Bridging Gaps in Newborn Screening
A Comparative Study of Point-of-Care Testing versus Traditional Reference Laboratory Method for Congenital Hypothyroidism
DOI:
https://doi.org/10.15605/jafes.041.02.6233Keywords:
congenital hypothyroidism, NEWBORN, reproducibility result, Preventive Medicine, healthAbstract
Objective. This study aimed to compare the reliability, agreement, and practical application (turnaround time) of a point-of-care testing (POCT) device using two different reagents versus the traditional reference laboratory method for thyroid-stimulating hormone (TSH) measurement in newborn congenital hypothyroidism screening.
Methodology. This prospective cross-sectional method-comparison study included 122 term newborns at a mother and child hospital in Surabaya, Indonesia. Heel-prick capillary blood samples were simultaneously analyzed using the Standard F-200 POCT device with two reagents (Group 1: n = 62, StandardTM F TSH-II; Group 2: n = 60, FastClear F TSH-II) and compared to the standard dried blood spot method (GSP® Neonatal hTSH, PerkinElmer) as reference. Analyses included Pearson and Spearman correlations, linear regression, Bland-Altman plots, intraclass correlation coefficient (ICC), Cohen’s Kappa, and mean difference tests.
Results. Strong positive correlations were observed in both Group 1 (Pearson’s r = 0.87, Spearman’s ρ = 0.85; p <0.001) and Group 2 (Pearson’s r = 0.88, Spearman’s ρ = 0.91; p <0.001). Bland-Altman analysis showed minimal systematic bias with acceptable agreement between the two techniques. The ICC values indicated excellent reliability (Group 1: 0.89; Group 2: 0.91). High categorical agreement was confirmed by Cohen’s Kappa values of 0.85 and 0.87 (p <0.001). No significant differences in mean TSH levels were found between the POCT and reference methods. The POCT turnaround time was 30 minutes, significantly shorter than the 15–22 days required for the traditional method.
Conclusion. POCT devices present a promising alternative to traditional reference screening method for congenital hypothyroidism.
Downloads
References
1. Kaluarachchi DC, Allen DB, Eickhoff JC, Dawe SJ, Baker MW. Increased congenital hypothyroidism detection in preterm infants with serial newborn screening. J Pediatr. 2019;207:220–5. https://pubmed.ncbi.nlm.nih.gov/30579585 DOI: 10.1016/j.jpeds.2018.11.044
2. Octavius GS, Daleni VA, Sagala YDS. An insight into Indonesia’s challenges in implementing newborn screening programs and their future implications. Children (Basel). 2023;10(7):1216. https://pubmed.ncbi.nlm.nih.gov/37508713 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10378005 DOI: 10.3390/children10071216
3. Faizi M, Rochmah N, Hisbiyah Y, Perwitasari R, Deakandi W, Titiharja FF. Effectiveness of health education toward healthcare knowledge improvement about congenital hypothyroidism newborn screening. Int J Thyroidol. 2022;15(2):105–9. DOI: 10.11106/ijt.2022.15.2.105
4. Salim IA, Putri R, Rosmalawati TA, Cahyono HA, Muttaqin F. Screening for congenital hypothyroidism in Malang, East Java in 2020. Pediatr Sci J. 2022;2(2):38–43. https://doi.org/10.51559/pedscij.v2i2.28
5. Octavius GS, Daleni VA, Sagala YDS. An insight into Indonesia’s progress for newborn screening program: What is currently going on. Heliyon. 2024;10(13):e33479. PMID: 39035496 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11259875 https://doi.org/10.1016/j.heliyon.2024.e33479
6. Anggraini A, Suryawati C, Fatmasari Y. Evaluasi pelaksanaan program skrining hipotiroid kongenital oleh puskesmas karangrejo Kota Metro Lampung. Sari Pediatri. 2019;7(1):2356–3346.
