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Common Problems with in Vitro Diagnostic Reagents

In vitro diagnostic reagents refer to in vitro diagnostic reagents managed by medical devices, including in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation, and health status evaluation. Reagents, kits, calibrators, quality control products and other products used for in vitro testing of human samples. It can be used alone or in combination with instruments, appliances, equipment or systems.


Ⅰ. Which in-vitro diagnostic reagents belong to drug management?


According to the requirements of blood donor health examination GB 18467-2011, the content of blood test after donation includes: blood type test (ABO and RhD blood type positive determination type), alanine aminotransferase, hepatitis B virus test, hepatitis C virus test, HIV testing and syphilis testing meet relevant requirements. The in vitro diagnostic reagents for blood screening are to ensure the safety of blood transfusions and avoid the blood-borne transmission of HIV and hepatitis viruses.


For radionuclide-labeled in vitro diagnostic reagents, the most approved by CFDA is radioimmunoassay kits. Radioimmunoassay is a method that uses isotope-labeled and unlabeled antigens to react competitively with antibodies to determine immune substances in the human body.


Ⅱ. What are the in vitro diagnostic reagents


1. Calibrator


2. Quality control products


3. Kits, such as C-reactive protein detection kits, etc.


4. Reagents for in vitro diagnostics


5. Other


Ⅲ. Which medical institutions use in vitro diagnostic reagents


In vitro diagnostic reagents belong to the category of medical device management. The use of medical devices in our country refers to institutions that use medical devices to provide medical and other technical services to others, including medical institutions that have obtained a medical institution practice license, and family planning technical service institutions that have obtained a family planning technical service agency license. As well as blood stations, plasma collection stations, and rehabilitation assistive device adaptation institutions that do not need to obtain a medical institution's practice license in accordance with the law.


Ⅳ. What are the performance evaluations of in vitro diagnostic reagents


1. Analytical performance: mainly includes precision, accuracy, sensitivity, specificity, linear range and other performance.


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


3. Stability: product expiry date, transportation stability, bottle opening stability, and accelerated stability, etc.


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 that affect the performance of in vitro diagnostic reagents include the establishment of raw materials, processes and reaction systems, performance evaluation methods, establishment of internal reference products, and clinical evaluation.


Ⅴ. Why is the core raw material of IVD reagents a breakthrough point in the IVD industry


The quality of in vitro diagnostic reagents is largely determined by the upstream core raw materials. Core materials such as diagnostic enzymes, primers, antigens, antibodies, etc., are the most important strategic nodes in the upstream of the in vitro diagnostic reagent industry, and their quality is the most important factor that determines the quality of in vitro diagnostic reagents. Among them, a good antibody is a prerequisite for making a good reagent, and a high-quality antibody can exert its best performance under the most suitable reagent preparation conditions. However, after the antibody is modified and coupled, the final immunoassay analysis system needs to go through a variety of complicated processes, and any change in any one of them will have an impact on the final reagent performance.


Moreover, our country's IVD raw materials are currently mainly dependent on imports. From the perspective of the long-term development of the industry, we must master the raw material preparation technology. In recent years, the number of IVD raw material manufacturers has continued to increase, and the quality of raw materials has also been continuously improved, which has greatly promoted the development of my country's in vitro diagnostic industry.