Billerica, Massachusetts, October 13, 2016 — MilliporeSigma today introduced the first Certified Spiking Solution® of intact, heavy labeled Thyroglobulin (Tg) in SigMatrix®, a synthetic surrogate serum. The matrix-based reference material is suitable as an internal standard for the quantification of Tg levels by LC-MS/MS methods to ensure accurate, identifiable and quantifiable clinical diagnostic testing. MilliporeSigma’s solution-based product is the first endogenous protein biomarker of the extensive Cerilliant® portfolio.

 

Measurement of patient Tg levels is primarily performed to monitor differentiated thyroid carcinoma recurrence following therapy.¹ Quantification of Tg levels is also useful in determining the cause of hyperthyroidism and for monitoring treatment effectiveness in Graves disease.¹

 

Anti-Tg autoantibody (TgAb) is present in about 25 percent of thyroid cancer patients and can interfere with Tg immunoassays (IA), causing false-negative results.^2,3 Quantitative mass spectrometry-based analysis of Tg concentrations in serum is the preferred assay for measuring Tg in TgAb positive patients.^2,3 Recent studies suggest that reflex testing of Tg levels by LC-MS/MS following a positive IA test for TgAb can lead to substantial cost savings as a result of improved test utilization.²

 

Cerilliant® Certified Spiking Solutions® are manufactured using validated processes to ensure the highest level of accuracy for critical quantitative mass spectrometry-based applications. The portfolio spans from therapeutic drug monitoring, diagnostic testing, clinical chemistry and endocrinology to pharmaceutical research, clinical toxicology, and forensic analysis. MilliporeSigma offers parent drug, metabolite, endogenous biomarker and internal standard Certified Spiking Solutions® for clinical and diagnostic testing applications which includes omega-3 and omega-6 fatty acids, bile acids, catecholamines, vitamins, immunosuppressants, cardiac drugs, antiretrovirals and antifungals to hormones including male, female, neonatal, thyroid and hydroxyvitamin D.