From the Editor

Abstract

The diagnostic modalities depicted here represent simplified versions of key laboratory and point-of-care techniques used to identify and characterize microorganisms from patient samples and/ or culture isolates. In general, these tests rely on the detection of specific nucleic acid sequences or proteins for diagnosis. Platform variations and examples have been included. In vitro diagnostics (IVDs) are an integral part of our health care system. Medical providers regularly rely on these diagnostic tests, which analyze samples like blood, saliva or urine, to assist with the diagnosis of disease or other medical conditions. Laboratory tests are routinely included in ~1/4 of adult patient care visits to assist with improved disease management and overall patient wellness. There are approximately 13 billion laboratory and diagnostic tests performed in the U.S. each year. This equates to the IVD and clinical laboratory services industries generating an estimated $87.3 billion in revenue! The extraordinary number of tests performed and the estimated revenue present an enticing opportunity for potential abuse and fraud, however. Although the number of cases tried for abuse and fraud in the biomedical industry is relatively low, results from investigations suggest that the losses due to fraud can be in excess of “tens or as high as hundreds of millions of dollars.” genome are relatively few and far between, Dr. Cooper warns that increased selective pressure, along with increased numbers of SARS-CoV-2 infections, facilitate continued virus evolution. In fact, a study in Nature Medicine describes the identification of 16 new lineages of SARS-CoV-2 isolated in South Africa between March 6 and August 26, 2020, many of which possess unique mutations that have not been identified elsewhere. Getting infection numbers under control and continuing to track SARS-CoV-2 variants are therefore key to managing the spread of the disease.