The new assay enables rapid, accurate reporting of TPOAb results that aid in the diagnosis of autoimmune thyroid disease, such as Hashimoto's thyroiditis and Graves' disease. The measurement of TPOAb levels helps physicians differentiate thyroid autoimmune disorders from non-autoimmune goiter or hypothyroidism.
The new test can be performed using serum or heparinized plasma and requires a sample volume of only 10 uL—increasing laboratory efficiency by requiring a minimal sample size. The ready-to-use liquid reagent features an analytical sensitivity of 0.25 IU/mL and total imprecision of less than 12 percent of the coefficient of variation (CV) at TPOAb concentrations greater than or equal to 0.6 IU/mL .
Plus, this assay delivers a “time to first result” of approximately 30 minutes and offers 56-day calibration and open-pack stability. Additional assay characteristics include the use of recombinant human TPO—which eliminates contamination from other thyroid antigens for more accurate results—and standardization to WHO 66/387 for confidence in results.
The Access family of immunoassay systems uses chemiluminescent technology as well as common reagents and consumables across all systems. Instruments include the Access and Access 2 benchtop immunoassay systems, as well as the high-throughput, automation-ready UniCel® DxI 800 Access immunoassay system, which can perform up to 400 tests per hour. The TPOAb assay will also be available on the company's newest integrated chemistry/immunoassay instrument, the UniCel DxC 600i SYNCHRON® Access clinical system.
Besides TPOAb, Beckman Coulter's thyroid immunoassay menu includes Thyroglobulin, Thyroglobulin Antibody, HYPERsensitive hTSH, Thyroid Uptake, Total T3, Free T3, Total T4 and Free T4. The company's immunoassay menu of approximately 50 tests also includes cancer, cardiac, infectious disease, reproductive and other endocrine tests. |
