The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care

Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.

Measurement of thyroglobulin (Tg) in serum has proven useful for detecting recurrence of treated differentiated thyroid carcinoma (DTC). According to the American Cancer Society, the United States has over 60 000 new thyroid cancer cases each year. The death rate is almost 2000 per year. Differentiated thyroid cancer accounts for over 90% of cases. Differentiated thyroid cancer produces Tg, making its measurement useful as a tumor marker for detecting recurrence. The NCCN and American Thyroid Association (ATA) guidelines recommend Tg testing following total thyroidectomy and radioiodine ablation treatment, including tests at baseline, 6 to 12 weeks after treatment, 6 months, 12 months, and annually thereafter. Patients free of disease have undetectable Tg.