Monday, May 10, 2021

In vitro diagnostics for COVID-19 testing


In vitro diagnostics for COVID-19 testing has come to demand due to the spread of the deadly virus. The demand for molecular testing, regarded as the gold standard for diagnosing infectious disease, has exploded. While the disease remains uncontained, such demand is likely to keep growing.  Meanwhile, the rush to meet it has already driven four main developments in the IVD industry

The highly contagious nature of this respiratory disease challenges advanced viral In vitro diagnostics for COVID-19 technologies for rapid, scalable, affordable, and high accuracy testing. There has been a chronic shortage of diagnostics in these countries and a high demand for quality testing equipment. Testing remains a crucial step in controlling the COVID-19 pandemic. 

There are several types of SARS-CoV-2 and in vitro diagnostics for COVID-19 tests:

  • Diagnostic Tests: Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
  • Serology/Antibody and Other Adaptive Immune Response Tests: Tests that detect antibodies (for example, IgM, IgG) to the SARS-CoV-2 virus or that measure a different adaptive immune response (such as, T cell immune response) to the SARS-CoV-2 virus. These types of tests cannot be used to diagnose a current infection.
  • Tests for Management of COVID-19 Patients: Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation.

Types of In vitro diagnostics for COVID-19 Testing Kits Available

  • Molecular Assays: These are the most widely adopted diagnostics tests for COVID-19. Molecular diagnostic assays are meant to detect the presence of viral RNAs that are very specific to the SARS-CoV-2 virus, which causes COVID-19. Polymerase chain reaction (PCR) is the process involved in these assays
  • Immunoassays: ELISA (enzyme-linked immunosorbent assays) is a type of immunoassay that has a greater advantage over PCR. Antigens and antibodies are considerably more stable than RNA, thus reducing the chance of false-negative results. 
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