Multicentre clinical evaluation of the new highly sensitive Elecsys® thyroglobulin <scp>II</scp> assay in patients with differentiated thyroid carcinoma

Trimboli, Pierpaolo; Imperiali, Mauro; Piccardo, Arnoldo; Campennì, Alfredo; Giordani, Ilaria; Ruggeri, R. M.; Baldari, Sergio; Orlandi, Fabio; Giovanella, Luca

doi:10.1111/cen.13487

Cited by 13 publications

(9 citation statements)

References 28 publications

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“…Collectively, Tg is a key tool in the clinical management of DTC patient and new‐generation thyroglobulin assay performance has implications for follow‐up of DTC 13‐15 . It is worthy of attention that anti‐immunoglobulin antibodies such as TgAbs, rheumatoid factor (RF), and anti‐human animal antibodies (HAMA) are able to interfere with immunometric Tg assays 16,17 .…”

Section: Introductionmentioning

confidence: 99%

Comparison between a new thyroglobulin assay with the well‐established Beckman Access immunoassay: A preliminary report

Cennamo

Civita

Curci

et al. 2020

Clinical Laboratory Analysis

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Objectives Measurement of serum thyroglobulin (Tg) plays a key role in the post‐thyroidectomy management of differentiated thyroid carcinoma (DTC). In this context, the performance of new‐generation thyroglobulin assay has clinical implications in the follow‐up of DTC patients. Aim of this study was to compare the new highly sensitive Liaison Tg II (Tg‐L) with the well‐established Tg Access assay (Tg‐A). Materials and methods A total of 91 residual serum samples (23 positive and 68 negatives for Tg auto‐antibodies) were tested by the Beckman Access and Diasorin Liaison assays. Study samples were from 21 patients with pathologically proven DTC and control samples from 70 (16 patients with benign thyroid disease and 54 apparently healthy subjects). Results Our results showed that Tg‐L was highly correlated with Tg‐A for both values ranging between 0.2 and 50 ng/mL (Pearson's r = 0.933 [95%CI 0.894‐0.958], P < .001) and higher than 50 ng/mL (Pearson's r = 0.849 [95%CI 0.609‐0.946], P < .001). For Tg values lower than 0.2 ng/mL, the overall concordance rate was 92%. Moreover, we tested 7 fine‐needle aspiration washout fluids (FNA), showing an overall concordance rate in discriminating negative and positive of 100%. Finally, we found no interference by Tg auto‐antibodies (TgAbs) for both Tg‐L and Tg‐A. Conversely, rheumatoid factor (RF) interferes with Tg‐A, but not with Tg‐L in one patient with no relapsing thyroid carcinoma. Conclusions Liaison Tg II demonstrated a good correlation with Access Tg assay both for sera and FNAs. Further studies on larger population are needed to evaluate Tg‐L clinical impact on DTC patient's follow‐up.

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Section: Introductionmentioning

confidence: 99%

Comparison between a new thyroglobulin assay with the well‐established Beckman Access immunoassay: A preliminary report

Cennamo

Civita

Curci

et al. 2020

Clinical Laboratory Analysis

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“…Among the 108 patients with an indeterminate response based on b-Tg, a change to the excellent response category after s-Tg was observed in 44 %. In agreement with this finding, Brassard et al [17] showed that 41 % of 117 patients with b-Tg > 0.27 ng/ml had s-Tg < 1.4 ng/ml, Malandrino et al [19] that 36 % of 69 patients with b-Tg between 0.15 and 1 ng/ml had s-Tg ≤ 1 ng/ml, and Trimboli et al [24] that 39 % of 57 patients with b-Tg > 0.1 ng/ml had s-Tg ≤ 1 ng/ml. Even more important, the risk of recurrence in patients whose response changed from indeterminate to excellent after s-Tg was compatible with the last category.…”

Section: Discussionmentioning

confidence: 68%

“…None of the 48 patients developed recurrence, similar to the observation in patients in which both, b-Tg and s-Tg, indicated an excellent response. Despite the use of a cut off that was slightly different from the currently recommended [1-4, 12, 13], similar results have been reported by Brassard et al [17] who demonstrated recurrence in only 1/48 patients (2 %) with b-Tg > 0.27 ng/ml but s-Tg < 1.4 ng/ml; by Malandrino et al [19] who found no short-term recurrence in 25 patients with b-Tg > 0.15 ng/ml but initial US showing no tumor and s-Tg ≤ 1 ng/ ml; and by Trimboli et al [24] who did not detect disease in 22 patients with b-Tg > 0.1 ng/ml but s-Tg ≤ 1 ng/ml. Different from these results, the frequency of recurrence was 7.5 % in patients with an indeterminate response based only on b-Tg and 11 % when both, b-Tg and s-Tg, defined this category.…”

Section: Discussionmentioning

confidence: 97%

Definition of the Response to Initial Therapy with Radioiodine in Patients with Differentiated Thyroid Carcinoma: Basal or Stimulated Thyroglobulin?

