Whether The Samples Can Be Reused For Multiple Times During The Evaluation Of Analytical Performances Of In Vitro Diagnostic Reagents?

The analytical performance of in vitro diagnostic reagents includes multiple contents such as accuracy, precision, limit of detection and specificity. It is necessary to include the samples from different sources, types, concentrations and other characteristics according to the specific requirements for various performances, so as to fully evaluate various performances of product. Therefore, the re-use of samples shall be avoided as far as possible in the evaluation process of analytical performances.