CN108802027A

CN108802027A - A kind of detection device

Info

Publication number: CN108802027A
Application number: CN201710296044.7A
Authority: CN
Inventors: 费凤琴; 张春霞; 商涛
Original assignee: Wallace & Samuel Gallery (hongkong) Ltd
Current assignee: Wallace & Samuel Gallery (hongkong) Ltd; Leadway HK Ltd
Priority date: 2017-04-28
Filing date: 2017-04-28
Publication date: 2018-11-13
Anticipated expiration: 2037-04-28
Also published as: CN113295681A; CN113295680A; CN108802027B

Abstract

The present invention relates to a kind of detection device, including pattern detection layer, pattern detection layer is equipped with the detection reagent reacted with analyte and results display area domain, which is characterized in that the device further includes symbol display layer, and being handled on symbol display layer has indicator；The indicator with can make its change colour gas contact after, the indicator becomes second of color from the first color.The device of the invention can make testing result stablize and explicitly show, so that common operator is more intuitively obtained testing result.To which the crowd for making detection device use and range are more extensive.

Description

A kind of detection device

Technical field

The present invention relates to detection fields, more particularly to be used for determine in sample with the presence or absence of analyte detection device and The manufacturing method of detection device, and the sample testing method using detection device detection sample.

Background technology

The existing detection device in the way of lateral flow generally comprises test strips, is assembled successively in test strips It is loaded pad, label pad, detecting pad and sample absorption pad, includes detection line and control line on detecting pad.Detection line is for judging It whether there is analyte in sample, shown if the positive, then it represents that there are analytes in sample, if being shown as negative, It indicates that analyte is not present in sample.Nature controlling line confirms whether this detection process succeeds for checking.

It whether there is analyte in sample to more intuitively show, had more money products that will detect the sun of line position Property result show by "-" form make as "+" form.When there are analyte, testing result is shown as "+" number, when When analyte being not present in sample, testing result is shown as "-" number.The display mode of "+" and "-" number more meets people and is practised The used positive and negative findings mark.

As US7537937 patent in, another test piece is provided with below the detecting pad for being marked with detection line, the test piece It is upper that there is an another pigment indicator line vertical with detection line.In test process, using detection cushion material in liquid chromatography(LC) The principle of bleach shows index line below afterwards.When analyte is not present in sample, the detection line on detecting pad Be not in, and the pigment indicator line below detecting pad in test piece is revealed by transparent detecting pad, entire detection knot Fruit is rendered as "-" symbol.When in sample there are when analyte, will appear detection line on detecting pad, below detecting pad in test piece Pigment indicator line be also revealed simultaneously by transparent detecting pad, detection line and the interlaced display of pigment indicator line, It is rendered as the symbol of "+".But because detection zone material also has certain transparency under drying regime, index line is in product test Before can indistinctly see, influence product appearance.

As CN200510049177.1 patent in, positive control area includes the water imbibition strip made of water-absorbent material Object, the water imbibition bar include that the first color is shown when dry, and one kind of second of color is shown when wet Or the substance of Multiple components.The vertical index line of wherein "+" product is using chance water color shifting ink processing in a layer absorbent item On shape object (blotting paper), then the blotting paper is cut into the line size of requirement, is pasted onto below detection zone.Test process In, on the one hand it is blotting paper discoloration, is on the other hand bleach after detection zone marking liquid chromatography, to is testing result difference "+" and "-" two ways is presented.

Main problem existing for this processing method is that production technology is more complicated, needs assembling and the processing ability of multi-step It can make.

Invention content

Based on above problem, the present invention provides a kind of new detection device and the preparation method of the detection device, with More preferably realize that the detection of detection device and result are shown.

Specifically, a kind of detection device provided by the invention, including pattern detection layer, pattern detection layer are equipped with and quilt The detection reagent of analyte response and results display area domain, the device further include symbol display layer, and being handled on symbol display layer has Indicator；The indicator with can make its change colour gas contact after, the indicator becomes second of face from the first color Color.

Preferably, when sample, which is added to pattern detection layer, to be detected, make indicator discoloration gas generate and with finger Show that agent contact makes indicator become second of color from the first color.

Preferably, detection device further includes gas-forming agent, and the gas-forming agent generation makes indicator that color change occur The gas of change.

Preferably, indicator is not contacted with the results display area domain of pattern detection layer.

