Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin
Background: Thyroglobulin (Tg) is a biomarker of iodine status. Newborn Tg is a more sensitive marker than neonatal TSH in detecting variations in iodine intake. This study aims to validate an enzyme-linked immunosorbent assay (ELISA) for Tg determination on dried blood spots (DBS) in newborns. This...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Bioscientifica
2024-11-01
|
| Series: | European Thyroid Journal |
| Subjects: | |
| Online Access: | https://etj.bioscientifica.com/view/journals/etj/13/6/ETJ-24-0142.xml |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850225884209872896 |
|---|---|
| author | Camilo Fuentes Peña María Cecilia Opazo Luis Méndez Claudia Riedel Bernard Hauquier Lionel Marcelis Frédéric Cotton Rodrigo Moreno-Reyes |
| author_facet | Camilo Fuentes Peña María Cecilia Opazo Luis Méndez Claudia Riedel Bernard Hauquier Lionel Marcelis Frédéric Cotton Rodrigo Moreno-Reyes |
| author_sort | Camilo Fuentes Peña |
| collection | DOAJ |
| description | Background: Thyroglobulin (Tg) is a biomarker of iodine status. Newborn Tg is a more sensitive marker than neonatal TSH in detecting variations in iodine intake. This study aims to validate an enzyme-linked immunosorbent assay (ELISA) for Tg determination on dried blood spots (DBS) in newborns. This study also sets out to assess the stability of Tg and the influence of newborns’ hematocrit on Tg determination.
Methods: A commercially available ELISA Tg assay was adapted for use on DBS. DBS-Tg in cord blood was measured in 209 newborns delivered from healthy euthyroid pregnant women. Sensitivity, linearity, repeatability, and intermediate fidelity were determined using the appropriate standards and quality control materials.
Results: The limit of detection of the DBS-Tg assay was 2.4 μg/L, and the limit of quantification was 5.8 μg/L. Repeatability and intermediate fidelity were 7.7–8.3% and 11.0–11.2%, respectively. The median cord plasma Tg and DBS-Tg values in newborns were not significantly different, 30.2 (21.3–44.4) μg/L and 31.6 (19.3–48.7) μg/L (P = 0.48) with the ELISA, respectively, and 76.5 (40.0–101.5) μg/L with the Elecsys assay with an R = 0.88. DBS-Tg concentrations decrease with increasing hematocrit values (P < 0.05). DBS-Tg values were stable at a concentration of 25 μg/L for 12 months at −20ºC and 4ºC.
Conclusion: This DBS-Tg assay demonstrated good analytical performance over a wide range of Tg concentrations, suggesting it is well suited to detecting variations in Tg concentrations. Studies comparing populations with different prevalence of anemia should consider the effect of hematocrit on DBS-Tg determination. The availability of a DBS-Tg assay for newborns makes it possible to integrate iodine status monitoring with newborn screening for inherited metabolic diseases. |
| format | Article |
| id | doaj-art-e931cf621ca64582b9c0763f831b1fbf |
| institution | OA Journals |
| issn | 2235-0802 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Bioscientifica |
| record_format | Article |
| series | European Thyroid Journal |
| spelling | doaj-art-e931cf621ca64582b9c0763f831b1fbf2025-08-20T02:05:13ZengBioscientificaEuropean Thyroid Journal2235-08022024-11-01136110https://doi.org/10.1530/ETJ-24-0142Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulinCamilo Fuentes Peña0María Cecilia Opazo1Luis Méndez2Claudia Riedel3Bernard Hauquier4Lionel Marcelis5Frédéric Cotton6Rodrigo Moreno-Reyes7Department of Nuclear Medicine, Hôpital Universitaire de Bruxelles (H.U.B) - Hôpital Erasme, Brussels, BelgiumInstituto de Ciencias Naturales, Facultad de Medicina Veterinaria y Agronomía, Universidad de Las Américas, Santiago, Providencia, ChileMillennium Institute on Immunology and Immunotherapy, Facultad de Ciencias de la Vida, Universidad Andrés Bello, Santiago, ChileMillennium Institute on Immunology and Immunotherapy, Facultad de Ciencias de la Vida, Universidad Andrés Bello, Santiago, ChileDepartment of Nuclear