CN209559900U - Three fluorescence immune chromatography test paper bars of thyroid gland, test board and kit - Google Patents
Three fluorescence immune chromatography test paper bars of thyroid gland, test board and kit Download PDFInfo
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- CN209559900U CN209559900U CN201821713673.1U CN201821713673U CN209559900U CN 209559900 U CN209559900 U CN 209559900U CN 201821713673 U CN201821713673 U CN 201821713673U CN 209559900 U CN209559900 U CN 209559900U
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Abstract
The utility model discloses a kind of three fluorescence immune chromatography test paper bars of thyroid gland, test board and kit, three fluorescence immune chromatography test paper bars of the thyroid gland are mainly made of sample pad, detection film and water absorption pad.It is coated with TSH fluorescence antibody, T3 fluorescence antibody and T4 fluorescence antibody in sample pad, detects and the first, second, and third detection line is set on film, it is respectively coated THS monoclonal antibody, T3 monoclonal antibody and T4 monoclonal antibody also set up nature controlling line, are coated with sheep anti-mouse igg polyclonal antibody.Above-mentioned test strips are packaged in the test board being made of upper casing and lower casing, and well and observation window is arranged in upper casing, corresponding with the detection line and nature controlling line of the sample pad of test strips and detection film respectively.It include above-mentioned test board, sample cell and the radio-frequency identification card for storing the information such as standard curve in kit.Quick, convenient, accurate, reliable detection to three, thyroid gland in measuring samples can be realized using the kit combination fluorescence immunity analyzer, without pre-processing to measuring samples.
Description
Technical field
The utility model relates to the fluorescence immune chromatography detection field of biotechnology, in particular to a kind of three Xiang Ying of thyroid gland
Light immuno-chromatographic test paper strip, test board and kit.
Background technique
Thyroid gland is the maximum endocrine gland of human body, can secrete the hormones such as thyroxine, trilute.These
The adjusting for the thyroid-stimulating hormone that hormone is secreted by adenohypophysis, to the generation of the protein of human body, fat, carbohydrate, vitamin, water and salt
Thank and the processes such as the growth and development of human body play the role of it is highly important.
In clinical practice, thyroid function mainly is evaluated by measuring three kinds of hormones of thyroid gland, these three
Hormone is thyrotropic hormone (TSH), free serum trilute (FT3) and serum free thyroxine respectively
(FT4), referred to as " three, thyroid gland ".Hyperthyroidism, first can be subtracted according to three, thyroid gland in patient blood samples concentration, first shape
The various diseases such as adenositis, thyroid adenoma are diagnosed, therefore three, thyroid gland have extensive, important meaning in clinical diagnosis
Justice.
Currently, three, thyroid gland detections mainly use enzyme linked immunosorbent assay (ELISA) or chemiluminescence immunoassay point
The methods of analysis method (CLIA).ELISA method it is cumbersome, take a long time, and detection range and sensitivity is not high, gradually by
It eliminates.The testing result of ECLIA method is more accurate, and sensitivity is higher, but it needs to be immunized using automations such as electrochemical luminescences
Detector, detection need to carry out under sealing condition, need to be equipped with expensive special instrument and kit, at high cost and can only carry out
Single index detection, takes a long time, so being not easy to promote.
In conclusion the detection method and tool of three, existing thyroid gland are cumbersome in the presence of detecting, take a long time, detection range
And sensitivity is not high, or needs to be equipped with the deficiency of expensive special instrument.It can be to thyroid gland three therefore, it is necessary to design one kind
Item carries out quick, convenient, accurate, reliable test strips, test board and kit.
Utility model content
The purpose of the utility model is to provide a kind of three fluorescence immune chromatography test paper bars of thyroid gland, test board and examinations
Agent box realizes quick, convenient, accurate, the reliable detection to three, thyroid gland in measuring samples in conjunction with fluorescence immunity analyzer.
In order to solve the above-mentioned technical problem, the utility model provides a kind of three fluorescence immune chromatography test paper bars of thyroid gland,
Three fluorescence immune chromatography test paper bars of the thyroid gland include sample pad, detection film and water absorption pad.
The sample pad includes glass fibre membrane.
The detection film includes nitrocellulose filter, cellulose acetate film.Further, detection film is nitrocellulose
Film.
The water absorption pad includes blotting paper.
The glass fibre, nitrocellulose filter, cellulose acetate film and blotting paper are commercially available commodity.
The sample pad, detection film and water absorption pad sequentially overlap.As shown in Figure 1 and Figure 2, sample pad and detection film
One end overlap joint, the other end and water absorption pad for detecting film overlap.Sample pad that mutually overlapped and detection film, detection film and water absorption pad
Overlying relation can be interchanged, and be not limited to attached drawing 3, attached overlying relation shown in Fig. 4.
