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Amylase detection reagent

A technology for detecting reagents and amylase, applied in the field of medical testing, can solve the problems of lack of testing professionals and insufficient automatic biochemical testing equipment and facilities, and achieve the effects of good sensitivity, low price and easy operation

Active Publication Date: 2013-08-28
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] With the "Eleventh Five-Year" plan for the purchase and strengthening of basic equipment for tertiary and secondary hospitals, hospitals above the middle level have good hardware and software facilities, but grassroots medical institutions, especially health centers, clinics and other units are not fully automatic. Biochemical testing equipment and facilities are generally insufficient, and there is not a sufficient number of testing professionals. Therefore, the establishment of a POCT analysis system that is easy to operate, low in price, and real-time reporting is of great significance to the role of grassroots hospitals in disease prevention and diagnosis and treatment.

Method used

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  • Amylase detection reagent
  • Amylase detection reagent
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Diluent:

[0036]

[0037] Reagent:

[0038]

Embodiment 2

[0040] Diluent:

[0041]

[0042] Reagent:

[0043]

[0044]

Embodiment 3

[0046] Diluent:

[0047]

[0048] Reagent:

[0049]

[0050] The performance of the reagent obtained in Example 1 of the present invention is described below in conjunction with the table.

[0051] 1. Precision

[0052] Table 1. Precision evaluation results

[0053]

[0054] 2. Linear

[0055] The standard serum sample is added with different concentrations of analytes for detection, and the AMY linearity results are shown in figure 1 .

[0056] 3. Methodological comparison test

[0057] Compared with the AMY result value measured on the automatic biochemical analyzer, the results are shown in figure 2 , where the X-axis represents the data measured on the automatic biochemical analyzer Hitachi 7180, and the Y-axis represents the data measured on the POCT analyzer (Taiwan Baosheng International, Amishield, TMO-100) that introduces microfluidic chip technology.

[0058] 4. Detection sensitivity

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Abstract

The invention discloses an amylase detection reagent which comprises a diluent and a reaction reagent, wherein the diluent is composed of a buffer solution, a surfactant, a preservative, a bilirubin interference remover and a vitamin C oxidase; and the reaction reagent is composed of a buffer solution, a substrate, an alpha-glucosaccharase, sodium chloride, calcium chloride, a preservative and a freeze-drying stability protective agent. The detection reagent disclosed by the invention has favorable sensitivity, accuracy, precision and linearity, and can completely satisfy the clinical examination requirements.

Description

technical field [0001] The invention relates to the technical field of medical testing, in particular to an amylase detection reagent used in a POCT analyzer. Background technique [0002] The determination of serum amylase (AMY) is often used as one of the routine inspection items in the clinical diagnosis of acute abdomen, and is generally used as one of the laboratory diagnostic indicators of acute pancreatitis. Acute pancreatitis is one of the common acute abdominal diseases in clinical practice, with a mortality rate of 5-10% and a misdiagnosis rate of 60-90%. When acute pancreatitis occurs, the amylase in the pancreas enters the blood, which increases the amylase content in the blood. Although the detection specificity of amylase is not high enough, the determination of amylase activity is still widely used clinically as an important qualitative index for the diagnosis of acute pancreatitis. [0003] Amylase is an enzyme that can hydrolyze starch molecules. It is abu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/40C12Q1/34
Inventor 邹炳德邹继华沃燕波张桂春黎鹏周海滨
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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