CN217820411U - Five joint detection cards of cerebral apoplexy - Google Patents
Five joint detection cards of cerebral apoplexy Download PDFInfo
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Abstract
The utility model belongs to the technical field of external diagnosis, a five joint detection cards of cerebral apoplexy is disclosed, adopt five independent test strips joint detection for the quantitative determination people whole blood, glia fiber acid protein, central nervous specific protein, amino-terminal brain natriuretic peptide precursor, D-dimer, lipoprotein relevant phospholipase A2 concentration in the plasma sample, mainly used cerebral apoplexy and brain damage's auxiliary diagnosis, obtain the testing result of five indexes through the immunofluorescence method, can regard as clinical examination to use; and this application has provided the design of baffle and water conservancy diversion mouth, after the in-process sample that uses adds, carry out water conservancy diversion, current-limiting for the first time through the water conservancy diversion mouth on the sample hole, then loop through the baffle that sets up and carry out the current-limiting for the second time, through the mode of twice current-limiting, can effectually avoid the sample that awaits measuring to permeate the detection inefficacy condition that leads to inadequately, the velocity of flow is too high, the reaction is insufficient, guaranteed the effective reaction of sample that awaits measuring and envelope antibody. The utility model discloses can assist doctor in time, convenient to cerebral apoplexy and brain damage patient develop the diagnosis treatment.
Description
Technical Field
The utility model belongs to the technical field of the external diagnosis, concretely relates to five joint detection cards of cerebral apoplexy that are arranged in the quantitative determination people whole blood, the Glia Fiber Acid Protein (GFAP) among the plasma sample, central nervous specific protein S100 beta, amino-terminal brain natriuretic peptide precursor (NT-proBNP), D-Dimer (D-Dimer), relevant phospholipase A2 of lipoprotein (Lp-PLA 2) concentration.
Background
The acute cerebrovascular disease, namely stroke, is also called stroke, common stroke can be roughly divided into ischemic stroke (cerebral infarction) and hemorrhagic stroke (cerebral hemorrhage), has the characteristics of high morbidity and high disability rate, and is one of three fatal diseases of human beings. In recent years, the incidence of stroke has been increasing year by year with the aging of the population. Although the clinical diagnosis and treatment of stroke have been advanced, the overall therapeutic effect is still unsatisfactory, and the treatment and intervention of stroke are very limited, so that only less than 2% of patients can receive effective treatment in time. At present, the image diagnosis is not as effective and rapid as imagination, if the instant rapid diagnosis of the cerebral apoplexy is solved, the patient obtains the timely treatment significance in a gold time window, therefore, the biological marker which is simple, convenient, stable and easy to detect, has higher specificity and sensitivity and can reflect the damage and repair conditions of the cerebral tissue is sought, the diagnostic and treatment of the cerebral apoplexy have important clinical practical significance, the clinical urgent need is also the hotspot problem of the research of the cerebral vascular diseases.
"a detection kit for the auxiliary diagnosis of cerebral apoplexy and a detection method thereof" in our patent, the patent number is as follows: 201710473312.8 discloses a cerebral apoplexy detection kit, which is used for assisting in diagnosing cerebral apoplexy by detecting the methylation degree of a dihydrofolate reductase gene promoter region related to cerebral apoplexy, but the method adopts a fluorescent quantitative PCR technology, and the technology is relatively troublesome to operate and long in detection time in clinical detection and is not easy to be used for clinical detection or rapid prediction.
Because cerebral apoplexy pathogenesis is complicated, most single index be used for clinical diagnosis still to be short in the aspect of specificity, rate of accuracy, and the information that provides is very limited, consequently, the utility model discloses a relevant biomarker detection index joint detection of five cerebral apoplexy for the auxiliary diagnosis of apoplexy risk and brain damage usage.
