Ortho's Next Gen TSH3 Assay to Assess Thyroid and/or Pituitary Disorders Achieves CE Mark

Ortho's Next Gen TSH3 Assay to Assess Thyroid and/or Pituitary Disorders Achieves CE Mark

PR Newswire

RARITAN, N.J., Nov. 13, 2020

RARITAN, N.J., Nov. 13, 2020 /PRNewswire/ -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced its VITROS® Immunodiagnostic Products TSH3 (Thyroid Stimulating Hormone) Reagent Pack and Calibrator has achieved CE Mark and will be commercially available in the beginning of December* to aid clinicians in assessing and diagnosing thyroid and/or pituitary gland function.

This is especially beneficial in Europe, as studies have shown that nearly half of the 11% of Europeans with thyroid dysfunction are unaware of their condition.1 If left untreated, thyroid disorders can be either life-threating or cause health complications. 

The VITROS® TSH3 assay has high value in offering reference intervals for both pediatric and pregnant patient populations, ensuring health care teams are able to more accurately diagnose and monitor patients' thyroid and/or pituitary function during these important phases of development causes thyroid hormones levels to fluctuate. 

"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," said Ajoy C. Mahtab, head of clinical labs business unit, Ortho Clinical Diagnostics. "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 health care teams can make the most appropriate clinical decisions for their patients."

VITROS® TSH3 is a third-generation TSH assay2 with improved accuracy that offers a 24-minute turnaround time (35% faster), 37% smaller sample volume to 50μL, and longer 40-day calibration stability, compared to the current VITROS® TSH assay. Further, the VITROS® TSH3 assay uses an Ortho  VITROS® MicroWell Assay Design that is not susceptible to biotin interference, same as Ortho'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 among others.

The assay runs on the VITROS® XT 7600 and VITROS® 5600 Integrated Systems, and VITROS® 3600 and VITROS® ECi/ECiQ Immunodiagnostic Systems, and VITROS® Automation Solutions.

*Not all products available in all countries.

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.

Because Every Test is a Life,™ we never stop innovating to offer streamlined, sustainable laboratory solutions that deliver fast, accurate, reliable test results that support exceptional patient care.

For more information about Ortho's solutions and services, visit Ortho's website or social media channels: LinkedIn, Twitter, Facebook, Instagram and YouTube.

1 The Incidence and Prevalence of Thyroid Dysfunction in Europe: A Meta-Analysis. Madariaga, A. et. al. J. Clin Endocrinol Metab, March 2014, 99(3);923-931.
2 PR-10241

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