by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP)
There may be circumstances when laboratories consider the option to modify an FDA-cleared or approved test system. These may be due to the specific needs of the population served, or based on cost/benefit analyses of instrumentation and reagent use; or based on the logistics of in-house testing capabilities. CLIA allows clinical laboratories to modify their FDA-approved tests, and even to develop their own tests, known as laboratory-developed tests (LDTs), as long as they follow the requirements to validate the performance characteristics of their modified or in-house developed tests.
by DUSTYN WILLIAMS, MD
Hypertension, or high blood pressure, is a leading cause of heart disease and stroke that has escalated to alarming rates in recent years, affecting nearly 1 in 3 adults in the U.S. In an attempt to reduce its prevalence, the Eighth Joint National Committee (JNC-8) released a set of hypertension management guidelines. However, various concerns arose regarding the recommendations and as a result, the American College of Cardiology (ACC) and the American Heart Association (AHA), along with nine additional specialty organizations, published an updated hypertension guideline in November 2017.