The methods of screening, diagnosis, and treatment were carried out according to the “Subspecialty Group of Endocrinologic et al. (2011) (link), which was promulgated by the Chinese Preventive Medicine Association. Briefly, DBS were collected from all infants on 903 filter paper (Wallac OY, Turku, Finland) at 72 h after birth. The levels of neonatal thyroid-stimulating hormone (NTSH) of DBS were detected by a time-resolved fluoroimmunoassay using the Wallac 1420 or Wallac 1235 AutoDELFIA (Perkin Elmer, Waltham, MA, United States). If the NTSH level was <9.0 mIU/L, the infants were considered normal. If the NTSH level was ≥9.0 and <20.0 mIU/L, the infants were recalled, and DBSs were collected for a second time (within 1 week) and the NTSH level re-determined. If the NTSH level was still >9.0 mIU/L, the infants were recalled again. The infant was considered normal if the second NTSH level was <9.0 mIU/L. If the NTSH level was ≥20.0 mIU/L, the infants were recalled, and the levels of serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4) were determined.
Wallac 1235 autodelfia
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The Wallac 1235 AutoDELFIA is a compact and fully automated fluoroimmunoassay system designed for high-throughput clinical laboratory testing. The system automates the complete assay workflow, from sample handling to results reporting, ensuring reliable and consistent performance.
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3 protocols using wallac 1235 autodelfia
1
Neonatal Thyroid Screening Protocol
2
Prenatal Screening for Chromosomal Abnormalities
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As described in our previous studies,9 (link),15 (link) all the subjects received prenatal screening in the second trimester after genetic counseling and obtaining their informed consent. Their blood samples were collected between 15 weeks 0 days and 22 weeks 6 days. The levels of α-fetoprotein (AFP) and free β subunit human chorionic gonadotropin (fβhCG) were quantified by time-resolved fluoroimmunoassay (TRFIA) using Wallac 1235 AutoDELFIA (DELFIA1235: Perkin Elmer, Waltham, MA). Combined with maternal age, gestational age, maternal weight, and insulin-dependent diabetes, the risk values were calculated using the Lifecycle software (4.0), including the risk value of neural tube defects (NTD), T21 and T18. High risk: T21 >1/300, T18 >1/350. The intermediate risk was T21 1/300~1/1000, T18 1/350~1/1000.16–18 (link) Women aged ≥35 were considered at an advanced maternal age.
Women with HR results received genetic counseling. Most of them underwent prenatal diagnosis. The pregnant women voluntarily chose traditional karyotype analysis and/or CMA after receiving genetic counselling from the clinicians. Both centers used the same detection platform, experimental scheme, and quality control standards, and participated in the laboratory quality control evaluation plan.
Women with HR results received genetic counseling. Most of them underwent prenatal diagnosis. The pregnant women voluntarily chose traditional karyotype analysis and/or CMA after receiving genetic counselling from the clinicians. Both centers used the same detection platform, experimental scheme, and quality control standards, and participated in the laboratory quality control evaluation plan.
3
Newborn Screening and Congenital Hypothyroidism
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Changzhou Maternal and Child Health Care Hospital is the only NBS institution in Changzhou. Participants were patients who were diagnosed and treated at this hospital. They all volunteered to participate in this study after informed consent. CH was diagnosed based on findings of elevated levels of serum thyroid-stimulating hormone (TSH; ≥9 mIU/L) and low levels of free thyroxine (FT4; <7.77 pmol/L) for newborns who were positive in the NBS program (heel blood TSH, ≥9.0 mIU/L). The levels of serum TSH and FT4 were determined by electrochemistry immunoassay using the COBAS e601 analyzer (Roche Diagnostics, Mannheim, Germany). The levels of heel blood TSH were detected by time-resolved fluoroimmunoassay using the Wallac 1235 AutoDELFIA (Perkin Elmer, Waltham, MA, USA). Following confirmation of diagnosis, the patients were immediately administered L-T4 at an initial dose of 10–15 μg kg−1 day−1. Patients with other congenital diseases or those whose mothers were diagnosed with Graves’ disease were excluded from the study. The study design and protocol were approved by the Ethics Committee of the Nanjing Medical University (approval no. 2019-258). Written informed consent for participation in this study was provided by the participants’ legal guardians.
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