CN206132782U - Quick detect reagent box of beta 2 microglobulin sxemiquantitative gold mark - Google Patents
Quick detect reagent box of beta 2 microglobulin sxemiquantitative gold mark Download PDFInfo
- Publication number
- CN206132782U CN206132782U CN201620689409.3U CN201620689409U CN206132782U CN 206132782 U CN206132782 U CN 206132782U CN 201620689409 U CN201620689409 U CN 201620689409U CN 206132782 U CN206132782 U CN 206132782U
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- Prior art keywords
- antibody
- colorimetric
- microglobulin
- mark
- card
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Abstract
The utility model discloses a quick detect reagent box of beta 2 microglobulin sxemiquantitative gold mark belongs to the clinical medical detection field. The kit is including card box, colorimetric card and test paper strip triplex: the card box is including lid (8) and box bottom (14) two parts, card box built -in colorimetric card (9) and test paper strip. Card box openly visible inspection window (1), application of sample hole (4) and color comparison window (7), the lid openly is printed on the characters that explanation (2), application of sample hole mark (3), trade name mark (5) and information recorded fence (6) are differentiated to the result. The utility model discloses use colloidal gold immunoassay chromatographic technique to high -efficient beta 2 microglobulin monoclonal antibody is as catching antibody and detect antibody, one and half quantitative determination kits of preparation, can be fast simple and convenient half quantitative determination serum or the beta 2 microglobulin in the urine.
Description
Technical field
The utility model belongs to field of clinical medical detection, and in particular to colloidal gold immunochromatographimethod detection technique.
Background technology
B2M (beta2-microglobulin, β 2-MG) is human cell surface HLA (human
Leukocyte antigen, HLA) chain moiety, be a list being made up of 100 amino acid residues
Key polypeptide, relative molecular mass 11.8kDa is synthesized by the normal cell or malignant cell of human interstitial, epithelium and hemopoietic system,
It is present in all cell surfaces in addition to ripe red blood cell and placental trophoblasts.The synthetic ratio of normal person β 2-MG and from thin
Burst size on after birth is fairly constant.
β 2-MG are a kind of relatively small albumen of molecular weight, and in human normal blood circulation, β 2-MG can Jing glomerulus
Freely filter, wherein more than 99.9% by proximal convoluted tubule reabsorption and decomposes, therefore β 2-MG content phases in normal human serum and urine
To constant.When detection of glomeruli filtration function goes down, the β 2-MG concentration in serum starts to raise, and and glomerular filtration rate(GFR
(glomerular filtration rate, GFR) is in significantly negatively correlated；When renal tubule absorption function weakens or glomerulus filter
When crossing function increase, β 2-MG contents are raised in urine, therefore detection serum or the β 2-MG concentration in urine can reflect early stage kidney work(
Can damage.Because the injury of kidney of diabetes and hypertension chronic diseases typically betides first renal tubule position, therefore detect blood
β 2-MG in liquid or urine can monitor such disease albuminuria.
At present, the detection method of β 2-MG is mainly immunoturbidimetry in serum or urine, more by automatic biochemistry analyzer point
Analysis is completed, and does not have the report that β 2-MG are detected using colloidal gold immunity chromatography.The utility model utilizes first colloid gold immune layer
Analysis method detects serum or the β 2-MG in urine, and not only detection method is simple, and as a result interpretation is quick, can carry out half-quantitative detection, carries
The high degree of accuracy to Renal function in early period damage check, for clinical diagnosis foundation is provided.
Immune colloidal gold technique（immunocolloidal gold technique）It is a kind of new diagnostic technology, by it
Combined with immunochromatography technique make detection kit have it is simple to operate, without the need for cold chain and special supplementary instrument, as a result sentence
The advantages of reading quick, its general principle is as follows：With the claret colloid gold particle labelled antigen of high electron density（Or antibody）If,
There is antibody to be checked in sample（Or antigen to be checked）, then antibody to be checked forms Ag-Ab-glue in the antigen and sample after marking
Body Au composite, by capillarity swimming on nitrocellulose filter (nitrocellulose filter membrane), and
With another epitope antigen being coated on nitrocellulose filter（Or antibody）With reference to, macroscopic red lines are formed, so as to
The presence of Reichl's test is treated in judgement；If without treating that Reichl's test or protein content to be checked are not up to threshold value in sample, will not be fine in nitric acid
Visible red line is formed on the plain film of dimension.The utility model is based on this technology.
