<p dir="ltr" style="line-height: 1.38; margin-top: 0pt; margin-bottom: 0pt;">[size= 15pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap]The clinical validation process for[/size][size= 15pt; font-family: Calibri,sans-serif; color: #1155cc; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: underline; -webkit-text-decoration-skip: none; text-decoration-skip-ink: none; vertical-align: baseline; white-space: pre-wrap] in vitro diagnostic (IVD) regulation[/size][size= 15pt; font-family: Calibri,sans-serif; color: #000000; background-color: transparent; font-weight: bold; font-style: normal; font-variant: normal; text-decoration: none; vertical-align: baseline; white-space: pre-wrap] involves demonstrating that the device accurately detects or measures the target analyte in clinical samples. Manufacturers must conduct studies to prove the IVD's sensitivity, specificity, and overall performance. Regulatory authorities review the clinical data to ensure the test's reliability and safety before granting market approval.[/size]