMlK-K1e0lz4WeRpWxrkxf9NI7OCPRfhlykrwG1kf6ggfbvNjiGmPZnbodcKTCQ$

https://www.cdc.gov/coronavirus/2019-ncov/testing/How-To-Collect-Anterior-Nasal-Specimen-for-COVID-19.pdf


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▪ Consider placing educational materials where people are waiting to

prepare them for the testing set up and teach them how to do self-

swabbing (e.g., show continuous video https://youtu.be/rRZLDwEHkgY)

▪ Consider using an appointment model or having assigned times for

participants to avoid crowding

▪ Provide adequate space or private area for confidential reporting of

results

Obtain supplies

Before testing begins, ensure that you have the following materials:

▪ Table space to lay the necessary number of cards flat during the 15-30

minutes when the tests will be running and read

▪ Paper towels or table covering like butcher paper to lay tests on

▪ Hand sanitizer to clean hands/gloves

▪ Trash cans with biohazard bags for used test kits and swabs

▪ Permanent markers like Sharpies (to mark the BinaxNOW COVID-19 Ag

Card test cards)

▪ Large digital clock to write down time the tests were performed on the

cards

▪ Optional Timers (to time the BinaxNOW COVID-19 Ag Card tests)

▪ Laminated reading materials: Interpretation Tree (Appendix C)

▪ Appropriate technology devices (iPads/tablets/laptops with cameras) to

use software to manage check-in and report results

▪ Paper consent forms in case of emergency (consent forms may be

submitted electronically via the chosen software platform). See Appendix

E for generic sample consent.

▪ Appropriate technology devices to run software (iPad/tablets/laptops with

webcams)

4. Train staff

Ensure staff complete required self-serve trainings

Complete virtual hands-on trainings and competency quiz (requires

antigen tests on hand)


https://youtu.be/rRZLDwEHkgY


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Onboard to Valencia Branch Laboratory for PCR testing (if partnering with

VBL for confirmatory PCR testing)

Ensure staff complete required trainings

The BinaxNOW COVID-19 Ag Card test can be supervised and conducted by

trained personnel including administrators. The Binax Lead is responsible for

ensuring that staff / volunteers receive training in the use of personal protective

equipment (PPE), performance of the test they are using, and state and federal

requirements, including privacy laws. All testing personnel must complete all

trainings in the training guide. Please refer to Appendix F for full list of trainings.

The observation of self-collection is not listed in the scope of practice for any

California licensed healthcare professionals and is not regulated under current

law. However, the CDC has published Interim Guidelines for Collecting,

Handling, and Testing Clinical Specimens for COVID-19 (Appendix I). Any trained

staff member can supervise the self-collection. Because testing needs to be

performed soon after swabbing, nasal swab self-collection should be done on

site.

For confirmatory PCR testing, collection sites must have staff on hand to oversee

test administration including: registering participants on the state’s IT platform,

collecting samples (monitoring or administering), and preparing samples for

shipment to the lab. Staff requirements will vary based on size.

Complete virtual hands-on training and competency quiz

For organizations using the state’s CLIA waiver and Ordering Physician, all staff

who will administer tests are required to complete virtual hands-on training with

the CDPH training group. This training can only be completed after receiving

antigen tests. However, the training must be completed before a site is

authorized to begin testing. CDPH will provide instructions on attending training

once an organization’s application has been approved.

In addition, all trained personnel must pass the competency quiz, which is

immediately available to retake until passing. All staff must receive a score of

100% in order to pass.

https://www.surveymonkey.com/r/AntigenQuiz


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Once antigen tests are received by the site, the Binax Lead should complete the

initial quality control and product inventory log and maintain within the Binax

binder. In addition, for each additional future antigen tests received by the site,

the log should be updated. For more details, please see Appendix G.

Organizations partnering with VBL for confirmatory PCR testing:

(preferred for all organizations using the state’s CLIA waiver and

Ordering Physician):

Onboard to Valencia Branch Laboratory for PCR testing

If indicated in your application form that you want to use VBL for confirmatory

PCR, the Testing Task Force will ship you PCR tests for confirmatory testing and

onboard you to the state’s IT platform for PCR testing. This will include creating

individual IT platform accounts for all staff members who will be registering

participants and/or collecting or supervising the confirmatory PCR samples. Each

of these staff members should create individual IT platform accounts which

allows them to access the IT platform for confirmatory PCR tests. Please note,

organizations will only be onboarded to VBL if they are approved and attest to

their responsibilities as an antigen test site.

