CN201087839Y - Brain sodium peptide color particle diagnosis test paper - Google Patents

Brain sodium peptide color particle diagnosis test paper Download PDF

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Publication number
CN201087839Y
CN201087839Y CNU2007201409317U CN200720140931U CN201087839Y CN 201087839 Y CN201087839 Y CN 201087839Y CN U2007201409317 U CNU2007201409317 U CN U2007201409317U CN 200720140931 U CN200720140931 U CN 200720140931U CN 201087839 Y CN201087839 Y CN 201087839Y
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China
Prior art keywords
colored particle
natriuretic peptide
test paper
particle
brain natriuretic
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Expired - Lifetime
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CNU2007201409317U
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Chinese (zh)
Inventor
万志静
万志强
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WHPM Bioresearch and Technology Co Ltd
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WHPM Bioresearch and Technology Co Ltd
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Abstract

The utility model relates to a diagnosis test paper used for a brain natriuretic peptide colored particle which is a diagnosis test paper for qualitatively detecting brain natriuretic peptide in a clinical sample (whole blood/serum/plasma) by quick immuno-chromatography, and belongs to the quick detecting field of the immunity-chromatography. The utility model is composed of a bottom plate, a water absorption plate, a nitrocellulose membrane, a colored particle fixation pad, a sample imbibition layer and a MAX line. The middle part of the bottom plate is the nitrocellulose membrane which is provided with a brain natriuretic peptide monoclonal antibody test line and a sheep anti mouse polyclonal antibody control line. The end of one end of the bottom plate is the water absorption plate, and the end of the other end of the bottom plate is the sample imbibition layer. Both ends of the nitrocellulose membrane are respectively and overlappedly connected with the water absorption plate and the colored particle fixation pad, and the sample imbibition layer is pressed on the colored particle fixation pad.