7. Rayhan Yasmin N, Kurniati I, Karima N. Result representation of congenital hypothyroid screening (CHS) based on area topography in Bandar Lampung City in May-October 2019. Rev Prim Care Prac and Educ. 2022;5(2):72–7. https://doi.org/10.22146/rpcpe.76332
8. Anggraini R, Yudha Patria S, Julia M. Ketepatan Waktu pelayanan skrining hipotiroidism kongenital di Yogyakarta. Sari Pediatri. 2017;18(6):436–42. 10.14238/sp18.6.2017.436-42
9. Setyaningsih W, Wulandari RD. The evaluation of congenital hypothyroidism screening program in Indonesia: a literature review. J Aisyah J Ilmu Kesehat. 2022;7(2). https://doi.org/10.30604/jika.v7i2.1161
10. Pulungan AB, Puteri HA, Faizi M, Hofman PL, Utari A, Chanoine JP. Experiences and challenges with congenital hypothyroidism newborn screening in Indonesia: A national cross-sectional survey. Int J Neonatal Screen. 2024;10(1):8. https://pubmed.ncbi.nlm.nih.gov/38390972 PMCID: PMC10885017 https://doi.org/10.3390/ijns10010008
11. Kopel J. A global perspective on newborn congenital hypothyroidism screening. Prov (Bayl Univ Med Cent). 2020;33(1):137–9. https://pubmed.ncbi.nlm.nih.gov/32063801 PMCID: PMC6988672 https://doi.org/10.1080/08998280.2019.1668715
12. Pulungan AB, Oldenkamp ME, van Trotsenburg ASP, Windarti W, Gunardi H. Effect of delayed diagnosis and treatment of congenital hypothyroidism on intelligence and quality of life: An observational study. Med J Indones. 2019;28(4):396–401. https://doi.org/10.13181/mji.v28i4.3473
13. Esposito A, Vigone MC, Polizzi M, et al. Effect of initial levothyroxine dose on neurodevelopmental and growth outcomes in children with congenital hypothyroidism. Front Endocrinol (Lausanne). 2022;13:923448. https://pubmed.ncbi.nlm.nih.gov/36133316 PMCID: PMC9484273 https://doi.org/10.3389/fendo.2022.923448
14. Pelaez JM, Rojas-Ramos JCR, Domingos MT, et al. Cognitive outcome of 458 children over 25 years of neonatal screening for congenital hypothyroidism. J Pediatr (Rio J). 2023;99(5):478–84. https://pubmed.ncbi.nlm.nih.gov/37088106 PMCID: PMC10492150 https://doi.org/10.1016/j.jped.2023.03.003
15. Ruth Adisty N, Hidayat B. Gambaran pertumbuhan anak dengan hipotiroid kongenital pasca-terapi levotiroksin di RSUP Dr. Hasan Sadikin pada tahun 2014 sampai dengan 2018. Sari Pediatri. 2020;22(2):98–103. https://doi.org/10.14238/sp22.2.2020.98-103
16. Boelen A, Zwaveling-Soonawala N, Heijboer AC, van Trotsenburg ASP. Neonatal screening for primary and central congenital hypothyroidism: Is it time to go Dutch? Eur Thyroid J. 2023;12(4):e230041. https://pubmed.ncbi.nlm.nih.gov/37326450 PMCID: PMC10388664 https://doi.org/10.1530/ETJ-23-0041
17. Donaldson MDC, Grosse SD. Does early identification of central congenital hypothyroidism result in improved outcomes? J Clin Endocrinol Metab. 2021;106(5):e2373–5. https://pubmed.ncbi.nlm.nih.gov/33517453 PMCID: PMC8328040 https://doi.org/10.1210/clinem/dgab059
18. Mashabi Y. Screening T4 and TSH in early detection of congenital hypothyroidism in newborns: what’s the dilemma? Jurnal Biomedika dan Kesehatan. 2024;7(1):1–5. https://doi.org/10.18051/JBiomedKes.2024.v7.1-5
19. Shurbaji S, Al Tamimi F, Al Ghwairi MM, et al. High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA). Heliyon. 2023;9(10):e20589. https://pubmed.ncbi.nlm.nih.gov/37842620 PMCID: PMC10569953 https://doi.org/10.1016/j.heliyon.2023.e20589
20. Badan Pusat Statistik Jawa Timur. Accessed December 15, 2024. www.jatim.bps.go.id
21. Therrell BL, Padilla CD, Loeber JG, et al. Current status of newborn screening worldwide: 2015. Semin Perinatol. 2015;39(3):171–87. https://pubmed.ncbi.nlm.nih.gov/25979780 https://doi.org/10.1053/j.semperi.2015.03.002
22. Therrell BL, Padilla CD, Borrajo GJC, et al. Current status of newborn bloodspot screening worldwide 2024: A comprehensive review of recent activities (2020–2023). Int J Neonatal Screen. 2024;10(2):38. https://pubmed.ncbi.nlm.nih.gov/38920845 PMCID: PMC11203842 https://doi.org/10.3390/ijns10020038
23. Kurniawan LB. Congenital hypothyroidism: Incidence, etiology and laboratory screening. Indonesian J Clin Pathology Med Lab. 2020;26(3):375–80. https://doi.org/10.24293/ijcpml.v26i3.1527
24. Pulungan AB, Soesanti F, Utari A, et al. Preliminary study of newborn Screening for congenital hypothyroidism and congenital adrenal hyperplasia in Indonesia. eJKI. 2020;8(2).
