NEW YORK – Ortho Clinical Diagnostics said on Friday that it has received the CE mark for its Vitros Immunodiagnostic Products TSH3 reagent pack and calibrator.
The test for diagnosing thyroid and/or pituitary gland function will be commercially available starting in December, the Raritan, New Jersey-based company said, adding it should be particularly useful in Europe where studies have shown that almost half of people there who have thyroid dysfunction don't know about their condition. About 11 percent of Europeans have thyroid dysfunction, Ortho Clinical Dx said.
The Vitros TSH3 assay can also offer reference intervals for pediatric and pregnant patient populations, the firm noted.
The third-generation assay has a 24-minute turnaround time, uses 50-microliter samples, and offers longer, 40-day calibration stability than the current Vitros TSH assay. It also leverages an Ortho Vitros MicroWell assay design that is not susceptible to biotin interference.
The test runs on the Vitros XT 7600 and Vitros 5600 integrated systems, as well as the Vitros 3600 and Vitros ECi/ECiQ immunodiagnostic systems, and Vitros Automation Solutions.