Preferably, gas passage is equipped between pattern detection layer and symbol display layer.

Preferably, gas is equipped between the indicator region on the results display area domain and symbol display layer on pattern detection layer Body channel.

Preferably, the results display area domain on pattern detection layer is opposite with the indicator regional location on symbol display layer It answers.Specifically, the position of indicator is spatially in superposition or overlapping relationship with the position in results display area domain, i.e., from The upper vertical of symbol display layer is looked down, and results display area domain is Chong Die with indicator region projection, more specifically, indicator The indicator in region and the detection line overlap of results display area.

Preferably, symbol display layer is located on pattern detection layer, and symbol display layer is that pattern detection can be observed The transparent or translucent material of layer testing result, when the indicator on symbol display layer, which meets gas, becomes second of color, with Detection line on pattern detection layer forms identifiable symbol.

Preferably, identifiable to meet for "+" or "-" symbol.

In some embodiments, symbol display layer material is selected from waterproof material or permeable material.Preferably, the symbol Display layer material is selected from waterproof material.

In some embodiments, symbol display layer material is selected from the not strong material of airtight or air permeability effect.When symbol is aobvious When showing that layer is the not strong material of airtight or air permeability effect, indicator can add this contacted with gas on symbol display layer On one side, namely this one side of neighbouring pattern detection layer (detecting pad).

In other embodiments, symbol display layer material is selected from gas permeable material.When symbol display layer is gas permeable material, Indicator can add this one side contacted with gas on symbol display layer or its another side, can also add and be shown in symbol The centre that the centre or two layers of vapor-permeable type symbol display layer of layer are superimposed upon, gas is after ventilative material is contacted with indicator Make indicator color change.

In some preferred embodiments, symbol display layer material is selected from transparent airtight material.Such as PV, PP, film Deng at this point, indicator processing is covered in the one side of pattern detection layer in symbol display layer.In other preferred embodiments, Symbol display layer material is selected from transparent permeable watertight material.Such as：Permeable hermetically sealable film, PTFE film etc., at this point, indicator Processing any surface in the two sides of symbol display layer.

In preferred embodiment, liquid barrier, the liquid are provided between pattern detection layer and symbol display layer Body barrier material is selected from transparent permeable watertight material.There is liquid barrier, indicator is made to be separated with detection layers, more has It is fixed on symbol display layer conducive to indicator.It can be connect between liquid barrier layer and symbol display layer and pattern detection layer It touches, can not also contact.Such as：Liquid barrier layer is only contacted with symbol display layer, alternatively, liquid barrier layer only with pattern detection Layer contact, alternatively, liquid barrier layer is all contacted with symbol display layer and liquid barrier layer or do not contacted.

Preferably, the combinations of pairs mode of the indicator and gas-forming agent is selected from acid-base indicator and acid-base reaction is sent out Raw reagent.

Preferably, the acid-base indicator is selected from bromthymol blue, and bromocresol green, phenolphthalein, the acid-base reaction tries Agent is selected from alkaline buffer salt or ammonium salt and alkaline buffer salt combination.

Preferably, the acid-base reaction generation reagent is processed on pattern detection layer；The ammonium salt and alkaline buffer salt Separately processing is on pattern detection layer, is added to that pattern detection layer goes forward ammonium salt and alkaline buffer salt is not contacted in sample.

Preferably, the pattern detection layer includes detecting pad, and results display area domain is located on detecting pad.

Preferably, pattern detection layer further includes sample pad and label pad；The sample pad and label pad, which are sequentially connected with, to be examined Survey pad upstream.

Preferably, the pattern detection layer further includes that gas pads；The gas occurs pad and is located at detection with detecting pad Pad upstream.

Preferably, gas occurs to pad and be connected between label pad and detecting pad.Preferably, symbol display layer is covered in detection Pad and gas occur on pad；There is gas passage between symbol display layer and detecting pad.

Preferably, alkaline buffer salt and/or ammonium salt are separately handled occurs pad or detecting pad in sample pad, label pad, gas On one or two pads；Ammonium salt and alkaline buffer salt treatment have therebetween certain spacing when on same pad.

In specific embodiment, when reagent occurs for acid-base reaction selected from alkaline buffer salt, alkaline buffer salt treatment is in sample This pad, label pad, gas occur on pad or detecting pad.

