BBI are here to help you meet the FDA’s Covid-19 EUA requirements

BBI are here to help you meet the FDA’s Covid-19 EUA requirements

A new template has been released by the FDA to assist manufacturers gather sufficient data for their emergency use authorisation submissions for molecular and antigen diagnostic COVID-19 tests in non-laboratory use. Section G, “Test result reporting”  includes the need for data to be reported to healthcare providers and relevant public health authorities, including the potential for the use of mobile device applications for reporting of test results,  whilst section H requires that the results are simple and easy to interpret and that there is clear guidance on how invalid test results should be handled.

Novarum™ is BBI’s Solutions’ patented smartphone-based reader technology which transforms a smartphone into a mobile diagnostic platform for rapid diagnostic tests like lateral flow assays. Our platform offers a simple way to read lateral flow assays and easily share the results directly with health care providers using our dedicated web portal interface or through existing data management platforms. The app is developed to meet FDA design control requirements for verification and validation, and usability principles that facilitate the use of assays through step-by-step test choreography which can include instructional videos, voice prompts or pictorial guides including timers to mitigate the highest risk steps of the process. Each app is customised to the particular assay and the appropriate end-user workflow but utilises our patented software for assay interpretation, this and our test choreography are designed to reduce the risk of user error and removes the subjectivity of interpreting assays in the non-laboratory environment and show an immediate positive, negative, or invalid result

Additionally, the app provides users with a full connected solution as the system allows results to be shared instantly to public health and/or other authorities to whom reporting is required. This can be developed in accordance with local, state, and federal requirements using our fully customisable modules.

If you would like to learn more or to request a demo of our Novarum mobile diagnostic solution, please contact us here

Learn more about our innovative smartphone diagnostic platform by visiting our Novarum™ pages here

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