Measuring thyroglobulin in patients with thyroglobulin autoantibodies: evaluation of the clinical impact of BRAHMS Kryptor® Tg-minirecovery test in a large series of patients with differentiated thyroid carcinoma

2019 ◽  
Vol 57 (8) ◽  
pp. 1185-1191 ◽  
Author(s):  
Luca Giovanella ◽  
Frederik A. Verburg ◽  
Pierpaolo Trimboli ◽  
Mauro Imperiali ◽  
Franco Keller ◽  
...  

Abstract Background The present study was undertaken to evaluate the clinical impact of a thyroglobulin (Tg) minirecovery test (Tg-mRec) in a large series of differentiated thyroid carcinoma (DTC) patients treated and monitored homogeneously in a tertiary referral center. Methods Included were 1120 serum samples from 798 DTC patients. Tg, Tg autoantibodies (TgAb) and Tg-mrec measurements were performed on the automated Kryptor® platform and results compared to the corresponding clinical status. Results Among included samples 228 (20%) were TgAb-positive (TgAb+) and 892 (80%) TgAb-negative (TgAb−), respectively. Tg cutoff points were settled at 0.31 μg/L and 0.15 μg/L for TgAb− and TgAb+ patients, respectively, by ROC curve analysis. The diagnostic performance of serum Tg was reduced in TgAb+ compared to TgAb− patients, however, 87% of TgAb+ patients with recurrent disease and, particularly, all patients with distant metastases were correctly detected by adopting an optimized Tg cutoff for TgAb+ patients. A disturbed recovery was found in only 1% of TgAb− patients and in these cases no clinically relevant information was added by the Tg-mRec. Among TgAb+ patients with undetectable Tg and undisturbed Tg-mRec, no one had recurrent disease. However, a falsely undetectable Tg was demonstrated in two patients with recurrent disease who next to increased TgAb also had a disturbed Tg-mRec test. Conclusions There is no additional clinical benefit from performing Tg-mRec in most patients. It can however be considered in TgAb+ patients with undetectable Tg levels as it may help differentiate between patients with true negative and false negative Tg levels in the presence of such antibodies.


2003 ◽  
Vol 42 (02) ◽  
pp. 71-77 ◽  
Author(s):  
I. Schreivogel ◽  
C. Angerstein ◽  
U. Siefker ◽  
K. Lehmann ◽  
G. Altenvoerde ◽  
...  

SummaryAim: Formal and clinical comparison of a new 3rd-gene-ration-Tg-IRMA (3-G-IRMA; Dynotest®Tg-plus) with a conventional Tg-IRMA (3-G-IRMA; SELco®Tg-assay) for patients with differentiated thyroid carcinoma. In addition we evaluated, if thyroglobulin (Tg) levels above a specific threshold concentration indicate the need for further investigations for residual disease. Patients, methods: Tg concentration of 105 sera of 93 consecutive patients with a differentiated thyroid cancer was determined with both assays and compared at different cut-off values (Dynotest®Tg-plus: 0.2, 1, 2 ng/ml; SELco®Tg-assay: 0.5, 1, 2 ng/ml) with the clinical results in respect to the corresponding TSH concentration. Results: Tg concentration did not show any significant difference (SELco®Tg-assay 0.5 ng/ml, Dynotest® Tg-plus 0.2 ng/ml). The Tg-values of both assays correlated with 97%. However, correlation of recovery in both assays was small (40%). The sensitivities and specificities of both assays at different cut-offs and TSH values did not reveal significant differences. In patients with TSH concentration >30 µU/ml the functional assay sensitivity was superior to arbitrary cut-offs in the decision to start further evaluations. Conclusions: In our study neither formal nor clinical significant differences between two Tg-assays were found. In a hypothyroid patient (TSH >30 µU/ml, Tg concentration exceeding the functional assay sensitivity) further investigations for residual disease are warranted. Higher thresholds are of limited value, due to a inacceptable high rate of false negative results.



2006 ◽  
Vol 52 (4) ◽  
pp. 686-691 ◽  
Author(s):  
Adrienne CM Persoon ◽  
Johannes MW Van Den Ouweland ◽  
Juergen Wilde ◽  
Ido P Kema ◽  
Bruce HR Wolffenbuttel ◽  
...  