It is described when reagent occurs for acid-base reaction selected from ammonium salt and alkaline buffer salt combination in another specific embodiment Ammonium salt and alkaline buffer salt are processed separately one or two pads that pad and detecting pad occur in sample pad, label pad, gas On；When on same pad, there is the two certain spacing, i.e. the two to be located at different location for ammonium salt and alkaline buffer salt treatment Place.

In preferred embodiment, processing on pad, which occurs, for gas ammonium salt.

More preferably, processing has alkaline buffer salt in sample pad.

Preferably, processing on pad, which occurs, for gas has alkaline buffer salt and ammonium salt, the alkaline buffer salt to be handled with ammonium salt Gas occurs at the upper different location of pad, has certain spacing therebetween.

Preferably, pattern detection layer further includes water absorption pad, and water absorption pad is connected to detecting pad downstream；It covers symbol display layer one end It covers in sample pad, the other end is covered on water absorption pad；Symbol display layer and label pad, detecting pad and gas pad between not Contact forms gas passage.

In some preferred embodiments, which further includes that gas pads；Pad and detection occur for the gas Vertical current connection relation is padded, pad occurs for the gas and symbol display layer is respectively in detecting pad two sides.

Preferably, further include sample pad, sample pad is connected to gas and the one side that pad is not connect with detecting pad occurs.

Preferably, the both ends of the detecting pad one side have sticking grume；Symbol display layer passes through grume and detection Pad connection；There is gas passage between symbol display layer and detecting pad.

In some rectilinear flow detection sample modes, for sample when being added to detection layers, sample does not contact symbol preferably Display layer, so needing to add in sample to detection layers after symbol is shown layer open.Therefore, pattern detection layer is shown with symbol The movable connection of layer, is perhaps detachable connection, is to be able to that symbol display layer is made to separate from pattern detection layer. The frame mode of flexible connection is various, for example, peelable bonding adhesion, either buckle or grafting etc..Pattern detection layer with Can be one end flexible connection between symbol display layer, the other end is fixedly connected；Can also be both ends be flexible connection.

In some embodiments, alkaline buffer salt and/or ammonium salt separately handle and pad or detecting pad occur in sample pad, gas On one or two pads；Ammonium salt and alkaline buffer salt treatment have therebetween certain spacing when on same pad.

Preferably, ammonium salt processing occurs in gas on pad.Preferably, gas, which occurs also to handle on pad, alkaline buffer salt, The alkaline buffer salt is handled with ammonium salt to be occurred in gas at the upper different location of pad.

Preferably, the ammonium salt processing is in sample pad.Preferably, also processing has alkaline buffer salt in sample pad, described Alkaline buffer salt is handled in sample pad with ammonium salt at different location.

Preferably, ammonium salt processing occurs in gas on pad, and alkaline buffer salt treatment is in sample pad.

Preferably, mat material matter occurs for gas selected from one of nitrocellulose, polyester film, glass fibre or filter paper.

In the present invention, also provide a kind of detection plate, including bottom plate and cover board, detection device between bottom plate and cover board, Include pattern detection layer in detection device, pattern detection layer is equipped with results display area domain, which is characterized in that further include that symbol is aobvious Show layer, being handled on symbol display layer has indicator, and the indicator is not contacted with the results display area domain of pattern detection layer, described Indicator with can make its change colour gas contact after, the indicator is changed to second of color by the first color.

Preferably, the symbol display layer is located on cover board, and pattern detection layer is located on bottom plate.

Preferably, pattern detection layer includes detecting pad, and results display area domain is located on detecting pad.

Preferably, pattern detection layer further includes sample pad, label pad and water absorption pad；The sample pad and label pad sequentially connect It is connected on detecting pad upstream, water absorption pad is connected to detecting pad downstream.

Preferably, processing has one or both of ammonium salt and alkaline buffer salt in sample pad；The ammonium salt and alkalinity are slow Salt treatment is rushed in sample pad at different location.

Preferably, the pattern detection layer further includes that gas pads；Gas occur pad be located at label pad and detecting pad it Between.

Preferably, there is window and well, the window's position is corresponding with testing result region, well on detection plate cover board At sample pad.

