STEP 5A

Register and obtain consent from participants

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 in Appendix B to determine if your IT platform has registration capability. If not, the table below outlines the fields that should be collected and tracked for each individual being tested.

Check-in participants on testing day

• 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

Supervise nasal swab sample collection

• Teach participant how to self-collect their sample (example video included here.)
• 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 COVID-19 Ag 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

01

Hold Extraction Reagent bottle vertically. Hovering 1/2 inch above the TOP HOLE, slowly add 6 DROPS to the TOP HOLE of the swab well.

DO NOT touch the card with the dropper tip while dispensing.

02

Insert sample or control swab into BOTTOM HOLE and firmly push upwards so that the swab tip is visible in the TOP HOLE.

03

Rotate (twirl) swab shaft 3 times CLOCKWISE (to the right). Do not remove swab.

04

Peel off adhesive liner from the right edge of the test card. Close and securely seal the card. Read result in the window 15 minutes after closing the card. In order to ensure proper test performance, it is important to read the result promptly at 15 minutes, and not before. Results should not be read after 30 minutes.

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
• Maintain the test cards in a confidential location during testing and when reading the results

More information in the package insert: Antigen Card has built in procedural controls.

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

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.
• 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
• 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.

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.

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)
• 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 page.

Dispose of cards appropriately

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 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 here.

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.