25. Rose SR, Wassner AJ, Wintergerst KA, et al; Section on Endocrinology Executive Committee; Council on Genetics Executive Committee. Congenital hypothyroidism: Screening and management. Pediatrics. 2023;151(1):e2022060419. https://pubmed.ncbi.nlm.nih.gov/36827521 https://doi.org/10.1542/peds.2022-060420
26. Rochmah N, Faizi M, Dewanti C, Suryawan A. Pediatric quality of life in congenital hypothyroidism: An Indonesian study. Int J Thyroidol. 2020;13(2):150–4. https://doi.org/10.11106/ijt.2020.13.2.150
27. Butler AM, Charoensiriwatana W, Krasao P, et al. Newborn thyroid screening: influence of pre-analytic variables on dried blood spot thyrotropin measurement. Thyroid. 2017;27(9):1128–34. https://pubmed.ncbi.nlm.nih.gov/28810813 https://doi.org/10.1089/thy.2016.0452
28. Adegoke SA, Makalo L, Sallah A, et al. Point-of-care newborn screening for sickle cell disease at selected health facilities in the Gambia. Hemoglobin. 2024;48(3):169–74. https://pubmed.ncbi.nlm.nih.gov/8980121 https://doi.org/10.1080/03630269.2024.2369523
29. Nnodu O, Isa H, Nwegbu M, et al. HemoTypeSC, a low-cost point-of-care testing device for sickle cell disease: promises and challenges. Blood Cells Mol Dis. 2019;78:22–8. https://pubmed.ncbi.nlm.nih.gov/30773433 PMCID: PMC6692636 DOI: 10.1016/j.bcmd.2019.01.00730. Karbalivand H, Iyare A, Aponte A, Xianhong X, Kim M, Havranek T. Hypoglycemia screening of asymptomatic newborns on the 2nd day of life. J Neonatal Perinatal Med. 2022;15(2):311–6. https://pubmed.ncbi.nlm.nih.gov/34974442 https://doi.org/10.3233/NPM-210861
31. Wada A, Takagi Y, Kono M, Morikawa T. Accuracy of a new platelet count system (PLT-F) depends on the staining property of its reagents. PLoS One. 2015;10(10):e0141311. https://pubmed.ncbi.nlm.nih.gov/26496387 PMCID: PMC4619826 https://doi.org/10.1371/journal.pone.0141311
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Endah Indriastuti, Rahmah Yasinta Rangkuti, Fatimah Nur Fitriani, Putri Alief Siswanto, Edwin Nugroho Njoto, Muhammad Nazhif Haykal, Fauqa Arinil Aulia
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The full license text is available at: http://creativecommons.org/licenses/by-nc/3.0/legalcode.
To request permission to translate, reproduce, download, or use articles or images for commercial reuse or business purposes from the Journal of the ASEAN Federation of Endocrine Societies (JAFES), kindly complete the Permission Request for Use of Copyrighted Material Form and email jafes@asia.com or jafes.editor@gmail.com.
A written agreement will be issued to the requester once permission has been granted.
