Outbreaks with a novel coronavirus disease COVID-19 is caused by the SARS-CoV-2 virus. The virus has shown to be very contagious and has caused a world wide pandemic in the first half of 2020.
The SARS-CoV-2 virus is a single strand RNA virus with glycoprotein spikes on its surface.
The spike protein (S) contains the receptor-binding domain (RBD) which has affinity to the angiotensin-converting enzyme 2 (ACE2). The interaction between RBD and ACE2 mediates the fusion of the viral and cellular membranes starting the infection process.
The S protein has two subunits, S1 and S2. S1 contains the RBD region and the S2 is associated with the membrane of the virus.
The nucleoprotein (N) is an abundant protein associated with virus structure and replication. Human ELISA assays have been developed using the S proteins and nucleoprotein of SARS-CoV-2 to detect antibodies to SARS-CoV-2.
XpressBio COVID-19 Products
“The COVID-19 pandemic has changed the game for global public health. Never before have diagnostics had the attention of the whole world.”
The diagnostics test market is literally being flooded with an increasing number of tests for SARS-CoV-2,
“Understanding which of these tests should be used when, where and how is critical and high priority for us. There is a chronic lack of data across the board that is compromising decision making and frankly putting lives at risk.” Dr. Catharina Boehme CEO FIND and member of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD).
Whereas RT PCR testing may support accurate detection of the SARS-COV-2 virus, inadequate swab processes may result in false negatives. The development of serologic assays that accurately assess prior infection and immunity to SARS–CoV-2 will be essential as part of a confirmatory strategy and further in epidemiologic studies, ongoing surveillance, vaccine studies, and potential for risk assessment of health care workers. Immunoassays are already on the market in some countries, but their diagnostic accuracy and optimal use remain undefined.
Never has Clinical Diagnostics been so centre-stage and now called upon to lead through this pandemic. Equally never has Quality Control been more important in allowing laboratories to release patient results with confidence.
“Demand better quality. Demand data on validation studies, sensitivity, specificity. Conduct those studies in your own lab. Share them with your colleagues. You should add third-party controls to your methods as soon as possible” James Westgard on COVID-19 testing