On January 12, LeadingAge hosted a training with Abbott on the Abbott BinaxNOW testing cards being shipped to nursing homes, assisted living communities, home health, and hospice agencies across the country by Department of Health and Human Services (HHS) to assist in testing of long-term care residents and staff of all of these provider types. A recording of the training is available here.

This training follows the recent announcement from HHS that they will continue to supply long-term care providers with testing supplies. HHS began shipping Abbott BinaxNOW test cards to providers in September 2020 and recently renewed a contract to continue distribution through March 2021. Test cards are shipped directly to nursing homes, assisted living communities, home health, and hospice agencies based on county positivity rates in the surrounding community. Tests are allocated to allow for routine testing of staff according to CMS requirements. Tests can also be used to test long-term care residents or visitors, hospice patients, or home health clients at the discretion of the provider.

Abbott BinaxNOW test cards differ from previous COVID-19 test allocations from HHS, such as the BD Veritor Plus testing system and the Quidel Sofia 2 testing system, in that the BinaxNOW cards do not require a machine to process samples. Similar to other point-of-care antigen tests, results are available within minutes and all tests must be reported according to HHS Lab Data Reporting Guidance, updated January 8.

The Abbott BinaxNOW cards also coordinate with the Navica mobile app, which allows test information to be communicated between providers (“administrators”) and patients (“consumers”). Consumers can access test results via the app and use the accompanying “Navica pass” to enter Navica-enabled organizations. A feature is also under development to enable consumers to locate nearby testing sites.

Resources and Tips

Abbott has set up a robust site, complete with training videos and hand-outs to assist providers in training staff and answering questions related to the Abbott BinaxNOW COVID-19 Ag Card and Navica app. Videos include conducting quality control checks, specimen collection, testing, and using the Navica app. Hand-outs include provider and patient fact sheets in English and Spanish, test kit product insert, test cards and nasal swab tips, and information on CLIA-waived testing.

Highlights from the LeadingAge / Abbott training include:

• Tests are for use in CLIA-waived or -certified settings only. All tests (positive, negative, and invalid) must be reported according to CARES Act requirements (HHS Lab Data Reporting Guidance).
• Test kits should be stored at room temperature (20-30° C). All testing components must be at room temperature prior to conducting testing.
• PPE required to conduct testing is consistent with CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19. No additional PPE beyond these CDC recommendations is required.
• Quality control checks must be completed for each new shipment, each new operator, and according to any local / state / federal regulations, accrediting organizations, or lab standard quality check procedures.
• When collecting specimens for testing, use only the nasal swabs provided in the test kit.
• Samples should be tested immediately upon collection. If immediate testing is not available, samples may be stored in a clean, unused, tightly-capped transport tube for up to 1 hour at room temperature. If testing is not completed within 1 hour, the sample must be disposed of and a new sample collected for testing.
• When adding extraction reagent to the testing card, hold the extraction reagent vial vertical to ensure full drops of extraction reagent. Because the extraction reagent is meant for use on multiple test cards, prevent contamination by ensuring the dropper does not touch the test card.
• Test results are read after 15 minutes. Do not read results prior to 15 minutes, even if a result appears visible. Wait the full 15 minutes. Do not read results after 30 minutes.
• A positive test result is indicated by 2 pink/purple lines on the testing card (one in the “control” position and one in the “sample” position). Any pink/purple line at the “sample” position indicates a positive result, regardless of how faint the line may appear.
• All testing components must be disposed of according to red-bag bio-hazard guidelines.

Customer support is available for both the Abbott BinaxNOW test card and the Navica app. Contact the Abbott Technical Services Team at 1-800-257-9525 between 8 a.m and 8 p.m. EST Monday-Friday or email ts.scr@abbott.com.

Questions and Answers

The training session was followed by a brief Q&A, with questions provided by members during the presentation.

Q: Each test kit comes with only one bottle of extraction reagent and 40 test cards. Will the one bottle of extraction reagent be enough for all 40 test cards?

A: Yes, the extraction bottle has enough reagent to supply all test 40 cards, plus enough to complete one positive and one negative quality control check, which should be completed with each new shipment.

Q: Can additional bottles of reagent be ordered separately?

A: Yes, you can order more extraction reagent by contacting the Abbott Technical Services Team at 1-800-257-9525. Select Option 1, additional QC material.

Q: Once the extraction reagent is opened, is there a timeframe for when it expires and must be discarded?

A: Check with the Abbott Technical Services Team about expiration, but remember that all testing materials must be stored and used at room temperature