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C-Reactive Protein Assay Kit (Latex-Enhanced Immunonephelometric Assay)
This product is used for the in vitro quantitative determination of C-reactive protein levels in human whole blood samples. Clinically, it is used as an aid in the diagnosis of non-specific inflammation. CRP is a classic acute-phase protein, and its molecule…
Certified
ISO 9001/13485
Delivery
3-7 Days
Specifications
- Model
- C-Reactive Protein Assay Kit
- Specification
- 1×25 mL, 2×25 mL, 4×25 mL
- Intended Use
- This product is used for the in vitro quantitative determination of C-reactive protein levels in human whole blood samples. Clinically, it is used as an aid in the diagnosis of non-specific inflammation. CRP is a classic acute-phase protein, and its molecule…
- Principle
- The kit uses a latex-enhanced immunonephelometric assay. Reagent and sample are mixed; antibody-coated latex microspheres agglutinate with C-reactive protein in the sample, forming complexes that increase turbidity. The CRP concentration is obtained by turbidity analysis and converted to the serum/plasma concentration using the blood cell volume ratio: CRP = CRP'/(100-BCV)×100, where CRP is the converted concentration, CRP' the value from the calibration curve and BCV the cell packed-volume fraction.
- Composition
- Note: reagents not included in the kit but required for testing: the C-reactive protein calibrator produced by our company (Zhejiang medical device registration No. 20252402035), the C-reactive protein quality control (Zhejiang medical device registration No. 20252402030), Hemolysing Agent-LC (Zhejiang Jinhua medical device filing No. 20250042) and Diluent-BCIII (Zhejiang Jinhua medical device filing No. 20150069). 1. Reagents from kits of different lot numbers must not be used interchangeably. 2. Calibrator traceability: this detection system is traceable to the national standard for C-reactive protein (360039) provided by the National Institutes for Food and Drug Control of China.
- Storage Conditions
- 1. Storage conditions: store the kit tightly sealed at 2-8 °C, protected from freezing. 2. Shelf life and stability: the kit is stable for 12 months when stored at 2-8 °C. Open-vial stability: after opening, the reagent is stable for 14 days when stored protected from light at 2-8 °C; do not freeze. Note: see the label for the date of manufacture and the expiration date.
- Other Information
- C-Reactive Protein Assay Kit (Latex-Enhanced Immunonephelometric Assay) Instructions for Use
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