Can Frozen Samples Be Used In Clinical Trials Of IVD Reagents?

In the clinical trials of IVD reagents, it is necessary to use samples of the subjects that meet the enrollment criteria for the clinical trial. At the same time, it should be noted that the sample collection, storage and transportation conditions should meet the requirements mentioned in the instructions for use. The operations of sample processing, testing, and data analysis in clinical trials should be as much as possible consistent with the clinical use process of the reagents after marketing. If the kit can only be tested on freshly collected samples in clinical use, freshly collected samples should be used for clinical trials. If there may be a sample preservation process during clinical use (such as frozen storage under certain conditions), and the corresponding sample storage conditions and expiry date are specified in the instructions for use, some samples under the corresponding storage conditions may be included in the clinical trial. It should be noted that the storage conditions and storage period of the samples in the clinical trial should be ensured to meet the requirements of the corresponding product instructions for use.