SAT-022 Improving The Diagnosis, Treatment, And Prevention Of Diseases Through Accurate And Reliable Laboratory Measurements With CDC Clinical Standardization Programs

Abstract

Laboratory measurements are critical for the correct diagnosis and treatment of patients as well as in the investigation of diseases, such as cardiovascular disease, hypogonadism, bone-related diseases, infertility, and certain cancers. Inaccurate and unreliable measurements can lead to the misclassification of patients and incorrect treatment. In CDC Clinical Standardization Programs (CDC CSP), accuracy, precision, and other analytical parameters are assessed against performance goals defined by clinical and medical organizations. CDC offers two approaches to improve the accuracy and reliability of laboratory measurements. The first approach focuses on calibration and annual certification of commercial assays and laboratory developed tests (LDTs). This approach is used in [1] CDC Hormone Standardization (CDC HoSt) Program for total testosterone (TT) and estradiol (E2), [2] Vitamin D Standardization-Certification Program (CDC VDSCP) and [3] Cardiovascular Disease Biomarker Standardization Programs for total cholesterol (TC), total glycerides (TG), HDL-cholesterol (HDL-C), and LDL-cholesterol (LDL-C). Free thyroxine (fT4) will also be available in late 2019. The second approach monitors the accuracy and imprecision of measurements performed routinely in patient care, public health, and research. This approach is focused on the accuracy and consistency of laboratory tests in the hand of end-users. CDC has implemented this approach in the Lipid Standardization Program (CDC LSP) for TC, TG, HDL-C, apolipoprotein AI and B, and CDC Accuracy-based Monitoring (CDC AMP) Program for TT and 25OHD. CDC AMP for E2 will be available for enrollment in late 2019. CDC CSP have improved the accuracy of participating laboratories. Among-laboratory bias decreased from 16.5% in 2007 to 2.8% in 2017 for TT and 54.8% in 2012 to 13.9% in 2017 for E2. Similar improvements have been observed for 25OHD, with a decrease in among-laboratory bias from 13.9% in 2012 to 5.2% in 2016 at 30 nmol/L (vitamin D deficiency) and 12.3% in 2012 to 3.0% in 2016 at 50 nmol/L (vitamin D insufficiency). CDC CSP efforts have helped maintain analytical performance over time. For example, data collected over the past 10 years from CDC LSP indicate that the majority of TC measurements, performed in research and patient care, are consistently within the recommended bias limits of +3%. CDC continues to address new clinical and public health needs by adding new analytes, such as free testosterone, sex hormone binding globulin (SHBG), fT4, parathyroid hormone (PTH), and glucose. CDC CSP also support projects with establishing reference ranges, creating population data using national surveys, and conducting special research studies. CDC CSP are supported by and collaborate with key stakeholders such as the Partnership for the Accurate Testing of Hormones (PATH) and affiliated organizations, including the Endocrine Society.