When The Reference Intervals Of IVD Reagents Change By Age9 What’s The Requirement For Subject Distribution By Age?

 In the design of clinical trials, in addition to the total sample size, the sample number for positive group and negative group, the stratification and subgroup sample size should also be considered.

If the quantitative IVD kit has different reference intervals in different age groups, samples of the different age groups should be considered when enrolling subjects.

In the case where similar products have been approved, a certain number of subjects in each age group should be included in the clinical trial, and there should be a certain number of subjects in the normal range and abnormal range in each age group.

In the cases where there is not any similar product launched on the market, the number of subjects in each age group should meet the statistical requirements to confirm the established reference intervals.