Clinica chimica acta; international journal of clinical chemistry · 2026
Validation of parathyroid hormone measurement in fine-needle aspiration biopsy washings according to the IFCC LEAP checklist.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Kozłowska Ewa, Chudziński Witold, Kumorek Aleksandra, Ciepiela Olga
Аннотация
BACKGROUND: Measurement of parathyroid hormone in fine-needle aspiration biopsy washings (FNAB-PTH) is widely used in clinical practice to confirm parathyroid tissue origin and support lesion localization, particularly when imaging findings are inconclusive. However, comprehensive analytical validation of FNAB-PTH according to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Laboratory Evaluation and Analytical Performance (LEAP) framework has not been performed for this non-standard matrix.
METHODS: FNAB washings were analyzed using the Elecsys PTH assay on the cobas platform. Analytical performance was evaluated in accordance with the IFCC LEAP framework, including precision, linearity, limits of detection and quantification, carryover, matrix effects, stability, and robustness. Results obtained in 0.9% saline were compared with measurements after supplementation with a protein-based diluent. Clinical performance was assessed by comparison with histopathology, which served as the reference standard.
RESULTS: FNAB-PTH demonstrated excellent precision (CV ≤10%), preserved linearity, negligible carryover, and acceptable analytical sensitivity. A pronounced concentration-dependent matrix effect was observed in saline washings, with median recovery increasing from 46.9% at low to 76.5% at high PTH concentrations; this effect was markedly reduced after protein supplementation. PTH in FNAB washings remained stable under routine preanalytical conditions, although reduced stability was observed in high-concentration samples during prolonged storage. In 100 cases, FNAB-PTH showed high agreement with histopathology (overall agreement 89.0%).
CONCLUSIONS: Analytical validation of FNAB-PTH according to the IFCC LEAP framework confirms good analytical quality and supports its clinical utility for confirming parathyroid tissue origin and assisting lesion localization, despite the presence of a concentration-dependent matrix effect.
METHODS: FNAB washings were analyzed using the Elecsys PTH assay on the cobas platform. Analytical performance was evaluated in accordance with the IFCC LEAP framework, including precision, linearity, limits of detection and quantification, carryover, matrix effects, stability, and robustness. Results obtained in 0.9% saline were compared with measurements after supplementation with a protein-based diluent. Clinical performance was assessed by comparison with histopathology, which served as the reference standard.
RESULTS: FNAB-PTH demonstrated excellent precision (CV ≤10%), preserved linearity, negligible carryover, and acceptable analytical sensitivity. A pronounced concentration-dependent matrix effect was observed in saline washings, with median recovery increasing from 46.9% at low to 76.5% at high PTH concentrations; this effect was markedly reduced after protein supplementation. PTH in FNAB washings remained stable under routine preanalytical conditions, although reduced stability was observed in high-concentration samples during prolonged storage. In 100 cases, FNAB-PTH showed high agreement with histopathology (overall agreement 89.0%).
CONCLUSIONS: Analytical validation of FNAB-PTH according to the IFCC LEAP framework confirms good analytical quality and supports its clinical utility for confirming parathyroid tissue origin and assisting lesion localization, despite the presence of a concentration-dependent matrix effect.