5. Begin testing and deliver antigen test results




Perform the tests


Distribute EUA Patient Fact Sheets (can be done via IT platform)

Conduct confirmatory PCR test (if applicable)




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(CalREDIE)

Report significant deviations of test performance (examples provided in

section below)


[email protected] (if using state’s CLIA waiver and Ordering

Physician)


The purpose of registration is to track and manage individual contact,

demographic, test date, and test card information. The state’s contracted IT

platform, Primary, has registration functionality. For organizations not using the

state’s CLIA ID and certificate of waiver and ordering physician, work with your IT

platform provider (see Appendix B) to determine if your IT platform has

registration capability. If not, the spreadsheet in Appendix J outlines the fields

that should be collected and tracked for each individual being tested.


▪ Identify participants in the software platform system or spreadsheet and

confirm their identity and information

▪ Verify participant identification with participant ID card (e.g., school ID,

driver’s license)

▪ Use the QR code on a newly opened BinaxNOW COVID-19 Ag Card to

associate the test with the person

▪ After check-in, open a test kit and mark it with participant’s name or initials


▪ Teach participant how to self-collect their sample (example video

included here: https://youtu.be/rRZLDwEHkgY)

▪ Once swabbing is complete, participant gives the swabs to the staff

assigned to perform and read the tests.





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Perform the tests

▪ Testing staff applies reagent to BinaxNOW COVID-19 Ag Card test card,

then accepts swab and inserts swab into card, twists swab 3 times, and

seals the card

▪ Testing staff then records the time the swab was inserted into card and

starts the timer

To avoid false results:

▪ Do not delay inserting the swab after applying the reagent

▪ Collected nasal swabs should not be placed back in original swab

packaging

▪ The swab should not touch anything after specimen collection

▪ Test cards must remain flat for the duration of the 15 minutes. If the card

needs to be moved, keep flat and move minimally

▪ The sample should be tested immediately after collection for best results


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▪ Maintain the test cards in a confidential location during testing and when

reading the results

More information in the package insert

https://www.fda.gov/media/141570/download

BinaxNOW COVID-19 Antigen Card has built-in procedural controls. For more

information on quality control, please refer to Appendix G.


▪ BinaxNOW COVID-19 Ag Card cards should be read after 15 minutes, and

before 30 minutes. Once read, each result must be recorded on the

software data platform. For details on reading and understanding results,

please view the BinaxNOW COVID-19 Ag Card Instructions for Use:


▪ Ideally two individuals independently read the results and/or take a

photograph of the results

▪ Negative results are communicated electronically to the individual tested.

They may also be shared verbally with participants who do not have

electronic access. The results may also be shared with a limited number of

previously designated administrative staff who are authorized to receive

the test results

▪ Positive results can be communicated electronically, but in the event of a

positive or ambiguous test result, the State recommends a confidential

phone call or in-person discussion of the result in a private area. Note: This

will be in addition to electronically reporting the results unless the individual

being tested does not have access to results electronically.

▪ Sites should provide paper reporting of results if individuals do not have

access to electronic results.

NOTE: For ambiguous test results (i.e., if there is any doubt about the absence or

presence of a line in sample window), the BinaxNOW COVID-19 Ag Card test

should immediately be repeated. For more details on ambiguous results, please

see Appendix G.

The following antigen test interpretation tree can help test readers interpret

results and identify next steps. See Appendix C for additional details on the

interpretation tree.




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Distribute EUA Patient Fact Sheet (can be done via IT platform)

Each participant should be given the EUA Patient Fact Sheet. For organizations

using the state’s CLIA waiver and Ordering Physician, Primary will distribute a link

to this fact sheet on its platform to participants receiving results electronically. If

the participant does not have access to the online platform for receipt of results,

a paper copy of the fact sheet should be provided. A version of the fact sheet

can be found in Appendix K.

Conduct confirmatory PCR test if applicable

Organizations using the state’s CLIA waiver and Ordering Physician will utilize the

Valencia Branch Laboratory for confirmatory PCR by following the steps below.

Organizations not using the state’s CLIA waiver and ordering physician may

conduct confirmatory PCR with an alternative partner. Please note, onboarding

with VBL (including access to software and transportation network) needs to be

completed in advance.

