Drugdu.com expert's response:

In the analytical performance evaluation of IVD (In Vitro Diagnostics), the requirement to use samples from different sources for research is primarily based on the following considerations:

I. Influence of Matrix Effects

For IVD products, the detection targets are typically human tissues or fluids, particularly liquid samples such as blood and urine. These samples contain various substances such as salts, proteins, lipids, etc., which collectively constitute the matrix of the sample. Different human samples, or even samples from the same individual at different time points, may exhibit variations in their matrices. This matrix variation can impact the test results of reagents, known as matrix effects. Matrix effects are objectively present but can be controlled through scientific methods. Therefore, when conducting analytical performance evaluations of IVD products, it is necessary to use samples from different sources as much as possible to fully consider the impact of matrix effects on test results and to control them from the source.

II. Representativeness and Diversity of Samples

Samples from different sources possess varying degrees of representativeness and diversity. These samples may originate from different times, locations, and applicable populations with different characteristics (e.g., age, gender, ethnicity). By using these samples from different sources for evaluation, a more comprehensive understanding of the detection capabilities and accuracy of IVD products can be obtained. This evaluation method helps to uncover the performance of the product under different conditions, thereby providing a more reliable basis for its clinical application.

III. Enhancing Reliability and Accuracy of Evaluation Results

Using samples from different sources for evaluation can also improve the reliability and accuracy of the evaluation results. Due to the differences among different samples, using samples from a single source for evaluation may not fully reflect the product's performance. However, by using samples from multiple sources for evaluation, the detection capabilities and accuracy of the product can be more accurately assessed, thereby providing more reliable support for its clinical application.

In summary, the requirement to use samples from different sources for research in IVD analytical performance evaluations is to fully consider the influence of matrix effects, enhance the representativeness and diversity of samples, and improve the reliability and accuracy of evaluation results. These measures help ensure the accuracy and reliability of IVD products, providing more powerful support for clinical diagnosis and treatment.