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Clinical Chemistry, Vol 42, 140-145, Copyright © 1996 by American Association for Clinical Chemistry
CA Spencer, M Takeuchi and M Kazarosyan
Department of Medicine, University of Southern California, Los Angeles 90033, USA. cspencer@hsc.usc.edu
Current medical needs dictate that laboratories offer thyrotropin (TSH) assays that can reliably measure low TSH concentrations--a prerequisite for using the more cost-effective TSH-centered strategy currently recommended by the American Thyroid Association. This study reviews the functional performance of the TSH immunometric assay methods currently used in clinical practice. Methodological differences between methods, the rationale for using the 20% interassay CV as the functional sensitivity limit for patient reports, and both TSH-related and non-TSH- related specificity problems are reviewed. We recommend that manufacturers and clinical laboratories use a clinically relevant standard protocol for functional sensitivity assessments. In this protocol, human serum pools are analyzed in random order 10 or more times across a clinically realistic time span (which approximates to 6- 8 weeks for TSH measurements used in an outpatient setting). Laboratories should independently establish and periodically check their functional sensitivity by the standard protocol and enlist the manufacturer's help to accomplish this if necessary. Manufacturers should (a) develop promotional material that realistically projects the assay's functional sensitivity expected in a clinical laboratory setting, (b) ensure that new clinical laboratory users achieve the projected functional sensitivity target when using the standard protocol, and (c) focus on the typical functional sensitivity obtained by clinical laboratory users rather than the assay's "generation" achieved under ideal conditions. If manufacturers and laboratories collaborate to solve the sensitivity and specificity problems discussed here, clinical laboratories should be better able to consistently deliver reliable serum TSH measurements across the full range of TSH concentrations encountered in clinical practice.
The following articles in journals at HighWire Press have cited this article:
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  E. Cavalier, A. Carlisi, J.-P. Chapelle, and P. Delanaye Analytical Quality of Calcitonin Determination and Its Effect on the Adequacy of Screening for Medullary Carcinoma of the Thyroid Clin. Chem., May 1, 2008; 54(5): 929 - 930. [Full Text] [PDF]
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K. Zophel, G. Wunderlich, and J. Kotzerke Should We Really Determine a Reference Population for the Definition of Thyroid-Stimulating Hormone Reference Interval? Clin. Chem., February 1, 2006; 52(2): 329 - 330. [Full Text] [PDF]
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A. Price, C. Burgin, I. Catch, and M. Cruise Functional Sensitivity and Recovery of Thyroid-stimulating Hormone Clin. Chem., November 1, 2001; 47(11): 2067 - 2067. [Full Text] [PDF]
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A. Clerico, S. Del Ry, and D. Giannessi Measurement of Cardiac Natriuretic Hormones (Atrial Natriuretic Peptide, Brain Natriuretic Peptide, and Related Peptides) in Clinical Practice: The Need for a New Generation of Immunoassay Methods Clin. Chem., October 1, 2000; 46(10): 1529 - 1534. [Abstract] [Full Text] [PDF]
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M. Burt, D. C. Anderson, J. Kloss, and F. S. Apple Evidence-based Implementation of Free Phenytoin Therapeutic Drug Monitoring Clin. Chem., August 1, 2000; 46(8): 1132 - 1135. [Abstract] [Full Text] [PDF]
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 P. W. Ladenson, P. A. Singer, K. B. Ain, N. Bagchi, S. T. Bigos, E. G. Levy, S. A. Smith, and G. H. Daniels American Thyroid Association Guidelines for Detection of Thyroid Dysfunction Arch Intern Med, June 12, 2000; 160(11): 1573 - 1575. [Abstract] [Full Text] [PDF]
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 W. Wang, H. Macapinlac, S. M. Larson, S. D. J. Yeh, T. Akhurst, R. D. Finn, J. Rosai, and R. J. Robbins [18F]-2-Fluoro-2-Deoxy-D-Glucose Positron Emission Tomography Localizes Residual Thyroid Cancer in Patients with Negative Diagnostic 131I Whole Body Scans and Elevated Serum Thyroglobulin Levels J. Clin. Endocrinol. Metab., July 1, 1999; 84(7): 2291 - 2302. [Abstract] [Full Text]
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M. A. Navarro, T. Palencia, M. R. Bonnin, and P. Rosel Daily BlankCell Procedure in Elecsys 2010 Improves the Reproducibility of Thyrotropin, Free Thyroxine, and Triiodothyronine Clin. Chem., August 1, 1998; 44(8): 1772 - 1773. [Full Text] [PDF]
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N. Despres and A. M. Grant Antibody interference in thyroid assays: a potential for clinical misinformation Clin. Chem., March 1, 1998; 44(3): 440 - 454. [Abstract] [Full Text] [PDF]
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P. Sotorrio, A. Quiros, and J. M. Izquierdo New Immunoelectrochemiluminometric Assay to Measure Serum Thyrotropin, Clin. Chem., December 1, 1997; 43(12): 2428 - 2430. [Full Text]
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W. A. Sadler, M. H. Smith, L. M. Murray, and J. G. Turner A pragmatic approach to estimating total analytical error of immunoassays Clin. Chem., April 1, 1997; 43(4): 608 - 614. [Abstract] [Full Text] [PDF]
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R. Sapin, F. Gasser, M. d'Herbomez, J. L. Wemeau, C. Ebert, and J. L. Schlienger Elecsys(R) Thyrotropin (TSH) Assay Evaluated Clin. Chem., March 1, 1997; 43(3): 545 - 547. [Full Text]
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C. Calzolari, P.-Y. Marquet, B. Pau, C. A. Spencer, and M. Takeuchi Thyroglobulin IRMA Pasteur Immunoassay: Sensitivity of the Assay and Interference from Thyroglobulin Autoantibodies • The authors of the above-mentioned article and editorial reply: Clin. Chem., February 1, 1997; 43(2): 413 - 415. [Full Text]
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