Description

Brain natriuretic peptide colored particle diagnose test paper
Technical field
The present invention relates to a kind of brain natriuretic peptide colored particle diagnose test paper, belong to immunochromatography fast detecting field.
Background technology
Brain natriuretic peptide (BNP) is a kind of neural parahormone of being made up of 32 amino acid polypeptides by ventricular muscle cell secretion, have sharp sodium, diuresis, vasodilatory effect, all significant at the aspects such as morbidity, diagnosis, treatment and prognosis of diseases such as heart failure, myocardial infarction.Brain natriuretic peptide has very high negative predictive value to heart failure patient, and the level of brain natriuretic peptide can accurately reflect the order of severity of left heart failure, and its specificity and susceptibility all obviously are better than indexs such as TNF, interferon, renin.The first visit doctor is got rid of heart failure or makes further clinical assessment, and the assessment order of severity and prognosis are very helpful.
The brain natriuretic peptide inspection method often adopts radioimmunoassay method (RIAs), this method needs to extract earlier blood plasma, to remove disturbing factor and to improve special, used blood sample will be one day same time period, rest a period of time, extract the blood at same position during same position, blood sample need be stored in the specific silicone tube of cold treatment in advance, the sample low-temperature centrifugation is preserved under the specified temp and is opened up to mensuration then.This method is quite complicated, and length consuming time and the plasma volume that needs are also many.In addition, noncompetitive is put the method for exempting from can overcome some problems and the difficulty that RIAs occurs, but still has certain limitation in clinical use, is not easy to apply.
Summary of the invention
The utility model has overcome some problems that exist in the prior art, a kind of fast immune chromatographic method of utilizing is provided, detect the diagnose test paper of brain natriuretic peptide in the clinical samples (whole blood/blood serum) qualitatively, be a kind of supplementary means that heart diseases such as miocardial infarction, acute coronary artery syndrome are detected, only be used for in-vitro diagnosis.
For solving the problems of the technologies described above, the present invention is achieved by the following technical solutions:
Brain natriuretic peptide colored particle diagnose test paper is made up of base plate, water sucting plate, nitrocellulose filter, colored particle fixed bolster, sample liquid-adsorption layer, MAX line.The base plate middle part is a nitrocellulose filter, a brain natriuretic peptide monoclonal antibody test wire and a sheep anti mouse polyclonal antibody control line are arranged on the nitrocellulose filter, in base plate one end termination is water sucting plate, other end termination is the sample liquid-adsorption layer, the nitrocellulose filter two ends overlap mutually with the colored particle fixed bolster with water sucting plate respectively and are connected, and are pressed with the sample liquid-adsorption layer on the colored particle fixed bolster.
Wherein colored particle can be a kind of metal colloid particles, can comprise colloid gold particle, silver-colored particle, iron particle, magnetic-particle etc., a kind of marking particle can comprise dye granule, latex particle, fluorescent grain etc., can realize sxemiquantitative or full detection by quantitative when adopting magnetic-particle.
The sample liquid-adsorption layer is made up of trilaminate material stack, and ground floor is that certain specification nonwoven layer, the second layer are that glass layer, the 3rd layer are the certain specification nonwoven layer, and above-mentioned substance all need pass through surfactant damping fluid immersion treatment, and drying is afterwards standby.
During detection, collect sample in clean sample cup, the sampling end of test paper is put into detection sample (liquid level must not surpass the MAX line) because the capillarity test sample will move to the water sucting plate end along test strips, BNP antigen can move and the antibodies that is coated on the nitrocellulose filter with continuation after the anti-BNP labeling of monoclonal antibody probe generation specific bond in the sample, thereby by anti-BNP monoclonal antibody identification, the specific bond of double antibodies sandwich takes place.In the testing process, will show corresponding redness when up liquid level promptly is stranded in this regional label probe, it is positive two red lines to occur, a red line occurs and is expressed as negative findings.
When moving to sheep anti mouse polyclonal antibody control line, no matter BNP content has or not in the sample, and label probe all can combine delay with the sheep anti-mouse igg of bag quilt on the nitrocellulose filter, and it is red that control line is shown.So control line does not have, and colour band produces then representative operation wrong (during detection, the sample liquid level surpasses the MAX line) or test paper is expired.
Because adopt technique scheme, brain natriuretic peptide colored particle diagnose test paper provided by the present invention has such beneficial effect: i.e. high specificity, highly sensitive, easily store, need not the technical skill personnel operation, do not need instrument and equipment, and readability as a result.
Description of drawings
Fig. 1 is the main TV structure figure of brain natriuretic peptide colored particle diagnose test paper.
Fig. 2 is the plan structure figure of brain natriuretic peptide colored particle diagnose test paper.
Fig. 3 is the positive findings figure of brain natriuretic peptide colored particle diagnose test paper.
Fig. 4 is the negative findings figure of brain natriuretic peptide colored particle diagnose test paper.
Among the figure 1, water sucting plate, 2, nitrocellulose filter, 3, sheep anti mouse polyclonal antibody control line, 4, test wire, 5 colored particle fixed bolsters, 6, the sample liquid-adsorption layer, 7, base plate, 8, the MAX line.
Specific embodiment
Shown in Fig. 1~4, brain natriuretic peptide colored particle diagnose test paper is by base plate (7), water sucting plate (1), nitrocellulose filter (2), colored particle fixed bolster (5), sample liquid-adsorption layer (6), MAX line (8) is formed, the base plate middle part is a nitrocellulose filter, a brain natriuretic peptide monoclonal antibody test wire (4) and a sheep anti mouse polyclonal antibody control line (3) are arranged on the nitrocellulose filter, in base plate one end termination is water sucting plate, other end termination is the sample liquid-adsorption layer, the nitrocellulose filter two ends overlap mutually with the colored particle fixed bolster with water sucting plate respectively and are connected, and are pressed with the sample liquid-adsorption layer on the colored particle fixed bolster.
1. the preparation of synthetic immunogen: with the BNP synthetic immunogen of the synthetic two kinds of different binding sites of chemical synthesis process;
2. MONOCLONAL ANTIBODIES SPECIFIC FOR: the BNP synthetic immunogen of two kinds of different binding sites that will prepare is immune BALB/c mouse respectively.Set up the knurl strain with the SP20 Fusion of Cells and screen, get oncocyte and be injected in the BALB/c mouse abdominal cavity, make it produce ascites.Extract the screening of mouse ascites purifying, obtain the two kinds of BNP monoclonal antibody I, the BNP monoclonal antibody II that combine with BNP molecule different loci.Wherein BNP monoclonal antibody I is used for test wire bag quilt, and BNP monoclonal antibody II is used for colored particle to be fixed.
3. combining of colored particle and BNP monoclonal antibody: the colored particle of BNP labeling of monoclonal antibody is adsorbed onto on the fibrous material, and dry back is standby.
4. film-making machine system film: utilize computer control transmission speed, guarantee that the antibody amount of bag quilt on the per unit film equates.
5. test strips combination: press the known technology combination.
6. using method:
Gather whole blood (venous blood or finger tip blood), serum or blood plasma.As use whole blood sample, please use immediately.Sample should not placed at ambient temperature for a long time.As use the blood serum sample to detect, and should isolate serum or blood plasma as early as possible, avoid haemolysis.The sample of haemolysis can not use.The venous blood sample can be preserved two days under 2-8 ℃ of condition, can not be freezing.Serum or plasma specimen can be preserved two days under 2-8 ℃ of condition.Need freezing (20 ℃) as long preservation.Avoid multigelation.
Collect sample in clean sample cup, test paper liquid-adsorption layer end is inserted in the sample, the sample to be tested interface does not surpass " MAX " line on the diagnose test paper, observations in 10~15 minutes.The colour developing district is two red line, and then testing result is positive; Negative when a control line only occurring; Colour band does not appear in control line, shows the expired or misoperation of test paper, please gets test paper in addition and detects again.

