Hysbysiad contract
Adran I:
Endid
contractio
I.1) Enw a chyfeiriad
THE UNIVERSITY OF BIRMINGHAM
RC000645
Edgbaston
BIRMINGHAM
B152TT
UK
Person cyswllt: Kseniya Samsonik
E-bost: k.samsonik@bham.ac.uk
NUTS: UKG31
Cyfeiriad(au) rhyngrwyd
Prif gyfeiriad: https://www.birmingham.ac.uk/
I.3) Cyfathrebu
Mae'r dogfennau caffael ar gael ar gyfer mynediad uniongyrchol anghyfyngedig a llawn, yn rhad ac am ddim ar:
https://in-tendhost.co.uk/universityofbirmingham/aspx/Home
Gellir cael gwybodaeth ychwanegol o'r cyfeiriad uchod
Rhaid anfon tendrau neu geisiadau i gymryd rhan yn electronig at:
https://in-tendhost.co.uk/universityofbirmingham/aspx/Home
I.4) Y math o awdurdod contractio
Corff a lywodraethir gan gyfraith gyhoeddus
I.5) Prif weithgaredd
Addysg
Adran II: Gwrthrych
II.1) Cwmpas y caffaeliad
II.1.1) Teitl
TENDER FOR THE DEVELOPMENT AND SUPPLY OF A SALIVA-BASED LATERAL FLOW IMMUNOASSAY
Cyfeirnod: SC12346/24
II.1.2) Prif god CPV
38000000
II.1.3) Y math o gontract
Cyflenwadau
II.1.4) Disgrifiad byr
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.
II.1.5) Cyfanswm gwerth amcangyfrifedig
Gwerth heb gynnwys TAW: 230 000.00 GBP
II.1.6) Gwybodaeth am lotiau
Mae’r contract hwn wedi’i rannu’n lotiau:
Na
II.2) Disgrifiad
II.2.3) Man cyflawni
Cod NUTS:
UKG3
II.2.4) Disgrifiad o’r caffaeliad
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.
II.2.5) Meini prawf dyfarnu
Nid pris yw’r unig faen prawf dyfarnu a dim ond yn y dogfennau caffael y mae’r holl feini prawf wedi’u nodi
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 12
Gall y contract hwn gael ei adnewyddu: Na
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Section IV: Gweithdrefn
IV.1) Disgrifiad
IV.1.1) Y math o weithdrefn
Gweithdrefn agored
IV.1.8) Gwybodaeth am Gytundeb Caffael y Llywodraeth (GPA)
The procurement is covered by the Government Procurement Agreement:
Ydy
IV.2) Gwybodaeth weinyddol
IV.2.2) Terfyn amser i dendrau neu geisiadau i gymryd rhan ddod i law
Dyddiad:
26/04/2024
Amser lleol: 12:00
IV.2.4) Ym mha iaith/ieithoedd y gellir cyflwyno tendrau neu geisiadau i gymryd rhan
EN
IV.2.7) Amodau ar gyfer agor tendrau
Dyddiad:
26/04/2024
Amser lleol: 12:01
Section VI: Gwybodaeth ategol
VI.1) Gwybodaeth am ailddigwydd
Caffaeliad cylchol yw hwn:
Na
VI.4) Gweithdrefnau adolygu
VI.4.1) Corff adolygu
University of Birmingham
Edgbaston
B15 2TT
UK
VI.5) Dyddiad anfon yr hysbysiad hwn
27/03/2024