CN210376247U - Imatinib drug concentration detection kit - Google Patents
Imatinib drug concentration detection kit Download PDFInfo
- Publication number
- CN210376247U CN210376247U CN201920500545.7U CN201920500545U CN210376247U CN 210376247 U CN210376247 U CN 210376247U CN 201920500545 U CN201920500545 U CN 201920500545U CN 210376247 U CN210376247 U CN 210376247U
- Authority
- CN
- China
- Prior art keywords
- blood spot
- kit
- quality control
- card
- imatinib
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Images
Abstract
The utility model discloses an imatinib drug concentration detect reagent box, include: the calibration kit comprises a kit body, an internal standard extracting solution container and a calibrator card, wherein the internal standard extracting solution container and the calibrator card are placed in the kit body; the calibration card is a blood spot acquisition card which is fixed with a group of imatinib blood spot samples as blood spot calibration points, and the number of the dried blood spot calibration points is at least 6; the internal standard extracting solution container is internally provided with an internal standard extracting solution, and the internal standard adopts isotope substituted imatinib. The utility model provides a brand-new imatinib drug concentration detects product, the overall layout of this kit is reasonable, has integrated and has detected required reagent and consumptive material, uses convenient operation, portable, and the calibrator (and quality control article) need not additionally to be prepared, uses this kit can effectively shorten to detect consuming time, helps improving the efficiency that the analysis detected.
Description
Technical Field
The utility model relates to an In Vitro Diagnosis (IVD) field, concretely relates to kit that detects is carried out imatinib drug concentration In dry blood spot sample.
Background
Imatinib (Imatinib, trade name: gleevec, research and development number STI-571) was developed by nova corporation, switzerland and approved for marketing by the U.S. Food and Drug Administration (FDA) in 2001. Imatinib for first line treatment of philadelphia chromosome (Ph +) Bcr-Abl positive CML significantly prolongs the overall survival of patients. Imatinib is also used for treating gastrointestinal stromal tumors (GIST), an oral small molecule targeted drug.
The detection of therapeutic drugs refers to the clinical practice of drug therapy, which comprises collecting the blood of patients (sometimes collecting urine, saliva, etc.) at regular time while observing the therapeutic effect of drugs, measuring the drug concentration therein, and discussing the in vivo process of drugs, so as to individualize the administration scheme according to the specific conditions of patients, guided by the basic theories of pharmacokinetics and pharmacodynamics, by means of advanced analysis techniques and electronic computer means, and by using the principle and formula of pharmacokinetics. Thereby achieving satisfactory curative effect and avoiding toxic and side effects, providing valuable laboratory basis for diagnosis and treatment of drug excessive poisoning, and improving clinical medication from traditional experience mode to more scientific level.
Currently, imatinib is determined mainly from plasma as a sample source using analytical methods including liquid chromatography-mass spectrometry (LC-MS), liquid chromatography/tandem mass spectrometry (LC-MS/MS), liquid-ultraviolet detection (HPLC-UV), and liquid-diode array detector (HPLC-DAD). Generally, the LC-MS or LC-MS/MS method needs 200 mu L of blood plasma, and the protein precipitation method is used for sample preparation, so that the sample requirement is large, the pretreatment is complicated, and the time and the labor are wasted. Moreover, blood sample transport and storage requires freezing or cryogenic conditions, is costly and risky, and can only be performed under specific laboratory conditions.
Therefore, the imatinib detection kit which is convenient to use, quick to operate, small in sampling amount, high in accuracy and stable to store is needed in the art.
SUMMERY OF THE UTILITY MODEL
The utility model aims to solve the technical problem that a imatinib drug concentration detect reagent box is provided, can be arranged in to the detection of imatinib drug concentration in the dry blood spot sample, have convenient to use, operation swift, need not additionally to prepare the calibrator, the sampling volume is few, the degree of accuracy is high, save one of at least advantages such as stable.
