Antigen Testing Playbook - CDPH Testing Task Force - DRAFT 3/8/2021 Version 1.0 All healthcare guidance contained in this manual is based on CDPH ...
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Information contained in this document is preliminary | Working draft as of 3/8/2021.
CDPH Testing Task Force
Antigen Testing
Playbook
DRAFT
3/8/2021
Version 1.0
All healthcare guidance contained in this manual is based on CDPH / CDC guidelines
1
Information contained in this document is preliminary | Working draft as of 3/8/2021.
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 .......................................... 5
2. Onboard to chosen IT platform .......................................................................... 7
3. Prepare logistics for testing .................................................................................. 7
4. Train staff, sign Agreement, and order antigen tests ..................................... 10
5. Begin testing and deliver antigen test results .................................................. 12
Appendix .................................................................................................................... 18
2
Information contained in this document is preliminary | Working draft as of 3/8/2021.
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). Given various nuances, a set of population specific
antigen testing playbooks are also available:
• Schools playbook: please contact schoolbinax@cdph.ca.gov
• Department of Social Services (DSS) playbook: please contact
CDPHRCFEBinax@cdph.ca.gov
Roles and responsibilities for antigen testing
State responsibilities
Approve organizations, provide support and instructions for conducting
testing
Provide an opportunity for organizations to make available 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 patient 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
3
Information contained in this document is preliminary | Working draft as of 3/8/2021.
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
Agreement
Provide staff and manage on-site logistics (e.g., procuring PPE, providing
physical space, supervising sample collection, ordering test kits,
onboarding onto IT platform)
Ensure training of staff supervising the test
Report results to the patient, ordering physician, and local public health
jurisdiction via IT platform options
Comply with governing CDPH policies and procedures regarding data
storage and privacy protection
5 steps to conduct antigen testing
The state has partnered with Abbott to offer BinaxNOW antigen tests, 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
Submit application form
Develop plans for confirmatory PCR testing
2. Onboard to chosen IT platform
Onboard to chosen IT platform
3. Prepare logistics for testing
Set up facility
Identify staff to deliver reagent and read tests (recruit staff if needed)
4. Train staff, sign Agreement, and order antigen tests
Ensure staff complete required trainings
Sign Agreement
4
Information contained in this document is preliminary | Working draft as of 3/8/2021.
Order antigen tests
Onboard to Valencia Branch Laboratory for PCR testing (If partnering with
VBL for confirmatory PCR testing)
Order PCR test kits (If partnering with VBL for confirmatory PCR testing)
5. Begin testing and deliver antigen test results
Register and obtain consent from participants
Check-in participants
Supervise sample collection
Perform the tests
Read tests, communicate results, and identify next steps
Conduct confirmatory PCR test (if applicable)
Dispose of cards appropriately
Report results via IT platform to CalREDIE
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
Submit application form
Develop plans for confirmatory PCR testing
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 employers in 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
5
Information contained in this document is preliminary | Working draft as of 3/8/2021.
Testing frequency is recommended to be at least 2 times per week
Based on total number of individuals being tested and a testing frequency of
at least 2 times per week, determine testing volume for each potential site
Determine location where testing will be performed in the facility
Choose an IT platform for reporting
The state recommends using an IT platform to help with registration, patient
consent, test result management, and mandated electronic reporting. Most IT
vendors will provide training related to use of their software. 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 patient data is collected on these paper forms, the
testing site is responsible for securely shredding these documents. This is
necessary because the data is considered personal health information (PHI),
which is protected by HIPAA.
The preferred IT platform must be specified in the application form.
Submit 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 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 license
and their existing antigen test supplies to test worker cohorts.
Once submitted, a representative will reach out to you within 3-5 business days.
Develop plans for confirmatory PCR testing
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).
6Information contained in this document is preliminary | Working draft as of 3/8/2021.
Therefore, CDPH strongly recommends setting up plans for confirmatory PCR
testing. There are 2 available options:
1) Partner with the Valencia Branch Laboratory (VBL) and set up PCR testing at
your organization.
