Drugdu.com expert's response:

The analytical performance evaluation documents of in vitro diagnostic reagent products are crucial files ensuring the quality and accuracy of reagent products. To comprehensively evaluate the analytical performance of reagent products, the following information is typically required:

I. Basic Information

Registrant Name: Clarifies the responsible entity for easy traceability by regulatory authorities.

Product Name: Ensures the accuracy of the reagent product being evaluated.

II. Performance Evaluation Scheme and Requirements

Evaluation Method: Detailed description of the adopted evaluation method, including experimental design, operational steps, etc.

Evaluation Requirements: Clearly defined evaluation standards and judgment criteria.

III. Reagent Information

Name, Batch Number, Expiry Date: These details facilitate tracing the reagent's source and quality, ensuring the evaluated reagent is within its validity period and of stable quality.

Calibrator and Control Material Information: If calibrators and control materials are used, their relevant information should also be provided to ensure the accuracy and reliability of the evaluation.

IV. Instrument Information

Model, Serial Number (SN): Reflects the instrument's performance and calibration status, significantly impacting the evaluation results.

V. Evaluation Time and Location

Time: Records the specific time of the evaluation, aiding in analyzing the time-dependency of the evaluation results.

Location: Provides information on the evaluation site, aiding in understanding the experimental environment and conditions.

VI. Testing Personnel Information

The professional qualifications and operational proficiency of testing personnel have a significant impact on evaluation results. Therefore, information such as the names, professional backgrounds, and qualification certificates of the testing personnel should be provided.

VII. Performance Evaluation Data and Analysis Judgment

Specific Data: Provides specific data collected during the evaluation process, including experimental results, measurements, etc.

Analysis Judgment: Analyzes and judges the collected data based on evaluation standards and requirements to draw evaluation conclusions.

Additionally, for certain specific types of in vitro diagnostic reagent products, such as chemiluminescent immunoassay reagents, extra information may be required, such as the source of calibrators, the assignment process, measurement uncertainty, and studies on the impact of interfering substances in samples on test results.

In summary, the analytical performance evaluation documents of in vitro diagnostic reagent products should contain comprehensive and accurate information to ensure the accuracy and reliability of the evaluation. This information not only aids regulatory authorities in understanding the performance and quality of reagent products but also provides important references for clinical use and decision-making.