Answers to frequently asked questions about in vitro diagnostic reagents (Q&A)

People basically use in vitro diagnostic reagents (IVD) when they go to the hospital or go for a physical examination. In vitro diagnostic reagents are the "doctor's eyes", which can assist clinicians in diagnosing the condition, observing curative effects, and adjusting treatment plans. Product quality and safety level are an important basis for ensuring the correctness of relevant test results and diagnosis.

As people’s demand for health and disease prevention and treatment services grows, in the process of medical and health services, the public’s awareness of the quality and safety of diagnostic reagents is getting stronger and stronger. For the test results of one item in multiple hospitals, for one item The comparison of test results in different time periods in the same hospital has begun to require knowledge and attention to quality control, which also requires high attention and common progress from all aspects of society!

Different colors of in vitro diagnostic reagents

At present, most of the in vitro diagnostic reagents in my country are regulated in accordance with medical device standards, and some are regulated in accordance with drug standards. The popular science knowledge introduced here is mainly aimed at how to buy correctly, understand the technical parameters that need to be paid attention to when purchasing products, transportation requirements, and storage requirements during use. It has certain guidance and help for readers to understand, correctly understand and apply in vitro diagnostic reagents. Here are a few frequently asked questions and answers.

1. 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 precision, accuracy, sensitivity, specificity, linear range or measurement range, etc., which may be reflected in some technical indicators in the product manual There is not a complete agreement.

2. Diagnostic performance: the degree of sensitivity and specificity to the tested substance. 3. Stability: the production date, expiration date, expiration date, and calibration requirements of the product.

The raw materials and processes used in the reagents should have clear quality requirements and have been verified. The performance of the final product meets the requirements for clinical use. The main factors affecting product performance include the establishment of raw materials, processes and reaction systems, performance evaluation methods and methods, the establishment of internal reference products, and clinical evaluation.

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

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

According to the types and performance of in vitro diagnostic reagents, product partitioning and classified storage management should be implemented. The product storage warehouse shall meet the requirements of temperature and humidity, dustproof, ventilation, protection from light, and storage period regulations, and shall be equipped with temperature and humidity monitoring and control facilities or equipment, and maintain monitoring records.

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

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

Answer: The transportation of IVD reagents should meet the requirements of transportation conditions and product packaging. Product manuals and labels that require low temperature and refrigeration shall be transported and stored in low temperature and refrigeration facilities in accordance with relevant regulations.