SUMMERY OF THE UTILITY MODEL
In order to solve the technical problem, the utility model provides a five joint detection cards for cerebral apoplexy, the detection card in contain the test strip of five detection items, be respectively the acidic protein test strip of glial fibrillary, the specific protein S100 beta test strip of central nervous, the precursor test strip of amino-terminal brain natriuretic peptide, D-dimer test strip, lipoprotein-associated phospholipase A2 test strip; each detection strip is an independent detection strip; the test strips of the five test items are arranged in parallel, and the arrangement sequence of the test strips is not limited. And the five items are detected simultaneously to assist a doctor to diagnose and treat the stroke and the brain injury patients timely and conveniently.
The invention discloses a five-item combined detection card for cerebral apoplexy, which comprises an upper cover, a slot plate and detection strips for detection, wherein the upper cover and the slot plate are mutually clamped, the slot plate is provided with five detection strip slots, the detection strips are limited and placed in the detection strip slots,
the detection strip comprises a bottom plate, a sample pad, a combination pad, a coating pad and an absorption pad, wherein the coating pad is arranged in the middle of the bottom plate, one end of the coating pad is lapped with the absorption pad, the other end of the coating pad is sequentially lapped with the combination pad and the sample pad, and the coating pad is provided with a detection line and a quality control line;
the upper cover is provided with a sample hole and a display window, the sample hole exposes out of the sample pad, and the display window exposes out of the coating pad;
a plurality of baffles are arranged on the cover body between the upper cover sample hole and the display window;
the clamping groove plate is provided with a plurality of supporting parts for supporting the detection strips.
Preferably, the heights of the plurality of baffles are arranged in a gradient manner, and the heights are gradually reduced from the sample hole to the display window.
Preferably, the baffles are uniformly distributed on the cover body between the sample hole and the display window at equal intervals.
Preferably, the sample hole is in an inverted boss shape, and a flow guide opening is formed in one side of the sample hole, which is far away from the display window.
Preferably, the supporting part comprises a sample area supporting part, a coating area supporting part and an absorption area supporting part, the sample area supporting part and the absorption pad area supporting part are rectangular tables and are connected with the detection strip clamping groove, and the coating area supporting part is a supporting plate.
Preferably, the upper cover is provided with a handheld anti-skid area, and the handheld anti-skid area is formed by arraying a plurality of salient points.
The detection strips are respectively a glial fibrillary acidic protein detection strip, a central nervous specific protein S100 beta detection strip, an amino-terminal brain natriuretic peptide precursor detection strip, a D-dimer detection strip and a lipoprotein-associated phospholipase A2 detection strip.
Preferably, the bottom plate is made of a polyester plate, the sample pad and the combination pad are made of glass fibers, the coating pad is made of a nitrocellulose membrane, and the absorption pad is made of absorbent paper.
The utility model discloses following beneficial effect has:
1. the utility model discloses the creative five cerebral apoplexy detection indexes and immunofluorescence detect reagent box combine together, carry out the detection that corresponds to five indexes of cerebral apoplexy through adopting independent test strip, obtain the testing result of five indexes through the immunofluorescence method, can regard as clinical detection to use to improve in clinical diagnosis and treatment and judge cerebral apoplexy patient's specificity, rate of accuracy.
2. The utility model provides a baffle and water conservancy diversion mouth's design, the in-process sample that awaits measuring of using adds the back, carries out water conservancy diversion, current-limiting for the first time through the water conservancy diversion mouth on the sample hole, then loops through the baffle that sets up and carries out the current-limiting for the second time, through the mode of twice current-limiting, can effectually avoid the sample that awaits measuring to permeate not enough, the velocity of flow is too high, the detection inefficacy condition that the reaction is insufficient to lead to has guaranteed the effective reaction of sample that awaits measuring and envelope antibody.
Drawings
Fig. 1 is a schematic structural diagram of embodiment 1 of the present invention.
Fig. 2 is a schematic structural view of an upper cover in embodiment 1 of the present invention.
