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Tender description

Public Health England on behalf of NSC intends to award a contract to Perkin Elmer and ImmunoIVD for supply of Kits to undertake Screening evaluation for Severe Combined Immunodeficiency Disease (SCID) under the NHS Newborn Blood Spot Screening Programme (NBS-SCID). The aim of this evaluation is to identify all babies born with SCID as early as possible. This will allow successful treatment before the baby acquires infections. The scope of the evaluation study is to establish if NBS for SCID is beneficial at the population level, to identify the best TRECs assay, to establish ideal cut-offs for TREC levels, to establish numbers of false positives and relevant clinical information on false positives and to establish if screening for SCID is economically viable. This evaluation study will establish if screening for SCID is viable so as NBS screening for SCID becomes part of the national programme. Once established and agreed by NSC, the screening will be openly tendered for contract. The UK National Screening Committee (NSC) is responsible for delivery and co-ordination of the NHS Newborn Blood Spot Screening Programme. Public Health England on behalf of NSC intends to award a contract to Perkin Elmer and ImmunoIVD for supply of Kits to undertake Screening evaluation for Severe Combined Immunodeficiency Disease (SCID) under the NHS Newborn Blood Spot Screening Programme (NBS-SCID) Severe Combined Immunodeficiency (SCID) is a disease caused by a variety of known or, as yet, unknown genetic lesions. These lead to babies being born with a severe T cell lymphopaenia (very low or absent T cells) and, therefore, an inability to fight off opportunistic infections. A baby with SCID will likely become seriously ill within the first few months of life and will die within the first year of life. In June 2017 the NSC announced its intention to support an evaluation to assess newborn screening for SCID. The aim of this evaluation is to identify all babies born with SCID as early as possible. This will allow successful treatment before the baby acquires infections. The scope of the evaluation study is to establish if NBS for SCID is beneficial at the population level, to identify the best TRECs assay, to establish ideal cut-offs for TREC levels, to establish numbers of false positives and relevant clinical information on false positives and to establish if screening for SCID is economically viable. During the planning stage, there were two suppliers identified with commercially available kits, namely EnLite Neonatal TREC kit (PerkinElmer) and SCREEN-ID kit (ImmunoIVD). Both the supplier’s assays are used in a national level screening programme and have been validated for the results of the test. Supplier engagement confirmed their willingness to support the NBS programme to perform the evaluation in England. In 2018-19 the design and strategy for evaluation was formalised by the NBS programme. Strategy that the evaluation will be based in six regional centres and cover more than 800 000 births was developed. On that basis, the evaluation programme will be conducted in six laboratories which together cover approximately two thirds of the English population. NBS for SCID is as a pilot study across England at six different NBS centres over 2 years (plus 1 extra year for data analyses). There are two commercially available kits and each is being trialled at three centres for the duration of the evaluation period. Three labs (Sheffield, Birmingham and Manchester) will evaluate the EnLite kit (Perkin Elmer) and three (Great Ormond Street, SE Thames and Newcastle) will evaluate the ImmunoIVD kit (Mabtech). A sample swap process between the six participating NBS labs is also underway to test performance of the two different methods. The initial screening test, the assay of TRECs, uses blood collected on day 5 using the standard newborn screening blood sample collection card. A Quality Assurance Scheme for TREC analysis has been developed by Gen QA. The start date for the study is planned for September 2020, for which the laboratories need to begin receiving reagent delivery in May 2020 to allow the preparatory work to be undertaken and orders need to be placed before end of March to achieve this. At the end of 2 years, the collected data on SCID NBS will be analysed and the six participating labs will continue to screen for SCID during this further period (anticipated to be 1 year). A decision on whether to adopt NBS for SCID will be made based on the data analysis. PHE believes that ImmunoIVD and Perkin Elmer are the only available suppliers who currently manufacture Assays to perform SCID testing and awards a contract for provision of SCID reagents to ImmunoIVD and Perkin Elmer for the whole duration of the evaluation. The evaluation study will establish if screening for SCID is viable so as NBS screening for SCID becomes part of the national programme. Once established, the screening will be tendered in the open market for contract.