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Direct bilirubin detection reagent

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

Active Publication Date: 2013-10-02
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Diluent:

[0041] Tris hydroxymethyl amino buffer (pH7.0) 0.1mol / L

[0042] TWEEN80 5%

[0043] Proclin300 0.1%

[0044] Vitamin C oxidase 1KU / L

[0045] Reagent:

[0046] Phosphate buffer (pH4.0) 0.1mol / L

[0047] Sodium chloride 45g / L

[0048] Disodium EDTA 2g / L

[0049] Hydroxylamine Sulfate 2g / L

[0050] etidronate 2g / L

[0051] Sodium persulfate 100g / L

[0052] Sulfuric acid 0.1ml / L

[0053] Potassium sorbate 0.1g / L

[0054] Bovine serum albumin 5g / L.

Embodiment 2

[0056] Diluent:

[0057] Tris hydroxymethyl amino buffer (pH7.5) 0.5mol / L

[0058] TRITONX-100 5%

[0059] Methylparaben 1%

[0060] Vitamin C oxidase 2KU / L

[0061] Reagent:

[0062] 2-(N-morpholine)sodium ethanesulfonate buffer solution (pH3.0) 0.5mol / L

[0063] Sodium chloride 45g / L

[0064] Disodium EDTA 10g / L

[0065] Hydroxylamine Sulfate 5g / L

[0066] etidronate 5g / L

[0067] Sodium persulfate 150g / L

[0068] Sulfuric acid 1ml / L

[0069] Proclin300 1g / L

[0070] Trehalose 10g / L.

Embodiment 3

[0072] Diluent:

[0073] 3-Morpholinepropanesulfonic acid buffer (pH6.5) 1.0mol / L

[0074] SPAN20 10%

[0075] Sodium Benzoate 1%

[0076] Vitamin C oxidase 10KU / L

[0077] Reagent:

[0078] Sodium citrate buffer (pH5.0) 1mol / L

[0079] Sodium chloride 45g / L

[0080] Disodium EDTA 5g / L

[0081] Hydroxylamine Sulfate 10g / L

[0082] etidronate 10g / L

[0083] Sodium persulfate 50g / L

[0084] Sulfuric acid 1ml / L

[0085] Proclin300 1g / L

[0086] Fatty alcohol polyoxyethylene ether 10g / L.

[0087] The performance of the reagent obtained in Example 1 of the present invention is described below in conjunction with the table.

[0088] 1. Precision

[0089] Table 1. Precision evaluation results

[0090]

[0091] 2. Linear

[0092] The high-concentration serum samples collected from the hospital were diluted into different concentrations of analytes for detection, and the obtained DBIL linear results are shown in figure 1 .

[0093] 3. Methodological comparison test ...

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Abstract

The invention discloses a direct bilirubin detection reagent. The direct bilirubin detection reagent comprises diluents and reaction reagents. The diluents comprise a buffer 1, a surfactant, an antiseptic and ascorbate oxidase. The reaction reagents comprise a buffer 2, common salt, disodium ethylene diamine tetraacetate, hydroxylamine sulphate, etidronic acid, sodium persulfate, sulfuric acid, an antiseptic and a freeze-drying protective agent. The direct bilirubin detection reagent has good sensitivity, accuracy, precision and linearity and can satisfy clinical examination requirements.

Description

technical field [0001] The invention relates to the technical field of medical testing, in particular to a direct bilirubin detection reagent for a POCT analyzer. Background technique [0002] Direct bilirubin (DBIL) is also called conjugated bilirubin. Unconjugated bilirubin is converted in liver cells and combined with glucuronic acid to form conjugated bilirubin. Determination of DBIL is mainly used to identify the type of jaundice. Elevated serum DBIL indicates that bilirubin is processed by liver cells and the excretion of bilirubin from the biliary tract is impaired. DBIL is one of the routine items of medical examination and plays a very important role in the diagnosis of liver and gallbladder diseases. At present, DBIL is generally detected by various large-scale automatic biochemical analyzers, but due to the high price of large-scale automatic biochemical analyzers and complicated operations, operators need to have relevant professional knowledge and receive corres...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/26G01N21/31
Inventor 邹炳德邹继华沃燕波张桂春周海滨
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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