The region contacted between the sample pad and detection film, detection film and water absorption pad can be auxiliarily fixed without using any
Articles, such as sample pad, detection film and water absorption pad are put into card slot and keep its specific positional relationship.Also bonding can be used
Mode keep its specific positional relationship.
The outer dimension of the sample pad, detection film and water absorption pad is routine, is limited with can be realized measurement target.
The sample pad the preparation method is as follows: step 1) impregnate: sample pad is put into the solution of sealant compositions
It impregnates 0.5 hour~2.0 hours；Step 2) is dry: the sample pad of step 1) taken out, it is 3 hours dry in 20 DEG C~40 DEG C
~7 hours.
Sealant compositions used in the closing sample pad include Emulsifier EL-60, polyvinyl alcohol, trehalose, sugarcane
Sugar and buffer, the mass concentration percentage of Emulsifier EL-60, polyvinyl alcohol, trehalose and sucrose in the buffer
For (0.25%~0.55%): (0.05%~0.30%): (1.0%~6%): (10%~20%)；
The buffer includes phosphate buffer, and phosphate concentration is 40mmol/L to 100mmol/L, and pH value is
6.0 to 8.0.
Sample pad using above-mentioned enclosure method preparation has lower non-specific adsorption effect, in sample to be examined
Target substance absorption is few, ensure that the combination of target substance and fluorescence antibody, improves the accuracy of detection；Make sample pad with it is glimmering
Adsorption between photoactivated antibody is in reasonable interval, improves the desorption efficiency of fluorescence antibody in immune chromatography test paper use, drop
Low detection limit, improves detection accuracy；Immune chromatography test paper is set to be suitable for the detection to whole blood sample, without to whole blood sample
It is pre-processed, simplifies detection process.
Thyrotropic hormone fluorescence antibody, trilute fluorescence antibody and first shape are coated in the sample pad
Parathyrine fluorescence antibody, these fluorescence antibodies are referred to as " the thyrotropic hormone monoclonal of coupling fluorescent microsphere is anti-
Body ", " the trilute monoclonal antibody of coupling fluorescent microsphere " and " the thyroxine monoclonal of coupling fluorescent microsphere
Antibody " can also be briefly referred to as " TSH fluorescence antibody ", " T3 fluorescence antibody " and " T4 fluorescence antibody ".
" trilute " abbreviation " T3 "；" free trilute " abbreviation " FT3 "；" thyroid gland
Element " abbreviation " T4 "；" free thyroxine " abbreviation " FT4 ".
The coating weight of every kind of fluorescence antibody in the sample pad is 0.1 μ of μ g~2 g.
The TSH fluorescence antibody, T3 fluorescence antibody and T4 fluorescence antibody, thyrotropic hormone monoclonal antibody, triiodo
Thyronine monoclonal antibody, thyroxine monoclonal antibody and fluorescent microsphere are commercial antibodies available on the market and glimmering
Luminescent material.
The preparation method of the TSH fluorescence antibody, T3 fluorescence antibody and T4 fluorescence antibody uses this field routine techniques
Preparation, by taking TSH fluorescence antibody as an example, the specific steps are as follows: first remove thyrotropic hormone monoclonal antibody with the method for dialysis
Sodium azide in reagent；Then 2- (N- morpholino) ethanesulfonic acid (MES) buffer with the pH6.0 of concentration 50mM is dilute by antibody
Release 1mg/mL；Fluorescent microsphere is added in 2- (N- morpholino) ethanesulfonic acid (MES) buffer of the pH6.0 of concentration 50mM,
Sonic oscillation 10min makes its dispersion；1- (3- dimethylamino-propyl) -3- ethyl carbodiimide salt is added in above-mentioned suspension
Hydrochlorate (EDC) makes its final concentration of 10 mg/mL, is incubated for 15min at 26 DEG C, fluorescent microsphere is activated；Fluorescent microsphere is hanged
Supernatant liquid centrifugation, removes supernatant, and 2- (N- morpholino) ethanesulfonic acid (MES) for adding the pH6.0 of isometric concentration 50mM is slow
Fliud flushing, suspend fluorescent microsphere again, is centrifuged and removes supernatant；Again with the 2- (N- of the pH6.0 of isometric concentration 50mM
Quinoline generation) ethanesulfonic acid (MES) buffer, suspend fluorescent microsphere again, and above-mentioned antibody-solutions are added, 5h are reacted at 26 DEG C, during which not
Failure of oscillation swings or stirs；Ethanol amine, mixing oscillation 15min is added；It will be finally centrifuged containing TSH fluorescence antibody suspension, removal
Supernatant, for use.T3 fluorescence antibody and T4 fluorescence antibody are identical as the preparation method of TSH fluorescence antibody, only by correlation step
Thyrotropic hormone monoclonal antibody replaces with corresponding monoclonal antibody.
