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Third Party NAT Testing for Hepatitis A virus and human parvovirus B19 to support UK Plasma for Fractionation
Descriptions
Prior Information Notice (PIN) to alert potential suppliers of NHSBT’s requirement for third party Nucleic acid Amplification Testing (NAT) for hepatitis A virus and human parvovirus B19 to support NHSBT’s intention to provide UK plasma to a commercial fractionator for the manufacture of medicinal products., The UK Department of Health and Social Care (DHSC) has announced that it has approved the use of UK plasma for the production of immunoglobulins., For NHSBT blood donors, this will mean that the excess plasma recovered from whole blood donations will be provided for fractionation to produce plasma-derived medicinal products (PDMPs). These domestically sourced PDMPs will be supplied exclusively to the NHS for the benefit of UK patients., For NHSBT to provide domestic plasma for the fractionation supply chain, further NAT testing will be required in addition to NHSBT’s current routine testing, specifically hepatitis A virus (HAV) RNA and human parvovirus B19 (B19V) DNA. NHSBT would like to engage with the marketplace to understand if there are any establishments who would be able to undertake this specific testing (volumes specified below) on their premises on behalf of NHSBT., NHSBT is anticipating beginning collections before the contract is executed and will therefore have a stockpile of up to 60,000 frozen samples some of which may have been frozen for 12 weeks or more., NHSBT will require:, •Following testing the initial stockpile, weekly sample numbers of between 5,000 and 10,000 (subject to agreed change during the term of the contract) will require HAV and B19V NAT testing , •This may be by individual donation testing or by pooling donations , •The ability to test a plasma sample stored frozen in a gel separated EDTA sample tube, •If testing is undertaken in pools, resolution down to the individual reactive sample will be required , •Confirmatory testing for screen reactive donations by an alternative assay is desirable , •Transport of samples to your testing facility will take place approximately 5-6 days per week, •Results will be expected to be returned to NHSBT electronically via a secure SFTP data file / transfer process, •An initial contract term of 12 months, It is NHSBT's intention to engage with the market to gather detailed information about the market's capabilities. The format for this will be communicated to those that respond to this PIN. Virtual Supplier engagement days will be two-fold with a Webinar for NHSBT to present the project (a copy of the presentation will be sent ahead of the Webinar) and individual supplier presentations to be held thereafter. , If you are interested in this requirement, please email Rosalind.Gill@nhsbt.nhs.uk by no later than 1200 hours on Monday 12th April 2021. , With your response, please include:, •NAT testing platform to be used, •Assay details (e.g. commercial, in-house) , •Testing pool sizes and ability to resolve to individual reactive donation if testing in pools , •Details of proposed testing facilities including location, •Ability to test plasma samples that have been stored at <-20°C and transported frozen, •Ability to complete confirmatory testing using different assays on screen reactive donations, •Confirmation of your ability to meet the above criteria, If you do not respond by this date your organisation will not be excluded from taking part in the forthcoming tender., A subsequent contract notice relating to the future tender will be submitted for publication at the same time as the Invitation To Tender (ITT) is issued.
Timeline
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Tender Regions
CPV Codes
33141625 - Diagnostic kits
71900000 - Laboratory services
71600000 - Technical testing, analysis and consultancy services
33696200 - Blood-testing reagents
33141520 - Plasma extracts
33124000 - Diagnostics and radiodiagnostic devices and supplies
33696500 - Laboratory reagents
33124130 - Diagnostic supplies
48921000 - Automation system
33124110 - Diagnostic systems
85146000 - Services provided by blood banks
85111810 - Blood analysis services
71632000 - Technical testing services
Keywords
CBC testing
blood collection
blood typing
plasma extracts
enzyme reagents
blood storage
diagnostic kits
SCADA client
plasma products
purity testing
soil testing lab
blood pathology
reagent strips
immunohematology
serology testing
blood testing
donor screening
blood screening
process control system
diagnostic consumables
test bench analysis
laboratory blood work
blood chemistry reagents
compliance analysis
lab diagnostic kits
diagnostic supplies
laboratory reagents
composition testing
prototype trial testing
medical test supplies
sample preparation
diagnostic haematology
diagnostic platforms
blood supply management
diagnostic systems
rapid diagnostic sets
instrument calibration
transfusion preparation
chemical testing lab
haematology diagnostics
blood bank logistics
materials analysis
measurement consultancy
blood safety services
blood testing reagents
clinical disposables
glucose test reagents
blood plasma derivatives
medical test kits
blood sample analysis
cell culture reagents
microbiology reagents
quality assurance lab
laboratory testing
plasma separation
biochemical blood tests
lab test chemicals
test method validation
analytical services
coagulation reagents
consultancy testing
hematology reagents
microbiological analysis
radiodiagnostic supplies
technical advisory
environmental analysis
technical testing
PLC interface software
robotics control package
routine blood test kits
calibration laboratory services
testing protocol development
industrial automation software
automated workflow system
calibration protocol application
medical diagnostic systems
control instrument calibration
supervisory automation suite
technical equipment testing
performance certification
integrated diagnostic solutions
real-time control software
quality control materials
medical diagnostics hardware
sensor-actuator interface platform
environmental lab testing
materials characterization
system compliance validation
diagnostics and radiodiagnostic devices
metrological verification
manufacturing automation engine
diagnostic imaging equipment
Workflows
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