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Bladder chalone C determining reagent kit

A technology for detecting kits and cystatin, which is applied in the field of medical immunology in vitro diagnosis, can solve the problems of unavailable measurement, long measurement time, and inability to be fully automated, and achieve high clinical application value, good accuracy, and strong anti-interference ability Effect

Active Publication Date: 2009-03-04
BEIJING STRONG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the presence of radioactive contamination in the RIA method, the FIA ​​method requires expensive instruments, and the RIA, FIA, and EIA methods take a long time to measure and cannot be fully automated, so they cannot be used for the determination of large quantities of clinical specimens

Method used

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  • Bladder chalone C determining reagent kit
  • Bladder chalone C determining reagent kit
  • Bladder chalone C determining reagent kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1 detection reagent and standard preparation and assay method

[0021] The main raw materials needed for detection kit of the present invention and standard are as follows:

[0022] 1 Rabbit anti-human cystatin C polyclonal antibody, entrusted to our company to make it according to conventional methods, this antibody only reacts with human cystatin C, has no immune cross-reaction with other antigens, and the titer can meet the requirements of this reagent.

[0023] 2 polystyrene latex, there are many commercial latexes available on the market, including American sigma company and Japanese UNF company; latex particles with various diameters can be selected, and the present embodiment only uses a diameter of 100-150nm as an example Experiments are carried out on latex particles, and the corresponding reagent detection dominant wavelength is 570nm.

[0024] 3 Pure recombinant human cystatin C (purchased from Dako Company) was used to prepare the standard required...

Embodiment 2

[0031] Embodiment 2: Correlation test and sensitivity test of detection reagent

[0032] 1 Correlation test

[0033] Respectively use the reagent of the present invention (the specific formula is the same as in Example 1) and the commercially available cystatin C latex-enhanced reagent of Company A, and adopt the Olympus AU400 automatic biochemical analyzer to test 50 parts of human serum (including normal and abnormal specimens) were measured at the same time according to their respective parameters. The main parameters of our reagents were the same as above, that is, the determination method of cystatin C reagent. Correlation analysis was carried out on the measured values ​​(see results in image 3 , X and Y axes are measured values ​​(mg / L of cystatin C content). The correlation coefficient of the two tests is R 2 =0.9919, the regression equation is y=1.1119x-0.2466. The results show that this reagent has a good correlation with imported reagents in the determination of...

Embodiment 3

[0047] Embodiment 3: the anti-interference test of detection reagent

[0048] The present invention has carried out anti-interference test to detection reagent (specific formula is the same as embodiment 1) and control reagent simultaneously, and test result is as shown in table 3, after adding interfering substance, the relative error to various interfering substances is all within 10%. . The relative errors of the control reagents for various interfering substances are all more than 10%. It shows that even if there is a certain concentration of interfering substances including hemoglobin, bilirubin, Vc, triglyceride, etc. in the detection sample, it has little effect on the measurement results of the present invention.

[0049] table 3:

[0050] interferer This reagent Relative error A company reagent Relative error sample+water 0.48 ----- 0.61 ---- Sample+1600mg / dl glycerol

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Abstract

The invention discloses a latex intensified immunological turbidimetry kit for detecting cystatin C in serum or plasma. The kit adopts antibodies which resist the cystatin C coated by latex to generate chain reaction with cystatin C to be detected, latex gathers layer by layer by immunoreaction to form insoluble immune particle complexes, the particle size of the latex has a change to cause the turbidity to have obvious change, light transmission strength (570 mm) or light scattering strength is used to detect the change, and the concentration of the traget detection object cystatin C in a sample is got from a standard curve made by a cystatin C standard product with the known concentration. The kit comprises a reagent R1, a reagent R2 and the cystatin C standard product. Detection of the cystatin C by the reagents is carried out by latex agglomeration tests, as well as the reagents are ideal endogenous markers for detecting glomerular filtration rate GFR and are more sensitive than and have earlier period than creatinine. Using the method, the sensitivity is high, and the cystatin C with extremely low level can be ensured to be detected, thus the invention has high clinical application value.

Description

technical field [0001] The invention belongs to the field of in vitro medical immunodiagnosis, and relates to an immunoturbidimetric detection reagent. Furthermore, the invention relates to a latex particle-enhanced cystatin C detection kit. Background technique [0002] Cystatin C (Cystatin C) is a low-molecular-weight protein that can be produced by all nucleated cells in the body with a constant production rate. Cystatin C in the circulation is only cleared by glomerular filtration, which is an ideal endogenous marker to reflect changes in glomerular filtration rate, while glomerular filtration rate (glomerular filtration rate , GFR) is an important indicator for monitoring renal function, especially for kidney transplant patients, it is very important to quickly and accurately grasp the changes of glomerular filtration rate. In addition, because the molecular weight of cystatin C is greater than that of creatinine, and it is positively charged, it is more likely to refl...

Claims

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Application Information

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IPC IPC(8): G01N33/546
Inventor 孙国敬
Owner BEIJING STRONG BIOTECH
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