TSH fluorescence antibody, T3 fluorescence antibody and T4 fluorescence antibody described in the utility model are also by closing step.
By taking the closing of TSH fluorescence antibody as an example, the closing step includes: that the TSH fluorescence antibody after washing suspends
It is closed in the solution of sealant compositions.
Sealant compositions used in the closing TSH fluorescence antibody include Emulsifier EL-60, polyvinyl alcohol, seaweed
Sugar, sucrose and buffer, the mass concentration of Emulsifier EL-60, polyvinyl alcohol, trehalose and sucrose in the buffer
Percentage is (0.02%~0.25%): (0.05%~0.30%): (1.0%~6%): (10%~20%)；
The buffer includes phosphate buffer, and phosphate concentration is 10mmol/L to 40mmol/L, and pH value is
6.0 to 8.0.
The closing step of T3 fluorescence antibody and T4 fluorescence antibody is identical as the closing of TSH fluorescence antibody.
There is special property through above-mentioned enclosure method treated fluorescence antibody, fluorescence antibody can be made in test strips system
It is adsorbed in sample pad during standby, and desorbs fluorescence antibody easily from sample pad in using test strips detection process
Get off, in sample liquid or test liquid be moved to detection film, and be moved to corresponding position, have test strips preferably
Detectability.After the enclosure method processing, acting on the non-specific adsorption of fluorescence antibody is reduced, and is reduced to blood
The absorption of other biological macromolecular substances in sample can be such that accuracy in detection and stability improves.
The first detection line, the second detection line, third detection line and nature controlling line, such as Fig. 1 are disposed on the detection film
Shown, the first detection line, the second detection line, third detection line and nature controlling line are parallel to each other, wherein the first detection line is close to sample
Pad, nature controlling line is far from sample pad.
First detection line, the second detection line, third detection line be coated respectively with thyrotropic hormone monoclonal antibody,
Any one in trilute monoclonal antibody, thyroxine monoclonal antibody, and the first detection line, the second inspection
The monoclonal antibody that survey line, third detection line are coated with is different.
For example, as an example, the first detection line is coated with thyrotropic hormone monoclonal antibody, the second detection line is applied
It is furnished with trilute monoclonal antibody, third detection line is coated with thyroxine monoclonal antibody；As another example,
First detection line is coated with trilute monoclonal antibody, and it is anti-that the second detection line is coated with thyroxine monoclonal
Body, third detection line are coated with thyrotropic hormone monoclonal antibody；As another example, the first detection line is coated with thyroid gland
Plain monoclonal antibody, the second detection line are coated with thyrotropic hormone monoclonal antibody, and third detection line is coated with triiodo first shape
Gland original ammonia acid monoclonal antibody.
Between the distance between the nature controlling line and water absorption pad, each detection line, the distance between detection line and nature controlling line
For the conventional arrangement of this field.
The amount for each monoclonal antibody being coated in each detection line is 0.1 μ of μ g~2.0 g.
The nature controlling line is coated with sheep anti-mouse igg polyclonal antibody.
The amount for the sheep anti-mouse igg polyclonal antibody being coated on the nature controlling line is 0.1 μ of μ g~6.0 g.
The sheep anti-mouse igg polyclonal antibody is commercial antibody available on the market.
The preparation process of the detection film is as follows: with the drying process after drawing film, stroke film of continuous state operation, and setting
After drawing film after drying process, with drying process after the film closing of continuous state operation, closing；Described stroke of film is done after drawing film
The runing time of drying process is 2~4min, and the runing time of drying process is 3~6min after the film closing, closing.
The step of preparation process of the detection film, is as follows:
A, dry after drawing film, drawing film:
A1, it draws film: NC film roll being taken to be placed in out on reel, then by drawing film instrument, the antibody of required concentration will be diluted to
Solution is crossed on NC film or sprays line；
A2, draw drying after film: while NC film rear end is crossed, the NC film front end that scribing line is completed enters at once to be mentioned
Before be preheated in the drying tower of drying temperature, complete drying；
B, drying process after film closing, closing
B1, film closing: by the NC film after step a2 is dry, at the uniform velocity by the immersion liquid slot added with confining liquid, to NC film into
Row closing；
The confining liquid is mainly dissolved in the PB of pH7.0~8.0,50~60mM by closing component, surface active agent composition
It is made in solution；The closed group point includes at least one of PEG4000, bovine serum albumin, gelatin, formaldehyde, casein, institute
Stating mass percentage of the closing component in confining liquid is 0.5~1.0%；The surface active agent composition includes tween-
20, Pluranic L64, Cremophor EL, Surfynol 485, Tetronic 1307, in TRITON X-100 at least
One kind, mass percentage of the surface active agent composition in confining liquid are 0.5~1.0%；
It is dry after b2, closing: while NC film rear end is closed, closed NC film front end is completed to enter at once and mention
Before be preheated in the drying tower of drying temperature, complete it is dry after wind.
