While quick results, multiple simultaneous testing, the convenience of data collection, and scalability are all advantages of IVD, test reliability and repeatability are the key reasons for superiority.
FREMONT, CA: In Vitro Diagnostic (IVD) tools are more important than ever before in expanding the options for identifying and diagnosing viral-mediated illnesses. With the emergence of SARS-CoV-2, it became critical to identify and anticipate outbreak locations and monitor the virus and variants. It is now the time for IVDs to establish their value in diagnostic testing by providing critical information about the disease's scope, location, and trajectory.
It is critical to be able to assess the infection status of entire populations, including symptomatic patients and asymptomatic carriers, as well as the possible immunity of people who were at risk or who were exposed to the virus. While quick results, multiple simultaneous testing, the convenience of data collection, and scalability are all advantages of IVD, test reliability and repeatability are the key reasons for superiority.
While accurate testing is necessary for dealing with COVID-19, developing IVDs to combat viruses is not a simple task. Because no diagnostic test can be a one-size-fits-all solution, the IVD test complexity of components and reagents and the test tradeoffs should be carefully evaluated before implementation.
Speed–Time frame from sample collection to final test outcome.
Intended Purpose–IVD target product profile.
Instructions for Use–Dependable testing at scale.
Accuracy–Disease diagnosis without false-positive or false-negative results (sensitivity and specificity valuation to avoid continuous spreading).
Input sample–The source of the sample (oral or nasal swab, blood, sputum).
Costs/pricing–The overall cost of the test, automation possibilities, and so on.
COVID-19 test development has accelerated dramatically in recent years. Because of the rapid spread of disease and the need to conduct large-scale testing, the diagnostic sector has decided to focus its production and development resources on a single purpose. Regardless of the speed or urgency, ensuring the reliability of a test is vital. To preserve correctness and comparability, developers must assure in-depth quality control and quality assurance infrastructure, despite the large number of tests that must be readily available.
Several test formats are currently available or in development to successfully respond to the outbreak:
Molecular diagnostic tests for virus detection, disease diagnosis, and monitoring,
Immunoglobulin G (IgG) or Immunoglobulin M (IgM)-based testing to assess potential immunity, or
Testing to assess viral load.
These tests would allow for quick, point-of-care testing, but they would rely heavily on validated particular antibodies, which would delay their development. All of these test alternatives are based on the reliability of their individual components. Virus-shedding carriers may be mistakenly recognized as virus-free if one fails. A proper validation approach, batch release controls, and verification techniques must be designed for both the IVD analytical and clinical performance to ensure the tests' reliability.