One Abbott Solution for ID NOW™ COVID-19 Testing and Reporting
COVID-19 REPORTING CHALLENGES
Decentralized healthcare settings present a challenge to ensure COVID-19 testing and patient data are collected and reported to local and federal public health authorities. The Coronavirus Aid, Relief, and Economic Security (CARES) Act, Section 18115 [pdf 266KB] requires results and demographics to be reported within 24 hours to appropriate local and federal public health departments.*
The One Abbott Solution For Patient Testing, Result Reporting, and Data Capture
The One Abbott Solution for ID NOW™ COVID-19 testing is a simple, reliable and secure end-to-end connectivity and reporting solution. It offers speed and performance of ID NOW COVID-19 testing and reporting within 24 hours for decentralized environments to help you manage data without infrastructure burden.
Testing Patients at the Point Of Care
The ID NOW™ platform, the leading molecular point-of-care platform in the United States, offers the fastest molecular test for COVID-19 on the market, with results in 13 minutes or less.1 It is also portable and allows use in virtually any patient care setting, including decentralized locations.
Capturing Results Without Manual Entry
RALS™ LiNK tracks, captures and consolidates patient and quality control results from multiple ID NOW instruments and sends data to STARLIMS with no manual entry. RALS LiNK also provides customizable dashboards for ID NOW COVID-19 testing data and analytics.
Capturing and Reporting Demographics Within 24 Hours
The STARLIMS Digital Solution collects ordering physician data, patient demographics and test results for ID Now COVID-19 testing and reports this data to the AIMS Platform2 for submission of required data fields to public health authorities within 24 hours.**
* For CARES Act Reporting Requirements, Visit Hhs.gov/Coronavirus. **Reporting services may not be available in certain States. 1. Internal clinical data held on file. 2. The AIMS Platform is managed by the Association of Public Health Laboratories (APHL). Reporting is subject to Public Health Authorities accepting all the required data fields. Some PHAs may not accept all of the information collected in the STARLIMS Digital Solution.
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 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.