▪ Log into the VBL IT platform and register the individual

▪ Utilize the PCR kits and have individual self-collect a second sample (self-

swabbing procedure is the same as it is for an antigen test)

https://www.color.com/cdph-site-setup


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▪ Package and mail specimen to VBL by either utilizing independent courier

or utilizing the California COVID-19 Courier Network (for more details, see

this site)

For more information on potential PCR results, please view this site.


Disposal of BinaxNOW COVID-19 Ag Card test cards – once result is finalized and

recorded, disposal of used BinaxNOW COVID-19 Ag Card test cards is

determined based on negative or positive result.

Per CDPH Novel Coronavirus Disease 2019 (COVID-19) Medical Waste

Management - Interim Guidelines, waste from COVID-19 positive participants

must be handled as standard regulated medical waste (RMW). This includes

used swabs and test components.

● Test items must be placed in a red biohazard container that is certified to

meet the ASTM D1709 dart drop test and kept in a properly marked

biohazard container with a lid.

— Per local ordinance, all biohazard bags/container must also be labeled

with the generator name, address, and phone number. If the integrity of

the primary bag is compromised in any way (leaks, tears, etc.), a

compliant secondary bag must be used.

— When the biohazard bag is ready for transport offsite, it must be tied off

and placed into a USDOT-approved container lined with a biohazard bag

that is ASTM D1709 and ASTM D1922 certified. Check local enforcement

guidance on medical waste management and can be found:

https://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/EMB/MedicalWas

te/Local-Enforcement-Agencies.aspx

Waste from COVID-19 negative participants can be disposed of as follows:

● Negative test cards can be disposed of in regular waste containers

Unused test cards that are deemed unsuitable for use (e.g., due to product

issues, past the test expiration date) should be kept separately from the other

test cards and may be disposed of in regular waste containers. If there are

significant issues with the test cards (e.g., the box has multiple cards with control

lines missing), please confirm with the CDPH Antigen Testing Laboratories that no

additional documentation (including photos) are needed before disposing of

the test cards. Sites should verify with CDPH and/or manufacturer that the test

expiration dates have not been extended.


https://testing.covid19.ca.gov/pcr-step-7/#processsampleresults

https://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/EMB/MedicalWaste/Local-Enforcement-Agencies.aspx

https://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/EMB/MedicalWaste/Local-Enforcement-Agencies.aspx


21


(CalREDIE)

For organizations using the state’s CLIA waiver and ordering physician, the

state’s contracted IT platform (Primary) will automatically report all results directly

to CalREDIE in accord with California Code of Regulations Title 17, Section 2505

reporting requirements.

Organizations using their own CLIA ID and ordering physician may have IT

vendors who also automatically report all results to CalREDIE (e.g., Navica).

Otherwise, organizations can use the CalREDIE Manual Lab Reporting Module as

their IT reporting platform and must report on a daily basis aggregate tests

performed including: total tests, total positive results, total negative results, and

total inconclusive or invalid results into the Daily Survey and report ONLY positive

results on a daily basis into the CalREDIE Manual Lab Reporting Module to meet

statutory and regulatory requirements. The Testing Task Force will provide access

to the Daily Survey as needed. For more details, please view Appendix B.

Report significant deviations of test performance

Laboratories performing the test, including organizations using the state’s CLIA

waiver, are required to report suspected occurrence of false positive (testing

positive on antigen test and confirmatory PCR is negative) or false negative

(symptomatic individual tests negative and the PCR comes back positive) results

and significant deviations of test performance to the FDA and the manufacturer.

To assist with this reporting, testing sites that are using the State’s CLIA waiver and

Ordering Physician should report significant product issues to antigenlabdirector-

[email protected] to facilitate the laboratory’s reporting to the FDA and to

the manufacturer. Emails summarizing any significant product issues/deviations

should be sent no less frequently than once weekly during the testing week in

which they occur. Sites can also independently report issues with tests to the FDA

and to the manufacturer by emailing [email protected] and

[email protected], respectively. Sites can also contact Abbott Technical

Support at +1-800-257-9525.

Examples of product issues and deviations may include: test kits not performing

correctly, controls not working, blue control line missing in untested test cards,

not able to see control lines in the test card window, etc. Sites can record

product issues in the Binax Antigen Test Product Issues log (See Appendix H)






22


[email protected] (if using state’s CLIA waiver and Ordering

Physician)

Send electronic copies of the site training documents, inventory quality control

documentation, and any test deviation reports, adverse events, or product

issues to the CDPH Laboratory Director. The Laboratory Director can be

contacted at [email protected].