In addition, the present invention also provides a kind of sample testing methods that can intuitively read testing result, wherein filled including detection It sets, which includes pattern detection layer and symbol display layer；The symbol display layer is located on pattern detection layer；The symbol Processing has indicator on number display layer；

It allows fluid sample to apply and flows through pattern detection layer, pattern detection layer carries out pattern detection, generates detection line；

Meanwhile detection device generates the gas for making indicator discoloration；

Gas is contacted with the indicator of symbol display layer makes indicator become the second color from the first color；

The indicator of second color is superimposed to form identifiable symbol with detection line.

Preferably, further include gas-forming agent, the gas-forming agent occurs instead when sample is applied in detection device The gas for making indicator that color change occur should be generated.

Preferably, gas-forming agent is completely or partially processed on pattern detection layer.

Preferably, the indicator is selected from bromthymol blue, bromocresol green, phenolphthalein；The gas-forming agent is selected from alkalinity Buffer salt, ammonium salt and alkaline buffer salt combination.

Preferably, after applying sample to pattern detection layer, with after-applied alkaline buffer salt to pattern detection layer, make alkalinity Buffer salt follows fluid sample closely and flows through pattern detection layer.

Preferably, pattern detection layer includes sample pad, label pad, gas generation pad and detecting pad connected in sequence；By ammonium Salt treatment is generated in gas on pad；Sample sequentially flows through sample pad, label pad, gas generation pad and detecting pad, gas and pads Upper generation gas, sample generate detection line on detecting pad.

On the other hand, the present invention also provides a kind of methods of manufacture detection device, including：

(1) pattern detection layer is prepared：A kind of detecting pad with results display area domain is provided, and will with it is analyzed

The detection reagent of object reaction is added on the detecting pad；

(2) symbol display layer is prepared：A kind of transparent or semitransparent carrier is provided, indicator solution is prepared, and

By indicator solution processing on the carrier, the indicator and can make its discoloration gas contact after,

Second of color is changed to by the first color；

(3) the symbol display layer in the pattern detection layer and step 2 in step 1 is assembled together, and made

The indicator is not contacted with the results display area domain of pattern detection layer；

(4) gas-forming agent for the gas for making indicator discoloration can be generated by providing.

Preferably, all or part of gas-forming agent processing is in the detection layers.

Preferably, pattern detection layer includes detecting pad, sample pad and label pad, the sample pad, label pad and detecting pad Along liquid flowing direction be sequentially connected to one another, gas-forming agent at least handle the sample pad, label pad and detecting pad it One.

Preferably, further include that gas pads, any position that pad is mounted on before detecting pad occurs for gas, and gas occurs Agent addition occurs in gas on pad.

Preferably, it corresponds to set on symbol display layer according to the detection line position in results display area domain in detection layers and indicate Agent positions and dimensions；Indicator is configured to certain density solution, according to the indicator positions and dimensions even spread of setting On symbol display layer.

Preferably, the indicator is selected from bromthymol blue, and bromocresol green, phenolphthalein, the gas-forming agent is selected from alkaline Buffer salt, ammonium salt and alkaline buffer salt combination.

Preferably, the ammonium salt is selected from NH4Cl or ammonium carbonate, and the alkaline buffer is selected from Tris buffer solutions.

Preferably, ammonium chloride or ammonium carbonate etc. are configured to 1% solution, handled on pattern detection layer.

Preferably, the material that the gas pads is selected from glass, one of filter paper or polyester film.

Preferably, symbol display layer material is selected from transparent or semitransparent waterproof material.

Preferably, liquid barrier, the liquid barrier material are provided between pattern detection layer and symbol display layer Material is selected from transparent permeable watertight material.

The present invention also provides a kind of methods that can intuitively read testing result, including detection device, the detection device to include Pattern detection layer and symbol display layer；The symbol display layer is located on pattern detection layer；Being handled on the symbol display layer has Indicator；The indicator with can make its change colour gas contact after, the indicator becomes second of face from the first color Test result on color, with pattern detection layer forms identifiable symbol.

Advantageous effect

The device of the invention and detection plate can make testing result stablize and explicitly show, keep common operator more straight The acquisition testing result of sight.To which the crowd for making detection device use and range are more extensive.

