Definition of the upper reference limit for thyroglobulin antibodies according to the National Academy of Clinical Biochemistry guidelines: comparison of eleven different automated methods

D’Aurizio, Federica; Metus, Paolo; Ferrari, Anna; Caruso, Benedetta; Castello, R.; Villalta, Danilo; Steffan, Agostino; Gaspardo, K.; Pesente, Fiorenza; Bizzaro, Nicola; Tonutti, Elio; Valverde, Sara; Cosma, Chiara; Plebani, Mario; Tozzoli, Renato

doi:10.1007/s13317-017-0096-3

Cited by 24 publications

(12 citation statements)

References 34 publications

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“…Despite the fact that differences of up to a factor of 100 between different Tg antibody assays have been reported in the literature [ 15 ], 1 particular study showed very good correlation between the assays included in our current study when trying to establish upper reference limits for Tg antibody assays [ 36 ]. According to the latter study, the ULN for the 4 assays tested in our current study should not differ as much as they do, based on the information provided by the manufacturers ( Table 1 ).…”

Section: Discussionmentioning

confidence: 76%

“…According to the latter study, the ULN for the 4 assays tested in our current study should not differ as much as they do, based on the information provided by the manufacturers ( Table 1 ). For example, the Kryptor assay has an ULN is 33 U/mL; for the LIAISON® assay, it is 100 IU/mL, while the study by D’Aurizio et al could justify similar cutoffs [ 36 ]. If we would apply a cutoff of 100 IU/mL to both assays, this would result in 2,5% discordance instead of 13% discordance.…”

Section: Discussionmentioning

confidence: 99%

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Impact of Thyroglobulin and Thyroglobulin Antibody Assay Performance on the Differential Classification of DTC Patients

Schoonen

Neele

Toor

et al. 2021

Journal of the Endocrine Society

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Context Measurements of thyroglobulin (Tg) and Tg antibodies are crucial in the follow-up of treated differentiated thyroid cancer (DTC) patients. Inter-assay differences may significantly impact follow-up. Objective The aim of this multicenter study was to explore the impact of Tg and Tg antibody assay performance on the differential classification of DTC patients, as described in national and international guidelines. Design Four commonly used Tg and Tg antibody assays were technically compared to reflect possible effects on patients with DTC follow-up. Storage stability at different storage temperatures was also investigated for LIAISON® and Kryptor assays, as this is an underexposed topic in current literature. Results B.R.A.H.M.S. assays yield approximately 50% lower Tg values over the whole range compared to the DiaSorin and Roche assays investigated. These differences between assays may result in potential misclassification in up to 7% of patients if fixed cut-offs (e.g. 1 ng/mL) are applied. Poor correlation was also observed between the Tg antibody assays, when the method-specific upper limits of normal are used as cut-offs. Storage of Tg and Tg antibodies was possible for three to four weeks at -20 °C and -80 °C. Calibration of the assays, however, was found to be crucial for stable results over time. Conclusions Technical aspects of Tg and Tg antibody assays, including inter-assay differences, calibration and standardization, and cut-off values, may have a significant clinical impact on the follow-up of DTC patients.

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Section: Discussionmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 99%

Impact of Thyroglobulin and Thyroglobulin Antibody Assay Performance on the Differential Classification of DTC Patients

Schoonen

Neele

Toor

et al. 2021

Journal of the Endocrine Society

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“…The similar susceptibility regarding anti‐Tg, especially between Abbott and Roche, is further corroborated by the additional data of the method comparison data, though we did not assess anti‐Tg interference directly and acknowledge the poor agreement of anti‐Tg assays. 15 …”

Section: Discussionmentioning

confidence: 99%

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

Evans

Lotz

Bhandari

et al. 2022

Clinical Laboratory Analysis

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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.

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“…In terms of serum levels, despite the lower median of TGAb and TPOAb serum levels in individuals with sufficient vitamin D level compared to those with vitamin D deficiency, no significant differences were observed. Apparently, determining the cut-off measurement of these autoantibodies plays a role in these differences [22]. Tehran thyroid study, in which the median of TPOAb level of individuals with positive titer was considered to be 177 (79-366), was used as a measurement reference in specifying the diagnostic levels in the present research [20].…”

Section: Discussionmentioning

confidence: 99%

Lower levels of TSH in vitamin D sufficient Graves patients and higher rates of vitamin D deficiency in graves patients: a case-control study

S¹,

Kazemi²,

Hatemi³

2019

Preprint

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Vitamin D deficiency is associated with an increased incidence of autoimmune thyroid diseases. Its association with Hashimoto has previously been discussed in several studies, but its role in Graves' disease is yet to be elucidated; the aim of this study was to evaluate the effect of vitamin D on hyperthyroid patients regardless of the cause (autoimmune, non-autoimmune and control) ‏. A total of 187 patients were divided into three groups: 74 patients with autoimmune hyperthyroidism (Graves), 43 non-immune patients (Toxic thyroid adenoma and goiter multi-nodular) and 70 healthy patients as the control group. The primary outcome was the frequency of vitamin D deficient patients and the level of vitamin D in each group. The secondary outcomes were measured as the values of anti-thyroid antibody and anti-thyroglobulin antibodies, TSH, T3, and T4. Based on the results, higher levels of TSH were observed in Graves patients who were vitamin D sufficient in comparison to Graves subjects with moderate vitamin D deficiency (P=0.022). Also, vitamin D sufficient control subjects had higher TSH levels than subjects with severe (p<0.0001) and moderate (P<0.0001) vitamin D deficiency. Vitamin D deficiency was more frequent in Graves patients, however the difference was not significant (P-value>0.05). Vitamin D deficiency as an effective factor in thyroid autoimmune diseases is more frequent in autoimmune hyperthyroid disease patients. Moreover, vitamin D sufficient Graves' participants had higher TSH levels compared with vitamin D deficient ones, probably protecting them from developing osteoporosis. Low TSH levels in hyperthyroid patients are one of the osteoporosis risk factors‏.

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Definition of the upper reference limit for thyroglobulin antibodies according to the National Academy of Clinical Biochemistry guidelines: comparison of eleven different automated methods

Cited by 24 publications

References 34 publications

Impact of Thyroglobulin and Thyroglobulin Antibody Assay Performance on the Differential Classification of DTC Patients

Impact of Thyroglobulin and Thyroglobulin Antibody Assay Performance on the Differential Classification of DTC Patients

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

Lower levels of TSH in vitamin D sufficient Graves patients and higher rates of vitamin D deficiency in graves patients: a case-control study

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