In order to solve the technical problem, the utility model provides a technical scheme does:
an imatinib drug concentration detection kit, comprising: the calibration kit comprises a kit body, an internal standard extracting solution container and a calibrator card, wherein the internal standard extracting solution container and the calibrator card are placed in the kit body;
the calibration card is a blood spot acquisition card which is fixed with a group of imatinib blood spot samples as calibration points of dry blood spots, and the number of the calibration points of the dry blood spots is at least 6;
the internal standard extracting solution container is internally provided with internal standard extracting solution. The internal standard adopts isotope substituted imatinib. Wherein, the isotopic substitution may be deuterium substitution (D4, D5, D6, D7, D8 substitution, etc.), or C13 substitution, N15 substitution, etc.
In a preferred embodiment, the kit further comprises an openable/closable lid, which is connected to the case body or is independent of the case body. When the box cover is matched and closed with the box body, the kit is kept in a sealed state.
In a preferred embodiment, a lining is arranged in the box body, and the lining divides the interior of the box body into a plurality of accommodating spaces; the plurality of accommodating spaces include:
the calibrator card accommodating space is used for placing and fixing the calibrator card;
the internal standard extracting solution container accommodating space is used for placing and fixing the internal standard extracting solution container.
In a preferred embodiment, the inner lining is a cardboard, sponge, foam or plastic block.
In a preferred embodiment, the liner is removably secured to the interior of the shell.
In a preferred embodiment, the internal standard extraction solution container is a glass bottle, a plastic bottle, or a sample tube.
In a preferred embodiment, the dried blood spot calibration points are circular spots. Preferably, the diameter of the circular spot is 5-10 mm. The at least 6 dried blood spot calibration points have different concentrations of imatinib, and the dried blood spot calibration points are arranged in sequence according to the concentration of imatinib in blood spots.
In a preferred embodiment, the internal standard extracting solution is used for extracting a blood spot sample, and the obtained extract is used for sample injection detection analysis.
In a preferred embodiment, the number of dried blood spot calibration dots is at least 7.
In a preferred embodiment, the number of dried blood spot calibration dots is 7.
In a preferred embodiment, the kit further comprises a quality control card, wherein the quality control card is a blood spot collecting card fixed with at least one group of imatinib blood spot samples as dry blood spot quality control points, and the number of each group of dry blood spot quality control points is at least 3. The dried blood spot quality control point contains imatinib. According to different concentrations of imatinib, each group of dried blood spot quality control points comprises three dried blood spot quality control points, namely a low-concentration quality control point, a medium-concentration quality control point and a high-concentration quality control point.
In a preferred embodiment, the dried blood spot quality control point is a circular spot. Preferably, the diameter of the circular spot is 5-10 mm.
In a preferred embodiment, each set of dried blood spot quality control points in the quality control card comprises a blank control dried blood spot quality control point. The blank control dry blood spot quality control point is blank whole blood which does not contain imatinib.
In a preferred embodiment, the blood spot source of the dried blood spot calibration dots is rabbit blood. In a preferred embodiment, the blood spot source of the dried blood spot quality control point is rabbit blood. In a preferred embodiment, the blood spot source of the blank control dry blood spot quality control point is rabbit blood.
The utility model provides a brand-new imatinib drug concentration detects product, the overall layout of this kit is reasonable, has integrated and has detected required reagent and consumptive material, uses convenient operation, portable, and the calibrator (and quality control article) need not additionally to be prepared, uses this kit can effectively shorten to detect consuming time, helps improving the efficiency that the analysis detected. The utility model discloses a kit can realize detecting imatinib concentration in the imatinib blood spot model that awaits measuring through interior label extract and calibrator card. In addition, a quality control card can be added for testing and quality control of large-batch samples or long-time detection.
The utility model discloses a kit adopts dry blood spot technique to detect imatinib drug concentration, adopts fingertip blood dry blood spot as the sample, has avoided plasma sample collection complicated, is difficult to preserve the drawback of transportation, has solved the blood concentration monitoring among the prior art and has used whole blood, plasma, serum as sample source more, and the blood sample volume is great, the sample is unstable to need cold chain transportation, the sample volume needs enough accurate, pathogenicity and occupation expose a great deal of defect such as the possibility is higher.
