Elecsys® Anti-TSHR

Elecsys Anti-TSHR (TRAK) is a fully automated test for detection of autoantibodies to the TSH receptor

Elecsys® Anti-TSHR

Complex testing simplified and automated

Elecsys Anti-TSHR (TRAK) is a fully automated test for detection of autoantibodies to the TSH receptor

 

Clinical utility

 

  • Aid in detection or exclusion of Graves’ autoimmune hyperthyroidism and differentiation from disseminated autonomy of the thyroid gland1
  • Aid in monitoring therapy and prediction of relapse1
  • Aid in assessing the risk of developing fetal ­hyperthyroidism in the last trimester of pregnancy2

 

Improved efficiency

 

  • Fully automated test for more workflow efficiency, allows for consolidation of tests required for differential diagnosis of ­thyroid diseases
  • Rapid availability of Anti-TSHR results supports cost- and time-efficient differential diagnosis of thyroid diseases and ­early treatment

 

High quality results

 

  • Advanced assay quality, based on proven and leading ECL technology
  • Excellent precision across the entire ­measuring range (figure 1)
  • High diagnostic value, based on high ­sensitivity paired with high specificity (figure 23)
Elecsys Anti-TSHR

Figure 1: The functional sensitivity of Elecsys Anti-TSHR at approx. 0.9 IU/L is significantly below the cut-off (≥1.75 IU/L), allowing clear differentiation of pathological results.

Elecsys Anti-TSHR

Figure 2: The high sensitivity of 97% and high specificity of 99.5% of the Elecsys Anti-TSHR assay support clinical accuracy

The clinical study comprised:

  • 436 samples from apparently healthy individuals
  • 210 patients with thyroid diseases excluding Grave's disease
  • 102 patients with untreated Grave’s disease

Using a cutoff of 1.75 IU/L a clinical sensitivity of 97% and a specificity of 99% was obtained.

Elecsys® Anti-TSHR

  • Assay time

    27 min

  • Sample volume

    50 μL

  • Detection Limit *

    LoB = 0.5 IU/L
    LoD = 0.8 IU/L
    LoQ = 1.1 IU/L

  • Measuring range

    0.8 - 40 (results below the LoD are reported as <0.8 IU/L)

  • Cut-off

    1.75 IU/L 

  • Precision

    < 6%

  • Traceability

    NIBSC 1st IS 90/673

  • Total imprecision

    cobas e 411 - 1.3-12.3%
    cobas e 60x - 1.3-9.1%
    cobas e 801 - 1.7-17.3%

* LoB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitation with a total allowable error of ≤20 %.

References

 

  1. Barbesino, G. and Tomer, Y. (2013). Clinical review: Clinical utility of TSH receptor antibodies. J Clin Endocrinol Metab, 98(6):2247-55.
  2. Erik, K.A. et al. (2017). Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease during Pregnancy and the Postpartum. Thyroid. DOI: 10.1089/thy.2016.0457.
  3. Hermsen, D. et al. (2009). Technical evaluation of the first fully automated assay for the detection of TSH receptor autoantibodies. Clin Chim Acta, 401(1-2):84-89.
  4. Elecsys® Anti-TSHR Mat. No. 08496609190 / 08496633190