Cystatin C detection reagent and method

A technology for detecting reagents and cystatin, which is applied in the field of cystatin C detection reagents, can solve problems such as lack of anti-interference ability, achieve good stability of reagents, high accuracy, and improve work efficiency

Active Publication Date: 2017-10-03
吉林省汇酉生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the kits disclosed in the examples still...

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  • Cystatin C detection reagent and method
  • Cystatin C detection reagent and method
  • Cystatin C detection reagent and method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Embodiment 1: The present invention detects the reagent and method of cystatin C

[0072] The reagents for detecting cystatin C in this embodiment include:

[0073] Reagent 1: ammonium chloride 0.2mol / L, sodium azide 0.05%, Brij-35 0.3%, sodium chloride 150mmol / L, PEG6000 2%, adjust the pH value with ammonia water, pH 7.5;

[0074] Reagent 2: Antibody-coated latex particles (0.1% concentration), Tris-Hcl buffer 50mmol / L, sucrose 3%, gelatin 0.5%, NP30 0.1%, Proclin300 0.3%, pH7.0.

[0075] Wherein, the preparation method of the latex particle coated with antibody is:

[0076] (1) Take 1ml (10mg / mL) of the washed latex particles, add it to 50mL of ethylenediamine (EDA, 1mol / L, pH4.75), and incubate for 90min.

[0077] (2) Add solid EDC to a final concentration of 10 mM, and stir slowly for 90 min.

[0078] (3) Wash thoroughly with pure water, and resuspend in pH7.5 phosphate buffer for the last time.

[0079] (4) Latex particles (99nm in diameter) with an antibody co...

Embodiment 2

[0082] Embodiment 2: the accuracy analysis of reagent of the present invention and method

[0083] Test instrument: Hitachi 7080 automatic biochemical analyzer

[0084] Test samples: blood samples from 20 medical examiners;

[0085] Comparative method kit: commercially available domestic cystatin C kit (latex-enhanced immune turbidimetric method);

[0086] 20 examples of samples were measured respectively with the detection method of Example 1 and the comparison method, and the detection results are shown in Table 1.

[0087] Table 1 analysis results

[0088]

[0089] The results show that the R calculated according to the test results 2 The value is 0.988, which is greater than 0.95, showing that the detection result of the method of the present invention has no obvious difference with the detection result of the comparison kit, and has a relatively high degree of accuracy (degree of coincidence).

Embodiment 3

[0090] Embodiment 3: the precision analysis of reagent of the present invention and method

[0091] Test instrument: Hitachi 7080 automatic biochemical analyzer;

[0092] Test sample: any serum sample:

[0093] Using the detection method of Example 1 and the detection method of Example 3 of the comparative patent (CN201410735830.9 - an improved cystatin C detection kit) to repeat the detection 10 times on the same sample to be tested, the detection results are shown in Table 2.

[0094] Table 2 detects sample cystatin C concentration (10 times) and standard deviation rate (variation coefficient)

[0095]

[0096] The results show that the standard deviation rate of the present invention is 2.4%, less than 10% of the standard requirement, and less than 3.81% of the comparative patent method, indicating that the method of the present invention has relatively high precision.

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Abstract

The invention relates to the technical field of in-vitro diagnostic reagents and particularly relates to a cystatin C detection reagent and method. The detection reagent is composed of a reagent 1 and a reagent 2. The reagent 1 comprises ammonium chloride, polyoxyethylene lauryl ether, sodium chloride, PEG 6000, a preservative and water. The reagent 2 comprises latex microspheres coated with a cystatin C monoclonal antibody, a Tris-HCl buffer solution, sucrose, gelatin, NP30, a preservative and water. The detection reagent has high detection result accuracy, a good precision, a wide linear range, good specificity, good stability and strong anti-interference ability, can be conveniently detected on a full-automatic biochemical analyzer, has a wide application range and is easy to promote.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnostic reagents, in particular to a cystatin C detection reagent and method. Background technique [0002] Cystatin C is a cysteine ​​protease inhibitor with a molecular weight of 13.3KD and consists of 122 amino acid residues. It can be produced by all nucleated cells in the body with a constant production rate. Circulating cystatin C is cleared only by glomerular filtration, is an endogenous marker of changes in glomerular filtration rate, and is reabsorbed in the proximal convoluted tubule, but is completely eliminated after reabsorption It is metabolized and decomposed and does not return to the blood. Therefore, its blood concentration is determined by glomerular filtration, independent of any external factors, such as gender, age, and diet. It is an ideal indicator to reflect changes in glomerular filtration rate. Homology markers. It is a newly developed index with good sensitivity a...

Claims

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Application Information

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IPC IPC(8): G01N33/543G01N33/577G01N21/31
Inventor 董理
Owner 吉林省汇酉生物技术股份有限公司
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