Medicine, Hôpital Universitaire de Bruxelles (H.U.B) - Hôpital Erasme, Brussels, BelgiumLaboratory of Paediatric Research, Université Libre de Bruxelles, Brussels, BelgiumDepartament of Clinical Chemistry, LHUB-ULB, Université Libre de Bruxelles, Brussels, BelgiumÉcole de Santé Publique, Université Libre de Bruxelles, Brussels, BelgiumBackground: Thyroglobulin (Tg) is a biomarker of iodine status. Newborn Tg is a more sensitive marker than neonatal TSH in detecting variations in iodine intake. This study aims to validate an enzyme-linked immunosorbent assay (ELISA) for Tg determination on dried blood spots (DBS) in newborns. This study also sets out to assess the stability of Tg and the influence of newborns’ hematocrit on Tg determination. Methods: A commercially available ELISA Tg assay was adapted for use on DBS. DBS-Tg in cord blood was measured in 209 newborns delivered from healthy euthyroid pregnant women. Sensitivity, linearity, repeatability, and intermediate fidelity were determined using the appropriate standards and quality control materials. Results: The limit of detection of the DBS-Tg assay was 2.4 μg/L, and the limit of quantification was 5.8 μg/L. Repeatability and intermediate fidelity were 7.7–8.3% and 11.0–11.2%, respectively. The median cord plasma Tg and DBS-Tg values in newborns were not significantly different, 30.2 (21.3–44.4) μg/L and 31.6 (19.3–48.7) μg/L (P = 0.48) with the ELISA, respectively, and 76.5 (40.0–101.5) μg/L with the Elecsys assay with an R = 0.88. DBS-Tg concentrations decrease with increasing hematocrit values (P < 0.05). DBS-Tg values were stable at a concentration of 25 μg/L for 12 months at −20ºC and 4ºC. Conclusion: This DBS-Tg assay demonstrated good analytical performance over a wide range of Tg concentrations, suggesting it is well suited to detecting variations in Tg concentrations. Studies comparing populations with different prevalence of anemia should consider the effect of hematocrit on DBS-Tg determination. The availability of a DBS-Tg assay for newborns makes it possible to integrate iodine status monitoring with newborn screening for inherited metabolic diseases.https://etj.bioscientifica.com/view/journals/etj/13/6/ETJ-24-0142.xmlthyroglobulindried blood spotiodineelisanewborn |
| spellingShingle | Camilo Fuentes Peña María Cecilia Opazo Luis Méndez Claudia Riedel Bernard Hauquier Lionel Marcelis Frédéric Cotton Rodrigo Moreno-Reyes Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin European Thyroid Journal thyroglobulin dried blood spot iodine elisa newborn |
| title | Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin |
| title_full | Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin |
| title_fullStr | Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin |
| title_full_unstemmed | Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin |
| title_short | Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin |
| title_sort | development of an enzyme linked immunosorbent assay for newborns dried blood spot thyroglobulin |
| topic | thyroglobulin dried blood spot iodine elisa newborn |
| url | https://etj.bioscientifica.com/view/journals/etj/13/6/ETJ-24-0142.xml |
| work_keys_str_mv | AT camilofuentespena developmentofanenzymelinkedimmunosorbentassayfornewbornsdriedbloodspotthyroglobulin AT mariaceciliaopazo developmentofanenzymelinkedimmunosorbentassayfornewbornsdriedbloodspotthyroglobulin AT luismendez developmentofanenzymelinkedimmunosorbentassayfornewbornsdriedbloodspotthyroglobulin AT claudiariedel developmentofanenzymelinkedimmunosorbentassayfornewbornsdriedbloodspotthyroglobulin AT bernardhauquier developmentofanenzymelinkedimmunosorbentassayfornewbornsdriedbloodspotthyroglobulin AT lionelmarcelis developmentofanenzymelinkedimmunosorbentassayfornewbornsdriedbloodspotthyroglobulin AT fredericcotton developmentofanenzymelinkedimmunosorbentassayfornewbornsdriedbloodspotthyroglobulin AT rodrigomorenoreyes developmentofanenzymelinkedimmunosorbentassayfornewbornsdriedbloodspotthyroglobulin |