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CRP latex-reinforced immunonephelometry reagent, its kit and use of kit

An immunoturbidimetric and latex-enhanced technology, applied in the field of medical testing, can solve the problems of poor repeatability, antibody inactivation, time-consuming, etc., and achieve the effect of adapting to a wide range of instruments, simple composition, and good stability

Active Publication Date: 2014-09-17
SUZHOU DIAGVITA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Premixing R1 and R2 will easily cause the antibody in R2 to be inactivated, and the latex particles will easily aggregate, so the kit cannot be stored for a long time
Especially for the determination of whole blood samples, the current commercially available kits require two steps of hemolysis first and then determination, which is time-consuming and has poor repeatability

Method used

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  • CRP latex-reinforced immunonephelometry reagent, its kit and use of kit
  • CRP latex-reinforced immunonephelometry reagent, its kit and use of kit
  • CRP latex-reinforced immunonephelometry reagent, its kit and use of kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] 1. Preparation of assay reagents and kits:

[0048] 1. Dilute the surface carboxylated polystyrene latex particles (103nm) with 50mM pH 6.0 MES buffer to 10ml, the final concentration is 1%;

[0049] 2. Add 200 mg of EDC to the above solution, add 10 mg of CRP antibody from affinity chromatography, and mix at room temperature for 2 hours;

[0050] 3. Add 10ml of 100mM glycine to the above solution for 2 hours to block the excess active groups on the surface of latex particles;

[0051] 4. Centrifuge at 12000rpm for 20 minutes, remove the supernatant;

[0052] 5. Dilute the above-mentioned labeled CRP antibody latex particles to the working concentration with the following buffer solution, and prepare the single-reagent CRP latex enhanced immunoturbidimetric kit with calibrator. Single reagent formula: 35mM DIPSO-NaOH, pH 7.0; 0.2% Triton X-100; 0.7%NaCl; 0.5% BSA; 2% glycerol; 1% trehalose; 0.1% sodium azide.

[0053] 6. CRP calibrator: Dissolve commercially available ...

Embodiment 2

[0069] 1. Preparation of assay reagents and kits:

[0070] 1. Dilute the surface carboxylated polystyrene latex particles (150nm) with 50mM pH 6.0 MES buffer to 10ml, the final concentration is 1%;

[0071] 2. Add 200 mg of EDC to the above solution, add 10 mg of CRP antibody from affinity chromatography, and mix at room temperature for 2 hours;

[0072] 3. Add 10ml of 100mM glycine to the above solution for 2 hours to block the excess active groups on the surface of latex particles;

[0073] 4. Centrifuge at 12000rpm for 20 minutes, remove the supernatant;

[0074] 5. Dilute the above-labeled CRP antibody latex particles to the working concentration with the following buffer

[0075] Degree, together with the calibrator is the single reagent CRP latex enhanced immune turbidimetric kit. Single reagent formulation: 45mM MOPS-NaOH, pH 7.5; 0.3% Tween 20; 0.8%NaCl; 1% gelatin; 5% glycerol; 3% trehalose; 0.1% sodium azide.

[0076] 6. CRP calibrator: Dissolve commercially avai...

Embodiment 3

[0093] 1. Preparation of assay reagents and kits:

[0094] 1. Dilute the surface-aminated polystyrene latex particles (200nm) to 10ml with 50mM pH 6.0 MES buffer, the final concentration is 1%;

[0095] 2. Add 200 mg of EDC to the above solution, add 10 mg of CRP antibody from affinity chromatography, and mix at room temperature for 2 hours;

[0096] 3. Add 10ml of 100mM glycine to the above solution for 2 hours to seal the latex

[0097] Excess active groups on the particle surface;

[0098] 4. Centrifuge at 12000rpm for 20 minutes, remove the supernatant;

[0099] 5. Dilute the above-labeled CRP antibody latex particles to the working concentration with the following buffer

[0100] Degree, together with the calibrator is the single reagent CRP latex enhanced immune turbidimetric kit. Single reagent formulation: 55mM Tris-HCL, pH 8.0; 0.4% Triton X-100; 0.9% KCl; 1.5% BSA; 8% glycerol; 5% trehalose; 0.1% sodium azide.

[0101]6. CRP calibrator: Dissolve commercially ava...

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Abstract

The invention provides a CRP latex-reinforced immunonephelometry reagent. The CRP latex-reinforced immunonephelometry reagent comprises CRP antibody-labeled latex particles, a buffer, a surfactant, an inorganic salt, a stabilizing agent, a suspending assistant, an excipient and an antiseptic. The invention also provides a kit for single-reagent CRP latex-reinforced immunonephelometry and a use thereof. The CRP latex-reinforced immunonephelometry reagent has simple composition, can be used simply and conveniently, has a fast reaction rate, high sensitivity and good repeatability, can be operated by a simple apparatus, has a wide apparatus adaptation range, has a low cost, can be widely used in large, middle and small hospitals and is suitable for clinical fast infection diagnosis and infection prognosis evaluation.

Description

technical field [0001] The invention relates to the field of medical detection, in particular to a CRP latex-enhanced immune turbidimetric quantitative assay reagent, a kit and an application thereof. Background technique [0002] CRP is one of the important proteins in the acute phase response protein, and it is a sensitive inflammatory marker, and its blood concentration rises sharply during acute trauma and infection. The content of CRP in normal human serum is very small, but in the case of infection, inflammatory disease, tissue damage, surgical trauma and tissue necrosis, it rises rapidly within a few hours, and continues to rise sharply, reaching the peak at 24-72 hours. After the lesion subsides, CRP can drop rapidly to normal. The speed, magnitude and duration of CRP rise are closely related to the severity of the disease and tissue damage, and are not affected by radiotherapy, chemotherapy, corticosteroids and other treatments. Therefore, CRP is more sensitive an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N21/82
CPCG01N33/539G01N33/544G01N33/6803
Inventor 王滨赵年福吴一凡刘飞
Owner SUZHOU DIAGVITA BIOTECH
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