Attachment 3: This guideline is intended to guide applicants on the C-reactive protein assay kit, including the conventional C-reactive protein assay kit/supersensitive (high-sensitivity) C-reactive protein assay kit/full-range C-reactive protein assay kit. The preparation and writing of the application materials also provide reference for the technical review department to review the registration application materials. This guideline is a general requirement for the C-reactive protein assay kit. Applicants should determine whether the content is applicable based on the specific characteristics of the product. If not, the reasons and corresponding scientific basis should be specified, and registration application materials should be enriched and refined based on the specific characteristics of the product. This guiding principle is a guidance document for applicants and reviewers. It does not involve administrative matters such as registration approval, nor is it enforced as a regulation. If there are other methods that can meet the requirements of the regulations, it can also be used, but detailed research should be provided. Data and verification data should be provided. This guidance should be used in accordance with the relevant regulations. This guiding principle is formulated under the current regulations, standards system and current cognitive level. With the continuous improvement of laws and standards system and the continuous development of science and technology, the relevant content of this guiding principle will be adjusted in a timely manner.
Scope of application This guideline applies to clinical chemical in vitro diagnostic reagents for the quantitative detection of C-reactive protein in human serum or plasma in medical laboratories based on the principle of spectrophotometry using manual and semi-automatic, fully automated biochemical analyzers. (box). This guideline does not apply to:
Evaluation of C-reactive protein calibrators and controls.
Various types of colloidal gold mark test paper. 2.The registration application requirements 2.1 Summary information C-reactive protein (CRP) is synthesized by hepatocytes and is produced during the fetal period and is not transmitted from the mother’s placenta. The mechanism is: when the body is infected or the tissue is damaged, macrophages and other white blood cells are activated, producing interleukin-6 (IL-6), interleukin-1 (IL-1), tumor necrosis factor. When cytokines such as TNF-a and other C-reactive Protein Assay Kit Registration Technical Review Guideline (2016 Revision) — 2 —— mediators reach the liver, they stimulate the synthesis of CRP by hepatocytes and epithelial cells. Structurally, CRP contains five polypeptide chain subunits, which are non-covalently bound to discshaped polymers with a molecular weight of 115,000 to 140,000. CRP is a typical acute phase protein. The full C-reactive protein includes conventional C-reactive protein (conventional CRP) and high-sensitivity C-reactive protein (hsCRP). One-time detection of conventional CRP and hsCRP is called full-range C-reactive protein detection. Conventional CRP and hsCRP are chemically indistinguishable and are the same substance, except that the quantitative lower limit of the detection method is different. Conventional CRP assays include qualitative, semi-quantitative, and quantitative assays that can be used to assess infection, tissue damage, and inflammatory diseases. For routine CRP measurements, the reference value is generally considered to be value that is clinically higher than 10 mg/L. The CRP level in the blood of healthy people is less than 5 mg / liter, and under various conditions, the CRP value reaches about 20 to 500 mg / liter within 4-8 hours of acute inflammation. Conventional CRP as an acute inflammation assessment index is more sensitive and reliable than erythrocyte sedimentation rate (ESR) and white blood cell count. The low-end range of high-sensitivity C-reactive protein is lower than that of conventional CRP. This lower range can be used to expand the indications. C-reactive protein is non-specific and must be combined with clinical symptoms to assess the risk of a specific disease or disease. This factor alone can not be used as basis of diagnosis.