The content of the invention
The utility model aims to provide a kind of kit of β 2-MG contents in half-quantitative detection serum or urine, for sugar
The auxiliary diagnosis of urine disease and hypertension chronic diseases albuminuria.The utility model can solve β 2-MG inspections in serum or urine
Survey needs specific apparatus and the problems such as time-consuming, there is provided one kind detection high specificity, quick kit simple to operate, can extensively use
In the clinical detection of medical institutions at different levels.
The utility model includes cartridge, colorimetric card and the part of test strips three.
The cartridge includes lid and cassette bottom two parts, and material is ABS resin（Acrylonitrile-butadiene-styrene (ABS) copolymerization
Thing）；Lid is connected by post and post groove with cassette bottom with inserting mode, and lid is fillet rectangle with cassette bottom；Cartridge front is visible
Inspection window, well and colorimetric window, inspection window is oblong, and well is ellipse, and colorimetric window is fillet rectangle；In inspection
The visible reaction film of viewing window position, detection line T and nature controlling line C, in the visible test strips sample pad in sample-adding hole site, in colorimetric window position
It can be seen that the colorimetric card mark and colour band and corresponding concentration explanation on colorimetric card；Lid front is printed on result and differentiates explanation, well
Mark, name of an article mark and information record hurdles；Cassette bottom lower edge right side is provided with rectangle hole to be put into colorimetric card.
The colorimetric card is inserted in sliding manner inside cartridge, and the colorimetric draw-in groove in cassette bottom is placed；It is printed on colorimetric card
Colorimetric card mark, colour band and corresponding concentration explanation.
The test strips are placed in inside cartridge, are placed in the test paper bar groove in cassette bottom；Test strips by substrate, double faced adhesive tape,
Sample pad, colloidal gold pad, adhesive tape, reaction film, sample suction pad composition.Substrate material is PVC plastic（Polyvinyl chloride）, sample pad and glue
Body gold pad material is non-woven fabrics, and reaction film is nitrocellulose filter, and sample suction pad material is oil filter paper.The test strips use a pair
The good anti-β2-microglobulin monoclonal antibody in mouse source of pairing property is referred to as antibody a and antibody b as detection antibody；Antibody a
Antibody a- colloidal gold composites being formed with colloid gold label and being solidified in colloidal gold pad, antibody b is coated in reaction film detection line T
Position；Nature controlling line location of C is coated with sheep anti mouse polyclonal antibody.
The utility model application colloidal gold immunochromatographimethod technology, for the β 2-MG in detecting serum or urine.During detection,
If the antibody a- colloidal gold composite shapes containing the β 2-MG for reaching threshold value in testing sample, in enough β 2-MG and colloidal gold pad
Into β 2-MG- antibody a- colloidal gold composites, under capillary action, β 2-MG- antibody a- colloidal gold composites are moved on reaction film
It is dynamic, detection line T at and antibody b combines to form macroscopic red detection line T, and the antibody a- glue not combined with β 2-MG
Body Au composite then crosses detection line T and combines to form with the sheep anti mouse polyclonal antibody for being coated on reaction film nature controlling line location of C red
Color nature controlling line C；If without the β 2-MG up to threshold value in sample, detection line T is invisible, a show color nature controlling line C；Seen by contrasting
Detection line T color and colour band in colorimetric window and corresponding concentration explanation in window are examined, the β 2-MG contents in sample can be made and be defined.
The antibody a and antibody b that the utility model is used is to screen the high-titer mouse for preparing pairing Dan Ke for β 2-MG
Grand antibody, it is complementary with height, improve the recall rate and accuracy of β 2-MG in sample.
