Balkan Journal of Medical Genetics

HIGH INCIDENCE OF CONGENITAL HYPOTHYROIDISM IN ONE REGION OF THE REPUBLIC OF MACEDONIA
Anastasovska V, Koviloska R, Kocova M,
*Corresponding Author: Professor Dr. Mirjana Kocova, University Clinic of Pediatrics, Vodnjanska 17, 1000 Skopje, Republic of Macedonia. Tel.: +389(0)2-3123-224. Fax: +389(0)2-3111-713. E-mail: mirjanakocova@ yahoo.com
page: 31

MATERIALS AND METHODS

Neonatal screening for CH was performed in 9757 out of 10,446 live born neonates from the nursery at the General Hospital Borka Taleski, Prilep for the period from June 2002 to December 2011. Heelstick blood samples were taken by trained nurses, mostly 48 hours after birth and transferred to Whatman 903 filter papers (LKB Vertriebs GmbH, Vienna, Austria). They were dried and mailed daily (or every second day) to the internationally accredited central screening laboratory located at the University Clinic of Pediatrics in Skopje, Republic of Macedonia. Premature or sick full-term neonates, who usually have a prolonged stay in neonatal intensive care units, are screened between the first and second week of age. Neonates discharged from the nurseries before 48 hours of birth at the parent’s request, are screened at the moment of discharge. Birth weight, gestational age at birth, gender, and timing of sampling were recorded by the nursery. A time-resolved fluoroimmunoassay was applied to measure the TSH concentration in the dry blood spot samples using the DELFIA neonatal human thyroid-stimulating hormone (hTSH), kit manufactured by Wallac Oy, Turku, Finland. It is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies are directed against two separate antigenic determinants on the hTSH molecule. The method was performed as per the manufacturer’s instructions. Internal and external quality assurance controls were included in the TSH assay. Internal controls were made simultaneously with samples to assure the day-to-day validity of results, while external controls from Reference Institute for Bioanalytics, Bonn, Germany were included every 3 months. The TSH values lower than 10 mU/L were considered negative for specimens taken 48 hours after birth and no further action was pursued. Results between 10 and 20 mU/L were designated borderline and a blood sample on a new filter paper (LKB Vertiebs GmbH) was requested by telephone. On this repeat sample, TSH values less than 8 mU/L were considered normal. Thyroid-stimulating hormone results greater than 20 mU/L on the initial sample were considered positive for CH and the newborn was referred for biochemical and clinical evaluation immediately. Neonates with confirmed hypothyroidism received therapy with levothyroxine of 10-15 μg/kg/day [1]. Statistical Analysis. Data were analyzed using the Statistical Package for the Social Sciences, version 20 software (SPSS Inc., Chicago, IL, USA) and the statistical significance was set at p <0.05. Pearson χ2 was used for the comparison of proportions. The Mann-Whitney U test was used for the comparison of TSH mean values between different groups (according to the day of sampling, birth weight and gestational age at birth). The factorial-analysis of variance (F-ANOVA) test was used for establishing the interaction between categorical variables and the Spearman’s coefficient for correlation.

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