CN205333654U - Early detection test strip of kidney damage based on biomarker - Google Patents
Early detection test strip of kidney damage based on biomarker Download PDFInfo
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- CN205333654U CN205333654U CN201620062145.9U CN201620062145U CN205333654U CN 205333654 U CN205333654 U CN 205333654U CN 201620062145 U CN201620062145 U CN 201620062145U CN 205333654 U CN205333654 U CN 205333654U
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Abstract
The utility model relates to a life and health technical field, concretely relates to early detection test strip of kidney damage based on biomarker, the test paper strip include the end liner and set up in coated film on the end liner has set gradually sample pad, peridium line district and the paper that absorbs water on, peridium line district sets gradually underlined line, matter accuse line, mAlb detection line and NGAL detection line, the mark line includes by the 2nd mAlb monoclonal antibody of fluorescence latex mark, the 2nd NGAL monoclonal antibody and rabbit igG antibody, matter accuse solenoid is drawn together goat -anti rabbit igG antibody and is stated the mAlb monoclonal antibody that the mAlb detection line includes the ability and waits to detect antigen mAlb specifically bind to, the NGAL detection line includes an ability and a NGAL monoclonal antibody who waits to detect antigen NGAL specifically bind to, the utility model provides a test paper strip passes through two joint inspections of mAlb and NGAL, and complementation is in coordination played in the diagnosis that the damage takes place to the kidney, can judge for the kidney damage provides supplementary in early days according to the real -time monitoring result, shortens the detection cycle, has increased the sensitivity that detects, has made things convenient for user's use.
Description
Technical field
This utility model relates to life and health technical field, is specifically related to a kind of injury of kidney early stage test strip based on biomarker。
Background technology
Microalbumin (has another name called Microalbuminuria, Micoralbuminuria, mAlb) and refers to the microalbumin occurred in urine。The improper appearance of microalbumin, is typically considered one of important clinical marks such as renal failure, diabetes and cardiovascular disease complication。Therefore, in urine there is the detection of level to the early diagnosis of nephropathy, diabetes and cardiovascular diseases, early treatment and reduction risk by important reference value and clinical meaning in albumin。Neutrophil gelatinase-associated lipocalin NGAL (neutrophilgelatinase-associatedlipocalin, NGAL) be found first in neutrophilic granulocyte for 1993, to inflammation, fetal development, immunne response, chemotaxis, signal transduction and kinds of tumors to betide the processes such as development relevant。Recent domestic research shows, NGAL albumen has the feature of specific expressed change in multiple disease generating process so that NGAL becomes the biomarker of detection disease。In recent years the result of study of U.S. clinical chemistry association (AACC) annual meeting deliver learn detection urine in neutrophilic granulocyte gelatinase relative carrier lipoprotein potentially contribute to clinician detect turnover in patients following heart transplantation ciclosporin induction toxicity, and regulate ciclosporin dosage to prevent its irreversible injury that kidney is caused。Chinese patent CN101163971 studied acute renal failure (ARF), acute tubular necrosis (ATN) and acute tubular interstitial kidney diseases (ATIN) are fallen ill early stage, in urine and blood, NGAL level dramatically increases, and therefore NGAL is the early stage detection kidney mark to ischemia injury。The biomarker that two renal functioies of good performance that mAlb and NGAL is newly discovered are good, particularly just there is obvious change in acute or renal dysfunction early stage, thus it is subject to the welcome of Clinical detection personnel, if detected by two kinds of marks simultaneously, then more accurately can reflect renal function performance all sidedly。The early diagnosis of injury of kidney only relies solely on the detection of single renal function mark in the market, usually because single round of visits is long, sensitivity is low, thus cannot guaranteeing the diagnosis of injury of kidney and even can affecting the follow-up treatment of impaired renal patient and life and health。