See Appendix F for the Training Log

See Appendix G for the Inventory Quality Control documentation

See Appendix H for the Binax Antigen Test Product Issues Log





23

Appendix Table of Contents

Appendix A: Comparison of PCR vs Antigen tests ....................................................... 24

Appendix B: Software information ................................................................................. 25

Appendix C: Interpreting test results and next steps.................................................... 25

Appendix D: Setting up PCR testing through VBL ......................................................... 28

Appendix E: Consent protocol ....................................................................................... 31

Appendix F: BinaxNOW COVID-19 Ag Card Training Materials .................................. 32

Appendix G: Inventory Quality Control Log.................................................................. 41

Appendix H: Binax Antigen Test Product Issues Log ..................................................... 44

Appendix I: CDC Guidelines ........................................................................................... 45

Appendix J: Sample registration fields ........................................................................... 45

Appendix K: BinaxNOW COVID-19 Ag Card Fact Sheets ............................................ 45

Appendix L: Guidelines for self-swabbing ..................................................................... 54

Appendix M: Useful links .................................................................................................. 56

FAQs .................................................................................................................................. 57


24

Appendix A: Comparison of PCR vs Antigen tests

PCR testing through VBL Antigen testing

Cost $55/test

Note: these tests can be

billed to the individual’s

insurance or entities can

choose to be invoiced for

the test

$0/test7

Note: Organizations are not

permitted to charge for antigen

tests

For confirmatory PCR tests

conducted through VBL, the

cost is $55/PCR test

Note: PCR tests can be billed to

the individual’s insurance or

entities can choose to be

invoiced for the test.

Staffing 5 people for 8 hours of

testing of up to 500 people

in a site

# people to test in an hour

with staff of 5: 60 (~5 min per

participant)

4-6 people for testing of 40-100

participants in a site per hour

Timing Upon receipt of specimens

to the Lab, tests will be

resulted in 24-48 hours

Turnaround time from collection

of specimens to results: 15-30

minutes

Packaging

and

shipment

Send to VBL

Can use the state’s

California COVID-19 Courier

Network (CCN) to transport

samples to VBL free of

charge

Only for confirmatory PCR tests

being sent to VBL

Can use the state’s California

COVID-19 Courier Network

(CCN) to transport samples to

VBL free of charge

7 Price subject to change in the future


25

Appendix B: Software options for organizations not using the

State’s CLIA waiver and Ordering Physician

IT

platform

Primary

Navica CalREDIE

Website https://primary.health/ https://www.abbott.com/

BinaxNOW COVID-19 Ag

Card-Test-NAVICA-

App.html

https://www.hsag.com/cont

entassets/a990207566d046aa

bb7a4c253d130d3b/3_calred

iemanuallabreporting.pdf

Costs Onboarding cost and

per-test fee (requires

separate contract if

chosen as IT platform

for organizations not

using the state’s CLIA

waiver and Ordering

Physician )

Free Free

Functional

ity

Customized

functionality by

organization and test

site support (e.g.,

participant

registration, hands-on

support, results

dashboard)

Participant registration

and bulk upload

capability

Automated reporting to

participant, collection

site, and public health

Direct system upload

Note: CalREDIE is NOT for site

support and does not include

functionality such as

participant registration,

consent, or results reporting

to participant. CalREDIE

should only be used for direct

public health reporting.

Timeline

for

adoption

Requires contract and

configuration for each

entity

Immediately available Login access required for all

reporting entities

User Organization Individual Organization

Appendix C: Interpreting test results and next steps

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

Positive result Negative result Ambiguous result

https://primary.health/

https://www.abbott.com/BinaxNOW-Test-NAVICA-App.html




https://www.hsag.com/contentassets/a990207566d046aabb7a4c253d130d3b/3_calrediemanuallabreporting.pdf





26

Asymptomatic Positive results in

an asymptomatic

individual require

confirmation with

PCR within 24

hours and

individuals should

isolate until results

are available

▪ If PCR is

positive, the

tested

individual

should remain

isolated and

close

contacts*

should remain

quarantined

▪ If PCR is

negative, the

tested

individual and

close

contacts* may

return to daily

activities and

work

Negative results in

an asymptomatic

individual means

that the tested

person is likely not

infectious and

can return to daily

activities and

work

Those who have

had recent close

contact (<10

days) with an

infected person

should be

quarantined and

not report to daily

activities or work

Ambiguous results

require a repeat

antigen test

Symptomatic Positive results in

symptomatic

individuals require

confirmatory PCR

▪ If PCR is

positive, the

tested

individual

should remain

Negative antigen

test results in

symptomatic

individuals should

be confirmed with

a PCR test within

24 hours.

