In the clinical trials of in vitro diagnostic reagents, all tests shall be completed by the institution undertaking the clinical trials. However, a third-party testing institution may be entrusted if all the following conditions are met:
The reference methods for laboratory testing are adopted for the comparison methods,These methods are not routine clinical testing technologies,Require special equipment, instruments and test conditions, andClinical trial institution do not have relevant testing conditions
The test results of the third party shall be recognized by the clinical trial institution. For example,tests for nucleic acid sequencing and GC-MS / MS test could meet the above conditions. However, if the comparison method is a routine clinical test method, such as general pathogen isolation and culture, micro broth dilution method (for in vitro antibiotic susceptibility test), although the test operation is complex and requires special laboratory conditions and testing technology, the test should still be completed by the clinical institution instead of a third-party laboratory. In order to ensure the quality of clinical trials, clinical institutions capable of undertaking relevant trials should be selected to carry out clinical trials. In the process of clinical trials, relevant trials should be strictly standardized, and the consistency evaluation between institutions and operators should be carried out.
