TENDER FOR THE DEVELOPMENT AND SUPPLY OF A SALIVA-BASED LATERAL FLOW IMMUNOASSAY
Published
Value
Description
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. Lot 1: 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.
Timeline
Publish date
4 months ago
Close date
3 months ago
Buyer information
University of Birmingham
- Contact:
- Kseniya Samsonik
- Email:
- k.samsonik@bham.ac.uk
Explore contracts and tenders relating to University of Birmingham
Go to buyer profileSource
"Find-a-Tender"Tender tracking
Access a feed of government opportunities tailored to you, in one view. Receive email alerts and integrate with your CRM to stay up-to-date.
Proactive prospecting
Get ahead of competitors by reaching out to key decision-makers within buying organisations directly.
360° account briefings
Create in-depth briefings on buyer organisations based on their historical & upcoming procurement activity.
Collaboration tools
Streamline sales workflows with team collaboration and communication features, and integrate with your favourite sales tools.
Explore similar tenders and contracts
Browse open tenders, recent contract awards and upcoming contract expiries that match similar CPV codes.
- Openclosing
Multiple excitation wavelength, portable, Raman spectrometer
EH Curatorial (Collections and Conservation)
139,000 GBP
Published a day ago
- Openclosing
Supply, Delivery and Installation of Collaborative Robots for CMAC
University of Strathclyde
Published a day ago
- Openclosing
Benchtop X-Ray Diffraction instrument
EH Curatorial (Collections and Conservation)
130,500 GBP
Published a day ago
- Openclosing
Supply, Delivery and Installation of Collaborative Robots for CMAC
University of Strathclyde
Published a day ago
- Openclosing
HSE RFQ - Flash point Apparatus
Health and Safety Executive
14,583 GBP
Published 2 days ago
- Openclosing
HSE RFQ - Desktop PC Workstations
Health and Safety Executive
22,500 GBP
Published 2 days ago
- Openclosing
Supply, Delivery, Installation and Commissioning of One (1) Hot Melt Extruder System for CMAC
University of Strathclyde
Published 2 days ago
- Openclosing
Supply, Delivery, Installation and Commissioning of One (1) Hot Melt Extruder System for CMAC
University of Strathclyde
Published 2 days ago
- Openclosing
Optical Related Equipment Components and Consumables
Nottingham Trent University
600,000 GBP
Published 3 days ago
Explore other contracts published by University of Birmingham
Explore more open tenders, recent contract awards and upcoming contract expiries published by University of Birmingham.
- Closed
THE SUPPLY AND INSTALLATION OF TWO ULTRA-FAST MAS PROBES FOR NMR SPECTROSCOPY OF BIOSOLIDS AT 1.2 GHZ - UNIVERSITY OF BIRMINGHAM
University of Birmingham
210,000 GBP
Published a month ago
- Closed
TENDER FOR THE SUPPLY AND INSTALLATION OF TWO ULTRA-FAST MAS PROBES FOR NMR SPECTROSCOPY OF BIOSOLIDS AT 1.2 GHZ - UNIVERSITY OF BIRMINGHAM
University of Birmingham
Published a month ago
- Closed
Framework for the Provision of Temporary Agency Catering, Cleaning, Hospitality and Events Workers For the University of Birmingham
University of Birmingham
Published a month ago
- Closed
Framework for the Provision of Temporary Agency Catering, Cleaning, Hospitality and Events Workers For the University of Birmingham
University of Birmingham
Published a month ago
- Unknown
Supply, Installation and Support of Canvas Virtual Learning Environment
University of Birmingham
Published a month ago
- Closed
Framework for the Digital Preservation Services for the University of Birmingham
University of Birmingham
Published a month ago
- Closed
Framework for the Digital Preservation Services for the University of Birmingham
University of Birmingham
Published a month ago
- Closed
Framework for the Provision of Out Of Hours Library Services
University of Birmingham
Published 2 months ago
- Closed
Framework for the Provision of Out Of Hours Library Services
University of Birmingham
Published 2 months ago
Explore more suppliers to University of Birmingham
Sign upExplore top buyers for public sector contracts
Discover open tenders, contract awards and upcoming contract expiries of thousands of public sector buyers below. Gain insights into their procurement activity, historical purchasing trends and more.
Explore top sources for public sector contracts
Stotles aggregates public sector contract data from every major procurement data source. We ingest this data and surface the most relevant insights for our users. Explore our list of public sector procurement data sources below.