Drying temperature described in step a2, b2 is 35~40 DEG C.
The confining liquid is mainly dissolved in pH by closing component PEG4000, surface active agent composition Surfynol 485
7.0, in the PB solution of 50mM and adjust confining liquid pH to 7.0 be made；Described PEG4000, Surfynol 485 is in confining liquid
Mass percentage be respectively 0.5%, 0.6%.
Surface active agent composition in the confining liquid further includes Pluranic L64, and the Pluranic L64 is being closed
Mass percentage in liquid is 0.2%.
Using the above-mentioned detection film with highly sensitive, low detection limit characteristic, it is possible to prevente effectively from because in blood sample
TSH, FT3, FT4 concentration are lower and show that detected value is zero, can not make correct medical judgment, influence the feelings of diagnosing and treating
Condition；Also it is possible to prevente effectively from the diagnostic result of false positive, for example, TSH actual concentrations are about 0.25mU/L in blood sample, other
The detected value of test board is shown as 0.45mU/L, within the normal range (NR) of diagnosis (0.3mU/-0.5mU/), and is diagnosed as
The case where normal situation, causes mistaken diagnosis, delays treatment Best Times.
The non-specific adsorption to test substance can be reduced using the sample pad that above-mentioned sample pad enclosure method obtains.It adopts
The absorption to interfering substance can be reduced with the fluorescence antibody that above-mentioned fluorescence antibody enclosure method obtains, and can be with sample pad
Preferable separation, into detection film.There is highly sensitive, low detection limit using the detection film of above-mentioned detection membrane preparation method preparation
Characteristic, can enable to detect film and effectively avoid the interference of other substances, there is higher spy to the detection of TSH, FT3, FT4
It is anisotropic.The characteristic of above-mentioned sample pad, fluorescence antibody and detection film makes the minimum detection limit of TSH fluorescence immune chromatography reach 0.1mU/
L, measurement range are 0.1mU/L~12mU/L, linearly dependent coefficient r >=0.96；Above-mentioned sample pad, fluorescence antibody and detection film
Characteristic so that the minimum detection limit of FT3 fluorescence immune chromatography is reached 1.0pmol/L, measurement range be 0.25pmol/L~
8pmol/L, linearly dependent coefficient r >=0.95；The characteristic of above-mentioned sample pad, fluorescence antibody and detection film makes FT4 fluorescence immunoassay layer
The minimum detection limit of analysis reach its measurement range of 0.5 pmol/L be 0.5pmol/L~60pmol/L, linearly dependent coefficient r >=
0.96.And the accuracy of measurement result is higher, and standard deviation is no more than 7.2%.
In order to solve the above-mentioned technical problem, the utility model also provides a kind of three fluorescence immune chromatography tests of thyroid gland
Plate, three fluorescence immune chromatography test boards of the thyroid gland include getting stuck and being arranged in the interior test strips that get stuck.
It is described to get stuck including upper casing and lower casing, it is provided with well and observation window on upper casing, the well corresponds to test paper
The sample pad of item, corresponding the first detection line, the second detection line, third detection line and the nature controlling line detected on film of the observation window.
The card slot of fixed test strips is provided on the upside of the lower casing, shape is identical as test strips therein are placed.
The shape of the well and observation window includes but is not limited to attached shape shown in Fig. 4, such as well can be with
It is ellipse or quadrangle etc., observation window can also be oblong, and quadrangle has the rectangle etc. of radian.
The upper casing to get stuck and lower casing can be spliced using detachable, and internal test strips can be according to need
It replaces, gets stuck reusable；Upper casing and lower casing can also be welded by the way of welding, such as with the mode of ultrasonic welding
It picks up and.
The upper surface of the upper casing is also coated with two dimensional code, recognizes test card to be detected for fluorescence immunity analyzer,
It eliminates and the operation such as is manually entered, improve detection speed, save the operating time, it is ensured that the accuracy of detection and analysis.
