All of our available tests are either currently approved under the FDA’s Emergency Use Authorization (EUA) or are pending FDA EUA approval. Tests that are pending EUA have been submitted to the FDA by the manufacturer and are in review by the FDA. In accordance with FDA regulations, tests that are pending EUA approval can [...]
Our rapid antigen test has a sensitivity (true positive rate) of 88.3% and a specificity (true negative rate) of 100%. Our point-of-care antibody test can identify positive and negative results with an accuracy of 96-97%.
There is not a one-size-fits-all approach to testing. Testing strategies and frequency will vary based on the characteristics of the various segments of your workforce/community as well as by industry/sector. Based on input from Inspire’s expert medical advisory team, we will work with you to devise the optimal testing approach that considers your specific requirements [...]
The cost of the program may vary based on the testing strategy and frequency. However, the program can be tailored considering your financial objectives.
We have established a strategic partnership with the manufacturers of our point-of-care test kits in order to ensure availability of test kits to meet our clients’ needs. We do not currently anticipate any shortages.
Yes, for convenience and comfort, Inspire Diagnostics has test kits which are saliva-based only requiring test subjects provide sputum in a collection tube. The process is easy to explain, apply and can be adaptively supported by parents, teachers and administrators.
As a point-of-care test, we expect that the FDA’s Emergency Use Authorization will allow the test to only be administered by organizations that are either certified or waived under the CLIA (Clinical Laboratory Improvement Amendments) regulations which are enforced by the federal government, specifically the Centers for Medicare and Medicaid Services (CMS). The Inspire Community [...]
Test results will be reported to the customer’s designated healthcare professional via our Inspire Community Health cloud-based application. Test results can also be delivered directly to each individual test subject via this same platform through a HIPAA-compliant mobile app. Test results can be “pushed” electronically to other platforms as needed.
Depending on your specific needs, we can deliver a tailored COVID-19 testing solution which includes any or all of the following components: Rapid COVID-19 test kits and if required, analyzer devices, PCR testing service for confirmatory testing, cloud-based test management platform to facilitate large scale deployments, mobile app for self-service test report access and test [...]