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The Roche Elecsys and Siemens-Centaur Thyroglobulin Autoantibody Assays Show Comparable Clinical Performance to the Recently Unavailable Beckman-Coulter Access Thyroglobulin Autoantibody Assay in Identifying Samples with Potentially False-Low Thyroglobulin Measurements Due to Thyroglobulin Autoantibody Interference

2011; Mary Ann Liebert, Inc.; Volume: 21; Issue: 7 Linguagem: Inglês

10.1089/thy.2011.0158

1557-9077

Alicia Algeciras‐Schimnich, Michael A. Lasho, Karl M. Ness, Lynn A. Cheryk, Stefan K. Grebe,

Neuroendocrine Tumor Research Advances

ThyroidVol. 21, No. 7 Letters to the EditorOpen AccessThe Roche Elecsys and Siemens-Centaur Thyroglobulin Autoantibody Assays Show Comparable Clinical Performance to the Recently Unavailable Beckman-Coulter Access Thyroglobulin Autoantibody Assay in Identifying Samples with Potentially False-Low Thyroglobulin Measurements Due to Thyroglobulin Autoantibody InterferenceAlicia Algeciras-Schimnich, Michael A. Lasho, Karl M. Ness, Lynn A. Cheryk, and Stefan K.G. GrebeAlicia Algeciras-SchimnichSearch for more papers by this author, Michael A. LashoSearch for more papers by this author, Karl M. NessSearch for more papers by this author, Lynn A. CherykSearch for more papers by this author, and Stefan K.G. GrebeSearch for more papers by this authorPublished Online:27 Jun 2011https://doi.org/10.1089/thy.2011.0158AboutSectionsView articleSupplemental MaterialPDF/EPUBView Supplemental Data Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleDear Editor:Approximately 25% of thyroid cancer patients have circulating antithyroglobulin autoantibodies (anti-TgAB), which can cause false-low interference in Tg assays (1). It is therefore recommended that all Tg measurements are accompanied by TgAB testing (1).The Beckman-Coulter Access Tg- and TgAB assays have become perhaps the most widely used assay combination for thyroid cancer follow-up in the United States, because they run on the same automated instrument and they are more sensitive than most alternative Tg/TgAB assays. Unfortunately, Beckman-Coulter has recently indicated that their TgAB assay will be unavailable for the foreseeable future, necessitating a switch to other TgAB assays to accompany Tg testing.Such a change has a high risk of interfering with patient management. Different TgAB assays show at best a moderate numerical agreement with each other, have different detection sensitivities, and have different cutoffs for TgAB positivity (2–4). We have therefore performed a comparison study of the Beckman-Coulter TgAB assay with three other automated TgAB assays: Roche Elecsys TgAB, Siemens-Centaur TgAB, and Siemens-Immulite TgAB. As these assays are primarily marketed for the diagnosis of autoimmune thyroid disease, the manufacturer-provided diagnostic cutoffs are not optimized for the detection of interference in Tg assays. Therefore, we first determined optimal cutoffs for these assays by comparing them with the Beckman-Coulter assay in 100 archival patient samples. Next, we performed a clinical validation of these cutoffs in 130 samples from 113 Mayo Clinic patients. These samples were selected to include patients with (43 patients with 51 samples) and without (70 patients with 79 samples) definitive persistent/recurrent disease (clinical or imaging proven) (see Supplementary Methods; Supplementary Data are available online at www.liebertonline.com/thy).We found poor numerical agreement between the Beckman-Coulter assay and the other TgAB assays, but receiver-operating characteristics (ROC) curve analysis, using the Beckman-Coulter TgAB results as the “gold standard” (negative: <4 IU/mL, N = 32; positive: ≥4 IU/mL, N = 68), showed comparable areas