Determining the TSH reference range in national newborn screening program for congenital hypothyroidism. 2020

Fatemeh Dorreh, and Ali Chehrei, and Fatemeh Rafiei, and Afsaneh Talaei, and Mohammadreza Rezvanfar, and Amir Almasi-Hashiani
Department of Pediatrics, Thyroid Disorders Research Center, Arak University of Medical Sciences, Arak, Iran.

Objective: Since the initiation of the thyroid screening program in Iran in 2005, 5 mIU/L has been selected as the threshold for thyroid stimulating hormone (TSH) for screening for congenital hypothyroidism. Given the specific disease pattern in the region and current controversies of the TSH cutoff point, a new cutoff point has been proposed in this study.Methods: This study was conducted on the existing database of the screening program consisting of 127,112 neonates in Markazi Province, center of Iran, during 2006-2012. Data on 614 referred neonates consisting of 414 neonates diagnosed of having hypothyroidism and 200 screened healthy neonates, were analyzed. The heel prick test had been done on the studied neonates to determine the TSH levels. The receiver-operator characteristic (ROC) curve and diagnostic values were used for data analysis.Results: The 5-mIU/L cutoff point in the study had a sensitivity and specificity and AUC of 86.5, 10 and 47%, respectively. Among the eleven selected cutoff points, 6.5 mIU/L had the appropriate sensitivity, specificity and AUC (58.9, 56.5 and 57%, respectively), negative and positive likelihood ratios (0.73 and 1.35, respectively).Conclusion: Given the very low specificity of the 5-mIU/L cutoff point for referral and with respect to the high rate of referrals and many false positive cases, we suggest to use the 6.5-mIU/L cutoff point which is more suitable.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D007492 Iran A country bordering the Gulf of Oman, the Persian Gulf, and the Caspian Sea, between Iraq and Pakistan. The capital is Tehran. Islamic Republic of Iran
D012016 Reference Values The range or frequency distribution of a measurement in a population (of organisms, organs or things) that has not been selected for the presence of disease or abnormality. Normal Range,Normal Values,Reference Ranges,Normal Ranges,Normal Value,Range, Normal,Range, Reference,Ranges, Normal,Ranges, Reference,Reference Range,Reference Value,Value, Normal,Value, Reference,Values, Normal,Values, Reference
D003409 Congenital Hypothyroidism A condition in infancy or early childhood due to an in-utero deficiency of THYROID HORMONES that can be caused by genetic or environmental factors, such as thyroid dysgenesis or HYPOTHYROIDISM in infants of mothers treated with THIOURACIL during pregnancy. Endemic cretinism is the result of iodine deficiency. Clinical symptoms include severe MENTAL RETARDATION, impaired skeletal development, short stature, and MYXEDEMA. Cretinism,Myxedema, Congenital,Endemic Cretinism,Fetal Iodine Deficiency Disorder,Cretinism, Endemic,Hypothyroidism, Congenital
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013972 Thyrotropin A glycoprotein hormone secreted by the adenohypophysis (PITUITARY GLAND, ANTERIOR). Thyrotropin stimulates THYROID GLAND by increasing the iodide transport, synthesis and release of thyroid hormones (THYROXINE and TRIIODOTHYRONINE). Thyrotropin consists of two noncovalently linked subunits, alpha and beta. Within a species, the alpha subunit is common in the pituitary glycoprotein hormones (TSH; LUTEINIZING HORMONE and FSH), but the beta subunit is unique and confers its biological specificity. Thyroid-Stimulating Hormone,TSH (Thyroid Stimulating Hormone),Thyreotropin,Thyrotrophin,Hormone, Thyroid-Stimulating,Thyroid Stimulating Hormone
D015997 Neonatal Screening The identification of selected parameters in newborn infants by various tests, examinations, or other procedures. Screening may be performed by clinical or laboratory measures. A screening test is designed to sort out healthy neonates (INFANT, NEWBORN) from those not well, but the screening test is not intended as a diagnostic device, rather instead as epidemiologic. Infant, Newborn, Screening,Newborn Infant Screening,Newborn Screening,Neonatal Screenings,Newborn Infant Screenings,Newborn Screenings,Screening, Neonatal,Screening, Newborn,Screening, Newborn Infant,Screenings, Neonatal,Screenings, Newborn,Screenings, Newborn Infant

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