CLSI Blog Articles

Read the latest articles about CLSI and laboratory standards in the official CLSI Blog. Browse our most recent blog articles below.

Antimicrobial Resistance and the COVID-19 Pandemic

Antimicrobial resistance is one of the most serious global health threats in the world. In the United States, there are 2.8 million antibiotic-resistant infections each year that cause more than 35,000 deaths. Some experts fear that the real number is much higher. The superbugs that cause these infections thrive in hospitals and medical facilities, putting all patients at risk. The patients at greatest risk from superbugs are the ones who are already more vulnerable to illness from viral lung infections like influenza, severe acute respiratory syndrome (SARS), and COVID-19.

COVID-19 Testing Information and Resources for Laboratories

As of April 8, 2020, the global health threat now known as coronavirus disease-2019 (COVID-19) had infected more than 1.3 million people in over 200 countries and caused more than 79,000 deaths [1]. According to the “Operational Planning Guidelines to Support Country Preparedness and Response” developed by the World Health Organization (WHO), a coordinated global response plan that primarily involves prevention of human-to-human transmission of the virus, caring and monitoring of infected patients, and rapid diagnosis of the disease followed by effective infection control measures is required to control the COVID-19 pandemic [2].

Performing a Biological Risk Assessment in the Laboratory

While laboratory workers are always vigilant against laboratory-acquired infections, uncertainty has arisen in the medical laboratory community about the most effective way to protect against COVID-19. The United States Department of Labor Occupational Safety and Health Administration (OSHA) provides guidelines for safe COVID-19 specimen processing, as well as information about proper personal protective equipment (PPE) for laboratory workers.

Regulation of Laboratory Tests Is About to Change

The bipartisan bill, Verifying Accurate Leading-edge IVCT Development Act (VALID), was introduced to Congress on March 5, 2020. This legislative effort, if enacted, will overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a single system for regulation of LDTs and manufacturers’ IVCTs.