Claims (7)

1. brain natriuretic peptide colored particle diagnose test paper, it is characterized in that it is by base plate (7), water sucting plate (1), nitrocellulose filter (2), colored particle fixed bolster (5), sample liquid-adsorption layer (6), MAX line (8) is formed, the base plate middle part is a nitrocellulose filter, a brain natriuretic peptide monoclonal antibody test wire (4) and a sheep anti mouse polyclonal antibody control line (3) are arranged on the nitrocellulose filter, in base plate one end termination is water sucting plate, other end termination is the sample liquid-adsorption layer, the nitrocellulose filter two ends overlap mutually with the colored particle fixed bolster with water sucting plate respectively and are connected, and are pressed with the sample liquid-adsorption layer on the colored particle fixed bolster.
2. brain natriuretic peptide colored particle diagnose test paper according to claim 1 is characterized in that colored particle is a kind of metal colloid particles.
3. brain natriuretic peptide colored particle diagnose test paper according to claim 2 is characterized in that metal colloid particles can comprise colloid gold particle, silver-colored particle, iron particle, magnetic-particle.
4. brain natriuretic peptide colored particle diagnose test paper according to claim 1 is characterized in that the sample liquid-adsorption layer is made up of trilaminate material stack, and ground floor is that certain specification nonwoven layer, the second layer are that glass layer, the 3rd layer are the certain specification nonwoven layer.
5. brain natriuretic peptide colored particle diagnose test paper according to claim 1 is characterized in that being coated with on the described nitrocellulose filter two lines, a test wire, a control line.
6. brain natriuretic peptide colored particle diagnose test paper according to claim 1 is characterized in that colored particle is a kind of marking particle.
7. brain natriuretic peptide colored particle diagnose test paper according to claim 6 is characterized in that marking particle comprises dye granule, latex particle, fluorescent grain.
CNU2007201409317U 2007-03-30 2007-03-30 Brain sodium peptide color particle diagnosis test paper Expired - Lifetime CN201087839Y (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102753972A (en) * 2009-10-16 2012-10-24 阿米克股份公司 An assay method and devices involving the use of magnetic particles
CN102830234A (en) * 2012-08-10 2012-12-19 杭州华得森生物技术有限公司 Rapid diagnostic kit for detecting novel marker ST2 of human heart failure
CN103529224A (en) * 2013-10-17 2014-01-22 天津中新科炬生物制药有限公司 Quick quantitative detecting device and method for simultaneously detecting human brain natriuretic peptides and N-terminal pro-brain natriuretic peptides
CN104569429A (en) * 2015-01-04 2015-04-29 深圳市艾瑞生物科技有限公司 Homogeneous immunometric fluorescent compound set for quickly and quantificationally detecting brain natriuretic peptide (BNP) and preparation method of homogeneous immunometric fluorescent compound set
CN105044363A (en) * 2015-06-01 2015-11-11 上海凯创生物技术有限公司 Brain natriuretic peptide colloid gold detection kit
CN105259162A (en) * 2015-10-26 2016-01-20 深圳华迈兴微医疗科技有限公司 Magnetic particulate chemiluminiscence micro-fluidic chip capable of quantitatively detecting brain natriuretic peptide in whole blood
CN105785028A (en) * 2012-08-10 2016-07-20 杭州华得森生物技术有限公司 Rapid diagnosis kit for detecting novel human cardiac failure marker ST2