Abstract Background: Thyroglobulin (Tg) measurements are important in the follow-up of patients with differentiated thyroid carcinoma (DTC). We evaluated the analytical and clinical performance of a new automated immunochemiluminometric assay for Tg (Tg-ICMA; Nichols Advantage Tg; Nichols Institute Diagnostics). Methods: We used the Tg-ICMA to measure Tg concentrations in serum samples from 110 Tg antibody–negative DTC patients undergoing thyroid-hormone suppression therapy. Disease state at the time of measurement was assessed on the basis of routine follow-up data. We compared the clinical performance of this assay with the routinely used IRMA (ELSA-hTG; CIS Bio International). Results: The detection limit and functional sensitivity of the Tg-ICMA, based on direct calibration to CRM-457, were 0.05 and 0.6 μg/L, respectively. No Tg-IRMA-positive cases were missed by the Tg-ICMA. Tg was measurable by Tg-ICMA (0.6–8.6 μg/L) but undetectable by Tg-IRMA (<1.5 μg/L) in 12 patients (11%). Clinical data showed evidence of disease in 4 of 12 patients (33%). Conclusions: The Tg-ICMA is a sensitive and reproducible assay for identifying patients in follow-up for DTC with evidence of disease, but uncertainty remains with regard to interpreting findings of measurable serum Tg in patients with no evidence of disease. Follow-up data are required to determine the predictive value of these isolated Tg results. New concepts, i.e., serial Tg measurements and risk stratification of patients, need to be tested to confirm the applicability of this assay for clinical practice.



2011 ◽  
Vol 152 (19) ◽  
pp. 743-752
Author(s):  
Zoltán Lőcsei ◽  
Dóra Horváth ◽  
Károly Rácz ◽  
Erzsébet Toldy

Serum thyroglobulin is an essential marker during the follow-up of patients with differentiated thyroid carcinoma. Demonstration of the total absence of thyroglobulin is not possible by immunoanalytic methods if thyroglobulin antibody is present in serum samples that occur in almost 20% of patients with differentiated thyroid carcinoma. Therefore, current guidelines recommend estimation of thyroglobulin levels only if quantitative level of thyroglobulin antibody is known. However, normal thyroglobulin antibody level fails to exclude interference with the antibody, because antibody concentration within the normal range may interfere with the thyroglobulin assay. In this respect recommendations are not consistent because they distinguish only occasionally cases with normal and those with non-detectable serum thyroglobulin level. In addition, the possible impact of normal thyroglobulin antibody level on the thyroglobulin assay has not been entirely explored. Authors review literature data and current guidelines on the analytical and preanalytical limitations of the thyroglobulin and thyroglobulin antibody measurements. On the basis of their own studies, authors make recommendation for improvement of the diagnostic accuracy of the thyroglobulin measurement. Orv. Hetil., 2011, 152, 743–752.



2003 ◽  
Vol 24 (9) ◽  
pp. 959-961 ◽  
Author(s):  
E GOSHEN ◽  
O COHEN ◽  
G ROTENBERG ◽  
Y OKSMAN ◽  
A KARASIK ◽  
...  




2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Csaba Rikker ◽  
Edina Juhász ◽  
Renáta Gáspár ◽  
Maria Haraszti ◽  
Bálint Rikker ◽  
...  

Abstract Background and Aims Surveillance of vascular access function in patients on chronic hemodialysis (HD) by measuring the access blood flow rate (Qa) is a widely accepted method for early detection of dysfunction. Qa threshold can be lower in the more distal accesses than in the more proximal accesses. However, cut-off values of Qa in different access positions have not yet been established. The aim of our study is to determine the critical values of Qa indicative of stenosis in different access sites. Method Between July 2012 and July 2019, we performed 5798 Qa measurements of native arteriovenous fistulas (AVFs) (wrist [w]: 2932, forearm [fa]: 2035 and elbow/upper arm [e/ua]: 731) in 242 chronic HD patients using Fresenius 5008 and 5008 S blood temperature monitors (BTMs) at the beginning of HD sessions. As reference we performed 512 colour duplex ultrasonographies (CDUSs) and 205 angiographies (ANGs). CDUS was performed as surveillance method independently from the BTM, or at the presence of low Qa and/or clinical signs of access failure. ANG was performed only in CDUS positive cases or at clinical signs of access failure. We performed percutaneous transluminal angioplasty (PTA) in 174 cases and stent implantation in 2 cases. New AVFs were created in 25 cases. The results were evaluated retrospectively according to access positions using Receiver Operating Characteristic (ROC) curve analysis. Results The number of true positive (TP), true negative (TN), false positive (FP), false negative (FN) cases, sensitivity (SENS) and specificity (SPEC) in different AVF sites and Qas are summarised in table below. Conclusion In order to prevent the fistula occlusion, the cut-off Qas can be different in various access positions. Based on our results we suggest 600-650 mL/min for w AVFs, 650-700 mL/min for fa AVFs and 750-800 mL/min for e/ua AVFs as cut-off values.