Fig. 3 is a schematic structural view of a slot plate in embodiment 1 of the present invention.
Fig. 4 is a schematic structural diagram of embodiment 2 of the present invention.
Fig. 5 is a schematic structural view of an upper cover in embodiment 2 of the present invention.
Fig. 6 is a schematic structural view of a slot plate according to embodiment 2 of the present invention.
Fig. 7 is a schematic structural view of the detection strip of the present application.
Description of the main part symbols:
1. an upper cover 11, a sample hole 12, a display window 13, a baffle plate 14, a flow guide opening 15; the hand is held to prevent slipping;
2. a slot plate 21, a detection strip slot 22, a sample region support member 23, a coating region support member 24 and an absorption region support member;
3. test strip, 31, bottom plate, 32, sample pad, 33, binding pad, 34, coating pad, 35, absorption pad.
Detailed Description
The present invention will be further described with reference to the accompanying drawings and specific embodiments so that those skilled in the art can better understand the present invention and can implement the present invention, but the embodiments are not to be construed as limiting the present invention.
Example 1
Referring to fig. 1, 2, 3, and 7, the embodiment discloses a five-item combined detection card for cerebral apoplexy, which includes an upper cover 1 and a card slot plate 2 that are fastened to each other, and a detection strip 3 for detection, wherein the card slot plate 2 is provided with five detection strip slots 21, the detection strip 3 is placed in the detection strip slot 21 in a limited manner,
the detection strip 3 comprises a bottom plate 31, a sample pad 32, a combination pad 33, a coated pad 34 and an absorption pad 35, the coated pad 34 is arranged in the middle of the bottom plate 31, one end of the coated pad 34 is lapped with the absorption pad 35, the other end of the coated pad 34 is sequentially lapped with the combination pad 33 and the sample pad 32, and the coated pad 34 is provided with a detection line and a quality control line;
the upper cover 1 is provided with a sample hole 11 and a display window 12, the sample hole 11 exposes out of the sample pad 32, and the display window 12 exposes out of the coating pad 34;
the cover body between the sample hole 11 of the upper cover 1 and the display window 12 is provided with equal-height baffles 13 at equal intervals;
the sample hole 11 is in an inverted boss shape, and one side of the sample hole 11, which is far away from the display window 12, is provided with a flow guide port 14;
the card slot plate 2 is provided with a supporting part which comprises a sample area supporting part 22, a coating area supporting part 23 and an absorption area supporting part 24, the sample area supporting part 22 and the absorption pad area supporting part 24 are rectangular platforms and are connected with the detection strip card slot 21, and the coating area supporting part 23 is a supporting plate.
The upper cover 1 is provided with a handheld anti-skid area 15, and the handheld anti-skid area 15 is formed by arraying a plurality of salient points.
In this embodiment, the upper cover 1 and the slot plate 2 of the detection card are positioned and clamped in a column and hole manner, and the supporting part and the detection strip slot 21 are mutually matched to form a limiting and supporting structure of the detection strip 3.
In this embodiment, the baffle 13 is disposed at equal intervals, and may also be disposed in a manner of height gradient, and the height is gradually decreased from the sample hole 11 to the display window 12, so as to control the flow rate and flow velocity of the sample to be measured.
Example 2
Referring to fig. 4, 5, 6, and 7, the present embodiment discloses a five-item combined detection card for cerebral apoplexy, which has a main structure similar to that of embodiment 1, and omits a diversion port 14 on a sample hole 11, and only one set of baffle 13, and omits a sample region support 22 and a coating region support 23.
The design principle of the embodiment is as follows:
the detection card is suitable for a fluorescence immunoassay analyzer, and in order to adapt to more detection models as far as possible, the detection card takes two types of short cards and long cards as displays in the embodiment of the application.