Organizations can indicate interest in partnering with VBL for PCR testing on
the application form. Once approved, organizations will receive an email to
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
2. Onboard to chosen IT platform
Onboard to chosen IT platform
Onboard to chosen IT platform
Organizations will follow-up with chosen IT platform vendor for steps for
onboarding to the platform and training staff on how to register participants and
report results to participants. Depending on the vendor, choosing an IT platform
may require contracting with the vendor.
3. Prepare logistics for testing
Set up facility
Identify staff to deliver reagent and read tests (recruit staff if needed)
Set up facility
Identify appropriate facility
Designate a secure place to store the BinaxNOW tests where temperature does
not fall below 36°F or above 86°F. BinaxNOW tests have a shelf life between 6-9
months. Expiration date can be found on the outside of the boxes near the lot
number.
7Information contained in this document is preliminary | Working draft as of 3/8/2021.
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, 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 PPE
It is your responsibility as an organization to ensure all staff/volunteers have
appropriate personal protective equipment (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 Personnel observing All staff should follow Standard
of self- individuals performing self- Precautions. Face mask and gloves
collection collection should be trained required, eye protection (goggles
anterior on proper technique: or face shield) also recommended
nares swabs https://www.cdc.gov/corona since patients may sneeze when
virus/2019- they swab.
ncov/downloads/community/
COVID-19-anterior-self-swab-
testing-center.pdf
Collection In clinical settings, trained Staff should maintain proper
of anterior health care providers: infection control. N95 or higher-
nares swabs Allopathic and osteopathic level respirator (or facemask if a
(for physicians, physician respirator is not available), eye
individuals assistants, registered nurses, protection, gloves, and a gown,
who cannot licensed vocational nurses, when collecting specimens.
self-collect) medical assistants, EMTs and
paramedics
Manage crowd sizes
Certain measures must be used when testing large groups of people to avoid
people congregating in the same area:
Develop signage that directs participants where to check-in and line up
8Information contained in this document is preliminary | Working draft as of 3/8/2021.
Place markers on the ground to help participants maintain distance when
waiting in line and at the different stations
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
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 cards)
Large digital clock to write down time the tests were performed on the
cards
Optional Timers (to time the BinaxNOW 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 sample consent.
Appropriate technology devices to run software (iPad/tablets/laptops with
webcams)
Identify staff to deliver reagent and read tests (recruit staff if
necessary)
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
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.
9Information contained in this document is preliminary | Working draft as of 3/8/2021.
Organizations must have trained staff on site to oversee all aspects of testing.
Testing involves a number of roles. Number of staff required will vary based on
size and organization, and one person can perform multiple roles if necessary.
Roles:
Check-in: Performs check-in and associates the BinaxNOW card with the
staff member or student
Swab Supervisor: Monitors self-collection
Tester: Performs the BinaxNOW test
Reader: Tracks the time of the test and reads the results
Data Entry: Enters the data into the software platform
4. Train staff, sign Agreement, and order antigen tests
Ensure staff complete required trainings
Sign Agreement
Order antigen tests
Onboard to Valencia Branch Laboratory for PCR testing (if partnering with
VBL for confirmatory PCR testing)
Order PCR test kits (if partnering with VBL for confirmatory PCR testing)
Ensure staff complete required trainings
The BinaxNOW test can be supervised 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 trained personnel must complete all trainings in the training guide
(including virtual training with the CDPH training group). In addition, all trained
personnel must pass the competency quiz, which is immediately available to
retake until passing. Note that the virtual training with the CDPH training group
can be completed after receiving antigen tests, but must be completed before
beginning testing. 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,
10Information contained in this document is preliminary | Working draft as of 3/8/2021.
Handling, and Testing Clinical Specimens for COVID-19 (Appendix G). 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 patients 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. For detailed
instructions, please refer to the VBL playbook step 2 (Click “Access the
playbook” on this site)
Sign Agreement
Once all staff complete mandatory trainings and competency quiz, organization
signs Agreement and returns to the state. Upon receiving the Agreement, a
CDPH representative will countersign the Agreement and release the state’s
CLIA number to entities to use for reporting.
Note: entities that are also onboarding to VBL for PCR testing will need to sign a
separate Memorandum of Understanding with the state for PCR testing. For
detailed instructions, please refer to the VBL playbook step 3 (Click “Access the
playbook” on this site)
Order antigen tests
Once your Agreement is received, the state will send you instructions on
receiving your first 6-week supply. Please note, to receive your antigen tests,
please contact your local authority to complete the order. All orders should be
placed with a 2-week lead time.