2015 ◽  
Vol 27 (4) ◽  
pp. 540-546 ◽  
Author(s):  
Gili Schvartz ◽  
Tasha Epp ◽  
Hilary J. Burgess ◽  
Neil B. Chilton ◽  
Katharina L. Lohmann

To investigate the agreement between available serologic tests for the detection of antibodies against Anaplasma phagocytophilum and Borrelia burgdorferi, 50 serum samples from horses of unknown clinical status and at low risk for infection were tested. In addition to a point-of-care enzyme-linked immunosorbent assay (pocELISA), the evaluated tests included 2 indirect fluorescent antibody tests (IFATs) for antibodies against A. phagocytophilum and an IFAT, an ELISA confirmed with Western blot, and the Lyme multiplex assay for antibodies against B. burgdorferi. For each pair-wise comparison between serologic tests, the difference in the proportion of seropositive results as well as kappa and the prevalence-adjusted, bias-adjusted kappa were calculated. The proportion of seropositive results differed significantly in each pairwise comparison of tests for detection of antibodies against A. phagocytophilum, and between the pocELISA and IFAT as well as between the pocELISA and Lyme multiplex assay for detection of antibodies against B. burgdorferi. Agreement based on kappa varied from poor to fair while agreement was improved when evaluating prevalence-adjusted, bias-adjusted kappa. Lack of agreement may be explained by differences in methodology between the evaluated tests, cross-reactivity or false-positive and false-negative tests. In addition to the limitations of serologic test interpretation in the absence of clinical disease, this data suggest that screening of horses for exposure to tick-borne diseases in nonendemic areas may not be warranted.





2019 ◽  
Vol 104 (7-8) ◽  
pp. 304-313
Author(s):  
Chih-Yiu Tsai ◽  
Shu-Fu Lin ◽  
Szu-Tah Chen ◽  
Chuen Hsueh ◽  
Yann Sheng Lin ◽  
...  

Objective The aim of this study was to evaluate outcomes of the recurrent and non-recurrent groups including disease-specific mortality of patients with well-differentiated thyroid carcinoma after multimodality treatment. In addition, prognostic factors for disease-specific mortality were analyzed. Summary of Background Data Among 2,844, there were 166 patients with recurrent disease. Recurrent disease was defined as the presence of papillary or follicular thyroid cancer 6 months after the initial thyroidectomy, including locoregional or distant metastasis, diagnosed using diagnostic or therapeutic 131I scans or other imaging techniques. Methods The study was a retrospective analysis of prospectively collected data for a long-term follow-up result of well-differentiated thyroid carcinoma patients. Results The mean age of 166 patients was 45.8 ± 1.2 years, 116 (69.9%) were women, 111 (66.9%) had locoregional neck recurrence, and 55 (33.1%) had metastatic recurrence in distant organs. We found that when recurrences were observed, more than half were detected within the first 5 years following the initial therapy. The longest period of time before relapse was 29.8 years. After a mean follow-up period of 12.7 ± 0.5 years, 37 (22.3%) patients experienced disease-specific mortality. Multivariable analysis revealed that older age, male sex, and development of a second primary malignancy were associated with disease-specific mortality. Higher post-operative levels of thyroglobulin predicted a shorter time to relapse. Conclusions These data indicate that among the recurrent cases over 50% of recurrent well-differentiated thyroid carcinomas were diagnosed within 5 years after initial thyroidectomy. Additionally, more than 20% of the patients died of thyroid cancer.



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