The utility model adjusts colloidal gold-labeled method, and efficient combination antibody protein makes the kit can be at normal temperatures
（4℃~30℃）Preserve；Meanwhile, the utility model has that immune colloidal gold technique is simple to operate, result interpretation quick, without the need for special
The advantage of different equipment.
Description of the drawings
Fig. 1 is front schematic view of the present utility model.
Fig. 2 is colorimetric card schematic diagram of the present utility model.
Fig. 3 is lid schematic rear view of the present utility model.
Fig. 4 is cassette bottom front schematic view of the present utility model.
Fig. 5 is test strips front schematic view of the present utility model.
Fig. 6 is test strips side schematic view of the present utility model.
Each numeral represents that content is as follows in figure：1. inspection window；2. result differentiates explanation；3. well is marked；4. well；
5. the name of an article is marked；6. information record hurdles；7. colorimetric window；8. lid；9. colorimetric card；10. colorimetric card is marked；11. colour bands and correspondence
Concentration explanation；12. posts；13. test paper bar grooves；14. cassette bottoms；15. post grooves；16. colorimetric draw-in grooves；17. sample pads；18. adhesive tapes；19.
Reaction film；20. detection lines T；21. nature controlling line C；22. sample suction pads；23. substrates；24. double faced adhesive tapes；25. colloidal gold pads.
Specific embodiment
It is for a further understanding of the utility model to provide following embodiments, it is not limited to the preferred forms,
Content of the present utility model and protection domain are not construed as limiting, anyone is under enlightenment of the present utility model or by this practicality
The same or analogous product of any and the utility model that new and other prior arts features are combined and draw, all falls within
Within protection domain of the present utility model.
A kind of β2-microglobulin semi-quantitative gold labeled quick detection reagent box of embodiment 1
The utility model is made up of cartridge, colorimetric card and the part of test strips three, and cartridge and colorimetric card select qualified confession
Answer business to be customized, in conjunction with Figure of description, the processing method of test strips is sketched：
The colloidal gold pad of the test strips（25）Preparation method is as follows：1. the preparation of collaurum：Concentration be 0.004% ~
Add the 1.3% ~ 2% of its volume, concentration to be 1% ~ 3% trisodium citrate in 0.012% gold chloride, boil 10 ~ 20 minutes, obtain
To colloidal gold solution；2. colloidal gold labeled monoclonal antibody a：1. pH will be adjusted extremely with 0.2M solution of potassium carbonate by middle gained colloidal gold solution
8.0 ~ 9.0, a certain amount of antibody a is added, put after stirring on magnetic stirring apparatus, add in the solution by 0.1 ~ 0.6g/100ml
Animal blood serum albumen, 4 DEG C stand 2 hours；3. will 2. 1000 revs/min of centrifugations of middle gained antibody a- collaurum mixed solutions Jing
30 minutes, abandon supernatant；4. will 3. middle gained sediment by 4 ~ 10ml/100ml be dissolved in the Tris-Hcl of 0.02M pH 7.4 delay
Rush liquid（Containing 0.2% ~ 0.6% animal blood serum albumen and 0.01% ~ 0.06% Sodium azide）In, obtain antibody a- colloidal gold composites molten
Liquid；5. by non-woven fabrics immersion 4. in middle gained colloidal gold solution, it is furnished with after liquid oozes out wait the nonwoven for immersing, 37 DEG C of dryings, i.e.,
The colloidal gold pad of antibody a- colloidal gold composites must be coated with.
The test strips reaction film（19）On detection line T（20）With nature controlling line C（21）Method for coating it is as follows：Take highly concentrated
Degree antibody b, degree of thickening to 1mg/ml adds appropriate formaldehyde, and detection line T is coated with reaction film stage casing with special Membrane jetter；Take height
Concentration sheep anti mouse polyclonal antibody, degree of thickening is 2mg/ml, appropriate formaldehyde is added, with special Membrane jetter in reaction film stage casing away from inspection
Nature controlling line C is coated with survey line 4 ~ 5mm of T；Detection line T and nature controlling line C arrange discharge rate by 10 ~ 20 μ l/ml, and reaction film completes bag
Rear, in being put immediately into 45 DEG C of baking ovens, drying is obtained final product for 1 hour.