The design of the distance between the sample hole 11 and the display window 12 of the upper cover 1 is also different because of the difference in the length of the test card. The distance between the sample hole 11 and the display window 12 in the short card is short, and if the penetration is insufficient and the flow rate is too high after the sample to be detected is added, a flow guide opening 14 and more baffles 13 are required to be designed for buffering; and the distance between the sample hole 11 and the display window 12 in the long card can be properly lengthened due to the enlarged space, the sample to be detected can be buffered by using the sample pad 32 body after being added, and the flow speed and the flow rate of the sample to be detected can be controlled only by arranging 1 group of baffle plates 13.
The detection theory basis is as follows:
the reagent card is used for quantitatively determining the concentrations of Glial Fibrillary Acidic Protein (GFAP), central nervous specific protein S100 beta, amino-terminal brain natriuretic peptide precursor (NT-proBNP), D-Dimer (D-Dimer) and lipoprotein-associated phospholipase A2 (Lp-PLA 2) in human whole blood and plasma samples in vitro, and is mainly used for the auxiliary diagnosis of cerebral apoplexy and cerebral injury in clinic.
Glial Fibrillary Acidic Protein (GFAP) has a molecular weight of 50-52KD and is a unique intermediate filament component of glial cells. When the central nervous system is diseased, GFAP overflows from the damaged glial cells, enters the intercellular spaces, and enters the blood through the blood-brain barrier. Research shows that the GFAP content of blood of hemorrhagic stroke is obviously increased within a few minutes after hemorrhage; when traumatic craniocerebral injury occurs, the content of GFAP is increased; after the cerebral infarction patient has the disease, GFAP is slowly released and reaches a peak value in 2-4 days. Therefore, GFAP has important significance for early diagnosis of stroke and brain injury.
The central nervous specific protein S100 beta (S100 alpha beta and S100 beta) is a calcium binding protein, is mainly secreted by brain vascular sheath activated glial cells, and has a molecular weight of 21KD. Abnormal rise of the central nervous specific protein S100 beta is closely related to neuropsychiatric diseases such as brain injury, cerebrovascular diseases, epilepsy, central system infection, mental diseases and Guillain-Barre syndrome, so the S100 beta protein can be used as a specific marker for early diagnosis and prognosis evaluation of brain injury.
The amino-terminal pro-brain natriuretic peptide NT-proBNP is generated by decomposition of pro-brain natriuretic peptide (proBNP). Research shows that NT-proBNP has close relationship with cerebrovascular disease, and NT-proBNP can be used as a biological marker for etiological diagnosis of acute ischemic stroke.
The D-Dimer (D-Dimer) is the simplest degradation product of fibrin monomers in blood, the increase of the mass concentration reflects the hypercoagulable state and secondary hyperfibrinolysis in vivo, and the mass concentration of the D-Dimer has important significance for the diagnosis, curative effect evaluation and prognosis judgment of thrombotic diseases. At present, research shows that the D-dimer detection can not only distinguish the type of ischemic stroke, but also has better clinical application value on the prediction capability of the death rate of stroke hospitalized patients and the evaluation of the severity of nerve injury in the early stage of hemorrhagic stroke.
Lipoprotein-associated phospholipase A2 (Lp-PLA 2) belongs to an expanded phospholipase A2 superfamily, and research shows that the Lp-PLA2 not only has the function of promoting atherosclerosis, but also is a novel inflammatory reaction marker for reflecting the severity of diseases. In addition, lp-PLA2 levels are associated with first stroke risk and can also predict the risk of stroke recurrence, e.g., the Lp-PLA2 levels are still high after stroke, which predicts stroke recurrence and increased risk of cardiovascular events.
The detection principle is as follows:
the detection card adopts a double-antibody sandwich immunofluorescence method, and different detection strips are arranged to respectively detect the concentrations of Glial Fibrillary Acidic Protein (GFAP), central nervous specific protein S100 beta, amino terminal brain natriuretic peptide precursor (NT-proBNP), D-Dimer (D-Dimer) and lipoprotein-associated phospholipase A2 (Lp-PLA 2).
