What Are The Issues To Be Considered When Designing Multi-marker Joint Detection Products? How To Determine Whether Different Combinations Of Multiple Markers Can Be Of Different Specifications In The Same Registration Unit?

When designing a multi-marker joint detection product, first of all, it should be considered that the multiple markers should have a collaborative diagnostic significance, target populations and proper indications, and the multi-marker joint detection is indeed necessary as a laboratory test. Multiple markers without collaborative diagnostic significance are not recommended to be designed as a joint detection reagent.

Different combinations of multiple markers can be of different specifications in the same registration unit. But it should be noticed that it is only limited to the situation where the reaction systems of different markers are relatively independent and not mixed.

For example, there are five test strips for different drug abuse tests (colloidal gold method), of which five test strips and three or four of them can be of different specifications in the same registration unit. Here each test is relatively independent and does not interfere with each other. In the case of different combinations, there is no difference in the performance of each testing item. When applying for registration with different combinations in the same registration unit, submitting evaluation data of the five-strip joint detection kit, as one of the specifications, can cover the verification and confirmation of all packaging specifications.

For another example, different combination tests of multiple markers by hybridization method on chip can be of different specifications in the same registration unit.

And different combinations of multiple PCR tests, of which every PCR test has its independent reaction system, can be placed in the same registration unit.

However, for the case where multiple markers are in the same reaction system, but not independent of each other, the different combinations of the multiple markers cannot belong to the same registration unit as different specifications.

For joint detection reagents that contain different combinations, the product can be named with the related indication. For example, a joint detection reagent containing three, four, and five drug abuse joint test strips, the product can be named ‘”multiple drug abuse test (colloidal gold method)59. However, the single marker test kit cannot be unified in the same registration unit with multiple test kits due to product name and indication are not the same.

If a product includes several different combinations of joint markers, the specification covering all of the markers should be used for the type examination and clinical investigation, and analytical performance study data should cover all markers.