Indian pediatrics · 2019
An Optimal Capillary Screen Cut-off of Thyroid Stimulating Hormone for Diagnosing Congenital Hypothyroidism: Data from a Pilot Newborn Screening Program in Delhi.
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Verma Prashant, Kapoor Seema, Kalaivani Mani, Vats Pallavi, Yadav Sangeeta, Jain Vandana, Thelma B K, Science and Engineering Research Board – Newborn Screening Initiative Group (SERB-NBS) members
Аннотация
OBJECTIVE: To determine an appropriate cut-off of capillary Thyroid stimulating hormone (TSH) for congenital hypothyroidism.
STUDY DESIGN: Cross-sectional.
PARTICIPANTS: 174,000 neonates born in different hospitals of Delhi, India, from November 2014 to October 2016.
MAIN OUTCOME MEASURES: Correlation between initial and repeat capillary TSH level and subsequent venous free thyroxine (fT4) level.
RESULTS: 102 newborns with initial/ repeat capillary TSH level of ≥20 mIU/L (n=174) were confirmed to have congenital hypothyroidism at mean (SD) age of 5 (4) days. A good correlation between capillary TSH level and confirmatory venous fT4 level and postnatal age of sampling was obtained (r -0.6, -0.4). The area under the ROC curve (AUC) was 0.81 (95%CI 0.75 to 0.88), indicating referral capillary TSH level of 20 mIU/L to be a good predictor of subsequent high venous TSH level.
CONCLUSIONS: A cut off of ≥20 mIU/L for capillary TSH screening beyond 24 hours of life is optimal in the Indian setting for deciding further recall and workup, keeping a balance between sensitivity and recall rate.
STUDY DESIGN: Cross-sectional.
PARTICIPANTS: 174,000 neonates born in different hospitals of Delhi, India, from November 2014 to October 2016.
MAIN OUTCOME MEASURES: Correlation between initial and repeat capillary TSH level and subsequent venous free thyroxine (fT4) level.
RESULTS: 102 newborns with initial/ repeat capillary TSH level of ≥20 mIU/L (n=174) were confirmed to have congenital hypothyroidism at mean (SD) age of 5 (4) days. A good correlation between capillary TSH level and confirmatory venous fT4 level and postnatal age of sampling was obtained (r -0.6, -0.4). The area under the ROC curve (AUC) was 0.81 (95%CI 0.75 to 0.88), indicating referral capillary TSH level of 20 mIU/L to be a good predictor of subsequent high venous TSH level.
CONCLUSIONS: A cut off of ≥20 mIU/L for capillary TSH screening beyond 24 hours of life is optimal in the Indian setting for deciding further recall and workup, keeping a balance between sensitivity and recall rate.