Provision of Lateral Flow Device Digital Reader Solution

The Authority has a requirement to procure digital read capability to interpret COVID-19 Self Report LFD test kit results using images of the LFD test supplied by the user when reporting their result on the GOV.UK website. The Authority requires market-ready solutions that can integrate with its standard API specification and that meet the requisite clinical accuracy, performance, and security requirements of DHSC and other regulating bodies (as will be further detailed in the ITT). The Authority is seeking up to three different suppliers and contracts will be tendered via further competition on CCS Spark Dynamic Purchasing System (RM6094) with planned service go-live by December 2021. Interested suppliers are requested to join the Spark DPS in order to participate in the further competitions. https://www.crowncommercial.gov.uk/agreements/RM6094 The Authority expects to launch the further competitions in Mid-October, subject to internal approvals. The Authority anticipates that it may apply the following filters: • The 'Subject Area' is Health • The 'Subject Areas' services within Health is expected to be Diagnostics • the type of 'Delivery Method' services is expected to be Artificial Intelligence (AI) and Automation • 'Delivery Method' services within Artificial Intelligence (AI) and Automation, is expected to be 'Machine Learning' and 'Computer Vision' • Location services is expected to be all UK locations • Security option is expected to be Official

Selected cohorts of users using the GOV.UK "Report a Lateral Flow Test Result" website are given an option to submit a photograph (image) of their LFD taken with their smart phone. The service then provides a "digital read" of their test result in real time. The GOV.UK service captures the image from the user and passes this via a standard API to a MHRA derogated cloud-based "digital read" service. The aim of the procurement activity under the Spark DPS is to procure up to three web service based digital readers, to provide technical and commercial resilience.

The successful suppliers will create a RESTful web API, to a specification provided by DHSC, that will securely accept an image of a Covid-19 LFD sent by DHSC. The suppliers will provide a cloud-based digital reader service that will take each supplied LFD image, and interpret this digitally in real time, to provide an accurate test result for each image via a callback URL to a DHSC hosted API. The test result will consist of the image identifier, interpreted test result value (which can be Positive, Negative or Void) and a value which represents confidence level in the returned result. In the case where the service cannot provide a digital read of the image (an "invalid" result), the supplier service will be capable of returning a standard error code describing the reason for the failed (invalid) read. Future procurements for LFD readers may allow for LFD digital reader technical approaches beyond the API method described above.

Additional information: • Must be able to evidence existing MHRA EUA as SaaMD for self-use digital reader of Covid-19 LFD or CE/CA mark equivalent (or significant progress towards obtaining either of these) where the digital read component is performed by a cloud based API. • Must be able to extend existing EUA or CE/CA to incorporate specific LFDs in use with DHSC for Self-Report covid-19 lateral flow testing. • Meet DHSC security, scalability and performance and clinical accuracy targets (as will be further detailed in the ITT). • The Suppliers will only be permitted to use UK based data centres and data processors. • The purpose of the publication of this prior information notice is to notify the market about this upcoming procurement, including the intended route to market .

Whilst the Authority expects to proceed to procurement in due course, there is no obligation to do so as a consequence of this early notification. The Authority reserves the right to not commit to advertising this tender if it does not so wish. Any information provided by suppliers prior to any advertising of the tender will not be used to determine the outcome of any processes. The publication of any documentation at this stage is intended to provide potential bidders with the opportunity to review the information and provide any comments or feedback. The Authority does not intend to be bound by any of the information supplied at this stage. The Authority makes no commitment to incorporate any recommendations or suggestions which may be made within the final suite of procurement documents. Once published, the ITT will contain the final requirements in relation to this procurement. All previous versions, including any documents published at this stage should then be disregarded.