under the curves (see Supplementary Fig. S1): Siemens-Centaur 0.88 (95% confidence interval [CI]: 0.79–0.97), Siemens-Immulite 0.86 (95% CI: 0.81–0.92), and Roche 0.87 (95% CI: 0.77–0.95). At their respective ROC curve–derived cutoffs, the Siemens-Centaur (44 IU/mL) and Roche (22 IU/mL) missed only 1 and 3 samples, respectively, which had been positive with the Beckman-Coulter assay, whereas the Siemens-Immulite (20 IU/mL) missed 18.The Roche assay showed the best agreement with the Beckman-Coulter assay in the clinical validation sample set with verified disease status (see Supplementary Table S1), with a negative and positive agreement of 96% and 95%, respectively. The Siemens-Immulite assay showed the worst agreement (negative and positive agreement of 79% and 78%). The Siemens-Centaur assay's performance fell in between these two with 92% negative agreement and 94% positive agreement. All 16 samples from 15 patients with clinical recurrent/persistent disease, who had undetectable serum Tg levels (<0.1 ng/mL), were positive for TgAB in all four assays, using the respective cutoffs. However, of 31 samples from 26 patients with clinical recurrence and a Tg of <2 ng/mL, a total of 3 samples from 3 patients (1 per patient) had a negative TgAB result in the Beckman-Coulter, Roche, and Siemens-Centaur TgAB assays, whereas 6 samples from 5 patients (1 patient with 2 samples) had a negative TgAB result by the Siemens-Immulite assay.We conclude that the automated Roche Elecsys (cutoff: 22 IU/mL) and Siemens-Centaur (cutoff: 44 IU/mL) TgAB assays show comparable clinical performance to the Beckman-Coulter Access TgAB assay (cutoff: 4 IU/mL). The Siemens-Immulite assay (cutoff: 20 IU/mL) had lesser TgAB detection sensitivity than the other assays. Incidentally, all these cutoffs are much lower than those listed in the respective package inserts, which are targeted at diagnosis of autoimmune thyroid disease. These manufacturer-stated cutoffs would miss many cases of clinically relevant TgAB levels that could cause interferences in Tg measurements.The satisfactory performance of the Roche and Siemens-Centaur TgAB assays in identifying samples with TgAB levels that might interfere with Tg measurements does not solve all problems related to the sudden unavailability of the Beckman-Coulter TgAB assay. In particular, it remains important for laboratorians and clinicians to be mindful of the poor numerical agreement between the Beckman-Coulter assay and the other TgAB assays, when analyzing patient samples. Practitioners, who have used serial TgAB measurements with the Beckman-Coulter assay as a semiquantitative follow-up marker in TgAB-positive patients, need to re-baseline these patients with one of the alternative assays and should ensure that subsequent samples are measured using the same assay.Disclosure StatementThe authors declare that no competing financial interests exist.References1 Grebe SKG2009Diagnosis and management of thyroid carcinoma: a focus on serum thyroglobulinExpert Rev Endocrinol Metab42543.1. Grebe SKG 2009 Diagnosis and management of thyroid carcinoma: a focus on serum thyroglobulin. Expert Rev Endocrinol Metab 4:25–43. Crossref, Google Scholar2 Spencer CABergoglio LMKazarosyan MFatemi SLoPresti JS2005Clinical impact of thyroglobulin (Tg) and Tg autoantibody method differences on the management of patients with differentiated thyroid carcinomasJ Clin Endocrinol Metab9055665575.2. Spencer CA, Bergoglio LM, Kazarosyan M, Fatemi S, LoPresti JS 2005 Clinical impact of thyroglobulin (Tg) and Tg autoantibody method differences on the management of patients with differentiated thyroid carcinomas. J Clin Endocrinol Metab 90:5566–5575. Crossref, Medline, Google Scholar3 La'ulu SLSlev