The utility model discloses a kit has expanded the possibility of family's sampling, need not to carry out sample acquisition at hospital or appointed institution, and the collection time is nimble, need not cold-stored transportation. The sample matrix is dry, has low biological hazard and can be stored for a long time.
The utility model discloses a kit, with calibrator (and quality control article) sample save in the blood spot card, its nature characteristics are "dry", are different from liquid matrix and easily receive the influence of PH, illumination, temperature, the utility model has the advantages of excellent stability has guaranteed the degree of accuracy of testing result.
The utility model discloses a kit, with the help of the excellent card paper homogeneity of blood spot card, the sample diffusion is even unanimous, adopts the hole puncher can accurately beat the blood spot sample of getting the same area, and the sample is accurate, has eliminated the testing result deviation that liquid matrix sample does not accurately lead to.
Adopt the utility model discloses a kit can trace to the national standard article with imatinib drug concentration detected value to make different laboratory's detected values have comparability.
Drawings
Fig. 1 is a schematic perspective view of a specific embodiment of the kit of the present invention.
Fig. 2 is a layout diagram of a calibrator card according to an embodiment of the kit of the present invention.
FIG. 3 is a layout diagram of quality control cards according to an embodiment of the kit of the present invention.
Description of the symbols in the drawings:
1 is a calibrator card; 11 is the calibration point of the dried blood spots; 2 is a quality control card; 21 is a dry blood spot quality control point; 3 is an internal standard extracting solution container; 4 is a sample plate; 5 is a sealing plate film; 6 is a specification; 7a is a box body; 7b is a box cover; 7c is a lining; LQC is a low-concentration quality control point; MQC is a medium concentration quality control point; HQC is a high-concentration quality control point; blank is a blank control dry blood spot quality control point; l1, L2 are card lengths; h1, H2 are card widths.
Detailed Description
The technical solution of the present invention will be described clearly and completely below, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative efforts belong to the protection scope of the present invention.
As shown in fig. 1, is a schematic perspective view of a specific embodiment of the kit of the present invention. The imatinib drug concentration detection kit comprises: a box body 7a, an internal standard extracting solution container 3 and a calibrator card 1. Wherein, the internal standard extracting solution container 3 and the calibrator card 1 are arranged in the box body 7 a.
The reagent box shown in figure 1 further comprises a box cover 7b, and the box cover 7b can be matched with the box body 7a to achieve the function of closing or opening the reagent box. In fig. 1, the box cover 7b is connected with the box body 7 a; in other embodiments, the lid 7b and the case 7a may be independent of each other. When the box cover 7b is matched and closed with the box body 7a, the reagent box can keep a sealed state. In other embodiments, the case 7a may be directly sealed with a plastic film.
The kit shown in fig. 1, further comprising an inner liner 7 c. The liner 7c partitions the inside of the case 7a to form a plurality of receiving spaces. The accommodation space at least comprises: a calibrator card-accommodating space for accommodating and fixing the calibrator card 1, and an internal standard extracting solution container-accommodating space for accommodating and fixing the internal standard extracting solution container 3. As shown in fig. 1, the liner 7c divides the box body 7a into two accommodating spaces; the inner liner 7c is positioned at the left side of the box body, a recess matched with the shape of the internal standard extracting solution container 3 is arranged on the inner liner 7c, and the recess is cylindrical and is used for placing and fixing the internal standard extracting solution container 3; the recess is an internal standard extracting solution container accommodating space. A calibration product card accommodating space for accommodating the calibration product card 1 is formed between the liner 7c and the inner wall of the case 7a (right side of the case 7 a).
