Since the advent of the COVID-19 pandemic, many governmental agencies and public health officials around the world have worked tirelessly to protect public health. Joining other federal, state, and local agencies, the U.S. Food and Drug Administration (FDA) has played a pivotal role in many aspects of the public health response to the pandemic, including …
Studying Lab-Grown Miniature Organs to Understand COVID-19
SARS-CoV-2 has a certain versatility in invading organs such as the kidneys, lungs, and liver. Physicians treating patients and scientists in research settings are witnessing firsthand how it can devastate those organs. It is unclear, however, whether the damage is due directly to the virus or is indirect damage from complications. The disease processes in …
The Atlantic Horseshoe Crab and COVID-19
How can these ancient arthropods play a vital role in ending a global pandemic? The Atlantic horseshoe crab, or Limulus polyphemus, is one of the oldest living things on the planet. Known as a “living fossil,” the horseshoe crab predates dinosaurs by 200 million years — and has remained largely unchanged for the last 450 …
CLIA Regulations During the COVID-19 Pandemic
During the ongoing pandemic, all COVID-19-related testing used for the diagnosis, prevention, or treatment of disease, or for a health assessment, must adhere to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Through the CLIA law, the Centers for Medicare & Medicaid Services (CMS) regulates all human diagnostic laboratory testing in the United States, except research, to ensure high-quality …
FDA Guidance Documents for COVID-19
COVID-19 was declared a global pandemic on March 11, 2020. As the novel coronavirus continues to dominate headlines and impact communities around the globe, many life-sciences and pharmaceutical companies are working hard to develop tests, treatments, and vaccines to combat the virus. To help steer these companies in the right direction, the United States Food …
Can Llama Antibodies Help Fight SARS-CoV-2?
Winter is a llama who lives on a farm in Ghent, Belgium — and she may be a vital figure in the fight against the novel coronavirus. Llamas have long been used for antibody research, and they have been integral in identifying potential therapies for viruses such as HIV and influenza. There is nothing particularly …
Racing Against the Clock: Developing Monoclonal Antibodies During a Pandemic
Between the current SARS-CoV-2 pandemic and the SARS, H1N1 and HIV/AIDS epidemics all taking place within the last 50 years, major infectious disease outbreaks are occurring more frequently. To contain these outbreaks more quickly, it is necessary to develop new approaches that enable the quickest possible evaluation of antibodies for passive immunization or treatment. A …
Novel Coronavirus Testing: Part IV
Saliva Testing Accurate, rapid testing for the novel coronavirus (SARS-CoV-2) is crucial to controlling the COVID-19 pandemic. In previous installments of this blog series, we covered the real-time reverse transcription polymerase chain reaction (rRT-PCR) test, the serology test, and the antigen test for the novel coronavirus. The rRT-PCR assay sample is gathered by nasal swab, …
Novel Coronavirus Testing: Part III
Antigen Testing Part I of this series on testing for the novel coronavirus covered the real-time reverse transcription polymerase chain reaction (rRT-PCR) assay, which is administered via nasal swab and can diagnose an active infection. Part II covered serology testing, which scans blood samples for antibodies to the virus and can indicate a previous infection …
Airborne Coronavirus Discovered in China – Could It Transmit the Novel Coronavirus?
Earlier this week, we discussed an aerosolized droplet study conducted by the University of Pennsylvania Perelman School of Medicine and the National Institutes of Health (NIH). That research provided evidence that the novel coronavirus could be transmitted from person to person through the aerosolized droplets that people produce when speaking. Unlike the larger particles produced …
