How does Novarum™️ work?
Novarum™️ technology enables the development of a reader module for your mobile diagnostic app suitable for your lateral flow assay format, whether a naked strip or a housed cassette. Our experienced team gains a deep understanding of your assay/product, assesses the target end user for your test, and builds features and functionality to address end-user needs and minimize the risk of end-user error. Our patented Novarum technology provides reliable and accurate results, ensuring the highest quality performance of your lateral flow assay.
Our team works with you to map out the three main stages of your end user’s journey, including pre-scan, in-scan, and post-scan workflows, and implements a range of different functionalities to support the user through the workflow of setting, running, and sharing the assay results. This includes GPS tracking, batch calibration, signature pad, questionnaire, multiple assay reading, multiple assay user test selection, data security, systems integration, and remote result sharing.
- Login/User ID
- Different user types could have different workflows
- Change app language to match that of the phone
- Check the camera is working
- Record the location of the phone
- Select the test type from the menu or scan the barcode which selects the correct test type
- Video or graphic instructions to guide the user through running the assay
- Automatic batch check for expiry date etc.
- Record patient ID or sample ID
- Provide and enforce countdown timers to ensure the assay is read at the correct time
- Read the test and apply the threshold to bin or quantify the result
- How is the result managed?
- The result is sent to a central database (manufacturer/health service/other) or shared with an EHR/LIMS
- The result is only stored on the phone locally
- How the result is displayed to the user
A range of different functionalities can be implemented to support the user through the workflow of setting, running and then sharing the assay results.
We provide support and aftercare to ensure your software remains up-to-date and running smoothly:
- We have successfully achieved CE marking and FDA pre-submission of IVD systems that include Novarum mobile medical apps and web portals.
- We provide full design history files of your product for submission purposes, electronically managed in our eQMS system . Our eQMS is customised from the combination of Atlassian products (Jira issue tracking, Confluence documentation, and Bitbucket code repositories)
- We are ISO13485:2016 compliant and we conform to IEC62304.
- 100% client audit record and proud to always be in the ‘audit ready’ status.
Watch the video here to see how BBI Solutions has created a bespoke mobile solution for the world’s first and quickest on-site Legionella test for our client Hydrosense Ltd.
Novarum has been awarded the patent (EP 12718728.4) for its smartphone diagnostic technology by the European Patent Office (EPO), having already secured the equivalent patent for its technology in the United States
Novarum™ worked with BÜHLMANN Laboratories AG to create the first CE-Marked smartphone-based calprotectin home test –IBDoc®, the first in vitro diagnostic testing device measuring the inflammatory marker for faecal calprotectin at home.