Utility model content
The main purpose of utility model is in that to provide a kind of injury of kidney early stage test strip based on biomarker, detection mAlb and NGAL simultaneously, cooperative compensating effect is played in the diagnosis occurred for injury of kidney, can according to actually detected result, provide assistance in diagnosis for injury of kidney early stage, shorten the detection cycle, add the sensitivity of detection, convenient for users。
A kind of injury of kidney early stage test strip based on biomarker in this programme, described test strips includes end liner and is arranged at the coated film on described end liner, described coated film is disposed with sample pad, is coated line district and absorbent paper；The described line district that is coated is disposed with mark line, nature controlling line, mAlb detection line and NGAL detection line；Described mark line includes by the 2nd mAlb monoclonal antibody of fluorescent latex labelling, the 2nd NGAL monoclonal antibody and rabbit igg antibody；Described nature controlling line includes goat anti-rabbit igg antibody；Described mAlb detection line includes can with a mAlb monoclonal antibody specific binding for antigen mAlb to be detected；Described NGAL detection line includes can with a NGAL monoclonal antibody specific binding for antigen NGAL to be detected。
Further, described antigen mAlb to be detected is people source mAlb, and described antigen NGAL to be detected is people source NGAL。
Further, the spacing distance that described mark line, nature controlling line, mAlb detect between line and NGAL detection line is respectively set to 3mm～5mm。
The beneficial effects of the utility model are: by two joint inspections of mAlb and NGAL, cooperative compensating effect is played in the diagnosis occurred for injury of kidney, it is possible to according to actually detected result, auxiliary judgment is provided for injury of kidney early stage, shorten the detection cycle, add the sensitivity of detection, convenient for users。
Accompanying drawing explanation
Fig. 1 is this utility model internal structure schematic diagram based on the injury of kidney early stage test strip preferred embodiment of biomarker；
Fig. 2 adopts this utility model based on the dependency graph of the injury of kidney mAlb that test strip and Roche E170 Chemiluminescence Apparatus are measured for identical clinical sample in early days of biomarker；
Fig. 3 adopts this utility model based on the dependency graph of the injury of kidney NGAL that test strip and Roche E170 Chemiluminescence Apparatus are measured for identical clinical sample in early days of biomarker。
Detailed description of the invention
Should be appreciated that specific embodiment described herein is only in order to explain this utility model, be not used to limit this utility model。
Main purpose of the present utility model is in that to provide a kind of injury of kidney early stage test strip based on biomarker, detection mAlb and NGAL simultaneously, cooperative compensating effect is played in the judgement occurred for injury of kidney, can according to actually detected result, auxiliary judgment is provided for injury of kidney early stage, shorten the detection cycle, add the sensitivity of detection, convenient for users。
With reference to Fig. 1, the described injury of kidney early stage test strip based on biomarker includes end liner 1 and is arranged at the coated film 3 on described end liner 1, described coated film 3 is disposed with sample pad 2, is coated line district and absorbent paper 4, wherein: described in be coated that line district is disposed with mark line 5, nature controlling line 6, mAlb detect line 7 and NGAL and detect line 8；Described mark line 5 includes by the 2nd mAlb monoclonal antibody of fluorescent latex labelling, the 2nd NGAL monoclonal antibody and rabbit igg antibody；Described nature controlling line 6 includes goat anti-rabbit igg antibody；Described mAlb detection line 7 includes can with a mAlb monoclonal antibody specific binding for antigen mAlb to be detected；Described NGAL detection line 8 includes can with a NGAL monoclonal antibody specific binding for antigen NGAL to be detected。Described antigen mAlb to be detected is people source mAlb, and described antigen NGAL to be detected is people source NGAL。The spacing distance that described mark line, nature controlling line, mAlb detect between line and NGAL detection line is respectively set to 3mm～5mm。