Individuals should

isolate while

awaiting results,

Ambiguous results

require a repeat

antigen test


27

isolated and

close

contacts*

should remain

quarantined.

▪ If PCR is

negative, then

the individual

should remain

isolated until

they can

speak with

their

healthcare

provider or

local public

health

department if

they do not

have a

healthcare

provider to

determine

whether it is

safe for them

to return to

work

but close

contacts* may

continue daily

activities

▪ If the PCR test

result is

positive, the

symptomatic

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

symptomatic

individual can

return to work

per employer

policy.


28

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

*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.


https://covid19.ca.gov/contact-tracing/#:~:text=A%20close%20contact%20is%20someone,time%20the%20patient%20is%20isolated.


29

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


https://www.cdc.gov/coronavirus/2019-ncov/downloads/community/COVID-19-anterior-self-swab-testing-center-sp.pdf.pdf


30

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 at https://arcg.is/3hNVmms, 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

https://arcg.is/3hNVmms


31

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.


32

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

Name ________________

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


33

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



34

Reading Material and Training Videos

Prior to the virtual training, trainees are required to review the following

information:

1. Reading Material:

a. COVID-19 Antigen Testing Playbook

b. Training Requirements for Performing the Abbott BinaxNOWTM 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, available here: https://www.globalpointofcare.abbott/en/support/product-installation-

training/navica-brand/navica-BinaxNOW COVID-19 Ag Card-ag-

training.html

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: Participant (Individual) Test

c. Preparing for & Running the BinaxNOWTM COVID-19 Ag Card Test. YouTube Video https://youtu.be/rRZLDwEHkgY

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

https://youtu.be/TjkuRmfkxHU

e. Video of children self-swabbing for reference

https://youtu.be/DU_G-D_sL3I f. Health Insurance Portability and Accountability Act (HIPAA) training

https://www.accountablehq.com/free-hipaa-training/privacy-rule

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


https://www.globalpointofcare.abbott/en/support/product-installation-training/navica-brand/navica-binaxnow-ag-training.html






https://youtu.be/DU_G-D_sL3I


35

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

[email protected]. CDPH can be reached at [email protected].

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.




36

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


37

▪ 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.


38

▪ 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



39

☐Abbott BinaxNOW COVID-19 Ag Card IFU


Videos

☐Abbott BinaxNOW COVID-19 Ag Card training modules available here:

https://www.globalpointofcare.abbott/en/support/product-installation-

training/navica-brand/navica-BinaxNOW COVID-19 Ag Card-ag-training.html

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 https://youtu.be/rRZLDwEHkgY

☐Reading the BinaxNOW COVID-19 Ag Card Covid-19 Ag card test.


☐Video of self-swabbing: https://youtu.be/rRZLDwEHkgY

☐HIPAA training

☐FERPA training per your organization guidance

☐Hands-on training

☐Pass the quiz: https://www.surveymonkey.com/r/AntigenQuiz

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:













40

b. Interpret results: https://unitedinhealth.org/binax-training

3. Personal Protective Equipment (PPE)

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

https://www.cdc.gov/hai/pdfs/ppe/ppe-sequence.pdf

4. Training log: to print and store on site

https://unitedinhealth.org/binax-training

https://www.cdc.gov/hai/pdfs/ppe/ppe-sequence.pdf


41

Training Attestation Statement

I have fulfilled all the required training elements, including HIPAA training, have run a

positive and negative control, and passed the competency quiz with a score of 100%.

Date of Print Name Signature Site Lead Verification

Appendix G: Inventory quality control

Quality control

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

Ag Card IFU



State of California - Health and Human Services AgencyCalifornia Department of Public Health

GAVIN NEWSOM TOMÁS J. ARAGÓN, MD, DrPH Director & State Public Health Officer Governor

Inventory Quality Control (QC) Log

Site Name: Binax Lead Name: Date Lot # Expiration Number Received in Comments Positive Negative Controls Staff Stored Inventory Remaining (# of Received Date of good Control Control Run Performing between tests)

Individual condition? DATE Controls 36°F to Tests Y/N

P/F P/F (Pass/Fail) (Pass/

Fail) INITIALS 86°F

Received

EXAMPLE #12345678 45210 140 Y No comment P P 44317 ABC X

Page of


42

Ambiguous Tests

The test is invalid if the control band remains blue or if the control band is absent

(see examples). If the test is invalid, a repeat BinaxNOW COVID-19 Ag Card test

is required.

