InsightsBlogEducationThe new FDA guidelines for lateral flow tests: What they mean for providers

The new FDA guidelines for lateral flow tests: What they mean for providers

The Covid-19 pandemic has put lateral flow testing firmly in the spotlight – and it’s been a key component in the fight against the virus. But because lateral flow testing isn’t always digitised, the US government feared that opportunities to capture critical data were being lost. 

So, in the summer of 2020, the Centres for Disease Control and Prevention (CDC) created a framework to harmonise all types of test results data – and the Food and Drug Administration (FDA) then issued guidelines specifically for lateral flow test manufacturers.

The FDA guidelines are intended to ensure that lateral flow tests become a conduit for data that will be able to power disease control, highlight trends and inform policy.

So what exactly do the guidelines say?


What the FDA saysWhat it means for lateral flow test providers
You will ensure all users of the test can report all test results to public health and/or other authorities to whom reporting is required, in accordance with local, state and federal requirements.

The approach adopted should facilitate reporting by all users and be easy to use and understand. There are several options to allow for reporting of test results including, but not limited to: automatic reporting through mobile app, instructions directing users to a website where reporting is easily facilitated, etc.
•Tests must be able to report results

•They must be able to share data in ways that comply with local, state and federal requirements

•The mechanism for reporting data should be available to all users – from trained nurses and clinicians, all the way through to teachers in schools, occupational health representatives in workplaces and consumers buying tests over the counter

•Sharing data has to be easy

•Integrating apps and digital interfaces is ideal
You should also describe how test reporting will capture the appropriate LOINC and SNOMED codes, in addition to location data, and other patient information that may be relevant or required. •The data your tests capture has to comply to LOINC and SNOMED standards

•Your tests should ideally be able to capture additional data, including information about location, symptoms and patient profile


What does the new FDA guidance mean for lateral flow test providers?

The FDA guidelines mean lateral flow test providers will, from now on, have to integrate a way of uploading test results and other data – in ways that conform to LOINC and SNOMED and that can be easily shared with government organisations. 

So how can LFT providers upgrade their tests to meet FDA requirements?


Will incorporating a desktop reader with LFTs satisfy the FDA guidelines?

Readers can be really useful pieces of kit – especially when it comes to extracting detailed analysis from LFTs – and they can produce information digitally. 

However, readers don’t meet the FDA’s additional requirements of being able to automatically share information with government organisations – and they can’t store and manage huge volumes of data in the cloud. 


Will lateral flow test providers have to create their own digital solutions?

It is certainly possible for an LFT provider with enough budget to pull together an army of developers to create their own digital solution. They would then need to align their new solution with regulatory regimes globally. And this latter part of the process in particular takes a lot of time.

Another drawback of creating in-house digital solutions is that they’re proprietary – or in other words, they only work with the test they’ve been designed for.

All of this means that in-house development of a solution is possible, but it’s an expensive, slow and risky approach. And, of course, the costs incurred in building, maintaining and constantly updating proprietary solutions have to be passed on to customers – which could make the product unviable.


Outsourcing – using lateral flow test digitisation technology

A third – and much easier – route for LFT providers is to incorporate digitisation using a SaaS solution like Transform®.

Within a matter of weeks, LFT providers can sign up to Transform® and integrate technology into tests that satisfy all the new FDA guidance, with:



Transform® has a host of other features, which you can find out about here.

We’ve already invested millions in developing Transform® – and having it comply with regulatory standards. And we have a dedicated team of developers that’s constantly improving functionality.

All of this means LFT providers have an easy, low-cost way to produce tests that comply with FDA standards – and that offer their customers a premium product in the process.


FDA requirementWith Transform®
All users of the test can report all test results to public health and/or other authoritiesTransform® includes an app with an easy-to-use interface – which means anyone can capture test results and other data. All data is uploaded securely to the cloud, managed to LOINC and SNOMED standards – and can be easily integrated with Lifepoint to be shared with government agencies.
There are several options… including… automatic reporting through mobile app, instructions directing users to a website…Transform®’s app captures information simply – and organisations can view data via easy-to-use dashboards.
Capture the appropriate LOINC and SNOMED codes…Transform® automatically formats data to LOINC and SNOMED standards.
in addition to location data, and other patient information… may be relevant or required…Transform® allows users to capture data including location, symptoms, gender, shift patterns – in fact any data at all.


You do the science, we do the data

Signing up to Transform® is straightforward – and when you do it, you’ll be supported by a friendly, commercially-savvy team who will help you take your new digitised product to market. Get in touch today and we’ll walk you through how it works.

Call our Commercial Director, Phil Groom on +44 29 2252 0142 – or drop us a line.