In-Vitro Diagnostics (IVD) is essential in the detection of infectious diseases.
FREMONT, CA: The COVID-19 outbreak is affecting millions of people globally. The outbreak of the pandemic has impelled the diagnostics industry into action. As laboratory errors have a significant impact on patient safety, the manufacturers of in vitro diagnostic (IVD) products ensure the highest possible safety and efficacy of their products. The immediate identification of COVID-19 cases needs the wide availability of diagnostics to control the virus's quick spread. A public health emergency was decided, justifying the authorization of emergency use of in-vitro diagnostics (IVDs) to diagnose COVID-19.
There are several types of IVD testing kits available. Molecular assays are the most extensively adopted diagnostics tests for COVID-19. Molecular diagnostic assays are meant to identify the presence of viral RNAs that are very particular to the SARS-CoV-2 virus, which causes COVID-19. Polymerase chain reaction (PCR) is the process involved in these assays. ELISA is a type of immunoassay that has a significant advantage over PCR. Antigens and antibodies are stable than RNA, thus mitigating the chance of false-negative outcomes. Antigens and antibodies are more uniform in sputum and blood samples raising its testing efficiency. There are nearly 200 immunoassays presently in use or development.
Digital solutions are presently in development to monitor and track the development of COVID-19, like InferRead CT Pneumonia by Beijing-based Infervision Technology, which identified lesions from possible pneumonia. Breath biomarkers are under development that can find and track the virus. Several diagnostics firms are ramping up their production of diagnostics kits, and personal protection is the device (PPE). The COVID-19 outbreak is now increasingly under control, leading to a fall in domestic demand for diagnostics.
It is not feasible in a global pandemic to go through a lengthy approval process for each novel diagnostic. The Emergency Use Authorization (EUA) authority enables the U.S. FDA to look after public health protection against COVID-19 by facilitating the use of needed medical supplies. Several molecular assays and immunoassays are in place to identify COVID-19 but quality diagnostics that offer faster and accurate test results are the requirement of the hour.