Description of the drawings

Fig. 1 is the schematic diagram of detection device of the present invention；

Fig. 2 is the schematic diagram of another detection device of the present invention；

Fig. 3 is the schematic diagram of another detection device of the present invention；

Fig. 4 is the schematic diagram of another detection device of the present invention；

Fig. 5 is the schematic diagram of a specific detection device of the invention；

Fig. 6 is the vertical view of Fig. 5 devices (positive test symbol is shown)；

Fig. 7 is another vertical view of Fig. 5 devices (negative result is shown)；

Fig. 8 is the decomposition diagram of Fig. 5 devices；

Fig. 9 is the schematic diagram of another specific detection device of the present invention；

Figure 10 is the decomposition diagram of Fig. 9 devices；

Figure 11 is the schematic diagram of the another specific detection device of the present invention；

Figure 12 is the front view of Figure 11 detection devices；

Figure 13 is the schematic diagram of another detection device of the present invention；

Figure 14 is the sectional view of Figure 13 detection devices；

Figure 15 is the decomposition diagram of Figure 13 detection devices；

Figure 16 is the schematic diagram (positive test symbol is shown) in results display area domain and indicator region Overlapping display；

Figure 17 is the schematic diagram of another detection device of the present invention；

Figure 18 is the detection plate structure schematic diagram of the present invention；

Figure 19 is the decomposition diagram of Figure 18 detection plates；

Figure 20 is another decomposition diagram of Figure 18 detection plates；

Reference numeral：

Detection device 10, pattern detection layer 1, symbol display layer 2, indicator/indicator show symbol 21, liquid barrier Layer/isolating pad 5, indicator region 23, (detection) results display area domain 18, detecting pad 17, gas generation pad 16, label pad 13, Sample pad 12, water absorption pad 8, bottom card 11, detection line 171, nature controlling line 172, grume 3, detection plate 40, bottom plate 41, cover board 42, window 43, well 45, space/gas passage 22

Specific implementation mode

Structure of the present invention or these used technical terms are described further below.

Detection

" detection " indicates chemical examination or tests a kind of substance or material whether there is, for example, but it is not limited to this, chemicals Matter, organic compound, inorganic compound, metabolism product, drug or drug metabolite, organic organization or organic organization Metabolin, nucleic acid, protein or polymer.In addition, detection indicates test substances or the quantity of material.Furtherly, chemical examination is gone back Indicate immune detection, chemical detection, enzyme detection etc..

The type of sample

Any kind of sample can enough the device of the invention tested, including body fluid is (for example, urine and other bodies Liquid and clinical sample).Fluid sample may originate from solid or semisolid sample, including excrement, biological tissue and food Sample.These solids and semisolid sample can be transformed into fluid sample by any suitable method, such as in one kind Mixed in liquid appropriate, stamp it is broken, macerate, be incubated, dissolving either digest solid sample (for example, water phosphate buffer or Other buffer solutions)." biological sample " includes the sample from animal living, plant and food, also includes urine, saliva, blood With blood constituent, cerebrospinal fluid, vaginal swab, sperm, excrement, sweat, secretion, tissue, organ, tumour, tissue and organ The conditioned media of culture, cell culture and there, either people's or animal.Foodstuff samples include finished food Object ingredient and last product, meat, cheese, wine, milk and drinking water.Plant sample include from any plant, plant tissue, The sample of the conditioned media of plant cell cultures and there." environmental sample " is that those are originated from the sample of environment (for example, lake water The sample of sample or other water bodys, sewage sample, pedotheque, groundwater sample, seawater sample, the sample of runoff water). Sewage and relevant waste can also be included in environmental sample.

The type of analyte

The example that can be used in the analyte of stable detection of the present invention promotees including (but including not only) human chorionic Gonadal hormone (hCG), lutropin (LH), ovarioestrogen (FSH), hepatitis C virus (HCV), hepatitis B (HBV), hepatitis B Surface antigen, the drug of AIDS virus and any abuse.Analyte can detect in any liquid or liquefied sample It arrives, such as urine, saliva, blood, blood plasma or serum.The example of other analytes also has flesh ammonia acid anhydride acid, bilirubin, nitrous Hydrochlorate, protein (nonspecific), blood, leucocyte, blood glucose, heavy metal and toxin, bacterial component is (for example, specific type Bacterium special protein and sugar, such as colon bacillus 0157:H7, staphylococcus aureus, salmonella, aerogenesis pod Film clostridium, campylobacter, listeria monocytogenes, V. parahaemolyticus or waxy bacillus).Any other suitable side The analyte of stream test form can be detected with the present apparatus.This hair is further described with reference to the accompanying drawings and examples It is bright, but protection scope of the present invention is not limited to this.

