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Elecsys® Tg II

The power to offer more for differentiated ­thyroid cancer (DTC) management
Elecsys® Tg II

The power to offer more for differentiated ­thyroid cancer (DTC) management

The main application for Thyroglobulin (Tg) testing is the post‑operative follow‑up of patients with differentiated thyroid carcinoma (DTC). Detectable levels of serum Tg after total thyroidectomy are indicative of persistent or recurrent DTC.1

Excellent functional sensitivity and precision

  • High sensitivity comes with better precision in the range around the clinical cut-off and improved negative predictive value3
  • Sensitive Tg assays can avoid TSH-­stimulated Tg testing during follow-up, in low-risk patients1
  • Patients with a basal Tg below the ­functional sensitivity of a sensitive Tg ­assay have a high chance of being free of disease2
  • High quality patient results and accurate long-term monitoring

 

Excellent precision across the entire ­measuring range supports accurate results3

 

  • Lot-to-lot consistency across all cobas® platforms allows a reliable long-term ­patient monitoring
  • Elecsys® Tg II shows lower TgAb interference, compared to other assays.4,5
  • Higher sensitivity allows for potentially earlier detection of persistence or recurrence1

 

Increasing concentrations of Tg (even at low concentrations) are an early and reliable indicator of recurrent disease1

 

  • Treatment is usually more successful with early detection, as the tumor burden is lower1
KONTAKTA OSS

Elecsys® Tg II

  • Assay time

    18 min

  • Sample material

    Serum, K2-EDTA ­plasma, K3-EDTA plasma

  • Sample volume

    21 / 35 μL (depending on analyzer)

  • Detection Limit *

    0.02 ng/mL, 0.04 ng/mL, 0.1 ng/mL

  • Measuring range

    0.04 – 500 ng/mL

  • Traceability

    BCR-CRM 457

  • Total imprecision:

    cobas e 411: 1.8 – 8.7%
    cobas e 601/2: 2.2 - 4.4%
    cobas e 402, cobas e 801: 1.9 – 3.2%

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

References

 

  1. Haugen, B.R., et al. (2015). American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid, 26:1-133.
  2. Giovanella, L., et al. (2014). Thyroglobulin measurement using highly sensitive assays in patients with differentiated thyroid cancer: a clinical position paper. Eur J Endocrinol, 171: R33–46.
  3. Elecsys® Tg II (Mat. No. 08906556) method sheet, V2 2022-05 & Elecsys® Tg II (Mat. No. 08906564190) method sheet, V4 2022-01.
  4. Rotteveel-de Groot D.M., et. al. (2016) Evaluation of the highly sensitive Roche thyroglobulin II assay and establishment of a reference limit for thyroglobulin-negative patient samples. Practical Laboratory Medicine, 5 , pp. 6-13.
  5. Internal data on file (2009), available upon request.