The kit as shown in fig. 1, further comprising: quality control card 2, sample plate 4, cover sheet membrane 5 and instructions 6. Wherein, the sample plate 4 is a 96-hole deep-hole plate or a shallow-hole plate made of polypropylene material and is provided with a transparent cover. Sample board 4 and shrouding membrane 5 are tiled and are placed in the right side of inside lining 7c, and calibrator card 1 and quality control article card 2 are tiled and are placed on sample board 4 and shrouding membrane 5, and description 6 is that vertical laminating box body 7 a's inner wall is placed. The instruction 6 describes the composition information and the method of use of the kit.
In the present invention, the box body 7a may be made of paper or plastic. Preferably, the case 7a is a carton. The lining 7c can be made of various materials which are conventional in the field of reagent kits. Such as cardboard, sponge, foam or plastic blocks. The liner 7c is detachably fixed to the inside of the case 2.
The utility model discloses in, interior mark extract container 3 is in order to choose for use the conventional various solution container in kit field. Such as glass bottles, plastic bottles, sample tubes, etc. The internal standard extraction solution container 3 may be made of a transparent material or a brown material. Preferably, the internal standard extraction liquid container 3 is a brown glass bottle, which can achieve the effect of shading storage.
Fig. 2 shows a layout of the calibrator card 1 according to an embodiment. The utility model discloses in, calibrator card 1 has the blood spot collection card of the dry blood spot calibration point 11 of a set of imatinib blood spot sample formation for the point system, and wherein, the quantity of dry blood spot calibration point 11 is at least 6. The number of dried blood spot calibration dots 11 shown in fig. 2 is 7. The utility model provides a dry blood spot calibration point 11 is to the whole blood sample point system that will contain imatinib on blood spot collection card and form the blood spot. Wherein, each dried blood spot calibration point 11 should have different concentration of imatinib, and the dried blood spot calibration points 11 are arranged in sequence according to the concentration of imatinib in the blood spots. As a preferred embodiment, imatinib in each dry blood spot calibration dot 11 should be arranged in a concentration gradient. In a specific embodiment, the concentration gradient of imatinib in the dried blood spot calibration dots 11 ranges from 50 to 5000ng/mL linear range. In a preferred embodiment, the calibrator card 1 has a card length L1 of 8.5cm and a card width H1 of 5.8 cm.
In a preferred embodiment, the kit of the present invention can be further equipped with a quality control card 2, wherein the quality control card 2 is a blood spot collecting card for spotting dried blood spot quality control points 21 formed by at least one set of imatinib blood spot samples, and the number of each set of dried blood spot quality control points 21 is at least 3. In FIG. 3, two sets of dried blood spot quality control points 21 are shown, and four points are present in each set of dried blood spot quality control points 21. The quality control card 2 has the advantages that in the analysis and detection of a large number of samples or long-time analysis and detection, the quality control can be inserted into the samples at intervals of a certain number for detection so as to verify the accuracy of the detection result, and whether the state of the instrument is good or not and whether the sample pretreatment operation is reasonable or not can be verified. The utility model provides a dry blood spot quality control point 21 is to point the whole blood sample point that contains imatinib on the blood spot collection card and form the blood spot. Each group of dried blood spot quality control points 21 should have three dried blood spot quality control points, namely a low-concentration quality control point LQC, a medium-concentration quality control point MQC and a high-concentration quality control point HQC. The three concentrations of the dry blood spot quality control point 21, i.e., the low, medium and high, fall within the range of the concentration gradient of the dry blood spot calibration point 11. Generally, the concentration of imatinib of the low-concentration quality control point LQC is within 3 times of the minimum value of the concentration gradient, the concentration of imatinib of the medium-concentration quality control point MQC is near the middle point of the concentration gradient range, and the concentration of imatinib of the high-concentration quality control point HQC is 75% -80% of the maximum value of the concentration gradient. Other dry blood spot quality control points 21 with special concentration requirements can also be designed according to the requirements of a specific test scheme. As shown in fig. 3, each group of dried blood spot quality control points 21 has a blank control dried blood spot quality control point blank in addition to the low concentration quality control point LQC, the medium concentration quality control point MQC, and the high concentration quality control point HQC. The blank control dried blood spot quality control point blank is blank whole blood which does not contain imatinib. As shown in FIG. 3, there are two groups of dried blood spot quality control points 21. In other embodiments, three, four, or more sets of dried blood spot quality control points 21 may be provided. In a preferred embodiment, the quality control card 1 has a card length L2 of 8.5cm and a card width H2 of 5.8 cm.