PRRoberts WL2007Performance characteristics of 5 automated thyroglobulin autoantibody and thyroid peroxidase autoantibody assaysClin Chimica Acta3768895.3. La'ulu SL, Slev PR, Roberts WL 2007 Performance characteristics of 5 automated thyroglobulin autoantibody and thyroid peroxidase autoantibody assays. Clin Chimica Acta 376:88–95. Crossref, Medline, Google Scholar4 Spencer CPetrovic IFatemi S2011Current thyroglobulin autoantibody (TgAb) assays often fail to detect interfering TgAb that can result in the reporting of falsely low/undetectable serum Tg IMA values for patients with differentiated thyroid cancerJ Clin Endocrinol Metab9612831291.4. Spencer C, Petrovic I, Fatemi S 2011 Current thyroglobulin autoantibody (TgAb) assays often fail to detect interfering TgAb that can result in the reporting of falsely low/undetectable serum Tg IMA values for patients with differentiated thyroid cancer. J Clin Endocrinol Metab 96:1283–1291. Crossref, Medline, Google ScholarFiguresReferencesRelatedDetailsCited byMulticentre clinical evaluation of the new highly sensitive Elecsys® thyroglobulin II assay in patients with differentiated thyroid carcinoma18 October 2017 | Clinical Endocrinology, Vol. 88, No. 2Thyroglobulin and Thyroglobulin Antibodies24 January 2018Variation in Results Release and Patient Portal Access to Diagnostic Test Results at an Academic Medical CenterJournal of Pathology Informatics, Vol. 8, No. 1Serial post-surgical stimulated and unstimulated highly sensitive thyroglobulin measurements in low- and intermediate-risk papillary thyroid carcinoma patients not receiving radioactive iodine17 May 2016 | Endocrine, Vol. 54, No. 2Serum 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 MisclassificationsThe Journal of Clinical Endocrinology & Metabolism, Vol. 99, No. 12Clinical Consequences of a Change in Anti-Thyroglobulin Antibody Assays During the Follow-up of Patients with Differentiated Thyroid CancerEndocrine Practice, Vol. 20, No. 10Thyroglobulin antibody levels do not predict disease status in papillary thyroid cancer28 February 2014 | Clinical Endocrinology, Vol. 81, No. 2DIAGNOSIS OF ENDOCRINE DISEASE: Thyroglobulin measurement using highly sensitive assays in patients with differentiated thyroid cancer: a clinical position paperEuropean Journal of Endocrinology, Vol. 171, No. 2Thyroid heterogeneity, as indicated by the CV of ultrasonographic intensities, correlates with anti-thyroid peroxidase antibodies in euthyroid Hashimoto’s thyroiditis23 March 2013 | Thyroid Research, Vol. 6, No. 1Evaluation of the BRAHMS Kryptor ® Thyroglobulin Minirecovery Test in patients with differentiated thyroid carcinoma19 August 2012 | Clinical Chemistry and Laboratory Medicine (CCLM), Vol. 51, No. 2Thyroglobulin Autoantibodies in Patients with Papillary Thyroid Carcinoma: Comparison of Different Assays and Evaluation of Causes of DiscrepanciesThe Journal of Clinical Endocrinology & Metabolism, Vol. 97, No. 11Can we interpret serum thyroglobulin results?15 May 2012 | Annals of Clinical Biochemistry: International Journal of Laboratory Medicine, Vol. 49, No. 4 Volume 21Issue 7Jul 2011 InformationCopyright 2011, Mary Ann Liebert, Inc.To cite this article:Alicia Algeciras-Schimnich, Michael A. Lasho, Karl M. Ness, Lynn A. Cheryk, and Stefan K.G. Grebe.The Roche Elecsys and Siemens-Centaur Thyroglobulin Autoantibody Assays Show Comparable Clinical Performance to the Recently Unavailable Beckman-Coulter Access Thyroglobulin Autoantibody Assay in Identifying Samples with Potentially False-Low Thyroglobulin Measurements Due to Thyroglobulin Autoantibody Interference.Thyroid.Jul 2011.813-814.http://doi.org/10.1089/thy.2011.0158creative commons licensePublished in Volume: 21 Issue 7: June 27, 2011PDF download