Cytokine detection, these new regulations you need to know

Q1: Why is the detection value of cytokines more important in clinical practice?

A1: Cytokines are widely used in the diagnosis and treatment of infectious diseases, hematological tumors, immunotherapy, transplantation, rheumatic immunity and other diseases. Timely and regular monitoring can help clinicians evaluate the immune status of patients. It is mentioned in the diagnosis and treatment related to the new crown: "Severe and critically ill patients often have elevated inflammatory factors. It is recommended to test cytokines conditionally", which also makes the clinic pay more attention to the diagnostic value of cytokines in various diseases, and the requirements for cytokine diagnostic reagents are also increasing. higher.


Q2: What regulations does the Food and Drug Administration have on the classified management of cytokines?


In 2013, the State Drug Administration clearly defined cytokine products such as interleukin detection reagents and alpha tumor necrosis factor detection reagents as Class II products for management.

In particular, it can be seen that the Drug Administration has identified its risk level as a moderate risk, and strict control and management are required to ensure its safety and effectiveness.


Q3: In 2021, the "Rules for the Classification of In Vitro Diagnostic Reagents" will be released. What are the new regulations for cytokines?

A3: In October 2021, the State Drug Administration issued the "Rules for the Classification of In Vitro Diagnostic Reagents" and stipulated that:

(1) Reagents used for the detection of other physiological, biochemical or immune function indicators are managed as the second category of in vitro diagnostic reagents;

(2) Calibrators and quality control products used in conjunction with Class I in vitro diagnostic reagents shall be managed as Class II in vitro diagnostic reagents;

(3) Antibody reagents for flow cytometry, antibody reagents for immunohistochemistry, and probe reagents for in situ hybridization with definite diagnostic value, according to their intended clinical use, according to the classification regulations, respectively, according to the second or third category in vitro Diagnostic reagent management.




The existing methodologies of cytokine detection reagents mainly include flow fluorescence and chemiluminescence. Many manufacturers of flow fluorescence have obtained record numbers. With the stimulation of clinical and testing needs, many companies have begun to apply for second-class registration; Luminescence has always been a Class II registered product, and it has been used routinely in more laboratories or clinical departments in the past two years.


● Pinfeng Medical cooperates with Zhonghong Special Inspection to provide a fully automatic chemiluminescence detection solution for cytokines, single-item detection reagents, which can be flexibly combined according to clinical requirements, and support original tubes to be directly tested on the machine, making the operation more convenient.

● Item menu: IL-1β, IL-2, IL-2R, IL-6, IL-8, IL-10, TNF-α