What is the detection system for in vitro diagnostic reagents?

The detection system of in vitro diagnostic reagents is a combination of sample processing products, detection reagents, calibrators, quality control products, and applicable instruments. The entire detection system has been fully evaluated and approved for safety and effectiveness.

During the product registration process of in-vitro diagnostic reagents, regardless of whether they contain other products that have completed the test, the supporting products should be specified in the instructions to ensure that the testing process is carried out in accordance with the detection system composed of all supporting products. For example, for nucleic acid detection reagents that do not include extraction reagents, in the process of performance evaluation and clinical evaluation, the supporting extraction reagents stated in the instructions should be used.

Similarly, if a comparative reagent is involved in the application materials, it should be operated in accordance with its approved testing system. If, if the complementary extraction reagents claimed in the instructions of the non-comparative reagents are used to extract nucleic acids and carry out subsequent tests, the test results obtained have not been fully verified and confirmed and cannot be used as the basis for evaluating the assessment reagents.

What are the requirements for the anticoagulant used in the sample in the clinical trials of in vitro diagnostic reagents?

When the test samples of in vitro diagnostic reagents involve different anticoagulants, different anticoagulants should be studied in the pre-clinical research stage to verify the applicability of the anticoagulants and their influence on the detection. Under normal circumstances, if the pre-research found that the available anticoagulants in the instructions do not have a differential impact on sample detection, there is no need to group into samples using different anticoagulants during the clinical trial process. All applicable anticoagulants can be found in Used in clinical trial samples; under special circumstances, when different anticoagulants have a significant impact on the test results, leading to different reference values ​​for the judgment of clinical test results, etc., sample collection and research should be conducted separately in clinical trials.

What are the main forms of in vitro diagnostic reagent test results?

At present, in-vitro diagnostic reagents are used for testing and testing, and the results report mainly has three forms:

The first is qualitative testing: the result is either "negative" or "positive". For example, if the test shows HBsAg positive, it means that the patient has hepatitis B virus. The second is semi-quantitative detection: mainly to detect titer, which is often used for antibody determination, such as anti-nuclear antibody 1:16, etc., which is a semi-quantitative report form. The third is quantitative testing: using specific numerical reports (also the most frequent method on the current inspection report). Looking at the report sheet that uses numerical values ​​to report the inspection results, you must pay attention to the measurement unit behind the item. The measurement unit is different, the data obtained is also different, and sometimes the difference is thousands of times. When judging the change trend of an index test result, don't just look at the numbers, but pay attention to the unit. Only when the unit of measurement is the same can the results be comparable.