The interior test strips that get stuck that are arranged in are three fluorescence immune chromatography test paper bars of thyroid gland described previously.
When carrying out three concentration mensurations of thyroid gland using the test board, required measuring samples amount is few, such as only needs
100 μ of μ L~300 L.
In order to solve the above-mentioned technical problem, the utility model also provides a kind of three fluorescence immune chromatography reagents of thyroid gland
Box, three fluorescence immune chromatography kits of the thyroid gland include three fluorescence immune chromatography test boards of thyroid gland, sample cell and penetrate
Frequency identification card.
Multiple test boards and sample cell are housed in the kit, test board and sample cell can also be packed independently,
To avoid unnecessary outside contamination, the Stability and veracity of detection is influenced.
Standard curve is stored in the radio-frequency identification card.
Kit testing principle described in the utility model and process are as follows, with a kind of described three fluorescence immunoassays of thyroid gland
For chromatography: the blood sample to be measured of prescribed volume being added in sample pad, TSH, T3 and T4 difference in blood sample to be measured
Corresponding fluorescence antibody combines, and it is anti-to be respectively formed fluorescence antibody-TSH compound, fluorescence antibody-T3 compound, fluorescence
Body-T4 compound, there are also the various fluorescence antibodies not in conjunction with TSH, T3, T4 in sample pad at this time.Fluorescence antibody-TSH is compound
The various fluorescence antibodies that object, fluorescence antibody-T3 compound, fluorescence antibody-T4 compound, He Weiyu TSH, T3, T4 are combined are in hair
Under spy uses, at chromatography to the first detection line, the second detection line, third detection line, fixed TSH monoclonal in the first detection line
Antibody forms TSH fluorescence antibody-TSH-TSH monoclonal antibody in conjunction with another site on the TSH of fluorescence antibody-TSH compound
Compound, the compound are retained in the first detection line；Same principle, on fluorescence antibody-T3 compound and the second detection line
Another site in fixed T3 monoclonal antibody combines, and forms T3 fluorescence antibody-T3-T3 monoclonal antibody complex, retains
In the second detection line；It ties in another site on fluorescence antibody-T4 compound and third detection line in fixed T4 monoclonal antibody
It closes, forms F4 fluorescence antibody-T4-T4 monoclonal antibody complex, be retained in third detection line.And not with corresponding thyroid hormone
In conjunction with fluorescence antibody not in conjunction with each thyroid hormone monoclonal antibody fixed in detection line, they can cross each inspection
Survey line, chromatography to nature controlling line are captured by the sheep anti-mouse igg polyclonal antibody on nature controlling line, are formed and each thyroid gland in nature controlling line
The corresponding sheep anti-mouse igg polyclonal antibody-fluorescence antibody compound of hormone.Since TSH fluorescence antibody is retained in the first inspection
On survey line 4, T3 fluorescence antibody is retained in the second detection line 5, and T4 fluorescence antibody is retained in third detection line, not with first
Each fluorescence antibody of three, shape gland combinations is retained on nature controlling line, and TSH, FT3, FT4 concentration are high in blood sample, then is integrated to
The fluorescent material of each detection line is more；TSH, FT3, FT4 concentration are low in blood sample, then the fluorescent material for being integrated to nature controlling line is more,
So the fluorescence intensity in fluorescence immunity analyzer detection two lines can be used, fluorescence intensity level is substituted into calibration curve equation
It is calculated, TSH, FT3, FT4 concentration in available blood sample.
Three fluorescence immune chromatography test paper bars of thyroid gland, test board and kit provided by the utility model, are realized for the first time
Three, thyroid gland fluorescence immune chromatography method measurements, overcoming can not be right simultaneously in three detection process of prior art thyroid gland
The concentration of thyroid gland three TSH, FT3 and FT4 are detected, and it is pre- to need to carry out measuring samples centrifugation removal haemocyte etc.
Processing, makes the extended defect of detection time；It is stronger to TSH, FT3, FT4 non-specific adsorption to also overcome sample pad, makes to detect
Value is lower than actual value, influences the deficiency of diagnostic result, can be realized to three, thyroid gland quick, convenient, quasi- in measuring samples
Really, it reliably detects.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of three fluorescence immune chromatography test paper bars of thyroid gland of the utility model；
Fig. 2 is the side schematic view of three fluorescence immune chromatography test paper bars of thyroid gland of the utility model；
Fig. 3 is the relative position of thyroid gland three fluorescence immune chromatography test paper bars and test board lower casing 9 of the utility model
Schematic diagram；
Fig. 4 is 8 schematic diagram of test board upper casing of the utility model；
Fig. 5 is the stereoscopic schematic diagram of three fluorescence immune chromatography test cards of thyroid gland of the utility model；
Wherein:
1, sample pad, 2, detection film, 3, water absorption pad, the 4, first detection line, the 5, second detection line, 6, third detection line, 7,
Nature controlling line, 8, upper casing, 9, lower casing, 10, well, 11, observation window.