This utility model is made by method for the above-mentioned injury of kidney early stage Test paper strip adoption based on biomarker。
The described preparation method based on the tumor early stage test strip of biomarker comprises the steps of
The preparation of 1.mAlb and NGAL monoclonal antibody fluorescent latex microsphere
After conventional method fluorescent latex ultrasound wave 200W-400W after covalent activated is processed the 20-30 second, the 2nd mAlb monoclonal antibody (purchased from Wuhan Sino-American Biotechnology Company) is added according to the ratio of 50-200 μ g traget antibody/100 μ l fluorescent latex, 2nd NGAL monoclonal antibody (purchased from Wuhan Sino-American Biotechnology Company) and rabbit igg antibody (purchased from Wuhan Sino-American Biotechnology Company), room temperature stirring reaction 2h after mixing, centrifuge washing 3 times, each 10000-15000xg, centrifugal 10min, precipitate and dissolve with PBS-TBN and ultrasound wave 100W process 30s, centrifugal front volume is recovered with PBS-TBN, 4 DEG C of preservations, standby。
2. the closing of sample pad
The preparation of 2.1 confining liquids: will containing 1%BSA, 0.2% tween 20,2.5% sucrose, 0.05% Hydrazoic acid,sodium salt, the PBS of 0.01M, pH7.4, with 0.22 μ membrane filtration, be placed in 4 DEG C standby, 3 days effect duration。
The closing of 2.2 sample pad: confining liquid is added in sample pad uniformly by the amount of 65ul/cm2 so that sample pad is completely drenched。
Drying of 2.3 sample pad: the sample pad closed being proceeded to air dry oven and dries, it is 12-24 hour that baking temperature controlled 37 ± 1 DEG C of drying times。
Being coated of 3.NC film
The preparation of 3.1 mark lines: be marked with the fluorescent latex of mAlb monoclonal antibody with being coated buffer dilution, be marked with the fluorescent latex of NGAL monoclonal antibody and be marked with the fluorescent latex of rabbit anti-igg antibody, the latex of these three traget antibody is mixed, lines formation mark line on coated film；Wherein the concentration of the NGAL monoclonal antibody of the mAlb monoclonal antibody of fluorescent latex labelling and fluorescent latex labelling is 0.5-1.0mg/ml, and consumption is 0.02-0.1 μ g/cm2；The concentration of the rabbit anti-igg antibody of fluorescent latex labelling is 1.0mg/ml, and consumption is 0.001-0.025 μ g/cm2；Described it is coated in buffer containing 1%BSA, 0.2% tween 20,2.5% sucrose, 0.05% Hydrazoic acid,sodium salt, the PBS of 0.01M, pH7.4)；
The preparation of 3.2 nature controlling lines and detection line: with the PBS of 0.01M, pH7.4 dilute goat anti-rabbit igg antibody, can with another strain mAlb monoclonal antibody of the mAlb monoclonal antibody being different from step 3.1 of antigen mAlb specific bond to be checked and can with another strain NGAL monoclonal antibody of the NGAL monoclonal antibody being different from step 3.1 of antigen NGAL specific bond to be checked, and three kinds of antibody after dilution are lined respectively successively abreast coated film is formed nature controlling line, mAlb detects line and NGAL detects line；Wherein, the concentration of the coated goat anti-rabbit igg antibody of nature controlling line is 1.0mg/ml, and consumption is 18-30 μ l/30cm；It is 1.0mg/ml that mAlb detects the concentration of the coated mAlb monoclonal antibody of line, and consumption is 18-30 μ l/30cm；It is 0.5mg/ml that NGAL detects the concentration of the coated NGAL monoclonal antibody of line, and consumption is 18-30 μ l/30cm；Described mark line, nature controlling line, mAlb detect line, NGAL detects spaced 3-5mm between line。
The preparation of 3.3 coated films: by being coated mark line, nature controlling line, mAlb detect line, NGAL detects the coated film of line and is placed in humidity <baking oven of 37 ± 1 DEG C of 30%, after dry 12～24h, balances more than 7 days in 2 DEG C of-30 DEG C of hermetically dryings。
4. the assembling of test strips
End liner 1, sample pad 2, sample pad 3 and absorbent paper 6 are parts generally in the art。By above-mentioned sample pad 2 and sample pad 3, be coated with the gold polyester film 4 of labeling antibody, coated film 5 and absorbent paper 6 sequentially mutually overlap joint stickup obtain test strips, finally test strips is cut into the test strips of different in width。