Medical facilities (e.g., SNFs, ALFs, RCFEs, Department of State Hospitals)
should contact their local Medical Health Operational Area Coordinator
(MHOAC).
Non-medical facilities (e.g., education, transportation) should contact
their local Office of Emergency Services (OES).
For future shipments, organizations will reorder through the local authority with a
two-week lead time for a six-week supply.
11Information contained in this document is preliminary | Working draft as of 3/8/2021.
If partnering with VBL for confirmatory PCR testing:
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 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 approve and attest to their responsibilities as an antigen test site.
Order PCR test kits
Once staff accounts are created, organizations can order kits through the
state’s IT platform Ordering Portal. Each order may take five or more business
days to arrive at site. The IT platform will provide appropriate materials to ship
samples back to the laboratory. Organizations must use the provided ship-back
boxes to ship the samples to the lab
For detailed instructions, please refer to the VBL playbook steps 4-8 (Click
“Access the playbook” on this site)
5. Begin testing and deliver antigen test results
Register and obtain consent from participants
Check-in participants
Supervise sample collection
Perform the tests
Read tests, communicate results, and identify next steps
Conduct confirmatory PCR test (if applicable)
Dispose of cards appropriately
12Information contained in this document is preliminary | Working draft as of 3/8/2021.
Report results via IT platform to CalREDIE
Register and obtain consent from participants
The purpose of registration is to track and manage individual contact,
demographic, test date, and test card information. Your chosen IT platform may
have registration functionality (see Appendix B), if not, the spreadsheet in
Appendix H outlines the fields that should be collected and tracked for each
individual being tested.
Check-in participants
Identify participants in the software platform system or spreadsheet and
confirm their identity and information
Use the QR code on a newly opened BinaxNOW card to associate the test
with the person
After check-in, open a test kit and mark it with participant’s name or initials
Supervise sample collection
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.
Perform the tests
Testing staff applies reagent to BinaxNOW 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
13Information contained in this document is preliminary | Working draft as of 3/8/2021.
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
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 I
14Information contained in this document is preliminary | Working draft as of 3/8/2021.
Read tests, communicate results, and identify next steps
BinaxNOW 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 Instructions for Use:
https://www.fda.gov/media/141570/download
Ideally two individuals independently read the results and/or take a
photograph of the results
Negative results are communicated electronically to the individual tested.
The results may also be shared with a limited number of previously
designated administrative staff
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: For ambiguous test results (i.e., if there is any doubt about the absence or
presence of a line in sample window), the BinaxNOW test should immediately be
repeated. For more details on ambiguous results, please see Appendix I.
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.
15Information contained in this document is preliminary | Working draft as of 3/8/2021.
Conduct confirmatory PCR test if applicable
If utilizing the Valencia Branch Laboratory for confirmatory PCR, follow the steps
below, otherwise conduct confirmatory PCR with 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)
Package and mail specimen to VBL by either utilizing independent courier
or utilizing the California COVID-19 Courier Network (see Appendix E in the
VBL playbook. Click “Access the playbook” on this site)
For more information on potential PCR results, please view this flyer.
Dispose of cards appropriately
Disposal of BinaxNOW Cards – once result is finalized and recorded, disposal of
BinaxNOW 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 patients 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 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
16Information contained in this document is preliminary | Working draft as of 3/8/2021.
Report results via IT platform to CalREDIE
Organizations using IT platforms (e.g., Primary) will automatically via the IT
platform report all results directly to CalREDIE. For more details, please view
Appendix B.
Organizations using the CalREDIE Manual Lab Reporting Module as their IT
reporting platform 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.
17Information contained in this document is preliminary | Working draft as of 3/8/2021.
