In vitro diagnostic reagent science knowledge answer (II)

11. Do in vitro diagnostic reagents need to be registered before they are marketed?

Answer: To apply for the registration of Class II and Class III in vitro diagnostic reagents, registration tests should be carried out. The production of registered inspection samples shall meet the relevant requirements of the medical device quality management system, and only those who pass the registration inspection can conduct clinical trials or apply for registration.

The first category of in vitro diagnostic reagents for the record, you can submit a product self-inspection report.

12. Do in vitro diagnostic reagents need to be tested before they are approved for marketing?

Answer: for the first kind of in vitro diagnostic reagents for the record, do not need to carry out clinical trials.

To apply for the registration of Class II and Class III in vitro diagnostic reagents, clinical trials shall be conducted.

One of the following circumstances, can be exempted from clinical trials:

The (I) reaction principle is clear, the design is finalized, the production process is mature, the same variety of in vitro diagnostic reagents that have been marketed for many years and have no record of serious adverse events, do not change the regular use, and the applicant is able to provide data on the evaluation of equivalence with the marketed products;

(II) can demonstrate that the in vitro diagnostic reagent is safe and effective by evaluating clinical samples covering the intended use and interfering factors.

The catalogue of in vitro diagnostic reagents exempted from clinical trials shall be formulated, adjusted and published by the State Food and Drug Administration.

13. What is the intended use of the in vitro diagnostic reagent product?

Answer: the intended use of in vitro diagnostic reagent products is generally approved by the food and drug supervision and administration department, and has its scientific and legal nature, such as "auxiliary diagnosis" and "diagnosis", "early diagnosis", "screening", "treatment monitoring", "personalized medicine" (accompanying diagnosis), etc., at the same time, the instructions should be marked with quantitative detection or qualitative detection, what are the requirements for the sample type, and so on.

The intended use of the product must be consistent with the corresponding contents of the product registration or filing documents, and shall not be exaggerated or changed at will.

Consumers should carefully check the intended use and precautions of the product before purchasing, and consult a doctor or professional to determine whether the product is applicable.

14. What are the special requirements for in vitro diagnostic reagents for consumer use?

Answer: In vitro diagnostic reagents used by consumers themselves should include the evaluation of the cognitive ability of consumers without medical background on the product instructions during clinical trials.

15. Are in vitro diagnostic reagent products valid?

Answer: In vitro diagnostic reagent products are valid.

The validity period of the in vitro diagnostic reagent product refers to the validity period that can be reached under the specified storage conditions, which is clearly marked on the product label; the product should be used within the validity period.

16. Are in vitro diagnostic reagents all liquid?

Answer: In vitro diagnostic reagents are mainly used for in vitro detection of human samples, including reagents, kits, calibrators, quality control products and other products.

In vitro diagnostic reagents are not all liquids, but also test strips and other forms of expression.

17. What are the main aspects of the safety of in vitro diagnostic reagents?

Answer: In vitro diagnostic reagents are used to diagnose whether patients or subjects contain certain infectious agents or whether certain functions of the body are normal, so the reagents themselves need to be safe and non-infectious.

In order to ensure that personnel are not infected by positive substances when using in vitro diagnostic reagents, all materials containing infectious agents shall be inactivated before use.

In order to ensure that the operator is not damaged, the container of each component of the kit should avoid the use of glass materials, try to use plastic products, but also avoid the use of metal aluminum cover, use plastic materials. In the chemical reagent components, avoid the use of strong acids, strong alkali reagents, etc.

18. How to judge the technical performance of in vitro diagnostic reagents?

Answer: The performance of in vitro diagnostic reagents is mainly reflected in three aspects:

1. Analytical performance: mainly includes items such as precision, accuracy, sensitivity, specificity, linear range or measurement range, which may be inconsistent with some technical indicators in the product manual.

Diagnostic performance: the degree of sensitivity and specificity of the detected substance.

3, stability: product production date, expiration date, validity period, and calibration requirements.

The raw materials and processes used in reagents should have clear quality requirements and be verified, and the performance of the final product meets the requirements of clinical use.

The main factors affecting product performance are the establishment of raw materials, process and reaction system, performance evaluation methods, the establishment of internal reference products, clinical evaluation and so on.

19. What are the special requirements for storage of in vitro diagnostic reagents?

Answer: The storage of in vitro diagnostic reagents is quite special and requires certain conditions to do so.

According to the variety and performance of in vitro diagnostic reagents, product partition and classification storage management shall be implemented. The product storage warehouse shall meet the requirements of temperature and humidity, dust prevention, ventilation, light protection, storage period regulations, etc., and shall be equipped with temperature and humidity monitoring and control facilities or equipment, and keep monitoring records.

Most in vitro diagnostic reagents need to be stored in low temperature between 2-8 ℃, a few varieties need to be frozen, and some varieties can be stored at room temperature. Specific requirements are clearly marked in the product specification.

20. Are there any special requirements for the transportation of in vitro diagnostic reagents?

Answer: The transportation of in vitro diagnostic reagents should meet the requirements of transportation conditions and product packaging. If the product instructions and labels require low temperature and cold storage, they shall be transported and stored in low temperature and cold storage facilities in accordance with relevant regulations.