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The in-vitro diagnostic (IVD) test can demonstrate the clinical evidence of a diagnostic test in line with the intended use claims, by providing objective proof through a clinical study done in a simulated environment. The objective of a diagnostic test can be detection or exclusion of disorders, assistance in the decision-making process for further diagnostic and therapeutic management, assessment of prognosis, or monitoring of the clinical course of an ongoing treatment. The manufacturers of the IVD devices used to design the clinical evidence study according to the international regulations/standards and chose a statistically defined sample size. However, the clinical utility of the test can’t be validated by a single study. Additional independent studies were often needed.
The whitepaper defines the importance of clinical utility in payer reimbursement and the suitable test selection in the COVID 19 era. The paper defines various approaches that are followed for conducting meta-analysis and features the best possible approach available till date. The paper also focuses on the different software used for conducting meta-analysis. Download the whitepaper to read more.