The effect of the utility model
Using three fluorescence immune chromatography test paper bars of thyroid gland, the beneficial effect of test board and kit of the utility model
It is: 1. realizes three, thyroid gland fluorescence immune chromatography method measurements, first is greatly shortened without using other reagents in continuous mode
The detection time of shape gland three TSH, FT3, FT4 realize three, thyroid gland quick detections, simplify clinically evaluation first shape
The process of gland function；2. improving the accuracy to thyroid gland three TSH, FT3, FT4 detection, clinical diagnosis mistake is reduced；③
Without being pre-processed to blood sample to be checked, the operating procedure of three, thyroid gland detections is simplified, detection time is saved；④
Required sample size is few.
Specific embodiment
Embodiment 1
Using three fluorescence immune chromatography test boards of thyroid gland of attached the utility model shown in fig. 5, upper casing 8 and lower casing
9 be to be internally provided with three fluorescence immune chromatography test paper bars of thyroid gland as shown in Fig. 1, sample by ultrasonic bonding
Pad 1 and water absorption pad 3 are placed on lower layer, and detection film 2 is placed on the upside of sample pad 1 and water absorption pad 3, sample pad 1 and detection film 2,
Detection film 2 overlaps with water absorption pad 3, that is, overlaps, as shown in Fig. 2.Test strips are placed on the card of 9 upside of lower casing
In slot, as shown in Fig. 3.The sample pad 1 of test strips uses glass fibre membrane, to use sample pad 1 described in the utility model
The glass fiber sample pad 1 that processing method obtains；TSH fluorescence antibody, T3 fluorescence antibody and T4 fluorescence antibody are through the utility model
After the enclosure method processing of description, it is coated in sample pad 1.The detection film 2 of test strips uses nitrocellulose filter, detects film 2
On be provided with the first detection line 4, the second detection line 5, third detection line 6 and nature controlling line 7, be coated with TSH in the first detection line 4
Monoclonal antibody is coated with T3 monoclonal antibody in the second detection line 5, T4 monoclonal antibody is coated in third detection line 6,
It is coated with sheep anti-mouse igg polyclonal antibody on nature controlling line 7, Seal treatment is then carried out using method described in the utility model.
First detection line 4, the second detection line 5, third detection line 6 are arranged in parallel with nature controlling line 7, and are parallel to the short side of detection film 2,
Wherein the first detection line 4 is close to sample pad 1, and nature controlling line 7 is far from sample pad 1.11 long side of observation window in 8 upside of test board upper casing
Side be also coated with two dimensional code, store test board identification relevant information.Above-mentioned test board is placed in kit, wherein also
There are sample cell and radio-frequency identification card, standard curve related data is stored in radio-frequency identification card.
Using the sample cell in kit, draws and contain thyrotropic hormone (TSH, 2.5mU/L), triiodo thryonine
The standard items 200 μ L of (T3,200ng/dL) and thyroid hormone (T4,1.5ng/dL) fixed concentration is complete by the standard items of absorption
Portion is added drop-wise in test board well 10, and test board is put into fluorescence immunity analyzer, and fluorescence immunity analyzer passes through scanning
Two dimensional code on test board reads relevant information, and fluorescence immunity analyzer adjust automatically location parameter is (when such as chromatography temperature, chromatography
Between, fluorescence exciting wavelength, Detection wavelength etc.), if storing the standard curve of the lot number in analyzer, phase on read test plate
The fluorescence intensity of pass, and the concentration of the standard items can be directly shown in the display screen of fluorescence immunity analyzer.If in analyzer
The standard curve for the lot number not read then prompts the relevant information in operator's typing radio-frequency card, will store standard song
The radio-frequency identification card of line is placed at the card reading of fluorescence immunity analyzer, and fluorescence immunity analyzer reads relevant criterion curve (one
A batch information need to be only written in Zhang Kayi batch information, the product with batch in analyzer, can also use in first time
Batch information is first written when the batch kit), typing post analysis instrument continues to scan on the fluorescent value on test board, by fluorescence intensity
Value substitutes into calibration curve equation and is calculated, and the display screen of fluorescence immunity analyzer can show the concentration of TSH, FT3, FT4.It is whole
A detection process is only about 16 minutes time-consuming.
