Performance Evaluation of the Serum Thyroglobulin Assays With Immunochemiluminometric Assay and Immunoradiometric Assay for Differentiated Thyroid Cancer

Overview

Journal Ann Lab Med

Specialty Pathology

Date 2016 Jul 5

PMID 27374705

Citations 1

Authors

Yoon Young Cho

Sejong Chun

Soo Youn Lee

Jae Hoon Chung

Hyung Doo Park

Sun Wook Kim

Affiliations

Soon will be listed here.

Abstract

Background: Measurement of postoperative serum thyroglobulin (Tg) is important for detecting persistent or recurrent differentiated thyroid cancer. We evaluated the analytic performance of the DxI 800 assay (Beckman Coulter, USA) for serum Tg and anti-thyroglobulin antibodies (TgAbs) in comparison with that of the GAMMA-10 assay (Shinjin Medics Inc., Korea) for serum Tg and RIA-MAT 280 assay (Stratec, Germany) for TgAb.

Methods: We prospectively collected blood samples from 99 patients thyroidectomized for thyroid cancer. The functional sensitivity was investigated in standards and human serum. Precision and linearity were evaluated according to the guidelines of the Clinical and Laboratory Standards Institute. The correlation between the two assays was assessed in samples with different Tg ranges.

Results: The functional sensitivity of the DxI 800 assay for serum Tg was between 0.0313 and 0.0625 ng/mL. The total CV was 3.9-5.6% for serum Tg and 5.3-6.9% for serum TgAb. The coefficient of determination (R²) was 1.0 and 0.99 for serum Tg and TgAb, respectively. The cut-offs for serum TgAb were 4.0 IU/mL (DxI 800) and 60.0 IU/mL (RIA-MAT 280), and the overall agreement was 68.7%. The correlation between the two assays was excellent; the correlation coefficient was 0.99 and 0.88 for serum Tg and TgAb, respectively.

Conclusions: The DxI 800 is a sensitive assay for serum Tg and TgAb, and the results correlated well with those from the immunoradiometric assays (IRMA). This assay has several advantages over the IRMA and could be considered an alternative test for Tg measurement.

Citing Articles

Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800.

Park J, Lee S, Kim Y, Choi A, Lee H, Lim J Ann Lab Med. 2018; 38(4):355-361.

PMID: 29611386 PMC: 5895865. DOI: 10.3343/alm.2018.38.4.355.

References

Spencer C, Petrovic I, Fatemi S, LoPresti J . Serum thyroglobulin (Tg) monitoring of patients with differentiated thyroid cancer using sensitive (second-generation) immunometric assays can be disrupted by false-negative and false-positive serum thyroglobulin autoantibody misclassifications. J Clin Endocrinol Metab. 2014; 99(12):4589-99. PMC: 4297889. DOI: 10.1210/jc.2014-1203. View

Lee J, Kim J, Choi J, Kim H, Jang H, Hur K . Differences in serum thyroglobulin measurements by 3 commercial immunoradiometric assay kits and laboratory standardization using Certified Reference Material 457 (CRM-457). Head Neck. 2009; 32(9):1161-6. DOI: 10.1002/hed.21308. View

Netzel B, Grebe S, Carranza Leon B, Castro M, Clark P, Hoofnagle A . Thyroglobulin (Tg) Testing Revisited: Tg Assays, TgAb Assays, and Correlation of Results With Clinical Outcomes. J Clin Endocrinol Metab. 2015; 100(8):E1074-83. PMC: 4524993. DOI: 10.1210/jc.2015-1967. View

Cooper D, Doherty G, Haugen B, Hauger B, Kloos R, Lee S . Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009; 19(11):1167-214. DOI: 10.1089/thy.2009.0110. View

Baloch Z, Carayon P, Conte-Devolx B, Demers L, Feldt-Rasmussen U, Henry J . Laboratory medicine practice guidelines. Laboratory support for the diagnosis and monitoring of thyroid disease. Thyroid. 2003; 13(1):3-126. DOI: 10.1089/105072503321086962. View

