Pediatric endocrinology

Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin

Eur Thyroid JPublished Assay development and validation study

Authors' 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.

Study context

Population
Newborns delivered from healthy euthyroid pregnant women; cord blood
Participants
209 newborns
Comparison
DBS-Tg enzyme-linked immunosorbent assay (ELISA) vs cord plasma thyroglobulin (Tg)
Outcome
Analytical performance of DBS-Tg assay
Methodological detailsELISA adapted for dried blood spots (DBS)
  • ELISA adapted for DBS

Performance

As reported in the abstract

Limit of detection

2.4 µg/L

Limit of quantification

5.8 µg/L

Repeatability

7.7-8.3%

Intermediate fidelity

11.0-11.2%

Further findings

Median Tg in newborns — between DBS-Tg (ELISA) and Cord plasma Tg (ELISA) · not significantly different

P = 0.48

Median Tg in newborns — Correlation (R)
0.88

Effect of hematocrit on DBS-Tg

DBS-Tg concentrations decrease with increasing hematocrit (P < 0.05)

Stability of DBS-Tg · 12 months

Stable at 25 µg/L for 12 months at −20ºC and 4ºC

Original publication

Development of an enzyme-linked immunosorbent assay for newborns dried blood spot thyroglobulin. Eur Thyroid J. Published 25 November 2024. doi:10.1530/etj-24-0142

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