Kit and method for detecting concentration of cyclosporine drug in dried blood spot sample

A technology for cyclosporine and drug concentration, which is applied in the direction of measuring devices, types of packaging items, special packaging items, etc., can solve the problems of interference of test results and increased volume, and achieve convenient operation and portability, avoid cross-contamination, and eliminate influence Effect

Pending Publication Date: 2022-04-15
WUXI APPTEC ZK SUZHOU BIOSCIENCE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the HCT increases, the diffusion area of ​​the dried blood film decreases, and the sample volume contained in the dried blood film of the same area increases, resulting in significant interference to the test results

Method used

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  • Kit and method for detecting concentration of cyclosporine drug in dried blood spot sample
  • Kit and method for detecting concentration of cyclosporine drug in dried blood spot sample
  • Kit and method for detecting concentration of cyclosporine drug in dried blood spot sample

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Such as Figure 1-5 As shown, a kit for detecting the drug concentration of cyclosporine in dried blood film samples, including box body 1, inner liner 2, sample extract, dried blood film cyclosporine calibrator, dried blood film cyclosporine The quality control product and the blank quality control product are characterized in that the inner liner 2 is arranged at the bottom end inside the box body 1, and the inner liner 2 is provided with a plurality of accommodating grooves, and jars 3, The first sample collection tube 4, the second sample collection tube 5 and the third sample collection tube 6, the sample extract is stored in the inside of the jar 3, and the dried blood spot cyclosporine calibrator is stored in the first sample collection tube. Inside the tube 4, the dry blood spot cyclosporine quality control product is stored in the second sample collection tube 5, the blank quality control product is stored in the third sample collection tube 6, the first sample...

Embodiment 2

[0053] The composition and preparation method of embodiment two kits

[0054] Based on a test kit in Example 1, the specific components and specific concentrations of the test kit in this embodiment are shown in the following table:

[0055]

[0056] This kit is attached with high, medium and low concentrations of dry blood film cyclosporine quality control substances for quality control of the test results, and a blank control for the specificity and specificity evaluation of cyclosporine , Monitoring of high-concentration sample residues.

[0057] The specific preparation method of the kit is as follows:

[0058] (1) Assembly of sample collection tube and filter paper

[0059] Place the glass fiber filter paper 7 at the bottom of the sample collection tube with tweezers.

[0060] (2) Assembly of desiccant

[0061] Fold the drying sheet and place it in a fixed tube in a low-humidity workshop.

[0062] (3) Preparation of calibrators and quality control products

[006...

Embodiment 3

[0083] Example 3 Using this kit to detect the concentration of cyclosporine in dried blood samples

[0084] The kit for detecting the drug concentration of cyclosporine in the dried blood film sample is used as a carrier, and the internal standard method is used in combination with liquid chromatography tandem mass spectrometer to quantitatively detect the drug concentration of cyclosporine in the dried blood film sample, including the following steps:

[0085] 1) Sample pretreatment:

[0086] First take two third sample collection tubes, add 300 μL of acetonitrile and water mixed solution to one as a double blank sample, the volume ratio of acetonitrile and water is 7:3, and add 300 μL of sample extract to the other as a single blank sample ;

[0087] Then take the first sample collection tube, the second sample collection tube and the sample collection tube of the dried blood spot sample to be tested, add 300 μL of sample extract, let all the sample collection tubes stand f...

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Abstract

The invention discloses a kit and a detection method for detecting cyclosporine drug concentration in a dried blood spot sample, the kit comprises a kit body, a lining, a wide-mouth bottle, a first sample collection tube, a second sample collection tube and a third sample collection tube, the wide-mouth bottle is filled with a sample extraction liquid, the first sample collection tube is filled with a calibrator, and the second sample collection tube is filled with a sample extraction liquid. A quality control product is placed in the second sample collection tube, a blank quality control product is placed in the third sample collection tube, and glass fiber filter paper is arranged in the first sample collection tube, the second sample collection tube and the third sample collection tube and is used as a carrier of a standard product and the quality control product. The detection method based on the kit provided by the invention comprises the following steps: pretreating a sample, loading and detecting the sample by combining a liquid chromatography tandem mass spectrometer, and finally carrying out quantitative analysis on cyclosporine by adopting an internal standard method. According to the invention, the influence of hematocrit effect is avoided, the risk of occupational exposure is reduced, and the detection stability and the practicability of the kit are improved.

Description

technical field [0001] The invention relates to the field of in vitro diagnosis, in particular to a kit and a detection method for detecting the drug concentration of cyclosporine in a dried blood sample. Background technique [0002] Cyclosporine is one of the potent immunosuppressants, and it has a good preventive effect on possible rejection after tissue transplantation and allogeneic organs. Cyclosporine is widely used to improve the survival rate of patients receiving organ transplantation, and many studies have also proved that cyclosporine plays an important role in resisting immune rejection after organ transplantation. Due to the individual variability of cyclosporine pharmacokinetics and a very narrow therapeutic window, the monitoring of immunosuppressants after transplantation is very important to reduce its toxicity and acute rejection, and it is also practical for the implementation of individualized administration. significance. [0003] At present, the moni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/88B65D81/18B65D81/26
Inventor 方焯刘釜均徐鸣成颜森森杨雪马超月
Owner WUXI APPTEC ZK SUZHOU BIOSCIENCE CO LTD
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