The principle of detection is illustrated by taking a Glial Fibrillary Acidic Protein (GFAP) test strip as an example,
and (3) marking and coating the mouse anti-human GFAP monoclonal antibody 2 on the coating pad to serve as a detection line T, and marking and coating the goat anti-rabbit IgG polyclonal antibody on the coating pad to serve as a quality control line C. One end of the coating pad close to the quality control line C is covered with an absorption pad, and the other end close to the detection line T is covered with a combination pad.
The fluorescent microspheres marked by another mouse anti-human GFAP monoclonal antibody 1 and the fluorescent microspheres marked by rabbit IgG antibody are uniformly mixed and sprayed on the bonding pad,
in the testing process, adding a prepared standard substance or a blood sample to be tested to a sample pad, allowing GFAP antigen added in the sample to enter a combination pad through the sample pad, combining with a mouse anti-human GFAP monoclonal antibody 1 marked by fluorescent microspheres to form a reaction compound, carrying out chromatography along the coating pad, capturing by a mouse anti-human GFAP monoclonal antibody 2 in a detection line T to form an immune compound, and displaying a certain fluorescence intensity; the fluorescent microsphere chromatography marked by the rabbit IgG antibody is captured by the goat anti-rabbit IgG polyclonal antibody in the quality control line C to form an immune complex, a certain fluorescence intensity is displayed, the ratio (T/C) of the light signal intensity on the detection line to the light signal intensity of the quality control line is in positive correlation with the sample concentration, and the concentration of the sample to be detected can be obtained through the calculation of a standard curve.
The product performance index is as follows:
1. linear range:
(1) GFAP: the linearity is within the range of (30.0-10000.0) pg/mL, and the value of the linear correlation coefficient R is more than or equal to 0.990;
(2) S100 beta: the linearity is within the range of (80.0-10000.0) pg/mL, and the value of the linear correlation coefficient R is more than or equal to 0.990;
(3) NT-proBNP: the linearity is within the range of (30.0-30000.0) pg/mL, and the value of the linear correlation coefficient R is more than or equal to 0.990;
(4) D-Dimer: the linearity is within the range of (200.0-10000.0) ng/mL, and the value of the linear correlation coefficient R is more than or equal to 0.990;
(5) Lp-PLA2: the linearity is in the range of (10.0-800.0) ng/mL, and the value of the linear correlation coefficient R is more than or equal to 0.990.
2. Detection limit:
(1)GFAP≤20.0pg/mL；
(2)S100β≤50.0pg/mL；
(3)NT-proBNP≤20.0pg/mL；
(4)D-Dimer≤100.0ng/mL；
(5)Lp-PLA2≤5.0ng/mL。
3. the accuracy is as follows: the recovery rate of the reagent is in the range of 85-115%.
4. Internal precision: CV is less than or equal to 15.0 percent.
5. Precision between batches: CV is less than or equal to 15.0 percent.
6. Specificity:
(1) GFAP: the following antigens were detected under the concentration conditions shown in the table, and no non-specific reaction was generated.
| Antigens | Concentration of |
| Keratin protein | 10ng/mL |
| Vimentin | 100ng/mL |
| Desmin | 100ng/mL |
(2) S100 beta: the following antigens were detected under the concentration conditions shown in the table, and no non-specific reaction was generated.
| Antigens | Concentration of |
| S100A1(S100αα) | 10ng/mL |
(3) NT-proBNP: the following antigens were detected under the concentration conditions shown in the table, and no non-specific reaction was generated.