Gorges R, Maniecki M, Jentzen W, Sheu S, Mann K, Bockisch A . Development and clinical impact of thyroglobulin antibodies in patients with differentiated thyroid carcinoma during the first 3 years after thyroidectomy. Eur J Endocrinol. 2005; 153(1):49-55. DOI: 10.1530/eje.1.01940. View

Kim T, Kim W, Kim E, Ryu J, Yeo J, Kim S . Serum thyroglobulin levels at the time of 131I remnant ablation just after thyroidectomy are useful for early prediction of clinical recurrence in low-risk patients with differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2004; 90(3):1440-5. DOI: 10.1210/jc.2004-1771. View

Haugen B, Alexander E, Bible K, Doherty G, Mandel S, Nikiforov Y . 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2015; 26(1):1-133. PMC: 4739132. DOI: 10.1089/thy.2015.0020. View

Spencer C, Takeuchi M, Kazarosyan M, Wang C, Guttler R, Singer P . Serum thyroglobulin autoantibodies: prevalence, influence on serum thyroglobulin measurement, and prognostic significance in patients with differentiated thyroid carcinoma. J Clin Endocrinol Metab. 1998; 83(4):1121-7. DOI: 10.1210/jcem.83.4.4683. View

10.

Preissner C, OKane D, Singh R, Morris J, Grebe S . Phantoms in the assay tube: heterophile antibody interferences in serum thyroglobulin assays. J Clin Endocrinol Metab. 2003; 88(7):3069-74. DOI: 10.1210/jc.2003-030122. View

11.

Kim W, Yoon J, Kim W, Kim T, Kim E, Kim J . Change of serum antithyroglobulin antibody levels is useful for prediction of clinical recurrence in thyroglobulin-negative patients with differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2008; 93(12):4683-9. DOI: 10.1210/jc.2008-0962. View

12.

Mazzaferri E, Robbins R, Spencer C, Braverman L, Pacini F, Wartofsky L . A consensus report of the role of serum thyroglobulin as a monitoring method for low-risk patients with papillary thyroid carcinoma. J Clin Endocrinol Metab. 2003; 88(4):1433-41. DOI: 10.1210/jc.2002-021702. View

13.

Spencer C, Fatemi S . Thyroglobulin antibody (TgAb) methods - Strengths, pitfalls and clinical utility for monitoring TgAb-positive patients with differentiated thyroid cancer. Best Pract Res Clin Endocrinol Metab. 2013; 27(5):701-12. DOI: 10.1016/j.beem.2013.07.003. View

14.

Spencer C, Takeuchi M, Kazarosyan M . Current status and performance goals for serum thyroglobulin assays. Clin Chem. 1996; 42(1):164-73. View

15.

Van Herle A, Vassart G, Dumont J . Control of thyroglobulin synthesis and secretion (second of two parts). N Engl J Med. 1979; 301(6):307-14. DOI: 10.1056/NEJM197908093010605. View

16.

Spencer C, Bergoglio L, Kazarosyan M, Fatemi S, LoPresti J . Clinical impact of thyroglobulin (Tg) and Tg autoantibody method differences on the management of patients with differentiated thyroid carcinomas. J Clin Endocrinol Metab. 2005; 90(10):5566-75. DOI: 10.1210/jc.2005-0671. View

17.

Persoon A, van den Ouweland J, Wilde J, Kema I, Wolffenbuttel B, Links T . Clinical utility of an automated immunochemiluminometric thyroglobulin assay in differentiated thyroid carcinoma. Clin Chem. 2006; 52(4):686-91. DOI: 10.1373/clinchem.2005.060095. View

18.

Van Herle A, Uller R, Matthews N, Brown J . Radioimmunoassay for measurement of thyroglobulin in human serum. J Clin Invest. 1973; 52(6):1320-7. PMC: 302394. DOI: 10.1172/JCI107303. View

19.

Webb R, Howard R, Stojadinovic A, Gaitonde D, Wallace M, Ahmed J . The utility of serum thyroglobulin measurement at the time of remnant ablation for predicting disease-free status in patients with differentiated thyroid cancer: a meta-analysis involving 3947 patients. J Clin Endocrinol Metab. 2012; 97(8):2754-63. DOI: 10.1210/jc.2012-1533. View