Date

Received

Lot # Expiration

Date

Number

of

Individual

Tests

Received

Received in

good

condition?

Y/N

Comments Positive

Control

P/F

(Pass/Fail)

Negative

Control

P/F

(Pass/Fail)

Controls

Run

DATE

Staff

Performing

Controls

INITIALS

Stored

between

36°F to

86°F

Inventory Remaining (# of

tests)

EXAMPLE #12345678 45210 140 Y No comment P P 44317 ABC X

Page of

Inventory Quality Control (QC) Log

TOMÁS J. ARAGÓN, MD, DrPH

Director & State Public Health Officer

GAVIN NEWSOM

Governor


Site Name: Binax Lead Name:


43

• 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

o 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

o 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 https://unitedinhealth.org/binax-training

• Whenever possible, antigen test results should be read by two

independent readers


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

TOMÁS J. ARAGÓN, MD, DrPH Director & State Public Health Officer

GAVIN NEWSOM Governor

Binax Antigen Test Product Issues Log

Testing Site Name: Binax Lead Name: Report DATE

Staff Completing Report NAME

Issue/Event DATE/TIME

Issue/Event BRIEF DESCRIPTIO N

Suspected false negative/positi ve result or other issue: Y/N or N/A

Report sent to CDPH AntigenLabDirector- [email protected]. gov Y/N and DATE

ADDITIONAL NOTES

EXAMPLE P. MANAGER 5/1/21 DESCRIPTION Y Y 5/1/21 NOTES NOTES

Pag e of


44

Appendix H: Binax Antigen Test Product Issues Log

Report

DATE

Staff Completing

Report NAME

Issue/Event

DATE/TIME

Issue/Event

BRIEF

DESCRIPTIO

N

Suspected

false

negative/positi

ve result or

other issue:

Y/N or N/A

Report sent to CDPH

AntigenLabDirector-

[email protected].

gov Y/N and DATE

ADDITIONAL

NOTES

EXAMPLE P. MANAGER 5/1/21 DESCRIPTION Y Y 5/1/21 NOTES NOTES

Binax Antigen Test Product Issues Log


Page of

Testing Site Name: Binax Lead Name:

TOMÁS J. ARAGÓN, MD, DrPH

Director & State Public Health Officer

GAVIN NEWSOM

Governor




45

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

First

Name

Last

Name

Gender Ethnicity Address City State Postal

Code

Date

of

Birth

Email Phone

Number

Additional

Information

(optional)

Tags

(optional)

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

BinaxNOW™ COVID-19 Ag CARD EUA FACT SHEET FOR

PATIENTS

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:

https://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

https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html



https://www.cdc.gov/nCoV


46

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 at the

following link: https://www.cdc.gov/coronavirus/2019- ncov/symptoms-

testing/symptoms.html.

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?

https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html




47

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


48

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: https://www.cdc.gov/coronavirus/2019-

ncov/downloads/sick-with-2019-nCoV-fact-sheet.pdf.

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 here: https://www.fda.gov/medicaldevices/device-

advicecomprehensive-regulatoryassistance/medical-devicedatabases.

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 at:

https://www.fda.gov/emergencypreparedness-andresponse/mcm-legal-

regulatory-andpolicyframework/emergency-use-authorization.

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.

https://www.cdc.gov/coronavirus/2019-ncov/downloads/sick-with-2019-nCoV-fact-sheet.pdf

https://www.cdc.gov/coronavirus/2019-ncov/downloads/sick-with-2019-nCoV-fact-sheet.pdf

https://www.fda.gov/medicaldevices/device-advicecomprehensive-regulatoryassistance/medical-devicedatabases


https://www.fda.gov/emergencypreparedness-andresponse/mcm-legal-regulatory-andpolicyframework/emergency-use-authorization


https://www.cdc.gov/nCoV


49

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).




50

▪ 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


51

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).


52

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:

https://www.fda.gov/medicaldevices/device-advicecomprehensive-

regulatoryassistance/medical-devicedatabases.

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 at: https://www.fda.gov/emergencypreparedness-

andresponse/mcm-legal-regulatory-andpolicyframework/emergency-use-

authorization.