In a specific embodiment of the present invention, the blood spot source of the dried blood spot calibration point, the dried blood spot quality control point and/or the blank control dried blood spot quality control point is rabbit blood. Rabbit blood was supplied from commercial rabbit blood.
The blood spot collecting card used in the utility model can select GE whatman903 card and DMPK-A card, but is not limited to the brand and the model.
In the utility model, the interior label extracting solution container 3 is internally provided with the extracting solution taking imatinib as-D8 as the interior label. The extract is used for extracting the blood spot sample, and the obtained extract is used for sample injection detection and analysis. The extractive solution is methanol, acetonitrile, mixture of methanol and water, mixture of acetonitrile and water, or mixture of methanol, acetonitrile and water. For example, 80% methanol solution is used.
The utility model discloses a use method does: a group of dried blood spots 11(7 points in figure 2) on the calibrator card 1 with the diameter being more than or equal to 3mm are punched into a 96-well plate by a dried blood spot puncher, the dried blood spots of a sample to be detected are punched into the 96-well plate by the dried blood spot puncher, an extracting solution in an internal standard extracting solution container 3 is added, and the extracting solution contains 40ng/mL imatinib-D8 isotope internal standard. Shaking, centrifuging, sucking supernatant into a new 96-well sample plate, centrifuging again, and taking the supernatant to perform LC-MS/MS analysis and detection. Drawing a calibration curve through the peak area ratio (Y) of imatinib and imatinib isotope internal standards detected by the dry blood spot calibration points 11 (7), and fitting a calibration curve equation; and then, bringing the peak area ratio of the imatinib of the detected sample and the peak area ratio of the isotope internal standard of imatinib into a calibration curve equation, and then quantitatively calculating the concentration of imatinib in the sample. When the kit is used for detection, the operation is convenient, the detection time is short, and the detection accuracy is high. According to the requirements of experiments, the quality control card 2 configured by the kit can be selectively used for carrying out quality control on the detection result, and a blank control dried blood spot quality control point blank is attached to the kit and is used for specificity and specificity evaluation of imatinib and monitoring of high-concentration sample residues.
In summary, the above embodiments are only preferred embodiments of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (10)
1. An imatinib drug concentration detection kit, comprising: the calibration kit comprises a kit body, an internal standard extracting solution container and a calibrator card, wherein the internal standard extracting solution container and the calibrator card are placed in the kit body;
the calibration card is a blood spot acquisition card which is fixed with a group of imatinib blood spot samples as calibration points of dry blood spots, and the number of the calibration points of the dry blood spots is at least 6;
the internal standard extracting solution container is internally provided with an internal standard extracting solution, and the internal standard adopts isotope substituted imatinib.
2. The kit of claim 1, further comprising an openable/closable lid, the lid being connected to or independent of the case body.
3. The kit according to claim 1, wherein a lining is arranged in the box body, and the lining divides the interior of the box body to form a plurality of accommodating spaces; the plurality of accommodating spaces include:
the calibrator card accommodating space is used for placing and fixing the calibrator card;
the internal standard extracting solution container accommodating space is used for placing and fixing the internal standard extracting solution container.
4. The kit of claim 3, wherein the inner liner is a cardboard, sponge, foam or plastic block.
5. The kit of claim 1, wherein the internal standard extraction solution container is a glass bottle, a plastic bottle, or a sample tube.
6. The kit of claim 1, wherein the at least 6 dried blood spot calibration dots differ in imatinib concentration from each other, and the dried blood spot calibration dots are arranged in order of magnitude of concentration of imatinib in blood spots.
7. The kit of claim 1, wherein the number of dried blood spot calibration dots is 7.
8. The kit according to any one of claims 1 to 7, further comprising a quality control card, wherein the quality control card is a blood spot collection card on which a group of Imatinib blood spot samples are fixed as dry blood spot quality control points, and the number of each group of dry blood spot quality control points is at least 3.
