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Clinical Chemistry 51: 1904-1905, 2005; 10.1373/clinchem.2005.055632
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(Clinical Chemistry. 2005;51:1904-1905.)
© 2005 American Association for Clinical Chemistry, Inc.

Letters to the Editor

Performance Characteristics of 6 Third-Generation Assays for Thyroid-Stimulating Hormone

David Waskiewicz1,a, Alan Burkhardt2 and Kenneth Emancipator2,3

1 Bayer HealthCare, Diagnostics Division, Walpole, MA, Bayer HealthCare
2 Diagnostics Division, and
3 Diabetes Care Division, Tarrytown, NY

aAddress correspondence to this author at: Bayer HealthCare, Diagnostics Division, 333 Coney St., Walpole, MA 02032. Fax 508-660-4500; e-mail david. waskiewicz.b{at}bayer.com.


To the Editor:

A recent report in this journal by Rawlins and Roberts (1) compared 6 commercial third-generation assays for thyroid-stimulating hormone (TSH). The authors reported a functional sensitivity of 0.039 mIU/L for the ADVIA Centaur® TSH-3, in contrast to the manufacturer’s claim of 0.019 mIU/L (2). Rawlins and Roberts (1) cited a single earlier ADVIA Centaur study (3), which they claim agrees with their results; however, the cited study actually evaluated the ADVIA Centaur TSH, a second-generation TSH assay that is different from the TSH-3. Previous publications on the ADVIA Centaur TSH-3 reported functional sensitivities in the range of 0.018–0.025 mIU/L (4)(5)(6) and are in general agreement with the manufacturer’s claim. We investigated further to resolve the apparent inconsistencies raised by Rawlins and Roberts (1).

We conducted a new evaluation of the functional sensitivity of the ADVIA Centaur TSH-3. Included were the same two lots used by Rawlins and Roberts (lots 26 and 29), which now had been expired for 8–9 months, as well as two in-date lots (lots 38 and 41). The method closely followed that of Rawlins and Roberts (1). Serum samples were used to prepare 8 patient pools distributed within the TSH-3 dose range of ~0.01–0.15 mIU/L.

Pools were tested on one ADVIA Centaur with each TSH-3 lot in duplicate, twice per week, for 3 weeks, for a total of 12 replicates. Each pool was tested with all TSH-3 reagent lots in one run to allow all results to be generated within several minutes. The Centaur was a routine production system used for various assay and patient sample evaluations in support of Centaur customers. Functional sensitivity was determined by plotting the total CV for each of the 8 pools as a function of TSH dose. The data were fit with a power equation of the form Total CV = a(TSH dose)b, and functional sensitivity was calculated to be the dose in the equation with a total CV of 20%. We found the functional sensitivity, using reagent lots 26 and 29, to be 0.012 mIU/L. This value is considerably lower than that of Rawlins and Roberts (1), although the same reagent lots were used. For the two newer in-date lots, functional sensitivity was calculated to be 0.022 mIU/L. Both determinations are consistent with the manufacturer’s claim of 0.019 mIU/L for the ADVIA Centaur TSH-3.

In summary, we believe that the data support our functional sensitivity claim for the third-generation ADVIA Centaur TSH-3 method and that this claim has been demonstrated in other studies (4)(5)(6).


References

  1. Rawlins ML, Roberts WL. Performance characteristics of six third-generation assays for thyroid-stimulating hormone. Clin Chem 2004;50:2338-2344.[Abstract/Free Full Text]
  2. . Bayer HealthCare. ADVIA Centaur assay manual. TSH-3 instructions for use, revision K 2004-03 2004 Bayer HealthCare Tarrytown, NY. .
  3. Ognibene A, Drake CJ, Jeng KY, Pascucci TE, Hsu S, Luceri F, et al. A new modular chemiluminescent immunoassay analyser evaluated. Clin Chem Lab Med 2000;38:251-260.[CrossRef][Web of Science][Medline] [Order article via Infotrieve]
  4. Vogeser M, Weigand M, Fraunberger P, Fischer H, Cremer P. Evaluation of the ADVIA Centaur TSH-3 assay. Clin Chem Lab Med 2000;38:331-334.[Medline] [Order article via Infotrieve]
  5. Kelly A, DeCarlo F, McCann L, Sasse E. Third generation TSH functional sensitivity and patient comparisons for the Abbott Architect and Bayer-Chiron Centaur [Abstract]. Clin Chem 2000;46(Suppl 6):A126.
  6. Gruson D, DeNayer P, Phillippe M. Evaluation of the analytical and clinical performance of a third generation TSH assay on Bayer Advia Centaur analyzer [Abstract]. Clin Chem 2004;50(Suppl 6):A97.




This Article
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Right arrow Clinical Immunology
Right arrow Endocrinology and Metabolism

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