What are the Requirements for Anticoagulants Used in Clinical Trials of In Vitro Diagnostic Reagents?

When different anticoagulants are involved in the test samples of in vitro diagnostic reagents, different anticoagulants should be studied in the preclinical research stage to verify the applicability of anticoagulants and their impact on the test.

In general, it is not necessary to include samples using different anticoagulants in groups during clinical trials. All applicable anticoagulants can be used in the clinical trial samples if the available anticoagulants claimed in the instructions have no differential effect on the sample test according to the previous study.

Under special circumstances, sample collections and research should be carried out separately in clinical trials, when different anticoagulants have a significant impact on the test results, resulting in different reference values for the determination of clinical test results.

The type of sample and the anticoagulant used in the sample should be clearly stated in the clinical trial protocol and report.