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102753972A (en) * 2009-10-16 2012-10-24 阿米克股份公司 An assay method and devices involving the use of magnetic particles
CN102753972B (en) * 2009-10-16 2016-01-13 阿米克股份公司 Relate to the assay method and device that use magnetic-particle
CN102830234A (en) * 2012-08-10 2012-12-19 杭州华得森生物技术有限公司 Rapid diagnostic kit for detecting novel marker ST2 of human heart failure
CN105785028A (en) * 2012-08-10 2016-07-20 杭州华得森生物技术有限公司 Rapid diagnosis kit for detecting novel human cardiac failure marker ST2
CN103529224A (en) * 2013-10-17 2014-01-22 天津中新科炬生物制药有限公司 Quick quantitative detecting device and method for simultaneously detecting human brain natriuretic peptides and N-terminal pro-brain natriuretic peptides
CN103529224B (en) * 2013-10-17 2016-09-07 天津中新科炬生物制药有限公司 Detect human brain natriuretic peptide and the Quantitative detection device of N-terminal plasma pro-brain natriuretic peptide levels and detection method simultaneously
CN104569429A (en) * 2015-01-04 2015-04-29 深圳市艾瑞生物科技有限公司 Homogeneous immunometric fluorescent compound set for quickly and quantificationally detecting brain natriuretic peptide (BNP) and preparation method of homogeneous immunometric fluorescent compound set
CN104569429B (en) * 2015-01-04 2017-01-18 深圳市艾瑞生物科技有限公司 Homogeneous immunometric fluorescent compound set for quickly and quantificationally detecting brain natriuretic peptide (BNP) and preparation method of homogeneous immunometric fluorescent compound set
CN105044363A (en) * 2015-06-01 2015-11-11 上海凯创生物技术有限公司 Brain natriuretic peptide colloid gold detection kit
CN105044363B (en) * 2015-06-01 2017-03-15 上海凯创生物技术有限公司 A kind of brain natriuretic peptide gold-immunochromatographyreagent reagent for assay box
CN105259162A (en) * 2015-10-26 2016-01-20 深圳华迈兴微医疗科技有限公司 Magnetic particulate chemiluminiscence micro-fluidic chip capable of quantitatively detecting brain natriuretic peptide in whole blood
CN105259162B (en) * 2015-10-26 2018-05-04 深圳华迈兴微医疗科技有限公司 Quantitatively detect the magnetic microparticle chemiluminescence micro-fluidic chip of brain natriuretic peptide in whole blood

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Granted publication date: 20080716