SOP: Newborn Screening Revised - 10/ 12/ 2022-12

This comprehensive booklet of SOPs is to facilitate standardization of the research protocol for the Newborn Screening Program of the SPARCO Consortium across seven countries in Sub-Saharan Africa. The overarching aim is to test the performance, acceptability and adoption of a newborn screening intervention using point-of-care testing for early identification of children born with sickle cell disease for enrollment into clinical care. Contained in this document are SOPs for screening of eligible participants, obtaining informed consent, enrollment of participants, transfer of case record forms within study sites, and follow-up of study participants. The document also contains protocols of procedures for the performance of HPLC and point-of-care tests, data storage and management; and protocol for qualitative evaluation of lived experiences of participants.