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

Abstract

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.

Newborn Screening for Congenital Hypothyroidism-Clinical Evaluation and Comparison of Two Different Test Kits for the Determination of TSH in Dried Blood Samples on Two Different Platforms

“…There is a very good agreement for TSH values up to 50 mU/L, and only for TSH values > 100 mU/L the variation increases significantly. The same observation was made, when the PerkinElmer AutoDelfia assay was compared to the PerkinElmer GSP assay [12], and also for other serum immunoassays [14]. However, there were no misclassifications of the confirmed positive cases.…”

“…The two assays showed a good correlation with r 2 = 0.8814 (Figure 1). Comparable correlation coefficients have been published for the comparison of automated serum immunoassays, where r 2 of 0.849 with a 95% CI of 0.609-0.946 (p < 0.001), was considered as "significant relationship" [14].…”

Evaluation of a new automated assay for high-sensitivity thyroglobulin measurement and comparison with two established high-sensitivity thyroglobulin assays

“…The only publication known to us that contains data on the evaluation of the new LIAISON® Tg II Gen assay comes from Cennamo et al [ 37 ]. In their study, they compared the serum Tg values of 91 individuals with the results of the well-established Beckman Access assay.…”

SERS biosensor for ultrasensitive detection of human thyroglobulin

“…We can estimate the LOD to be up to 7 pg/mL, assuming that the minimum amount of Tg that can be identified requires at least one pixel exceeding the established threshold. The limit of detection (LOD) achieved is well below the required concentration of 1 ng/mL and is clearly superior to commercial devices already used in clinical diagnostics, such as the Elecsys Tg II from Roche and the UniCeL DxI800 from Beckman [11]. We reanalyzed all SERS substrates used in the Tg detection assays by AFM microscopy to evaluate the distribution of immobilised f-AuNps on the functionalized SERS substrate as a function of Tg concentration to further confirm the highly specific Tg detection.…”