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Int. J. Neonatal Screen. 2018, 4(4), 40; https://doi.org/10.3390/ijns4040040

Introducing Newborn Screening for Severe Combined Immunodeficiency (SCID) in the Dutch Neonatal Screening Program

1
Department of Pediatrics, Laboratory for Immunology, Leiden University Medical Center (LUMC), P.O. Box 9600, 2300 RC Leiden, The Netherlands
2
Department of Biologicals, Screening and Innovation, Centre for Health Protection, National Institute of Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands
3
Department of Pediatrics, Leiden University Medical Center (LUMC), P.O. Box 9600, 2300 RC Leiden, The Netherlands
4
Department of Vaccine Supply and Prevention Programmes, National Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands
5
Centre for Population Screening, National Institute of Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands
6
Department of Clinical Chemistry, IJsselland Hospital, P.O. Box 690, 2900 AR Capelle aan den IJssel, The Netherlands
7
Department of Biomedical Data Sciences, section Medical Decision Making, Leiden University Medical Center (LUMC), P.O. Box 9600, 2300 RC Leiden, The Netherlands
8
Department of Child Health, TNO, P.O. Box 3005, 2301 DA Leiden, The Netherlands
*
Author to whom correspondence should be addressed.
Received: 15 September 2018 / Revised: 4 December 2018 / Accepted: 4 December 2018 / Published: 12 December 2018
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Abstract

The implementation of newborn screening for severe combined immunodeficiency (SCID) in the Netherlands is a multifaceted process in which several parties are involved. The Dutch Ministry of Health adopted the advice of the Dutch Health Council to include SCID in the Dutch newborn screening program in 2015. As newborn screening for SCID is executed with a new, relatively expensive assay for the Dutch screening laboratory, an implementation pilot study is deemed instrumental for successful implementation. A feasibility study was performed in which the practicalities and preconditions of expanding the newborn screening program were defined. Cost-effectiveness analysis (CEA) indicated that SCID screening in the Netherlands might be cost-effective, recognizing that there are still many uncertainties in the variables underlying the CEA. Data and experience of the pilot study should provide better estimates of these parameters, thus enabling the actualization of CEA results. Prior to the implementation pilot study, a comparison study of two commercially available SCID screening assays was performed. A prospective implementation pilot study or so-called SONNET study (SCID screening research in the Netherlands with TRECs) started in April 2018 and allows the screening for SCID of all newborns in three provinces of the Netherlands for one year. Based on the results of the SONNET study, the Dutch Ministry of Health will make a final decision about national implementation of newborn screening for SCID in the Netherlands. View Full-Text
Keywords: severe combined immunodeficiency; SCID; newborn screening; T-cell receptor excision circles; TREC; SONNET study severe combined immunodeficiency; SCID; newborn screening; T-cell receptor excision circles; TREC; SONNET study
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Blom, M.; Bredius, R.G.; Weijman, G.; Dekkers, E.H.; Kemper, E.A.; Van den Akker-van Marle, M.E.; Van der Ploeg, C.P.; Van der Burg, M.; Schielen, P.C. Introducing Newborn Screening for Severe Combined Immunodeficiency (SCID) in the Dutch Neonatal Screening Program. Int. J. Neonatal Screen. 2018, 4, 40.

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