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Analytical evaluation of an improved procedure for measuring thyrotropin
B González-de-la-Presa1, G Palacios, R Bonnin
1Sección de Hormonas (Servicio de Bioquímica), Ciutat Sanitària i Universitária de Bellvitge, Barcelona, Spain.
Clinical Chemistry and Laboratory Medicine
|May 22, 1998
Summary
The AxSYM Ultrasensitive hTSH-II assay demonstrates high precision and accuracy for measuring serum thyrotropin (TSH) levels. This sensitive assay is linear up to 87.0 mIU/l with a functional sensitivity of 0.018 mIU/l.
Area of Science:
- Clinical Chemistry
- Immunoassay Technology
- Endocrinology
Background:
- Accurate quantification of serum thyrotropin (TSH) is crucial for diagnosing and monitoring thyroid disorders.
- The development of sensitive and reliable TSH assays is essential for clinical practice.
Purpose of the Study:
- To evaluate the analytical performance of the AxSYM Ultrasensitive hTSH-II assay.
- To assess the assay's precision, sensitivity, linearity, and accuracy compared to a reference method.
Main Methods:
- Evaluation of within- and between-run imprecision.
- Determination of functional sensitivity and analytical interval.
- Assessment of relative inaccuracy using Passing-Bablok regression analysis against the Enzymum-Test TSH.
Main Results:
- Coefficients of variation for within-run and between-run imprecision were below 6.69% and 8.12%, respectively.
- Assay linearity was confirmed up to 87.0 mIU/l.
- Functional sensitivity was determined to be 0.018 mIU/l, with a Passing-Bablok equation indicating good agreement with the reference method.
Conclusions:
- The AxSYM Ultrasensitive hTSH-II assay exhibits excellent analytical characteristics for serum TSH quantitation.
- The assay's high sensitivity and accuracy make it suitable for routine clinical use in thyroid function testing.