ABBOTT ID NOW COVID-19/BINAXNOW
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid and/or antigen from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
IMPORTANT UPDATES and ALERTS
10/7/2020 Navica Binaxnow COVID-19 US Training
4/17/2020: Please do not submit spreadsheets to FEMA as initially requested. It appears there were changes in reporting processes for FEMA, they are now requiring data be inputted using the new HHS online portal; Some sites may have received an email from FEMA with a unique link to input information, please use this link for your daily submissions. For sites that did not receive an email from FEMA, HQ has been made aware of this issue and is working with FEMA to obtain access for your site. Please be on the lookout for an email with your facility's unique link for FEMA reporting in the coming days.
4/16/2020: Email sent to all Abbott POC's from Gene Robinson on Issues identified with FEMA reporting: Issues With Sending Abbott Testing Data to FEMA-HHS Email Address [Requires IHS Network Access]
4/21/2020: Resupply of Test Reagents- Email guidance received from Dr. Toedt to Area Directors and CMO's on utilitization of Abbott ID Now testing materials. Resupply of 20,000/week has been confirmed for IHS contingent upon reporting and use of testing material.
4/21/2020: Email sent to IHS Area Directors and Area CMO's from Dr. Michael Toedt on Use of Abbott ID Now: FW_ Use of Abbot ID email_4.21.2020 [Requires IHS Network Access]
4/17/2020: Additional test kits and ordering information: All reagent distribution is under pre-allocated amounts under the HHS and Abbott agreement. For week 2 resupply, the OASH increased the shipment to 627 kits (15,000 tests). NSSC should receive those on Monday, April 20, 2020. NSSC will break down the pallets upon receipt, inventory, allocate and re-distribute by FedEx, shiping to sites on Tuesday, April 21, 2020. For week 3 resupply, NSSC is hopeful shipment with be direct from Abbott. Once the OASH confirms what IHS will receive for week 3, then NSSC will update the spreadsheet for the allocation and send that information to Abbott by Thursday and Abbott will ship direct on Friday. If NSSC misses Abbott’s time frame then the shipment will be sent to NSSC and we will proceed like week 2. The same process will follow for weeks 4-6.
- Abbott Techinical Brieing (April 2020) [Requires IHS Network Access]: Will be removing use of VTM as it has shown to reduce performance in low positive samples leading to false negative results. Please use the direct swab method without the use of VTM for Abbott ID collections.
- FEMA reporting: 4/21/2020 - Accounts have been created with HHS, the POC's for your site should have received an email with a unique link to input data into the HHS online portal. Please contact Maureen James-Caires and Vanessa Vicenti if you have not yet received the email with the unique link.
At this time Abbott is not accepting orders outside this agreement. All test kits are directed to areas with the highest rates of infection in addition to government mandated sites. There is no timeline as to when the product will become available for other entities to purchase. Please do not contact Abbott to place orders as they will not be processed.
Abbott ID NOW analyzer
(previously known as Alere-I)
- You will include with result reported all authorized Fact Sheets, e.g. Fact Sheet for Patients: ID NOW COVID-19, Fact Sheet for Providers: ID NOW COVID-19
- You will use the product as outlined in the package insert. Deviations from the authorized procedures, speciment types, materials, etc., are not permitted.
- You will notify the appropriate public health authorizties of their intent to run your product prior to initiating testing.
- You will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
- You will report to DMD/OHT7-OIR/OPEQ/CDRH (via email and Abbott of any suspected occurances of false positive or false negative results and signficant deviations from established performance characteristics of your product of which they become aware.
- You will ensure all operators have been appropriately trained in performing and interpreting the results, use of appropriate PPE whem handling the kit, and use of the product in accordance with the authorized labeling.
- You will ensure any records associated with this EUA are maintained until otherwise notified by FDA.
Software version required: v6.1.25. If you need to update your software, please contact Sara Vu, Abbott Technical Representative
Technical Support for Abbott ID NOW: By phone 1-855-731-2288 | By email firstname.lastname@example.org