Diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation-enhanced lanthanide fluorescence immunoassay with the establishment of reference value in Pakistani neonates

Objective: 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. Methods: The multi-centre cross-sectional validation study...

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Main Authors: Ayesha Raza, Ambreen Barkat, Safia Fatima, Fizza Faizan Farooqui, Naureen Chaudhri, Shahzad Haider
Format: Article
Language:English
Published: Pakistan Medical Association 2020-11-01
Series:Journal of the Pakistan Medical Association
Online Access:https://www.ojs.jpma.org.pk/index.php/public_html/article/view/2056
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author Ayesha Raza
Ambreen Barkat
Safia Fatima
Fizza Faizan Farooqui
Naureen Chaudhri
Shahzad Haider
author_facet Ayesha Raza
Ambreen Barkat
Safia Fatima
Fizza Faizan Farooqui
Naureen Chaudhri
Shahzad Haider
author_sort Ayesha Raza
collection DOAJ
description Objective: 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. Methods: 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. Results: 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%). Continuous...
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spelling doaj.art-8f481e8d75334854a49c265538118bfb2023-05-25T04:24:59ZengPakistan Medical AssociationJournal of the Pakistan Medical Association0030-99822020-11-0171110.47391/JPMA.561Diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation-enhanced lanthanide fluorescence immunoassay with the establishment of reference value in Pakistani neonatesAyesha Raza 0Ambreen Barkat1Safia Fatima 2Fizza Faizan Farooqui3Naureen Chaudhri4Shahzad Haider 5Newborn Screening Lab, The ZB foundation Welfare Trust, Rawalpindi, PakistanNewborn Screening Lab, The ZB foundation Welfare Trust, Rawalpindi, PakistanDepartment of Chemical Pathology and Endocrinology, Armed Forces Institute of Pathology and National University of Medical Sciences, Rawalpindi, PakistanNewborn Screening Lab, The ZB foundation Welfare Trust, Rawalpindi, PakistanRawalpindi Medical University RMU, Rawalpindi, PakistanIzzat Ali Shah Hospital, Wah, Rawalpindi, Pakistan Objective: 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. Methods: 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. Results: 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%). Continuous... https://www.ojs.jpma.org.pk/index.php/public_html/article/view/2056
spellingShingle Ayesha Raza
Ambreen Barkat
Safia Fatima
Fizza Faizan Farooqui
Naureen Chaudhri
Shahzad Haider
Diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation-enhanced lanthanide fluorescence immunoassay with the establishment of reference value in Pakistani neonates
Journal of the Pakistan Medical Association
title Diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation-enhanced lanthanide fluorescence immunoassay with the establishment of reference value in Pakistani neonates
title_full Diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation-enhanced lanthanide fluorescence immunoassay with the establishment of reference value in Pakistani neonates
title_fullStr Diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation-enhanced lanthanide fluorescence immunoassay with the establishment of reference value in Pakistani neonates
title_full_unstemmed Diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation-enhanced lanthanide fluorescence immunoassay with the establishment of reference value in Pakistani neonates
title_short Diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation-enhanced lanthanide fluorescence immunoassay with the establishment of reference value in Pakistani neonates
title_sort diagnostic evaluation of heel prick newborn screening of thyroid stimulating hormone on dissociation enhanced lanthanide fluorescence immunoassay with the establishment of reference value in pakistani neonates
url https://www.ojs.jpma.org.pk/index.php/public_html/article/view/2056
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