(4) D-Dimer: the following antigens were detected under the concentration conditions shown in the table, and no non-specific reaction was generated.
| Antigen(s) | Concentration of |
| FDP | 100μg/mL |
(5) Lp-PLA2: the following antigens were detected under the concentration conditions shown in the table, and no non-specific reaction was generated.
| Antigens | Concentration of |
| CRP | 1000ng/mL |
7. Interfering substance: the following potential interfering substances were added to GFAP/S100. Beta./NT-proBNP/D-Dimer/Lp-PLA 2 negative and positive specimens at concentrations which did not affect the test.
| Antigen(s) | Concentration of |
| Bilirubin | 171μmol/L |
| Triglycerides | 17mmol/L |
| Hemoglobin | 2.5g/L |
| Rheumatoid factor | 150IU/mL |
The five combined detection cards for cerebral apoplexy claimed in the present application can be used for in vitro quantitative determination of the concentrations of Glial Fibrillary Acidic Protein (GFAP), central nervous specific protein S100 β, amino terminal brain natriuretic peptide precursor (NT-proBNP), D-Dimer (D-Dimer), and lipoprotein-related phospholipase A2 (Lp-PLA 2) in human whole blood and plasma samples, and have a wide linear detection range, excellent detection limit, and extremely strong specific detection capability and anti-interference capability for the analyte.
The above description is only a specific embodiment of the preferred embodiment of the present invention, but the protection scope of the present invention is not limited thereto, and the technical solutions including the adaptive structural improvement on the basis of the present invention should be covered within the protection scope of the present invention, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention should be covered within the protection scope of the present invention.
Claims (8)
1. The five-item combined stroke detection card is characterized by comprising an upper cover, a slot plate and detection strips, wherein the upper cover and the slot plate are mutually clamped, the detection strips are used for detection, five detection strip slots are formed in the slot plate, the detection strips are limited and placed in the detection strip slots,
the detection strip comprises a bottom plate, a sample pad, a combination pad, a coating pad and an absorption pad, wherein the coating pad is arranged in the middle of the bottom plate, one end of the coating pad is lapped with the absorption pad, the other end of the coating pad is sequentially lapped with the combination pad and the sample pad, and the coating pad is provided with a detection line and a quality control line;
the upper cover is provided with a sample hole and a display window, the sample hole exposes out of the sample pad, and the display window exposes out of the coating pad;
and a plurality of baffles are arranged on the cover body between the upper cover sample hole and the display window.
2. The five-item stroke combined detection card of claim 1, wherein the height of the baffles is arranged in a gradient manner, and the heights are gradually decreased from the sample hole to the display window.
3. The five joint detection cards for cerebral apoplexy according to claim 1, wherein the baffles are uniformly spaced at equal intervals on the cover between the sample hole and the display window.
4. The five-item stroke combined detection card as claimed in claim 2 or 3, wherein the sample hole is in the shape of an inverted boss, and a diversion port is provided on a side of the sample hole away from the display window.
5. The five joint detection cards for stroke as claimed in claim 1, wherein the slot plate is provided with a plurality of supporting portions for supporting the detection strips, the supporting portions include a sample region supporting member, a coating region supporting member and an absorption region supporting member, the sample region supporting member and the absorption pad region supporting member are rectangular platforms and are connected to the slots of the detection strips, and the coating region supporting member is a supporting plate.
6. The five-item stroke combined detection card as claimed in claim 1, wherein a hand-held anti-slip region is disposed on the upper cover, and the hand-held anti-slip region is composed of a plurality of bump array arrangements.
7. The five-item stroke combined detection card of claim 1, wherein the detection strips are a glial fibrillary acidic protein detection strip, a central nervous specific protein S100 β detection strip, an amino-terminal pro-brain natriuretic peptide detection strip, a D-dimer detection strip, and a lipoprotein-associated phospholipase A2 detection strip, respectively.
8. The five-item stroke combined detection card of claim 1, wherein the base plate is made of polyester plate, the sample pad and the bonding pad are made of glass fiber, the coating pad is made of nitrocellulose membrane, and the absorption pad is made of absorbent paper.
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