Assays help detect and monitor thyroid conditions.

Press Release Summary:




Access Fast hTSH assay enables laboratories to quantitatively determine levels of thyroid stimulating hormone in serum and plasma. It requires 55 µl of sample and delivers results in 20 min. Analytical sensitivity is less than 0.01 µIU/mL and functional sensitivity is less than or equal to 0.03 µIU/mL. Access® Free T3 assay quantitatively determines level of free triiodothyronine levels in serum and plasma with analytical sensitivity of 0.88 pg/mL.



Original Press Release:



Beckman Coulter Releases Fast hTSH Assay, Improves Free T3 Assay for Diagnosis and Monitoring of Thyroid Conditions



FULLERTON, Calif. (May 16, 2005) — Beckman Coulter, Inc. has released a new Fast hTSH assay and an improved free T3 test to aid in the detection and monitoring of thyroid conditions. The new Access Fast hTSH assay enables commercial laboratories, hospitals and endocrinology clinics to quantitatively determine levels of thyroid stimulating hormone (TSH) in serum and plasma. Fast hTSH requires a low volume of sample – only 55 µL – and delivers results in approximately 20 minutes. This is particularly useful when dealing with nominal sample volumes, such as pediatric samples. Analytical sensitivity is less than 0.01 µIU/mL and functional sensitivity is less than or equal to 0.03 µIU/mL. The onboard reagent stability and calibration curve both last 28 days. For added consistency and standardization across multiple test protocols, Fast hTSH uses the same reagents and calibrators as Beckman Coulter’s Access HYPERsensitive hTSH, a third-generation assay used to distinguish between hyperthyroid and euthyroid patients. The Access® Free T3 assay enables commercial laboratories, hospitals and endocrinology clinics to quantitatively determine the level of free triiodothyronine (T3) levels in serum and plasma. The new standardized assay meets industry requirements for improved result harmonization across commercially available free T3 assays. Access Free T3 delivers results within 25 minutes and minimizes response to known interferences, including heterophile antibodies. The assay’s analytical sensitivity is 0.88 pg/mL, while precision is less than or equal to 12 percent at concentrations greater than 2.0 pg/mL. Expected range of the assay is 2.5 to 3.9 pg/mL. Calibration stability has been extended to 28 days. Both the Fast hTSH and Free T3 assays are available on Beckman Coulter’s Access and Access 2 immunoassay systems, as well as the UniCel® DxI 800 Access immunoassay system, which can perform up to 400 tests per hour. All three systems use the same reagents and calibrators, allowing healthcare institutions and networks to standardize inventory and lab testing methods across multiple locations. Among other benefits, this allows for increased consistency and quality of results reporting. The assays also are available on the SYNCHRON LX®i 725 clinical system, which combines chemistry and immunoassay analysis technology on a single instrument. In addition to Fast hTSH, and Free T3, Beckman Coulter offers a number of other thyroid assays, including tests for thyroglobulin, thyroglobulin antibodies, thyroid uptake, total T3, total T4 and free T4. The company’s menu also includes cancer, cardiac, infectious disease, reproductive and other endocrine tests. The menu includes approximately 50 tests worldwide. Beckman Coulter, Inc. is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum — from pioneering medical research and clinical trials to laboratory diagnostics and point-of-care testing — Beckman Coulter’s 200,000 installed systems provide essential biomedical information to enhance health care around the world. The company, based in Fullerton, Calif., reported 2004 annual sales of $2.4 billion with 64 percent of this amount generated by recurring revenue from supplies, test kits and services. For more information, visit www.beckmancoulter.com or call (800) 352-3433.

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