Third Party NAT Testing for Hepatitis A virus and human parvovirus B19 to support UK Plasma for Fractionation

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 [email protected] 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.