2.3 Subjects
The study has been registered in ClinicalTrials.gov (Number: NCT03984266). Inclusion criteria (meet the Both): All newborns (including hospitalized infants and infants with abnormal results of conventional NBS); the guardian signs the informed consent and agrees to participate. Exclusion criteria (Meet one or more of the following criteria): Other similar clinical studies are underway; received transfusion of allogeneic blood products in recent 2 weeks.Rejection criteria : Specimen cannot be tested due to improperly collected or stored; samples with unstandardized data; Samples without follow-up data; Guardian’s request to withdraw.
From Oct 2019 to Sep 2021, a total of 3423 neonatal subjects were enrolled from 5 hospitals: Children’s Hospital of Chongqing Medical University, Inner Mongolia Maternal and Child Health Hospital, Northwest Women and Children’s Medical Center, Dalian Maternal and Child Health Hospital, and Xuzhou Maternal and Child Health Care Hospital.