Evaluating the Two-Step TSH Screening Protocol for Congenital Hypothyroidism:
Prevalence and Diagnostic Accuracy in Ninh Binh, Vietnam
DOI:
https://doi.org/10.15605/jafes.041.01.5795Keywords:
congenital hypothyroidism, thyroid-stimulating hormone screening, newborn screening, prevalence, wo-step TSH screeningAbstract
Objectives. This study aimed to determine the prevalence of congenital hypothyroidism (CH) among newborns in Ninh Binh Province, Vietnam, and to evaluate whether adding a second thyroid-stimulating hormone (TSH) screening reduces false positives and improves diagnostic accuracy compared with the traditional single-step screening commonly practiced in Vietnam.
Methodology. A retrospective cohort study was conducted on 11,306 newborns screened between January 2019 and December 2020. TSH levels were measured from dried blood spot samples, with a threshold of >9 mU/L indicating high risk. High-risk cases underwent a second screening, followed by confirmation with serum TSH and free thyroxine. Screening performance (sensitivity, specificity, positive predictive value [PPV], negative predictive value [NPV]) and risk factors for CH were analyzed.
Results. The prevalence of high-risk CH was 2.40% (271/11,306 newborns), with four confirmed cases (incidence: 1:2,826). The two-step screening program achieved a sensitivity of 75.00%, with one false-negative case later detected clinically. Specificity improved from 97.64% in the first screening to 99.81% in the second, while PPV increased more than tenfold (1.11% → 11.54%). Low birth weight infants (≤2,500 g) had a significantly higher CH risk (OR: 10.04, 95% CI: 1.053–95.820, p = 0.004).
Conclusions. This first provincial evaluation of two-step CH screening in Vietnam demonstrated that repeat testing significantly reduced false positives and improved diagnostic accuracy without compromising sensitivity. The findings highlight the value of implementing a two-step strategy to optimize newborn screening, reduce unnecessary referrals and save resources in developing countries.
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