The detection device 10 of the present invention includes two parts：Pattern detection layer 1 and symbol display layer 2；On symbol display layer 2 Reason has the indicator 21 that can change color；Detection device 10 is formed by this two-part combination, as shown in Figure 1.The detection Device 10 can be to forming the display of the testing result or detection information that easily recognize after pattern detection.Specifically, symbol is shown Layer 2 changes color by indicator 21 and forms a display symbol, which can indicate the detection letter of detection device 10 Breath or testing result.21 shape of indicator handled on symbol display layer 2 can be set as needed, in this way, changing face The symbol shown after color is identical as indicator shape, such as：Number, 1,0 etc.；Simple figure ,-, ∣, ×, Δ etc.；Word； Letter, Y, N etc.；Indicator can be utilized to indicate according to the needs of detection device 10 and set symbol shape.

In some preferred embodiments, the indicator on symbol display layer 2 is not contacted with pattern detection layer 1.Specifically , the region 23 with indicator is not contacted with pattern detection layer 1 on symbol display layer 2, in Fig. 2 and Fig. 3, symbol display layer 2 bottom surfaces are in direct contact pattern detection layer 1 and are covered on pattern detection layer 1, at this point, the processing of indicator 21 is in symbol display layer 2 Upper surface (do not contacted with pattern detection layer this one side).In one specific embodiment, pattern detection layer and symbol are aobvious Show and is equipped with gas passage between layer；Alternatively, in another specific embodiment, the results display area domain on pattern detection layer and symbol Gas passage is equipped between indicator region on number display layer, as shown in Fig. 5, Fig. 9 and Figure 11, when the processing of indicator 21 exists When this one side of proximity detection layer 1, then there is gap between the symbol display layer 2 and pattern detection layer 1 of the detection device 10 Or space 22, make not contact between indicator region 23 and detection layers 1, the gap or the gas that space 22 is gaseous volatilization are logical Road 22.

The position of pattern detection layer 1 and symbol display layer 2 in detection device 10 can be that symbol display layer 2 is covered in All or part of pattern detection layer 1.As shown in Figure 2,2 covering part pattern detection layer 1 of symbol display layer；Such as Fig. 3, symbol Display layer 2 covers whole pattern detection layers 1.Or pattern detection layer 1 and symbol display layer 2 are in the different positions of detection device 10 It sets, i.e., the two will not be covered mutually on vertical projection face.

Indicator is the second color, second color by the first color change after contact makes it change the gas of color Shown symbol may be used to indicate which kind of detection project is detection device 10 currently in use be.For example, being examined in drug abuse In the detection device of survey, the indicator shape of symbol display layer is different, and detection morphine sucks the detection device of situation, thereon Symbol display layer indicator shape be MOP (the english abbreviation MOP of morphine).Detection cocaine sucks the detection device of situation, Symbol display layer indicator shape thereon is COC (the english abbreviation COC of cocaine).Such as in one embodiment, adding Sample because the triggering of liquid sample itself or sample generates gas, makes indicator show symbol COC, indicating should after detection layers Detection device detection project is cocaine.

The symbol shown by the second color after indicator color change can also coordinate with the detection line of pattern detection layer It forms one and is easy the recognizable symbol understood by user.In some specific embodiments, such as Fig. 2 and Fig. 3, pattern detection layer Include results display area domain 18, indicator region 23 and 18, the results display area domain on pattern detection layer of symbol display layer 2 on 1 It sets corresponding.I.e. the position in indicator region 23 is spatially in superposition or overlapping pass with the position of results display area 18 System.To which the color symbol that indicator 21 is formed can be superimposed with the detection line 171 on pattern detection layer 1, i.e. indicator color Symbol in one plane forms a new symbol, as shown in Fig. 6 and Fig. 7 and Figure 16, shape afterwards with detection line upright projection The result that should be readily appreciated that and identify at one or more is shown.Fig. 6, after adding sample and in sample there are analyte or by When the content of analyte reaches preset test value, occurs detection line 171 on pattern detection layer, and with coloured finger Show and forms a "+" type symbol between agent 21；Analyte or analyte is not present in Fig. 7 after adding sample and in sample Content when being not up to preset test value, the results display area domain of pattern detection layer goes out not occurring detection line 171, individually It is existing to show a "-" type symbol with coloured indicator 21.Such symbol instruction meets people positive and cloudy Property detection in result interpretation custom, people get used to indicating positive with "+", and "-" indicates negative.And in common cross side In the detection for flowing test strips, testing result shows to be typically to show a detection line or do not show detection line, in common operation During person judges, result mistake can be led to due to being unfamiliar with.The color symbol and detection line of developer can be passed through in the present invention Superposition form "+" or "-" symbol.Certainly, the testing result of superposition shows that it can also be various to meet, for example indicator is aobvious Show " Ο ", combines to form " Φ ", " Θ " or " Ο " etc. and show negative and positive or the opposite testing result such as positive and negative with testing result.