Where can I go for updates and more information?

CDC webpages:







53

General: https://www.cdc.gov/COVID19

Symptoms: https://www.cdc.gov/coronavirus/2019-

ncov/symptomstesting/symptoms.html

Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-

nCoV/guidancehcp.html

Information for Laboratories: https://www.cdc.gov/coronavirus/2019-

nCoV/guidancelaboratories.html

Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-nCoV/lab-

biosafetyguidelines.html

Isolation Precautions in Healthcare Settings:

https://www.cdc.gov/coronavirus/2019-ncov/infectioncontrol/control-

recommendations.html

Specimen Collection: https://www.cdc.gov/coronavirus/2019-

nCoV/guidelinesclinical-specimens.html

Infection Control: https://www.cdc.gov/coronavirus/2019- ncov/infection-

control/index.html

Discontinuation of Isolation: https://www.cdc.gov/coronavirus/2019-

ncov/hcp/dispositionin-home-patients.html

FDA webpages:

General: www.fda.gov/novelcoronavirus EUAs: (includes links to patient fact

sheet and manufacturer’s instructions)

https://www.fda.gov/medicaldevices/coronavirus-disease-2019-covid-19-

emergencyuse-authorizations-medical-devices/vitro-diagnostics-euas

Abbott Diagnostics Scarborough, Inc.:

10 Southgate Road Scarborough, Maine 04074

Technical Support:

Telephone: (800) 257 9525

[email protected]

https://www.cdc.gov/COVID19

https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html

https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html

https://www.cdc.gov/coronavirus/2019-nCoV/guidancehcp.html

https://www.cdc.gov/coronavirus/2019-nCoV/guidancehcp.html

https://www.cdc.gov/coronavirus/2019-nCoV/guidancelaboratories.html

https://www.cdc.gov/coronavirus/2019-nCoV/guidancelaboratories.html

https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafetyguidelines.html

https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafetyguidelines.html

https://www.cdc.gov/coronavirus/2019-ncov/infectioncontrol/control-recommendations.html

https://www.cdc.gov/coronavirus/2019-ncov/infectioncontrol/control-recommendations.html

https://www.cdc.gov/coronavirus/2019-nCoV/guidelinesclinical-specimens.html

https://www.cdc.gov/coronavirus/2019-nCoV/guidelinesclinical-specimens.html

https://www.cdc.gov/coronavirus/2019-%20ncov/infection-control/index.html

https://www.cdc.gov/coronavirus/2019-%20ncov/infection-control/index.html

https://www.cdc.gov/coronavirus/2019-ncov/hcp/dispositionin-home-patients.html

https://www.cdc.gov/coronavirus/2019-ncov/hcp/dispositionin-home-patients.html

https://www.fda.gov/medicaldevices/coronavirus-disease-2019-covid-19-emergencyuse-authorizations-medical-devices/vitro-diagnostics-euas

https://www.fda.gov/medicaldevices/coronavirus-disease-2019-covid-19-emergencyuse-authorizations-medical-devices/vitro-diagnostics-euas


http://www.fda.gov/novelcoronavirus


54

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: https://youtu.be/rRZLDwEHkgY

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.



55

▪ 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


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Appendix M: Useful Links

Abbott BinaxNOW COVID-19 Ag Card

● Review the package insert https://www.fda.gov/media/141570/download

● 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:






57

● BinaxNOW COVID-19 Ag Card safety data sheet included in the following link:

https://nhfa-ems.com/wp-content/uploads/2020/11/BinaxNOW COVID-19 Ag

Card-COVID-19-Device-SDS-US-195-.pdf

HIPAA Training:

● For those who do not have a HIPAA certificate, there are online course. Here

is an example: (https://www.accountablehq.com/free-hipaa-

training/privacy-rule)

Staff:

● Personnel who are observing individuals performing self-collection should be

trained on proper technique: https://www.cdc.gov/coronavirus/2019-

ncov/downloads/community/COVID-19-anterior-self-swab-testing-center.pdf

Liability information:

● https://sharedsystems.dhsoha.state.or.us/DHSForms/Served/le3529.pdf

● https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.

CDC Isolation Guidance

● https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html

FAQs

Test Questions

What does a pink line down the side of the test mean?

A pink line down the side of the test is normal. As long as the control line appears

pink and extends edge to edge the test is valid.