Appendix Table of Contents
Appendix A: Comparison of PCR vs Antigen tests ....................................................... 19
Appendix B: Software information ................................................................................. 20
Appendix C: Interpreting test results and next steps.................................................... 20
Appendix D: Setting up PCR testing through VBL......................................................... 22
Appendix E: Consent protocol ....................................................................................... 25
Appendix F: BinaxNOW Training Materials .................................................................... 27
Appendix G: CDC Guidelines......................................................................................... 35
Appendix H: Sample registration fields .......................................................................... 35
Appendix I: Quality control ........................................................................................... 355
Appendix J: Guidelines for self-swabbing ..................................................................... 37
Appendix K: Useful links ................................................................................................... 40
FAQs .................................................................................................................................. 41
18Information contained in this document is preliminary | Working draft as of 3/8/2021.
Appendix A: Comparison of PCR vs Antigen tests
PCR testing through VBL Antigen testing
Cost $55/test $0/test
Note: these tests can be For confirmatory PCR tests
billed to the individual’s conducted through VBL, the
insurance or entities can cost is $55/test
choose to be invoiced for
Note: these tests can be billed
the test
to the individual’s insurance or
entities can choose to be
invoiced for the test
Staffing 5 people for 8 hours of 4-6 people for testing of 40-100
testing of up to 500 people participants in a site per hour
in a site
# people to test in an hour
with staff of 5: 60 (~5 min per
patient)
Timing Upon receipt of specimens Turnaround time from collection
to the Lab, tests will be of specimen to results: 15-30
resulted in 24-48 hours minutes
Packaging Send to VBL Only for confirmatory PCR tests
and being sent to VBL
Can use the state’s
shipment
California COVID-19 Courier Can use the state’s California
Network (CCN) to transport COVID-19 Courier Network
samples to VBL free of (CCN) to transport samples to
charge VBL free of charge
19Information contained in this document is preliminary | Working draft as of 3/8/2021.
Appendix B: Software information
IT platform Primary Color CalREDIE
Website https://primary.he https://www. https://www.h
alth/ color.com/ sag.com/cont
entassets/a990
207566d046aa
bb7a4c253d13
0d3b/3_calred
iemanuallabre
porting.pdf
Costs Onboarding cost TBD Free
and per-test fee
Functionality Customized TBD Direct system
functionality by upload
organization and
test site support
(e.g., patient
registration,
hands-on
support, results
dashboard)
Timeline for Requires contract TBD Login access
adoption and configuration required for all
for each entity reporting
entities
User Organization TBD Organization
Appendix C: Interpreting test results and next steps
This applies to BinaxNOW antigen testing only
Positive result Negative result Ambiguous result
Asymptomatic Positive results in Negative results in Ambiguous results
an asymptomatic an asymptomatic require a repeat
individual require individual means antigen test
confirmation with that the tested
PCR within 24 person is likely not
hours and infectious and
20Information contained in this document is preliminary | Working draft as of 3/8/2021.
individuals should can return to daily
isolate until results activities and
are available work
If PCR is Those who have
positive, the had recent close
tested contact (Information contained in this document is preliminary | Working draft as of 3/8/2021.
the individual positive, the
should remain symptomatic
isolated until individual
they can should be
speak with considered
their infected and
healthcare continue to be
provider or isolated, and
local public close
health contacts*
department if should go
they do not home to
have a quarantine.
healthcare If the PCR test
provider to result is
determine negative, the
whether it is symptomatic
safe for them individual can
to return to return to work
work per employer
policy.
*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 patients who do not
have symptoms, 2 days prior to their test) until the time the patient is isolated.
In some situations, it may be difficult to determine whether individuals have
met this criterion and an entire stable worker cohort or other group may need
to be considered exposed, particularly if the group has spent time together
indoors for an extended period. For more information, see CDPH guidance
here.
Appendix D: Setting up PCR testing through VBL
In order to partner with the Testing Task Force’s Valencia Branch Laboratory
(VBL), you will need to take the following 5 steps. For detailed instructions, please
refer to the VBL playbook steps 4-8 (Click “Access the playbook” on this site)
22Information contained in this document is preliminary | Working draft as of 3/8/2021.
Step 1: Register with Color and onboard onto the Color platform
Testing Task Force will submit a list of the emails addresses for all staff who will be
registering participants and/or collecting or monitoring self-administered
samples. Once the organization is approved, the individual managing the
collection site should alert each of these staff members to create individual
Color accounts which allows them to access the system.