Further, in preferably embodiment, the injury of kidney early stage test strip based on biomarker can also with combination of getting stuck, and the mode of composition test kit detects, but does not also limit this kind of mode；The carrier that other test strips match also can be coordinated to constitute the injury of kidney early stage detection kit based on biomarker detect。
1, with Roche E170 Chemiluminescence Apparatus to 150 example clinic mAlb and NGAL sample (such as: urine) as examination criteria, table 1 adopts test kit that the test strips of this utility model preferred embodiment the constitutes mAlb quantified results to 10 samples；Table 2 adopts test kit that the test strips of this utility model preferred embodiment the constitutes NGAL quantified results to 10 samples。
Table 1 adopts test kit that the test strips of this utility model preferred embodiment the constitutes mAlb quantified results to 10 samples
Table 2 adopts test kit that the test strips of this utility model preferred embodiment the constitutes NGAL quantified results to 10 samples
From table 1 and table 2 it can be seen that adopt the test kit that the test strips of preferred embodiment is constituted when sample is measured, it is possible to obtain the result suitable with examination criteria, illustrates that the test kit that this utility model test strips is constituted can realize accurate quantitative analysis measurement。
2, test strips is carried out the mensuration of aspect of performance---lowest detection limit
Fig. 2 adopts this utility model based on the dependency graph of the injury of kidney mAlb that test strip and Roche E170 Chemiluminescence Apparatus are measured for identical clinical sample in early days of biomarker；Fig. 3 adopts this utility model based on the dependency graph of the injury of kidney NGAL that test strip and Roche E170 Chemiluminescence Apparatus are measured for identical clinical sample in early days of biomarker。With reference to Fig. 2 and Fig. 3, in the present embodiment, mAlb tests 60 parts of clinical samples (such as: urine) with the E170 Chemiluminescence Apparatus of Roche Holding Ag, and the result correlation coefficient of both products is R2 > 0.9961, and Y=0.9987X+0.0317；NGAL tests 60 parts of clinical samples (such as: urine) with the E170 Chemiluminescence Apparatus of Roche Holding Ag, and the result correlation coefficient of both products is R2 > 0.9977, and Y=0.9935X+2.2989；Therefore, the test kit of this embodiment is good with the dependency of contrast agents, and the lowest detection limit that lowest detection limit is 20.0mg/l, NGAL of mAlb is 25ng/ml。
3, test strips is carried out the mensuration of aspect of performance---precision
Content is the sample of high level, low value and intermediate value by test kit that employing preferred embodiment is made up of test strips respectively, and at least detection 10 times, calculate the coefficient of variation (CV) continuously。
Be chosen as (157.7mg/l) for the high value of mAlb content, intermediate value is chosen as (64.1mg/l), low value is chosen as (25.6mg/l), above-mentioned 3 urine specimens are measured 10 times respectively, according to its determination data, SPSS software statistics is utilized to draw high level (156.5+4.2mg/l), CV1.53%；The same SPSS software statistics that utilizes draws intermediate value (63.8+2.2mg/l), CV1.53%；Same utilize SPSS software statistics to draw low value is chosen as (25.1+0.6mg/l), CV1.81%；Testing result CV value is respectively less than 5%。
Be chosen as (1405.1ng/ml) for the high value of NGAL content, intermediate value is chosen as (799.2ng/ml), low value is chosen as (149.6ng/ml), above-mentioned 3 urine specimens are measured 10 times respectively, according to its determination data, SPSS software statistics is utilized to draw high level (1404.8+5.1ng/ml), CV2.75%；The same SPSS software statistics that utilizes draws intermediate value (801.2+1.6ng/ml), CV1.85%；Same utilize SPSS software statistics to draw low value is chosen as (150.5+2.3ng/ml), CV2.04%；Testing result CV value is respectively less than 5%。These results suggest that the precision of the test kit that preferred embodiment is made up of test strips is good。