The test strips are by substrate（23）, double faced adhesive tape（24）, sample pad（17）, colloidal gold pad（25）, adhesive tape（18）, reaction
Film（19）, sample suction pad（22）Composition, the bottom is substrate（23）, material is PVC plastic（Polyvinyl chloride）；Adhere on substrate two-sided
Glue（24）One layer is used to fix substrate and miscellaneous part；Test strips front end（Left side shown in Fig. 5, Fig. 6）Place colloidal gold pad（25）,
And cover one layer of longer sample pad（17）, sample pad and colloidal gold pad material are non-woven fabrics, the solidification of antibody a- colloidal gold composites
In colloidal gold pad；Colloidal gold pad rear end is pressed in reaction film（19）On, and with adhesive tape（18）Fix in upper end, reaction membrane material is
Nitrocellulose filter, is coated with detection antibody on reaction film（Antibody b, i.e. detection line T（20））With quality control antibody（Sheep anti mouse
Polyclonal antibody is nature controlling line C（21））；Test strips end（Right side shown in Fig. 5, Fig. 6）For sample suction pad（22）, sample suction pad front end is covered
Lid reaction film rear end, to provide capillary force sample extraction raffinate is absorbed, and sample suction pad material is oil-Absorbing Sheets.
The test strips with after opening mode greatly and stacking successively and paste, grow up 5.8 ~ 6.0cm by cutting, and the fillet of wide 4mm is put
Put in kit cassette bottom（14）Test paper bar groove（13）It is interior；By lid（8）On post（12）With the post groove in cassette bottom（15）Alignment,
It is attached with inserting mode；Colorimetric card is put into into kit from cassette bottom lower edge right rectangular opening when using.
It is as follows using the kit test method：The kit for being dried sealing is taken out, is lain on laboratory table top,
Colorimetric card is inserted in cartridge colorimetric draw-in groove from cartridge lower edge right openings, confirms to see colorimetric card in colorimetric window；Use liquid relief
Device draws sample to be tested（Serum or urine）100 μ L add well, while sample number is filled in into lid positive information note
Record hurdle, starts to observe result；In 20 minutes effectively, nature controlling line C and the whether aobvious redness of detection line T at observation inspection window；If Quality Control
Line C and the aobvious redness of detection line T, then contrasting detection line T and colour band and corresponding concentration explanation in colorimetric window（11）Color, with determine
The content range of β 2-MG in sample.
The kit testing result is explained as follows：
When only there is nature controlling line C, illustrate that the β 2-MG contents in sample are less than 0.65 μ g/mL；
When there is nature controlling line C, and the color of detection line T is relatively deep compared with the colour band that colorimetric window internal standard is designated as 0.65 μ g/mL,
And when shallower compared with the colour band of 1.00 μ g/mL is labeled as, illustrate that β 2-MG contents are less than more than 0.65 μ g/mL in sample
1.00μg/mL；
When there is nature controlling line C, and the color of detection line T is relatively deep compared with the colour band that colorimetric window internal standard is designated as 1.00 μ g/mL,
And when shallower compared with the colour band of 5.00 μ g/mL is labeled as, illustrate that β 2-MG contents are less than more than 1.00 μ g/mL in sample
5.00μg/mL；
When there is nature controlling line C, and the color of detection line T is relatively deep compared with the colour band that colorimetric window internal standard is designated as 5.00 μ g/mL,
And when shallower compared with the colour band of 10.0 μ g/mL is labeled as, illustrate that β 2-MG contents are less than more than 5.00 μ g/mL in sample
10.0μg/mL；
When there is nature controlling line C, and the color of detection line T is relatively deep compared with the colour band that colorimetric window internal standard is designated as 10.0 μ g/mL,
And when shallower compared with the colour band of 20.0 μ g/mL is labeled as, illustrate that β 2-MG contents are less than more than 10.0 μ g/mL in sample
20.0μg/mL；
When there is nature controlling line C, and the color of detection line T is deeper compared with the colour band that colorimetric window internal standard is designated as 20.0 μ g/mL
When, illustrate that β 2-MG contents are more than 20.0 μ g/mL in sample；
After being loaded 20 minutes, inspection window redfree lines occur, then illustrate that the kit is invalid.