It is important that staff members complete this process and test their access to
the site at least two business days before testing in order to avoid issues on the
day of testing
For participants requiring confirmatory PCR testing, registration information must
be loaded onto the Color platform online. Paper forms may be included but all
information must be entered into the online platform. Samples cannot be
shipped to the lab until this has been done.
Step 2: Order kits
Organizations can order kits through the Ordering Portal. As the state provides
the ordering physician, test kit orders can be placed without the organization
needing their own physician sign-off. Unless expedited shipping is used (at an
additional cost), each order may take five or more business days to arrive at
collection site. Color will provide appropriate materials to ship samples to the
laboratory. Organizations must use the provided ship-back boxes to ship the
samples to the lab.
Kits have a shelf life of 1-2 years. Before kits are used for testing, they should be
stored somewhere secure with no direct exposure to sunlight or heat. The ideal
environment to store test kits is at room temperature (between 72 and 76
degrees Fahrenheit).
NOTE: These collection kits use PrimeStore transport media (the small amount of
liquid in each tube) to stabilize and inactivate the virus. This media contains
guanidine thiocyanate, which produces a dangerous chemical reaction that
releases cyanide gas when exposed to bleach (sodium hypochlorite). Do not
use bleach products near collection kits.
23Information contained in this document is preliminary | Working draft as of 3/8/2021.
Step 3: Supervise sample collection
In order to begin sample collection, organizations must register patients for
testing. The swabs provided are anterior nares (nasal) swabs which can be self-
administered. Individuals collecting their own samples must be supervised and
each individual must follow the following steps as shown in the printable flyer
here (Spanish version here).
Step 4: Ship collected samples
Collection sites are responsible for secure storage of samples prior to shipment
and selecting and coordinating pick-up by a courier. Collection sites are
responsible for properly packaging all samples appropriately for transportation.
Test kits provided by the state, through Color, will come with specific packaging
materials to help streamline the return process.
Color provides an electronic manifest and batch shipping tool to all collection
sites to help track samples as they are transported from the collection site to VBL
and ensure that VBL only receives activated samples that can be processed.
Once the samples have been collected, an electronic manifest will need to be
completed on the Batch Shipment tool for each shipment. A print out 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 all 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
24Information contained in this document is preliminary | Working draft as of 3/8/2021.
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 patients through SMS and/or email (using
the mobile phone number and/or email provided through the registration
process) that results are available. Patients 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 patient loses their Color barcode
for their test, they can call the Color support hotline. Patients can also access
their results by clicking on the link from their email or text notification.
Patients with positive test results will receive a follow-up call from the State’s
clinical call center within 48 hours to ensure they receive their test results. Spanish
and other languages are available on these calls through the language line
Organizations have two billing options*:
Direct billing: The state directly bills organizations for the cost of each test
conducted ($55/test). The state will invoice the organization monthly for
the tests conducted. Please note, hospitals seeking temporary support to
test healthcare worker 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 patients and employees.
Patients and employees will never be balance billed by the state.
*Schools have a separate billing structure
Appendix E: Consent protocol
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).
25Information contained in this document is preliminary | Working draft as of 3/8/2021.
Sample Consent
Organization is pleased to offer site-based screening for COVID-19 for the
organization population. Organization will be using Abbott laboratories
BinaxNOW tests. These are rapid, point-of-care tests that deliver results in 15-30
minutes. This test is voluntary and will only be completed if this form is signed.
To collect the specimen, the participant will place a swab, similar to a cotton
swab/Q-Tip, inside of the tip of the nose. A trained staff member will observe the
specimen collection.
I authorize Organization to conduct specimen collection and testing for
COVID-19 via nasal swab.
I acknowledge that a positive test results is an indication that I may have the
COVID-19 virus. If I receive a positive test result, I acknowledge that I must self-
isolate and continue to wear a face-covering to avoid infecting others.
I understand that Organization is not acting as my medical provider; that this
testing does not replace treatment by my medical provider; and I assume
complete and full responsibility to take appropriate action concerning my
test result. I agree to seek medical advice, care and treatment from my
medical provider if I have questions or concerns, or if my condition worsens.
I understand that, as with any medical test, there is the potential for incorrect
test results. I understand that a confirmatory test may be required depending
on the result.
