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

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