A kind of latex immunochromatography half-quantitative detection kit of β2-microglobulin half of embodiment 2
The composition structure of the kit removes gold standard pad（25）By the replacement of color latex pad outward, other conditions and the phase of embodiment 1
Together, the color latex pad except label used be color latex in addition to, the same gold standard pad of its preparation method.
Claims (2)
1. a kind of β2-microglobulin semi-quantitative gold mark detection kit, it is characterised in that comprising cartridge, colorimetric card (9) and test strips
Three parts；The cartridge includes lid (8) and cassette bottom (14) two parts, and lid is with cassette bottom by post (12) and post groove (15) with grafting
Mode connects, and lid is fillet rectangle with cassette bottom；The visible inspection window in cartridge front (1), well (4) and colorimetric window (7),
Inspection window is oblong, and well is ellipse, and colorimetric window is fillet rectangle；Inspecting the visible reaction film of window position
(19), detection line T (20) and nature controlling line C (21), in the visible test strips sample pad (17) in sample-adding hole site, can in colorimetric window position
Colorimetric card mark (10) seen on colorimetric card and colour band and corresponding concentration explanation (11)；Lid front is printed on result and differentiates explanation
(2), well mark (3), name of an article mark (5) and information record hurdles (6)；Cassette bottom lower edge right side is provided with rectangle hole, to put
Enter colorimetric card；Colorimetric card is inserted in sliding manner inside cartridge, and the colorimetric draw-in groove (16) in cassette bottom is placed；It is printed on colorimetric card
Colorimetric card mark, colour band and corresponding concentration explanation；The test strips are placed in inside cartridge, the test paper bar groove being placed in cassette bottom
(13) in, by substrate (23), double faced adhesive tape (24), sample pad, colloidal gold pad (25), adhesive tape (18), reaction film (19), sample suction pad
(22) constitute.
2. β2-microglobulin semi-quantitative gold mark detection kit according to claim 1, it is characterised in that the test strips
It is to use a pair of good anti-β2-microglobulin monoclonal antibodies in mouse source of pairing property as capture antibody and detection antibody, claims respectively
For antibody a and antibody b；Antibody a colloid gold labels form antibody a- colloidal gold composites and are solidified in colloidal gold pad, antibody
B is coated in reaction film detection line T (20) position；Nature controlling line C (21) position is coated with goat-anti mouse monoclonal antibody.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201620689409.3U CN206132782U (en) | 2016-07-01 | 2016-07-01 | Quick detect reagent box of beta 2 microglobulin sxemiquantitative gold mark |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201620689409.3U CN206132782U (en) | 2016-07-01 | 2016-07-01 | Quick detect reagent box of beta 2 microglobulin sxemiquantitative gold mark |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN206132782U true CN206132782U (en) | 2017-04-26 |
Family
ID=58560591
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201620689409.3U Expired - Fee Related CN206132782U (en) | 2016-07-01 | 2016-07-01 | Quick detect reagent box of beta 2 microglobulin sxemiquantitative gold mark |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN206132782U (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112710844A (en) * | 2020-12-16 | 2021-04-27 | 北京开景基因技术有限公司 | Semi-quantitative kit and method for detecting novel coronavirus neutralizing antibody |
| CN115308406A (en) * | 2022-07-19 | 2022-11-08 | 杭州协合医疗用品有限公司 | Double-sample pad colloidal gold immunochromatographic test strip |
-
2016
- 2016-07-01 CN CN201620689409.3U patent/CN206132782U/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112710844A (en) * | 2020-12-16 | 2021-04-27 | 北京开景基因技术有限公司 | Semi-quantitative kit and method for detecting novel coronavirus neutralizing antibody |
| CN115308406A (en) * | 2022-07-19 | 2022-11-08 | 杭州协合医疗用品有限公司 | Double-sample pad colloidal gold immunochromatographic test strip |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20170426 Termination date: 20210701 |
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| CF01 | Termination of patent right due to non-payment of annual fee |