What should I do if a faint line appears in the sample window?

https://nhfa-ems.com/wp-content/uploads/2020/11/BinaxNOW-COVID-19-Device-SDS-US-195-.pdf

https://nhfa-ems.com/wp-content/uploads/2020/11/BinaxNOW-COVID-19-Device-SDS-US-195-.pdf





https://sharedsystems.dhsoha.state.or.us/DHSForms/Served/le3529.pdf

https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx

https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html


58

• Photograph the test and ask health care personnel working with your

school (nurse or physician) to review the test

• Repeat test collection and BinaxNOW COVID-19 Ag Card test with a new

card

• If the line extends edge to edge, count it as a positive test

• If the line does not extend edge to edge, conduct a confirmatory PCR test

• If repeat does not have a faint line, count it as negative


59

Disclaimer: This guide is not sponsored by or affiliated with the manufacturer,

Abbott Laboratories. With respect to information contained in this guide, neither

the University of California nor any of their respective regents, officers, board

members, agents, employees, students, or volunteers makes any warranty,

express or implied, including the warranties of merchantability and fitness for a

particular purpose; nor assumes any legal liability or responsibility for the

accuracy, completeness, or usefulness of information; nor represents that its use

would not infringe privately owned rights. This guide should not be considered

medical advice; anyone who believes that they may be infected with the SARS-

COV-2 virus should immediately seek medical advice from their doctor or other

health professionals. More information can be found here:

https://unitedinhealth.org/binax-training.

What do I do if the control line is not a solid line?

If the control line does not extend edge to edge, repeat the test.

What do I do if the controls are not performing correctly?

Refer to the Abbott Training Module 2: Quality Control. If correct control results

are not obtained, do not perform participant tests or report results. Abbott

https://urldefense.com/v3/__https:/unitedinhealth.org/binax-training__;!!EIXh2HjOrYMV!PENteaWTBtNLjJcJDEiiOksg63HE6NZlhJWzgnibgJCjU-Qj90xE9HfA6LtL02AhGDjULA$


60

Technical Services should be contacted during normal business hours before

testing participant specimens. Abbott Technical Services can be reached at:

800-257-9525 8 AM – 8 PM EST or via email at [email protected].

Additionally, the CDPH Laboratory Director should be notified at

[email protected].

What do I do if antigen cards are mislabeled or mishandled?

Do not use tests that you believe may have been mislabeled or mishandled.

Promptly notify the site’s Binax Lead and document on the Binax Antigen Test

Product Issues Log (See Appendix H). The Binax Lead should send the Binax

Antigen Test Product Issues Log to CDPH at antigenlabdirector-

[email protected]. Emails summarizing product issues/deviations or

adverse events should be sent the day they occur if requiring prompt attention

or no less frequency than weekly to the reporting inbox; copies of all logs can be

sent monthly to the Laboratory Director.

What happens if I drop the swab or the swab accidently touches something

before I insert it in the card?

Repeat swabbing.

What happens if I forgot to twirl the swab in the test?

Repeat the test.

What should I do if my hand was shaky and one drop of reagent missed the

well?

Add one additional drop to the well. If a drop does not go in the well, do not

count it towards the 6 drops of reagent.

What if a card was not flat while it was running?

Repeat the test.

What should I do if I am testing in extreme weather conditions?

The BinaxNOW COVID-19 Ag Card tests perform ideally at their manufacturer-

specified storage temperatures between 36 degrees Fahrenheit and 86 degrees

Fahrenheit. If it is raining, the State recommends ensuring that the cards are kept

in a dry location.

Self-Swabbing Questions

What if a participant refuses to self-swab?






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If a participant refuses to self-swab, testing sites with trained healthcare

personnel can perform sample collection or may refer them to a testing center

where appropriate medical personnel who have been trained in specimen

collection can collect a specimen. For more information on trained healthcare

providers who can perform sample collection, please see the section “Identify

staff to deliver reagent and read tests”

What should I do if a participant experiences an adverse event (e.g., significant

nosebleed)?

Follow site safety guidelines and procedures. Ensure adherence to site infection

control procedures, per site’s protocols and procedures for injury and illness

prevention and potential exposures to infectious agents (see Cal/OSHA

guidance and CDC infection control guidance). Additionally, notify the CDPH

Ordering Physician and Laboratory Director at antigenlabdirector-

[email protected].

https://www.dir.ca.gov/dosh/coronavirus/

https://www.dir.ca.gov/dosh/coronavirus/

https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Finfection-control%2Fcontrol-recommendations.html



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