2019

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Basal thyroglobulin (b-Tg) measured with second-generation assay or stimulated Tg (s-Tg) can be used to define the response to therapy of differentiated thyroid carcinoma. However, they do not always define the same category and guidelines do not establish “if” or “when” s-Tg needs to be obtained. We studied 304 patients without clinically apparent disease or disease detected by neck ultrasonography and without anti-Tg antibodies 9–12 months after therapy. Based on b-Tg, 196 patients had an excellent response and 108 had an indeterminate response. Based on s-Tg, a change in category occurred in 10.2% of the patients with an initial excellent response (all to indeterminate response) and in half the patients with an initial indeterminate response (44.4% to excellent response and 5.5% to biochemical incomplete response). One case of recurrence was observed among patients with an initial excellent response but whose response changed to indeterminate after s-Tg, while no disease was detected among those who remained in the initial category; however, this difference was not significant. In patients with an initial indeterminate response, no recurrence was detected among those whose response changed to excellent after s-Tg, while 11.1 and 33.3% of those who remained in the initial category or whose response changed to biochemical incomplete, respectively, had structural disease. This study suggest that, in low- or intermediate-risk patients, s-Tg better defines the response to therapy with 131I when it is classified as indeterminate based on b-Tg using second-generation assay. However, s-Tg is not necessary when b-Tg defines the response as excellent.

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“…it difficult to assess patients transitioning from one test to another. For instance, the suggested cutoff of 0.1μg/L requires an analytical sensitivity of 0.05μg/L for the HS-Tg assay [1,5,[7][8][9], which may vary in equivalence to the Tg-ST among medical centers and laboratories [1]. A recent meta-analysis reported that while HS-Tg with a functional sensitivity of <0.1μg/L had a high negative predictive value, it lacked the accuracy and positive predictive value to provide a reliable alternative to Tg-ST [10].…”

Section: Introductionmentioning

confidence: 99%

Clinical Challenges of Transitioning to High Sensitivity Thyroglobulin Assay

JA¹,

A²,

MO³

et al. 2021

annalsthyroidres

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Background: Patients treated for Differentiated Thyroid Cancer (DTC) are followed by thyroglobulin (Tg) testing with standard Tg assays after a stimulation test (Tg-ST), which is expensive and time consuming. High-Sensitivity Thyroglobulin (HS-Tg) assays are purported to replace Tg-ST; acceptable cutoffs however may vary according to assays and patient population. We aimed to evaluate the HS-Tg assay (Roche Elecsys® Tg II) and apply it to clinical use. Method: Analytical evaluations were performed following CLSI standard protocols. Clinical evaluation was done prospectively on 35 DTC patients subjected to Tg measurements both pre- and post- Tg-ST Clinical accuracy performance of HS-Tg was compared to that of conventional Tg-ST protocol utilizing the Siemens Immulite 2000 XPI platform. Results: HS-Tg assay showed an excellent precision (CV=2-3%). The assay reached CV of 11.0% in pooled samples at a mean of 0.048μg/L. HS-Tg results are slightly higher than those from the conventional Siemens Tg assay. HS-Tg ≥ 0.2μg/L showed clinical sensitivity of 1.0 and specificity of 0.81 for predicting recurrence of DTC, which is superior to the Tg-ST protocol using 2μg/L as the cutoff. Two of six patients with HS-Tg results between 0.06-0.2 had a Tg-ST result of >2μg/L, but no recurrence. Conclusions: Although the HS-Tg cut-off of 0.2ug/L is a reliable alternative to Tg-ST in most cases, these tests show divergent results in a proportion of patients making transition from one test to another challenging. Further studies are required to determine the clinical significance of HS-Tg between 0.06-0.2 μg/L.

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Multicentre clinical evaluation of the new highly sensitive Elecsys® thyroglobulin II assay in patients with differentiated thyroid carcinoma

Abstract: Using appropriate assay-specific cut-offs, the clinical performance of the Elecsys® Tg II assay was comparable to that provided by the well-established Access® Tg assay.

Cited by 13 publications

References 28 publications

Comparison between a new thyroglobulin assay with the well‐established Beckman Access immunoassay: A preliminary report

Comparison between a new thyroglobulin assay with the well‐established Beckman Access immunoassay: A preliminary report

Definition of the Response to Initial Therapy with Radioiodine in Patients with Differentiated Thyroid Carcinoma: Basal or Stimulated Thyroglobulin?

Clinical Challenges of Transitioning to High Sensitivity Thyroglobulin Assay

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