A deep dive into four thyroglobulin immunoassays from analytical perspective

Deveci Bulut T. S., SERDAR M. A., YALÇIN M. M., Coşkun M., POYRAZ A., ACAR S., ...Daha Fazla

Scandinavian Journal of Clinical and Laboratory Investigation, cilt.85, sa.2, ss.148-159, 2025 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 85 Sayı: 2
  • Basım Tarihi: 2025
  • Doi Numarası: 10.1080/00365513.2025.2479037
  • Dergi Adı: Scandinavian Journal of Clinical and Laboratory Investigation
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, BIOSIS, CAB Abstracts, CINAHL
  • Sayfa Sayıları: ss.148-159
  • Anahtar Kelimeler: autoantibodies, clinical laboratory techniques, differentiated thyroid cancer, humans, immunoassay, interference of thyroglobulin autoantibody, method evaluation, thyroglobulin, Thyroid cancer, thyroid neoplasms
  • Acıbadem Mehmet Ali Aydınlar Üniversitesi Adresli: Evet

Özet

Backgrounds: Serum thyroglobulin immunometric assays (sTg) are crucial for monitoring differentiated thyroid cancer (DTC) treatment. However, challenges such as anti-thyroglobulin autoantibodies (TgAb) and assay variability hinder evaluations. This study assessed four sTg methods—three second-generation (Architect, Access, Elecsys) and one first-generation (Immulite)—following Clinical and Laboratory Standards Institute (CLSI) and American Thyroid Association (ATA) guidelines. Methods: The study compared sTg(Architect), sTg(Access), sTg(Elecsys), and sTg(Immulite). Precision was evaluated per CLSI EP05-A3, while the lower limits of detection (LLD) were assessed using EP17-A2. Passing–Bablok and Bland–Altman analyses were conducted as per EP09c, and semi-quantitative comparisons used Kappa statistics. Results: The second-generation sTgs (Architect, Access, Elecsys) exhibited satisfactory precision (<7% coefficient of variation, CV%), unlike sTg(Immulite), which showed significant deviations and inadequate sensitivity for DTC recurrence (Limit of quantitation, LoQ = 4.59 μg/L). Second-generation sTgs had strong correlations (r > 0.884) across all concentration ranges (≤1, 1-10, >10 μg/L), with biases (slope: 1.131-2.027). sTg(Immulite) correlated well with second-generation methods for concentrations >10 μg/L (r > 0.945) but less so for <10 μg/L (r < 0.642). TgAb significantly impacted sTg(Immulite). Kappa statistics revealed strong agreement among second-generation methods (κ > 0.800) but lower concordance with sTg(Immulite), especially in TgAb(+) samples (κ: 0.562-0.653). Agreement ratios were high for second-generation methods (0.667-1.000) but variable for sTg(Immulite), particularly at lower concentrations and in TgAb(+) cases (0.097-0.727). Conclusions: sTg(Immulite) did not meet LLD and precision criteria for DTC monitoring, facing issues with TgAb interference. Second-generation sTgs demonstrated consistent performance across all concentrations.