Improving the Diagnosis, Treatment, and Prevention of Endocrine Diseases Through Accurate and Reliable Laboratory Measurements With CDC Clinical Standardization Programs

Abstract

Abstract Laboratory measurements are critical for correct diagnosis and treatment of patients with chronic diseases such as hypogonadism, PCOS, and thyroid diseases. Inaccurate measurements of disease biomarkers can lead to misclassification of patients/incorrect treatment and prevent the effective use of research findings in patient care. The CDC Clinical Standardization Programs (CDC CSP) improve the accuracy and reliability of clinical biomarker measurements by assessing and improving the analytical performance of assays. The CDC CSP assist with assay calibration, the certification of analytical performance, and the monitoring of routine patient and research testing. The CDC CSP work with clinical/research laboratories and assay manufacturers to improve laboratory measurements. Its current programs include the following analytes: total testosterone (TT), estradiol (E2), vitamin D (VD), free thyroxine (FT4), total cholesterol (TC), total glycerides (TG), HDL-cholesterol (HDL-C), and LDL-cholesterol (LDL-C). The work is being conducted through certification/monitoring programs and technical assistance. Most assays participating in the certification programs have seen performance improvements and maintain performance over time by continuous participation. Most major commercial laboratories and assays manufactures are enrolled in the certification programs. Currently certified and non-certified assays are available. Assays certified by CDC CSP are listed on the website at https://www.cdc.gov/labstandards/hs.html. The CDC Lipid Standardization Programs and CDC Accuracy-based Monitoring Programs allow for weekly monitoring of analytical performance of routine tests for analytes including TT, VD, TC, TG, HDL-C, apolipoprotein A1 and B. These monitoring programs assist researchers with assessing measurement accuracy of research studies over time and across laboratories. The CDC CSP also support accuracy-based external quality assurance surveys such as those offered by the College of American Pathologists (CAP). The CDC CSP assist researchers and stakeholders with developing and establishing reference intervals and conducting studies to better assess and diagnose patients. Based on the needs and requests from clinical community, programs for new biomarkers such as Lp(a), PTH and glucose are being developed. The CDC CSP work with stakeholders, such as the Endocrine Society and the Partnership for the Accurate Testing of Hormones, to educate the clinical and laboratory communities about the importance of using standardized assays in patient care, research, and public health.