TENDER FOR THE DEVELOPMENT AND SUPPLY OF A SALIVA-BASED LATERAL FLOW IMMUNOASSAY

The University of Birmingham invites tenders for the development and supply of lateral flow immunoassay. The lateral flow is intended to be used to detect antibodies in human saliva samples. Specifically, the lateral flow assay needs to be able to detect IgG-class anti-tetanus antibodies. The lateral flow immunoassay will need to be developed to meet the following key target specifications:

High sensitivity detection that can differentiate protective antibody status. To enable its use with saliva specimens, the test will need to have a low limit of detection. The test positivity threshold needs to be equivalent to the WHO protective threshold of 0.1 IU/mL in serum. Proof of concept studies at the University of Birmingham estimate that the protective cut-off in serum is equivalent to ~ 0.0024 IU/mL in saliva.

Minimal time to perform, able to be completed with a small number of simple steps and return a result within 15 minutes.

Reader-free and return a qualitative (positive or negative) result.

The method of saliva sample collection to accompany the test needs to be suitable for use in young children and infants.

The test should be able to be completed by a non-specialist and in a community or field setting.

The test should have no linked required cold chain, able to withstand hot/humid temperatures on land and able to withstand conditions associated with transport by both aeroplane and drone.

The test needs to be stable, with a long-term stability time equivalent to existing commercial lateral flow tests.

The design of the test needs to be as low-cost as possible. This is to enable its use in low-middle income countries or low resource settings.

The test design also needs to strongly reflect environmental considerations. Specifically, an unhoused test strip is desirable. The sample collection and application, and any other test components, should be designed and utilised with the objective of using as little plastic as possible and minimal packaging.

The project will require developing the test to meet these desired specifications, evaluating the test performance (for example performance around the cut-off, reproducibility, stability and any other relevant domains, as informed by international guidelines on test evaluation e.g. CLSI) and supplying UoB with devices. Small batches of devices (~ 200) will need to be supplied to UoB at various points in the development to assess clinical accuracy. On completion of the project, the CRO will need to be able to supply UoB with up to 1000 devices suitable for use at the point of care as part of an in-field evaluation study.

The development needs to be carried out within appropriate Quality Management Systems and in accordance with regulatory requirements for medical devices. The supplier should be certified to ISO 13485 and able to develop test to be compliant with IVDR 2017/746 requirements. The project should include the compiling and supply of relevant documentation and files to support future submission for regulatory approval. Post-project, the CRO should be able to support any future manufacture, scale-up and distribution of the test.