9. The kit of claim 8, wherein each set of dried blood spot quality control points has three dried blood spot quality control points, a low concentration quality control point, a medium concentration quality control point, and a high concentration quality control point.
10. The kit of claim 9, wherein each set of dried blood spot quality control points further comprises a blank control dried blood spot quality control point in the quality control card.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201920500545.7U CN210376247U (en) | 2019-04-15 | 2019-04-15 | Imatinib drug concentration detection kit |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201920500545.7U CN210376247U (en) | 2019-04-15 | 2019-04-15 | Imatinib drug concentration detection kit |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN210376247U true CN210376247U (en) | 2020-04-21 |
Family
ID=70258031
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201920500545.7U Active CN210376247U (en) | 2019-04-15 | 2019-04-15 | Imatinib drug concentration detection kit |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN210376247U (en) |
-
2019
- 2019-04-15 CN CN201920500545.7U patent/CN210376247U/en active Active
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Ngo | Electrochemical sensors in immunological analysis | |
| CN108645924B (en) | Detection method of metabolite of newborn based on ultra-high performance liquid chromatography tandem mass spectrometry technology | |
| US7236888B2 (en) | Method to measure the activation state of signaling pathways in cells | |
| WO2021208262A1 (en) | Dried blood spot quantitative acquisition device and method | |
| Goryński et al. | SPME as a promising tool in translational medicine and drug discovery: From bench to bedside | |
| CN104865250A (en) | Dry chemical analysis reagent membrane for atypia histiocytes and preparing method thereof | |
| CN101509925B (en) | Chromatography type total cholesterol self-measuring instrument | |
| CA2828160A1 (en) | Paper support and method of recovering biological material therefrom | |
| CN210376247U (en) | Imatinib drug concentration detection kit | |
| KR910010187A (en) | Appendicitis detection method by measuring σ-hydroxy hypuric acid | |
| CN210109045U (en) | Dasatinib drug concentration detection kit | |
| CN210340904U (en) | Kit for detecting HER-2 gene copy number variation based on digital PCR technology | |
| Hunt et al. | Enzyme tests for the detection of glucose | |
| US20160151780A1 (en) | Device and method for storing and transporting a bodily fluid sample | |
| US3692486A (en) | Methods and apparatus for obtaining the quantitation and the concentrations of precipitin reactions and participating molecules in biological fluids | |
| CN108922584A (en) | Convenient and quick detection device and its application | |
| CN213779982U (en) | Risperidone and 9-hydroxy risperidone drug concentration detection kit | |
| Li et al. | Capillary electrophoresis with laser-induced fluorescence detection of main polyamines and precursor amino acids in saliva | |
| CN213633457U (en) | Enzyme linked immunosorbent assay plate and kit for detecting cytokine IL-6 | |
| CN209542626U (en) | A kind of Seperated multiple channel chromatographic apparatus | |
| CN106018768A (en) | Multi-project biochemical examination and analysis integrated kit | |
| Chaga | Antibody arrays for determination of relative protein abundances | |
| CN207313606U (en) | A kind of Human epidermal growth factor receptor gene sensitivity mutation detection kit | |
| CN209542463U (en) | A kind of water quality detection box | |
| CN111812237A (en) | Valproic acid drug concentration detection kit and application thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CP02 | Change in the address of a patent holder |
Address after: 215127 building 30, biomedical industrial park, No. 218, Sangtian street, Suzhou Industrial Park, Suzhou City, Jiangsu Province Patentee after: SUZHOU YAOMING ZEKANG BIOTECHNOLOGY CO.,LTD. Address before: 1336 Wuzhong Avenue, Yuexi street, Wuzhong District, Suzhou City, Jiangsu Province Patentee before: SUZHOU YAOMING ZEKANG BIOTECHNOLOGY CO.,LTD. |
|
| CP02 | Change in the address of a patent holder |