Clinical assay reagent, kit and method

A technology of clinical testing and kits, applied in the field of eliminating ascorbic acid interference, can solve the problems of ascorbic acid interference, affecting the reliability of clinical results, poor anti-interference ability of ascorbic acid, etc., and achieve the effect of increasing reliability

Active Publication Date: 2011-02-02
SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ascorbic acid in serum samples is a substance with redox properties, which may interfere with the results of the chemical oxidation method, resulting in abnormal results and affecting the reliability of clinical results
[0004] At present, the reagents on the market that use the chemical oxidation method to detect substrates, such as the kits for the determination of bilirubin by the vanadate oxidation method, generally have poor anti-interference ability to ascorbic acid, which is also a common problem of chemical oxidation reagents. defect
However, so far there is no relevant literature or patent report on how to solve the problem of ascorbic acid interference in the chemical oxidation method determination process

Method used

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  • Clinical assay reagent, kit and method
  • Clinical assay reagent, kit and method
  • Clinical assay reagent, kit and method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Elimination of ascorbic acid interference test of embodiment 1 peroxide

[0051] Formula Table

[0052] Reagent 1 (pH 3.0)

[0053] Citric acid 25.0g

[0054] Hydroxylamine Hydrochloride 3.0g

[0055] Thiourea 1.0g

[0056] Surfactant 1.0g

[0057] The specific dosage of carbamide peroxide (or hydrogen peroxide, or peracetic acid) is shown in Table 1

[0058] h 2 O to 1.0L

[0059] Reagent 2 (pH 7.0)

[0060] Sodium dihydrogen phosphate 1.0g

[0061] Sodium metavanadate 0.5g

[0062] h 2 O to 1.0L

[0063] The method for determining direct bilirubin in a sample by using the embodiment of the present invention is as follows: add reagent 1 to the sample (calibration tube as a sample) and mix well, and read the absorbance A1 after incubating at 37°C for 3 to 5 minutes; add reagent 2, mix well , read the absorbance A2 after reacting at 37°C for 5 minutes; according to the formula: direct bilirubin content = measured absorbance (A2-A1) × calibration solution / ca...

Embodiment 2

[0069] Elimination of ascorbic acid interference test of embodiment 2 persulfate

[0070] Formula Table

[0071] Reagent 1 (pH 3.0)

[0072] Citric acid 20.4g

[0073] Hydroxylamine Hydrochloride 1.5g

[0074]Thiourea 0.8g

[0075] Surfactant 1.5g

[0076] The specific dosage of potassium persulfate (or sodium persulfate) is shown in Table 2

[0077] h 2 O to 1.0L

[0078] Reagent 2 (pH 7.0)

[0079] Sodium dihydrogen phosphate 1.0g

[0080] Sodium metavanadate 0.5g

[0081] h 2 O to 1.0L

[0082] Take by weighing the material in the formula table, take by weighing persulfate wherein by the amount in table 2, by the preparation method among the embodiment 1, prepare the test kit (prescription 12-17) that contains different kinds and concentration persulfate respectively , Formulation 11 is a persulfate-free kit. The sample and detection method for detection are the same as in Example 1. The results are shown in Table 2. The results show that when using the kit c...

Embodiment 3

[0085] Elimination of ascorbic acid interference test of embodiment 3 sulfate

[0086] Formula Table

[0087] Reagent 1 (pH 3.0)

[0088] Citric acid 25.0g

[0089] Hydroxylamine Hydrochloride 1.5g

[0090] Thiourea 1.2g

[0091] Surfactant 3.0g

[0092] The specific dosage of sodium sulfite (or sodium bisulfite) is shown in Table 3

[0093] h 2 O to 1.0L

[0094] Reagent 2 (pH 7.0)

[0095] Sodium dihydrogen phosphate 1.0g

[0096] Sodium metavanadate 0.5g

[0097] h 2 O to 1.0L

[0098] Take by weighing the material in the formula table, take by weighing the sulfite wherein in the amount in table 3, by the preparation method in the embodiment 1, prepare the test kit (prescription 19-24) that contains different kinds and concentrations of sulfite respectively , Formula 18 is a sulfite-free kit. The sample and detection method for detection are the same as in Example 1. The results are shown in Table 3. The results show that when using the kit containing the sul...

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Abstract

The invention discloses a clinical assay reagent for eliminating interference of ascorbic acid in the clinical assay process of oxidizing a substrate by a substrate oxidant. The reagent contains a peroxide, persulfate, sulfite, inorganic ions and acid radical ions with oxidability. The invention also discloses a kit comprising the reagent, a preparation method for the reagent and a method for eliminating the interference of the ascorbic acid in process of detecting a clinical sample through chemical oxidation. The reagent can eliminate the interference of the ascorbic acid in the clinical assay process and improve the accuracy of detection results.

Description

technical field [0001] The invention relates to a clinical detection reagent and method, in particular to a detection reagent capable of eliminating ascorbic acid interference, a preparation method, a kit and a method for eliminating ascorbic acid interference in the process of detecting a substrate by a chemical oxidation method. Background technique [0002] Ascorbic acid participates in various reactions in the body, such as participating in redox processes, and plays an important role in biological oxidation and reduction and cellular respiration. There is about 1500mg of ascorbic acid in the metabolically active pool of ascorbic acid in a normal adult, and the highest storage peak can reach 3000mg. [0003] Determination of serum bilirubin is an important routine detection item in clinical medicine, an important indicator for the diagnosis and differential diagnosis of jaundice diseases, and is of great significance for understanding the development of diseases. The co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/50
Inventor 蔡锦刚杨薇李希文
Owner SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
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