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.