This utility model embodiment includes end liner and the coated film being arranged on end liner based on the injury of kidney early stage test strip of biomarker, coated film is disposed with sample pad, is coated line district and absorbent paper；It is coated line district to set gradually as mark line, nature controlling line, mAlb detects line and NGAL detects line；Mark line includes by the 2nd mAlb monoclonal antibody of fluorescent latex labelling, the 2nd NGAL monoclonal antibody and rabbit igg antibody, and nature controlling line includes goat anti-rabbit igg antibody；MAlb detect line and NGAL detect that line includes respectively can with a mAlb monoclonal antibody specific binding for antigen mAlb to be detected and can with a NGAL monoclonal antibody specific binding for antigen NGAL to be detected。The test strips that this utility model provides is by two joint inspections of mAlb and NGAL, and cooperative compensating effect is played in the judgement occurred for injury of kidney, it is possible to according to actually detected result, auxiliary judgment is provided for injury of kidney early stage, shorten the detection cycle, add the sensitivity of detection, convenient for users。
Above-described is only embodiment of the present utility model, and in scheme, the general knowledge such as known concrete structure and characteristic does not do too much description at this。Should be understood that; for a person skilled in the art, under the premise without departing from this utility model structure, it is also possible to make some deformation and improvement; these also should be considered as protection domain of the present utility model, and these are all without affecting effect and the practical applicability that this utility model is implemented。
Claims (3)
1. based on the injury of kidney early stage test strip of biomarker, it is characterised in that: described test strips includes end liner and is arranged at the coated film on described end liner, described coated film is disposed with sample pad, is coated line district and absorbent paper；The described line district that is coated is disposed with mark line, nature controlling line, mAlb detection line and NGAL detection line；Described mark line includes by the 2nd mAlb monoclonal antibody of fluorescent latex labelling, the 2nd NGAL monoclonal antibody and rabbit igg antibody；Described nature controlling line includes goat anti-rabbit igg antibody；Described mAlb detection line includes can with a mAlb monoclonal antibody specific binding for antigen mAlb to be detected；Described NGAL detection line includes can with a NGAL monoclonal antibody specific binding for antigen NGAL to be detected。
2. the injury of kidney early stage test strip based on biomarker according to claim 1, it is characterised in that: described antigen mAlb to be detected is people source mAlb, and described antigen NGAL to be detected is people source NGAL。
3. the injury of kidney early stage test strip based on biomarker according to claim 1, it is characterised in that: the spacing distance that described mark line, nature controlling line, mAlb detect between line and NGAL detection line is respectively set to 3mm～5mm。
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| Application Number | Priority Date | Filing Date | Title |
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| CN201620062145.9U CN205333654U (en) | 2016-01-21 | 2016-01-21 | Early detection test strip of kidney damage based on biomarker |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113252909A (en) * | 2021-06-15 | 2021-08-13 | 南京申基医药科技有限公司 | Immunofluorescence detection kit based on quantum dots and preparation method thereof |
| CN114578057A (en) * | 2020-11-30 | 2022-06-03 | 北京大学第一医院 | Application of monomer C-reactive protein (mCRP) in preparation of kit and kit |
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- 2016-01-21 CN CN201620062145.9U patent/CN205333654U/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114578057A (en) * | 2020-11-30 | 2022-06-03 | 北京大学第一医院 | Application of monomer C-reactive protein (mCRP) in preparation of kit and kit |
| CN113252909A (en) * | 2021-06-15 | 2021-08-13 | 南京申基医药科技有限公司 | Immunofluorescence detection kit based on quantum dots and preparation method thereof |
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| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20160622 Termination date: 20170121 |
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| CF01 | Termination of patent right due to non-payment of annual fee |