Contain thyrotropic hormone, triiodo first to above-mentioned using with three fluorescence immune chromatography test boards of a batch of thyroid gland
The standard items of the fixed concentration of gland original ammonia acid and thyroid hormone carry out 15 parallel determinations.Reuse method maturation, stability
Good ELISA kit measures the same fixed concentration containing thyrotropic hormone, triiodo thryonine and thyroid hormone
Standard items, it is same to carry out 15 parallel determinations.Calculate the correlation for the measurement result that two kinds of detection means obtain, two methods pair
Coefficient R=0.9885 of TSH measurement result, to coefficient R=0.9969 of FT3 measurement result, to FT4 measurement result
Coefficient R=0.9952, both show that correlation is good, three fluorescence immune chromatographies tests of thyroid gland of the utility model
The measurement result of plate can reach the measurement result of mature ELISA kit.But with mature ELISA kit measuring method
The step of comparing, avoiding sample pretreatment using three fluorescence immune chromatography test boards of thyroid gland of the utility model is reduced
Manual operation avoids personnel and operates bring error, and minute substantially shortens, and realizes three, thyroid gland quick inspections
It surveys, and the blood sample amount to be checked used is only 200 μ L.
Embodiment 2
Using three fluorescence immune chromatography test boards of thyroid gland of the utility model shown in attached drawing 5, upper casing 8 and lower casing 9
It is to be connected by a snap, is internally provided with three fluorescence immune chromatography test paper bars of thyroid gland, sample pad 1 and water absorption pad 3 is placed
In lower layer, the upside that film is placed on sample pad 1 and water absorption pad 3, sample pad 1, the width phase for detecting film 2 and water absorption pad 3 are detected
Together, sample pad 1 is overlapped and is bonded together with water absorption pad 3 with detection film 2, detection film 2, that is, is overlapped, such as 2 institute of attached drawing
Show.Test strips are sticked to 9 upside appropriate location of lower casing, which refers to the sample pad 1 of test strips and detect detects on film 2
Line, nature controlling line are respectively with the well 10 of upper casing 8 and observation window 11 to corresponding.The sample pad 1 of test strips uses glass fibre membrane,
For the glass fiber sample pad 1 for using 1 processing method of sample pad described in the utility model to obtain；TSH fluorescence antibody, T3 fluorescence
After the enclosure method processing that antibody and T4 fluorescence antibody are described through the utility model, it is coated in sample pad 1.The detection of test strips
Film 2 uses nitrocellulose filter, detects and is provided with the first detection line 4, the second detection line 5, third detection line 6 and Quality Control on film 2
Line 7 is coated with T3 monoclonal antibody in first detection line 4, and T4 monoclonal antibody, third detection are coated in the second detection line 5
It is coated with TSH monoclonal antibody on line 6, sheep anti-mouse igg polyclonal antibody is coated on nature controlling line 7, it is then practical new using this
Method described in type carries out Seal treatment.First detection line 4, the second detection line 5, third detection line 6 is parallel with nature controlling line 7 sets
It sets, and is parallel to the short side of detection film 2, wherein the first 4 lines of detection are close to sample pad 1, nature controlling line 7 is far from sample pad 1.It is surveying
The side of 11 long side of observation window of 8 upside of test plate (panel) upper casing is also coated with two dimensional code, stores test board identification relevant information.It is above-mentioned
Test board is placed in kit, wherein storing standard curve phase in radio-frequency identification card there are also sample cell and radio-frequency identification card
Close data.
Using the sample cell in kit, 200 μ L of blood sample to be checked is drawn, the sample of absorption is all added drop-wise to test
In plate well 10, test board is put into fluorescence immunity analyzer, fluorescence immunity analyzer passes through two on sweep test plate
It ties up code and reads relevant information, fluorescence immunity analyzer adjust automatically location parameter is (such as chromatography temperature, chromatography time, fluorescence excitation
Wavelength, Detection wavelength etc.), if storing the standard curve of the lot number in analyzer, relevant fluorescence is strong on read test plate
Degree, and the concentration of the standard items can be directly shown in the display screen of fluorescence immunity analyzer.If there is no reading in analyzer
The standard curve of lot number then prompts the relevant information in operator's typing radio-frequency card, and the radio frequency for storing standard curve is known
It Ka not be placed at the card reading of fluorescence immunity analyzer, fluorescence immunity analyzer reads relevant criterion curve (one one batch, card
A batch information need to be only written in secondary information, the product with batch in analyzer, can also use the batch reagent in first time
Batch information is first written when box), typing post analysis instrument continues to scan on the fluorescent value on test board, and fluorescence intensity level is substituted into standard
Curvilinear equation is calculated, and the display screen of fluorescence immunity analyzer can show the concentration of TSH, FT3, FT4.Entire detection process
It is only about 16 minutes time-consuming.The blood sample is measured in parallel 7 times, the average value of measurement result is calculated, then calculates its standard deviation
Difference, the results show that the standard deviation that the standard deviation of TSH measurement result is 6.4%, FT3 measurement result is that 7.2%, FT4 is surveyed
The standard deviation for determining result is 6.8%, shows that its is with good stability.
