Calibration product and quality control product for mass spectrometry detection of vitamin D and metabolite thereof, and preparation method and applications thereof

A technology for mass spectrometry detection and vitamins, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of inability to meet clinical precision measurement, large accuracy deviation, and high cost

Active Publication Date: 2019-07-05
BIOSINO BIO TECH & SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the mixed serum of normal people contains 20-35 ng / mL vitamin D metabolites, it is impossible to obtain 0.0 ng / mL blank serum of vitamin D metabolites by means of normal blood collection.
In the prior art, there is a method of using vitamin D metabolite antibody column to extract vitamin D metabolites from the mixed serum of normal people to prepare vitamin D metabolite blank serum, but this method is expensive and not suitable for industrial production and application
At present, the commonly used calibrators and quality controls of vitamin D metabolites are methanol or ethanol solutions of pure vitamin D metabolites. There is a very significant difference between this solution and the serum matrix, which makes the accuracy of the measurement deviate greatly and cannot Meet the needs of clinical precision measurement

Method used

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  • Calibration product and quality control product for mass spectrometry detection of vitamin D and metabolite thereof, and preparation method and applications thereof
  • Calibration product and quality control product for mass spectrometry detection of vitamin D and metabolite thereof, and preparation method and applications thereof
  • Calibration product and quality control product for mass spectrometry detection of vitamin D and metabolite thereof, and preparation method and applications thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0120] The preparation (1) of the mass spectrometry detection of embodiment 1 vitamin D metabolites

[0121] This embodiment provides a calibrator for mass spectrometry detection of vitamin D metabolites. The formula for preparing the matrix of the calibrator is as follows: 50 g / L of hydroxyethyl starch, 50 g / L of bovine serum albumin, and 0.5 g / L of egg yolk phospholipids , Triton100 0.5mL / L, sodium chloride 9g / L, Proclin300 0.5mL / L, natamycin 0.5mL / L.

[0122] The calibrator consisted of the matrix described above and various concentrations of vitamin D metabolites.

[0123] This embodiment provides the preparation method (1L volume) of the calibrator for the mass spectrometry detection of vitamin D metabolites, specifically as follows:

[0124] 1. Preparation of blank matrix

[0125] (1) Preparation of solution A: Accurately absorb 0.5ml of Proclin300 and 0.5ml of natamycin, dissolve them in 50ml of double distilled water, and mix well. Accurately weigh 9g of sodium chlo...

Embodiment 2

[0142] Example 2 Preparation of quality control product for vitamin D metabolite mass spectrometry detection (1)

[0143] 1. Preparation of vitamin D metabolites quality control level 1 and quality control level 2

[0144] The preparation of the blank matrix and high-value solution used for the preparation of quality control products is the same as that in Example 1.

[0145] Mix 100ml of the high-value solution and 800ml of the blank matrix solution to obtain a quality control level 1 (quality control L1) solution.

[0146] Mix 100ml of the high-value solution and 500ml of the blank matrix solution to obtain a quality control level 2 (quality control L2) solution.

[0147] The above solution is divided into 5ml medical brown glass bottles, and the filling volume is 3ml. Perform lyophilization. The freeze-drying process is a conventional freeze-drying process. During the freeze-drying process, the maximum temperature for heating is 37°C. After freeze-drying, semi-finished ...

experiment example 1

[0160] Experimental Example 1 Effect of quality control and calibrator on matrix effect in the detection of vitamin D metabolites

[0161] The evaluation method of matrix effect is a routine method in this field, and a brief description is as follows:

[0162] 1. Materials

[0163] 1.1. Reagents, calibrators and instruments evaluated

[0164] 1.2. Control reagents, calibrators and instruments

[0165] 1.3. Processed sample: it is the object to be evaluated in this experimental example (the calibrator prepared in Example 1 and the quality control product prepared in Example 2).

[0166] 1.4. Fresh human serum samples

[0167] At least 20 cases of fresh human serum samples, the concentration of serum should cover the linear range.

[0168] 2. Operation

[0169] 2.1. Prepare samples

[0170] Prepare samples according to the requirements of 1.

[0171] 2.2. Analysis of the evaluated method

[0172] The processed samples were spiked in 20 cases of fresh human sera and assay...

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Abstract

The invention relates to the technical field of biological detection, and specifically relates to a calibration product and quality control product for the mass spectrometry detection of vitamin D andmetabolite thereof, and a preparation method and applications thereof. The provided calibration product or the quality control product includes a matrix and one or more kinds selected from vitamin Dand metabolite thereof; and the matrix includes polysaccharide substances, protein substances, phospholipid, an electrolyte conditioning agent, a surfactant and a preservative. The matrix effects during sample detection can be effectively reduced by developing a matrix formula of the calibration product and quality control product for the mass spectrometric detection of the vitamin D and metabolite thereof; the calibration product including the provided matrix can realize the high accuracy of mass spectrometry detection systems of the vitamin D and metabolite thereof; and the quality control product including the provided matrix can guarantee the indoor precision of the mass spectrometry detection systems of the vitamin D and metabolite thereof.

Description

technical field [0001] The invention relates to the technical field of biological detection, in particular to a calibrator and a quality control product for mass spectrometry detection of vitamin D and its metabolites, and a preparation method and application thereof. Background technique [0002] Vitamin D (vitamin D) is a sterol derivative with anti-rickets effect, also known as anti-rickets vitamin. At present, it is considered that vitamin D is also a steroid hormone, and the most important members of the vitamin D family are VD2 (ergocalciferol) and VD3 (cholecalciferol). Vitamin D is a derivative of different provitamin D after ultraviolet irradiation. Plants do not contain vitamin D, but provitamin D exists in both animals and plants. Vitamin D is a fat-soluble vitamin with five compounds, among which vitamin D2 and vitamin D3 are more closely related to health. They have the following three characteristics: it exists in some natural foods; 7-dehydrocholesterol pro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/04G01N30/06G01N30/72
CPCG01N30/04G01N30/06G01N30/72G01N2030/042
Inventor 蒋琳陈锦添
Owner BIOSINO BIO TECH & SCI
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