Multi‐center evaluation of the highly sensitive Abbott ARCHITECT and Alinity thyroglobulin chemiluminescent microparticle immunoassay

• Published in: Journal of clinical laboratory analysis Vol. 36; no. 9; pp. e24595 - n/a
• Main Authors: Evans, Carol, Lotz, Johannes, Bhandari, Maria, Hellier, Rowan T., Wang, Xiao Yan, Lott, Rosemarie, Lackner, Karl J., Müller, Robert, Kulasingam, Vathany
• Format: Journal Article
• Language: English
• Published: New York John Wiley & Sons, Inc 01.09.2022; John Wiley and Sons Inc
• Subjects: anti‐Tg; Architects; Clinical medicine; Laboratories; Medical prognosis; method comparision; Patients; Reagents; Thyroglobulin; Thyroid cancer; Thyroid carcinoma; Thyroidectomy
• ISSN: 0887-8013; 1098-2825
• DOI: 10.1002/jcla.24595

Background Thyroglobulin (Tg) is an essential part for the management of patients with differentiated thyroid carcinoma (DTC) after thyroidectomy. Highly sensitive Tg assays are now established in clinical practice as they facilitate follow‐up of DTC patients. In this study, we evaluated the recently launched highly sensitive Abbott Tg assay for Alinity and ARCHITECT. Methods In this three‐center study, Tg values of 447 routine patient samples, characterized for the presence of anti‐Tg, were measured with the ARCHITECT Tg assay and compared with the Roche Elecsys TgII assay. In addition, a subset of 154 samples was compared also with the Beckman Tg Access assay and another subset (n = 122) with Abbott Tg on the Alinity i analyzer. Results LoQ was verified to be less than or equal to 0.1 ng/ml confirming that the Tg assay on ARCHITECT and Alinity is highly sensitive. Correlation of ARCHITECT, Alinity, and Roche was excellent with a slope between 0.9 and 1.1 and a correlation coefficient >0.98. Correlation to Beckmann Tg was also very good, but the differences in absolute values were significant (slope: 1.477). Conclusions The Abbott Thyroglobulin assay, which is standardized to CRM‐457, demonstrated a high correlation to the Roche and Beckman Tg assays, though good agreement of absolute values was only observed between Abbott and Roche. Strength of correlation and slope were not affected by the presence of anti‐Tg indicating that all assays included in the study have a similar susceptibility to anti‐Tg. Five‐day precision profiles for Tg on ARCHITECT (three sites) and Alinity (one site). Blue lines indicate requirements for imprecision (20% CV) and concentration (0.1 ng/ml).