Drugdu.com expert's response:

The inclusion of interference samples is necessary in IVD (in vitro diagnostic) clinical trials. According to the requirements of the Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents, subjects enrolled should be considered for inclusion of samples that may interfere with the test. This requirement aims to ensure the accuracy and reliability of IVD reagents in clinical use by evaluating their performance under complex conditions through the inclusion of interference samples.

In practical operations, the selection and preparation of interference samples need to follow certain methods. For example, samples near the upper and lower limits of the reference range and medical decision levels can be selected as test samples, with hemoglobin, rheumatoid factor, and other interferents added to clinical samples. The volume of added interferents should generally not exceed a certain proportion of the total sample volume to ensure the validity of the test.

In addition, the evaluation of interference samples also requires consideration of evaluation methods for interference performance and acceptable criteria. Statistical methods are used to judge whether the difference between the mean values of the interference samples and the control samples is less than the critical bias value or whether it is less than the pre-set clinically acceptable bias, thereby assessing the specificity of the IVD reagent.

In summary, the inclusion of interference samples in IVD clinical trials is essential, as it helps comprehensively evaluate the performance of the reagents and ensures their accuracy and reliability in practical applications. Meanwhile, during the design and execution of the trials, it is necessary to strictly comply with relevant guiding principles and methodological requirements to ensure the scientificity and validity of the trial results.