In A Clinical Trial Of An IVD Reagent, If A Comparative Study Is Performed Using A Laboratory Reference Method As A Comparator, Such As DNA Sequencing, GC-MS/MS And So On, Can The Reference Test Be Commissioned?

For some situations where a clinical reference standard does not exist or is not available, and, at the same time, there is still not any similar product approved in China, when designing a clinical trial, a widely accepted and reasonably used laboratory reference method may be chosen to be the comparator, such as DNA sequencing, GC-MS/MS and so on. These methods are not routine laboratory assays, requiring special equipment, instruments and test conditions which clinical trial institutions may not have.

In such cases, the sponsors should try to choose a clinical trial institution with appropriate conditions to perform the tests as much as possible. Some clinical trial institutions that do not have the testing conditions can entrust this part of the study to a specialized testing institution or a laboratory with a certain qualification, and verify if the test results can be accepted. All of the related dossiers should be submitted for registration, including certificate documents for the commission, methodological research data and quality control data of comparison methods. The laboratory of the sponsor should not be chosen to carry out the tests.