I have been informed about the test purpose, procedures, possible benefits
and risks and I have received a copy of this informed consent. I have been
given the opportunity to ask questions before I sign, and I may ask additional
questions at any time.
I understand that my test results will be shared with clinical and other staff at
the collection site and the local Public Health Department.
I have read, understand and agree to the above.
Signature of Participant
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,
26Information contained in this document is preliminary | Working draft as of 3/8/2021.
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 rapid
antigen test for the COVID-19 virus.
Appendix F: BinaxNOW Training Materials
Training Requirements for Performing the Abbott BinaxNOWTM COVID-19 Ag Card
Test for Organizations. Please NOTE: All organizations must complete the training
before proceeding with testing
Overview
From the Abbott BINAXNOW COVID-19 AG CARD (PN 195-000) – INSTRUCTIONS
FOR USE:
“The BinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for
the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in
direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by
their healthcare provider within the first seven days of symptom onset. Testing is
limited to laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to
perform moderate, high or waived complexity tests. This test is authorized for use
at the Point of Care (POC), i.e., in patient 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 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.
27Information contained in this document is preliminary | Working draft as of 3/8/2021.
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 training (or virtual by CDPH training group)
Pass the CDPH competency quiz
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 IFU https://www.fda.gov/media/141570/download
2. Videos:
a. Abbott BinaxNOW training modules, available here:
https://www.globalpointofcare.abbott/en/support/product-installation-
training/navica-brand/navica-binaxnow-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: Patient (Individual) Test
c. Preparing for & Running the BinaxNOWTM Rapid 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/rRZLDwEHkgY
f. HIPAA training https://www.accountablehq.com/free-hipaa-
training/privacy-rule
g. FERPA training as provided by your organization
28Information contained in this document is preliminary | Working draft as of 3/8/2021.
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 QC log (Appendix I) 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.
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 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. The Binax
Lead should periodically review the QC log. If the control swabs do not work as
expected, contact Abbott technical service and CDPH for guidance.
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.
29Information contained in this document is preliminary | Working draft as of 3/8/2021.
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 person who has
completed the Binax training (the “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 kits 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
30Information contained in this document is preliminary | Working draft as of 3/8/2021.
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 D)
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 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 patient samples will use 6 drops.
Insert the swab into bottom hole and rotate 3-times clockwise.
Peel off the adhesive liner and close and securely seal the card.
31Information contained in this document is preliminary | Working draft as of 3/8/2021.
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
32Information contained in this document is preliminary | Working draft as of 3/8/2021.
☐Abbott BinaxNOW IFU https://www.fda.gov/media/141570/download
Videos
☐Abbott BinaxNOW training modules available here:
https://www.globalpointofcare.abbott/en/support/product-installation-
training/navica-brand/navica-binaxnow-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: Patient (Individual) Test
☐Preparing for & Running the BinaxNOW Rapid Test. YouTube Video
https://youtu.be/rRZLDwEHkgY
☐Reading the BinaxNOW Covid-19 Ag card test. https://youtu.be/TjkuRmfkxHU
☐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 test kit
a. Video of Susan Coffin overview of the BinaxNOW test:
https://youtu.be/rRZLDwEHkgY
33Information contained in this document is preliminary | Working draft as of 3/8/2021.
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
Training Attestation Statement
I have fulfilled all of the required training elements and passed the
competency quiz with a score of 100%.
Date of completion Print Name Signature
34Information contained in this document is preliminary | Working draft as of 3/8/2021.
Appendix G: CDC Guidelines
CDC Guidelines for Specimen Collection
For information on collecting, handling, and testing clinical specimens, please
refer to the CDC’s guidelines
Appendix H: Sample registration fields
Facility Shipping Shipping City County State Zip Shipping Shipping Shipping Back up Back up Shipping Number of
name address address code contact contact contact shipping shipping hours BinaxNOW
line 1 line 2 phone email contact contact tests
number phone requested
number
Appendix I: Quality control
Quality control
For information on external quality control, please refer to BinaxNOW COVID-19
Ag CARD EUA
35Information contained in this document is preliminary | Working draft as of 3/8/2021.
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 test is required.
• If there is any doubt about the absence or presence of a line in the
sample window, the BinaxNOW 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
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