Folic acid detection kit and detection method

A kit and reagent technology, applied in the field of medical analysis, can solve the problems of complicated steps, many interferences, and long time-consuming for detecting folic acid, and achieve the effects of eliminating adverse effects, accelerating dissociation speed, and shortening reaction time.

Pending Publication Date: 2022-01-28
深圳市希莱恒医用电子有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The embodiment of the present invention provides a kit for detecting folic acid and its use method, which solves the technical problems of complex steps, long time-consuming and much interference in the operation of detecting folic acid

Method used

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  • Folic acid detection kit and detection method
  • Folic acid detection kit and detection method
  • Folic acid detection kit and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Embodiment 1: measurement blank limit and detection limit:

[0074] Limit of blank (LoB): the maximum value in the series of results of the blank sample; limit of detection (LOD): the specific analytical method that can detect the tested substance from the sample within a given confidence level. The minimum concentration or amount of a substance. The so-called "detection" is a specified detection, that is, it is determined that there is a substance to be tested at a concentration higher than that of the blank in the sample. .

[0075] Evaluate the blank limit and detection limit of the kit according to the evaluation method of blank limit and detection limit in CLSI document EP17-A2. Select 5 blank samples and 5 low-concentration level samples, and perform 4 repeated measurements on each sample for 3 consecutive days; blank sample: refers to the sample without the test substance; low-concentration sample: refers to the test substance, and the concentration value range...

Embodiment 2

[0087] Embodiment 2: precision analysis

[0088] The precision of the kit was evaluated according to the precision evaluation method in CLSI document EP05-A3. The experimental design follows the classic 20×2×2 design: use one measurement system, test for 20 days, test 2 batches per day, and test 2 times for each batch. The specific results are shown in Table 3 below.

[0089] Table 3 Calculation results of precision evaluation

[0090]

[0091] As shown in the calculation results of the precision evaluation in Table 3 above, the kit provided in the embodiment of the present application has an intra-laboratory precision of ≤ 6% CV.

Embodiment 3

[0092] Embodiment 3: correlation analysis of kit and Roche kit

[0093] Roche folic acid detection kit (referred to as Roche kit in this application) is currently one of the mainstream methods for detecting folic acid, but its price is relatively high. .

[0094] A folic acid detection kit according to the embodiment of the present invention is used as an assessment reagent, compared with the Roche kit, and 200 serum samples are detected simultaneously by electrochemiluminescence, and the comparison results of the two are as follows:

[0095] regression analysis

[0096] With the control reagent as the independent variable X and the assessment reagent as the dependent variable Y, calculate the simple linear regression equation, and calculate the standard error and confidence interval of the regression coefficient b and the intercept a, and conduct a test to establish a hypothesis:

[0097] The regression model F test and the t test of the regression coefficient b (the test h...

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Abstract

The invention relates to the technical field of chemical analysis and detection, and discloses a folic acid detection kit and a detection method. The kit is composed of an M reagent, a PT1 reagent, a PT2 reagent, an R1 reagent and an R2 reagent; the M reagent is a buffer solution containing streptavidin magnetic particles; the PT1 reagent is a buffer solution containing a reducing agent; the PT2 reagent is an aqueous solution containing a protein denaturant; the R1 reagent is a buffer solution containing biotin labeled folic acid binding protein; and the R2 reagent is a buffer solution containing acridinium ester labeled pteroic acid. According to the present invention, a mild reaction environment is provided for the dissociation and recombination of the folic acid in a sample by optimizing a sample treatment liquid formula and a buffer system; the adverse effects generated in the sample treatment process are effectively eliminated, meanwhile, the dissociation speed of the folic acid molecules is increased, the reaction time is effectively shortened, and the degradation of the folic acid molecules caused by the instability of the structures of the folic acid molecules is avoided; the detection result is good in precision, good in correlation with a Roche kit and high in accuracy.

Description

technical field [0001] The invention relates to the technical field of medical analysis, in particular to a folic acid detection kit and a detection method. [0002] technical background [0003] Folic acid is an important water-soluble vitamin of the B group. The structure of folic acid is composed of a pteridine, which is adjacent to p-aminobenzoic acid through a methylene bridge to form pteroic acid, and then combined with glutamic acid. Folic acid plays an important role in protein synthesis and cell division and growth. When it is deficient, it can reduce hemoglobin production in red blood cells, block cell maturation, and lead to megaloblastic anemia. Therefore, folic acid detection has important clinical significance, and accurate and efficient folic acid detection methods are extremely important. [0004] However, the poor stability of folic acid makes its detection and analysis quite difficult. Folic acid is a photosensitive substance. Special attention should be p...

Claims

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Application Information

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IPC IPC(8): G01N33/82G01N21/76
CPCG01N33/82G01N21/76
Inventor 王小龙徐辉陆建斌王建东
Owner 深圳市希莱恒医用电子有限公司
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