Analytical and clinical performance of the updated Elecsys Anti-TPO II assay for the detection of antibodies against thyroid peroxidase to aid in the diagnosis of autoimmune thyroid diseases.
Document Type
Article
Publication Date
6-8-2026
Publication Title
Clinical chemistry and laboratory medicine : CCLM / FESCC
Abstract
OBJECTIVES: Use of polyclonal antibodies (pAbs) in immunoassays has limitations related to inter-batch variation and supply chain stability which may affect assay reproducibility, scalability, and sustainability. The Elecsys
METHODS: Repeatability, intermediate precision, and reproducibility were assessed over 5 days at three sites, within/between multiple reagent lots and analyzers. Method comparisons were performed against Elecsys Anti-TPO and three other immunoassays, using 218 serum samples covering the measuring range. The clinical cutoff was derived from 85 patients with confirmed Hashimoto thyroiditis (HT); reference intervals determined using samples from 230 healthy euthyroid individuals. Clinical performance was evaluated in 608 patients with confirmed HT, Graves disease, non-autoimmune thyroid diseases, or non-thyroid autoimmune diseases.
RESULTS: Elecsys Anti-TPO II demonstrated high precision (standard deviations for repeatability, intermediate precision, and reproducibility < 1.6 IU/mL for measurements ≤30 IU/mL; coefficients of variation < 7 % for measurements >30 IU/mL) and improved semi-quantitative agreement (94.0-97.7 %) with comparator assays, vs. Elecsys Anti-TPO (88.5-90.8 %). The 95th percentile of the reference range cohort was < 8 IU/mL; specificity in this cohort was 97.4 % (cutoff of ≥20 IU/mL). Clinical sensitivity for HT was 90.5 %; clinical specificity in disease control groups was 90.7 %.
CONCLUSIONS: Elecsys Anti-TPO II offers robust analytical and clinical performance, supporting its utility in diagnosing auto-immune thyroid diseases in routine clinical practice.
Recommended Citation
Burman KD, Schmeltz LR, Momoyama Y, Erenler F, Nakhle S, Mendoza-Ballesteros FA et al Analytical and clinical performance of the updated Elecsys Anti-TPO II assay for the detection of antibodies against thyroid peroxidase to aid in the diagnosis of autoimmune thyroid diseases. Clin Chem Lab Med. 2026 Jun 8. doi: 10.1515/cclm-2026-0044. Epub ahead of print. PMID: 42259764.
DOI
10.1515/cclm-2026-0044
ISSN
1437-4331
PubMed ID
42259764