Newborn Screening Lab, The ZB foundation Welfare Trust, Rawalpindi, Pakistan.
Department of Chemical Pathology and Endocrinology, Armed Forces Institute of Pathology and National University of Medical Sciences, Rawalpindi, Pakistan.
J Pak Med Assoc. 2021 Jan;71(1(B)):191-194. doi: 10.47391/JPMA.561.
To develop and validate a method on Dissociation Enhanced Lanthanide Fluorescence Immunoassay for neonatal heel prick blood human thyroid stimulating hormone and the establishment of its reference value in the local population.
The multi-centre cross-sectional validation study was conducted from September 2016 to September 2018 at Zahra Beau Naqvi Foundation Welfare Trust laboratory, Islamabad, Pakistan, and comprised samples related to newborns aged 1 month or less taken from neonatal units of 39 hospitals based in Punjab, Khyber Pakhtunkhuwa, Gilgit-Baltistan and Azad Jammu and Kashmir. Samples were collected after 24 hours of birth using the heel prick test. The samples were dried and sent to the laboratory for assessment where Dissociation Enhanced Lanthanide Fluorescent Immunoassay was used to estimate thyroid stimulating hormone levels. Data recorded included age, gender, and birth detail, like gestational age, mode of delivery etc. Data was analysed using SPSS 21. Method validation and reference value were manually calculated.
Of the 14,147 samples received, 8,207(58%) related to boys and 5,940(42%) to girls. Most samples 4903(34.6%) came from Peshawar. The overall mean age of the newborns was 5.6±4.8 days. Thyroid stimulating hormone data was divided into three groups; positive with median value 27.8±36.6 uIU/ml, negative with median 1.42±1.60 uIU/ml, and borderline with median 11.4±4.12uIU/ml. Prevalence of congenital hypothyroidism in high-risk population in the positive group was 39(0.3%), negative 14,012(99.0%) and borderline 96(0.7%). Reference cut-off was calculated as 7.06uIU/ml for screening of healthy and positive cases of congenital hypothyroidism. Method Validation results showed limit of detection -0.5uU/ml, limit of quantitation LOQ 0.8uU/ml, accuracy 100±5%, precision coefficient of variation at each level of calibrators -4, 8.8, 1.2, 11.3, 7.2 and 4.3% respectively, and linearity from to 0.8uU/ml to 254.1uU/ml.
Neonatal human thyroid stimulating hormone by heel prick blood was found to be an affordable and highly sensitive method of screening for congenital hypothyroidism.
开发并验证一种用于新生儿足跟血的解吸增强镧系荧光免疫分析方法，并建立该方法在当地人群中的参考值。
本多中心横断面验证研究于 2016 年 9 月至 2018 年 9 月在巴基斯坦伊斯兰堡的扎赫拉·博纳克维基金会福利信托实验室进行，研究对象为来自旁遮普省、开伯尔-普赫图赫瓦省、吉尔吉特-巴尔蒂斯坦和自由查谟和克什米尔的 39 家医院新生儿病房的 1 个月或以下新生儿的足跟血样本。在出生后 24 小时使用足跟采血法采集样本。将样本干燥并送往实验室进行评估，使用解吸增强镧系荧光免疫分析来估计促甲状腺激素水平。记录的数据包括年龄、性别和出生详细信息，如胎龄、分娩方式等。使用 SPSS 21 进行数据分析。手动计算方法验证和参考值。
在收到的 14147 个样本中，8207 个（58%）为男孩，5940 个（42%）为女孩。大多数样本（4903 个，34.6%）来自白沙瓦。新生儿的总体平均年龄为 5.6±4.8 天。促甲状腺激素数据分为三组：阳性组中位数为 27.8±36.6 uIU/ml，阴性组中位数为 1.42±1.60 uIU/ml，边界组中位数为 11.4±4.12 uIU/ml。阳性组高危人群先天性甲状腺功能减退症的患病率为 39（0.3%），阴性组为 14012（99.0%），边界组为 96（0.7%）。筛查健康人群和先天性甲状腺功能减退症阳性病例的参考截止值计算为 7.06uIU/ml。方法验证结果显示，检测限为-0.5uU/ml，定量限 LOQ 为 0.8uU/ml，准确度为 100±5%，每个校准器水平的精密度变异系数分别为-4、8.8、1.2、11.3、7.2 和 4.3%，线性范围为 0.8uU/ml 至 254.1uU/ml。
通过足跟血检测新生儿人促甲状腺激素是一种经济实惠且高度敏感的先天性甲状腺功能减退症筛查方法。
