Receive our newsletter – data, insights and analysis delivered to you
  1. News
November 16, 2020

Ortho Clinical Diagnostics receives CE Mark for thyroid function assay

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 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.

Content from our partners
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 

“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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU