What Should Be Paid Attention To In The Clinical Trials Of In Vitro Diagnostic Reagent?

In clinical trials, when clinical samples of the type specified in the instructions for use (IFU) are tested, attention shall be paid to the conformity of technical contents such as sample collection, sample storage conditions, sample storage time, sample processing methods, etc. The claims in the test reagent IFU shall be supported by preclinical studies, and attention shall be paid to the requirements in the IFU of test reagent, reference reagent and recheck reagent.

For example, clinical trials of nucleic acid detection reagents should note that:

• Sample collection methods shall meet the requirements in the IFU;
• Sample storage time shall be within the claimed shelf life of samples;
• Clinical trials shall be performed using original samples, and extracted DNA or RNA nucleic acid shall not be regarded as original samples;
• The supporting nucleic acid extraction/purification reagent and sample storage solution (if applicable) shall be claimed in the IFU of the test reagent and reference reagent respectively;
• If the IFU of the product has requirements for the purity and concentration of extracted nucleic acid, they should meet the relevant requirements in the IFU of the product.