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Thyroid testing using the Cobas Core immunoassay system. A multicentre study

O Michotey1, R Dörr, D Bourderont

  • 1Centre Hospitalier de Mulhouse, France.

European Journal of Clinical Chemistry and Clinical Biochemistry : Journal of the Forum of European Clinical Chemistry Societies
|September 1, 1995
PubMed
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The Cobas Core immunoanalyzer and its thyroid assays accurately analyze thyroid diseases. This system demonstrates good precision and correlates well with clinical data for diagnosing thyroid conditions.

Area of Science:

  • Clinical Chemistry
  • Immunodiagnostics
  • Endocrinology

Background:

  • Thyroid disease diagnosis relies on accurate hormone level measurement.
  • Assessing the clinical utility of new diagnostic platforms is crucial.

Purpose of the Study:

  • To evaluate the clinical usefulness of the Cobas Core random access immunoanalyzer and its associated thyroid assays.
  • To assess the precision and diagnostic accuracy of the Cobas Core system for various thyroid tests.

Main Methods:

  • Multi-center study involving four clinical laboratories.
  • Assayed thyrotropin (TSH), free thyroxine (FT4), thyroxine (T4), triiodothyronine (T3), and free triiodothyronine (FT3).
  • Evaluated precision (within- and between-series CVs) and compared results with clinical data and a reference assay (Technicon Immuno-1).

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Main Results:

  • Mean CVs for precision were 4.3% (within-series) and 6.1% (between-series).
  • Cobas Core results showed good agreement with diagnosed thyroid diseases, differentiating normal, diseased, untreated, and treated states.
  • High correlation observed when comparing Cobas Core TSH and FT4 assays with Technicon Immuno-1 assays.

Conclusions:

  • The Cobas Core system and its thyroid assays are clinically useful for diagnosing thyroid diseases.
  • The system offers reliable precision and accurate discrimination of thyroid status.
  • Demonstrated good correlation with established methods for TSH and FT4 measurement.