It follows that three fluorescence immune chromatography test boards of thyroid gland described in the utility model can be directly to without centrifugation
The step of blood sample of processing removal haemocyte is measured, avoids sample pretreatment, reduces manual operation, avoids people
Member's operation bring error, and minute substantially shortens, and realizes the quick detection of three TSH, FT3, FT4 of thyroid gland, and
The blood sample amount to be checked used is only 200 μ L.
Comparative example 1
Sample pad, fluorescence antibody, detection film are prepared and located using the prior art as known to those skilled in the art
Reason, be then assembled into three fluorescence immune chromatography test boards of thyroid gland, to through centrifugal treating removal haemocyte blood serum sample into
Row 7 times parallel determinations.The average value for calculating measurement result, then calculates its standard deviation, as the result is shown the standard of measurement result
Deviation is 13.9%, shows that the stability of its measurement is poor.
In conclusion using three fluorescence immune chromatography test paper bars of thyroid gland, test board and kit of the utility model
The effect essentially identical with the Stability and veracity of ELISA kit method measurement result mature and stable at present can be obtained
Fruit, and three, thyroid gland detection times can also be greatly shortened, realize three, thyroid gland quick detections.Also overcome
The accuracy that the fluorescence immune chromatography method of the prior art detects TSH, FT3, FT4 is insufficient and stability needs not enough and also to make
The shortcomings that with various matched reagents.Directly whole blood sample can be detected, without being pre-processed to blood sample to be checked, letter
The operating procedure for having changed three, thyroid gland detections, saves detection time.
Claims (4)
1. a kind of three fluorescence immune chromatography test paper bars of thyroid gland, including sample pad (1), detection film (2) and water absorption pad (3),
It is characterized in that, the sample pad (1), detection film (2) and water absorption pad (3) sequentially overlap；
Thyrotropic hormone fluorescence antibody, trilute fluorescence antibody and first shape are coated on the sample pad (1)
Parathyrine fluorescence antibody；
The detection film (2) is disposed with the first detection line (4), the second detection line (5), third detection line (6) and nature controlling line
(7), the first detection line (4), the second detection line (5), third detection line (6) and nature controlling line (7) are parallel to each other, wherein the first detection
Line (4) is close to sample pad (1), and nature controlling line (7) is far from sample pad (1)；
First detection line (4), the second detection line (5), third detection line (6) are coated respectively with thyrotropic hormone monoclonal
Antibody, trilute monoclonal antibody, any one in thyroxine monoclonal antibody, and the first detection line
(4), the monoclonal antibody that the second detection line (5), third detection line (6) are coated with is different；
The nature controlling line (7) is coated with sheep anti-mouse igg polyclonal antibody.
2. three fluorescence immune chromatography test paper bars of thyroid gland according to claim 1, which is characterized in that the sample pad (1)
Including glass fibre；
The detection film (2) includes nitrocellulose filter, cellulose acetate film；
The water absorption pad (3) includes blotting paper.
3. a kind of three fluorescence immune chromatography test boards of thyroid gland, which is characterized in that including getting stuck and being arranged in interior examination of getting stuck
Paper slip:
It is described to get stuck including upper casing (8) and lower casing (9), well (10) and observation window (11) are provided on upper casing (8)；
The sample pad (1) of the corresponding test strips of the well (10)；
The first detection line (4), the second detection line (5), third detection line (6) on corresponding detection film (2) of the observation window (11)
With nature controlling line (7)；
It is described that test strips in getting stuck are set using test strips described in claim 1.
4. a kind of three fluorescence immune chromatography kits of thyroid gland, which is characterized in that including three, thyroid gland described in claim 3
Fluorescence immune chromatography test board, sample cell and radio-frequency identification card；
Standard curve is stored in the radio-frequency identification card.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110873801A (en) * | 2019-12-04 | 2020-03-10 | 海卫特(广州)医疗科技有限公司 | Thyroid hormone immunochromatography test strip and preparation method and kit thereof |
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2018
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110873801A (en) * | 2019-12-04 | 2020-03-10 | 海卫特(广州)医疗科技有限公司 | Thyroid hormone immunochromatography test strip and preparation method and kit thereof |
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