Ortho Clinical Diagnostics receives CE Mark for thyroid function assay

16 November 2020 (Last Updated November 16th, 2020 11:24)

Ortho Clinical Diagnostics has received CE Mark for its VITROS Immunodiagnostic Products TSH3 (thyroid-stimulating hormone) Reagent Pack and Calibrator to assess thyroid and / or pituitary gland function.

Ortho Clinical Diagnostics receives CE Mark for thyroid function assay
The test can offer reference intervals for paediatric and pregnant patient populations. Credit: Fernando Zhiminaicela / Pixabay.

Ortho Clinical Diagnostics has received CE Mark for its VITROS Immunodiagnostic Products TSH3 (thyroid-stimulating hormone) Reagent Pack and Calibrator to assess thyroid and / or pituitary gland function.

Expected to be commercially available from December, the VITROS TSH3 assay runs on the VITROS XT 7600 and VITROS 5600 integrated systems and can also offer reference intervals for paediatric and pregnant patient populations.

It helps healthcare teams to diagnose and monitor patients’ thyroid and / or pituitary function during the phases of development, which cause fluctuation in thyroid hormone levels.

Additionally, the assay runs on the VITROS 3600 and VITROS ECi/ECiQ Immunodiagnostic Systems and Vitros Automation Solutions.

A third-generation TSH assay with improved accuracy, VITROS TSH3 has 24-minute turnaround time, uses sample volume of 50μL, and delivers longer, 40-day calibration stability compared to the current VITROS TSH assay.

Ortho Clinical Diagnostics clinical labs business unit head Ajoy Mahtab said: “Labs can rely on Ortho’s TSH3 test when speed, accuracy, and reliability count, like in an acute case of ‘thyroid storm’ that is life-threatening, or monitoring treatment over time.

“Driven by Ortho’s belief that Because Every Test is a Life, Ortho is committed to providing labs with solutions to yield faster, more accurate, more reliable results so healthcare teams can make the most appropriate clinical decisions for their patients.”

The assay uses an Ortho VITROS MicroWell Assay Design that is not prone to biotin interference like the company’s VITROS Anti-SARS-CoV-2 Total and IgG tests, VITROS B•R•A•H•M•S PCT (Procalcitonin) assay, and VITROS High Sensitivity Troponin I Assay.