The indicator 21 of symbol display layer can be from a kind of color change to another by changing color to display symbol Kind color, makes operator pass through the change of color to obtain detection information.For example, colourless become red, become dark from light color, Red becomes green, blue etc.；Alternatively, being changed to by red colourless, light color etc. is changed to by dark color.Specifically, in general, It is in the detection device for represent positive findings, in order to make operation not get wrong that the identified color of energy, which is presented, in detection line after detection Information, indicator is usually by the bottom of colourless the first color and detecting pad 17 for being altered to the color or indicator that are easy to observe Color is same or like, is changed into second of color after detection.Indicator 21 uses colourless or and detecting pad before detection starts The first color of the close color for being not easy to be perceived by user of background color, this and indicator is the face for being easy to be aware Form and aspect ratio can also avoid user from being mistakenly considered the detection device being actually not used by and be used.It is examined after detection It is that indicator can also be made to observe color by being easy in the detection device for represent negative findings that the identified color of energy, which is presented, in survey line The background color for being altered to colourless or indicator second of color and detecting pad is same or like.

Contact of the change of color by indicator with gas reacts to realize.The reaction of this kind of change color There are many type, for example, soda acid Indicator Reaction.

Indicator is selected from acid-base indicator, such as nitropheneol, phenolphthalein class, riodoxol phthaleins, azo compounds species etc. Acid-base indicator；It is specific such as p- nitrophenols, phenolphthalein, thymolphthalein, alphanaphthol phthalein be phenol red, cresol red, bromophenol blue, thymol blue, Methyl orange, dimethyl diaminophenazine chloride etc..More specifically, such as select under acidic environment in orange, under alkaline environment in the methyl orange of yellow, Methyl red etc. is in yellow under acidic environment, is in the bromthymol blue etc. of blue under alkaline environment, is in nothing under acidic environment Color, the phenolphthalein etc. to take on a red color under alkaline environment, takes on a red color under acidic environment, in the reindeer moss etc. of blue under alkaline environment.It is different Acid-base indicator, can generate color change when the sour gas or alkaline gas for encountering mating reaction.

Triggering the gas that indicator 21 changes colour is generated by gas-forming agent, specifically, can be by different Gas is generated after material mixing, or generates gas after being mixed with liquid sample by different substances, these different substances Can't be mutually mixed when detection device 10 is not used by, at least will not all substances all mix, with hands-free It is preceding to generate and release gas, cause gas that can not be contacted with the indicator 21 in detection device.Such as utilize ammonia and bromine phenol The contact of blue indicator makes indicator from the light yellow scheme for becoming blue, the substance for generating ammonia includes ammonium chloride and alkalinity Buffer salt.Ammonium chloride and alkaline buffer salt are added to detecting pad different location and do not contact with each other；Or ammonium chloride and alkali Property buffer salt be added separately on the different pads in sample pad 12, label pad 13 and detecting pad 17；If alternatively, detection device 10 It is padded including gas, a kind of reagent addition in ammonium chloride or alkaline buffer salt occurs in gas on pad 16, another reagent Addition in the other positions that liquid flows through, as in sample pad 12, label pad 13 or detecting pad 17 one kind or multiple pads on.Or A kind of reagent in person's ammonium chloride and alkaline buffer salt is formulated into solution in use, another reaction reagent is added to sample Pad 12, label pad 13, gas occur on one or more of pad 16 or detecting pad 17 pad, and solution reagent is added when detecting and allows Ammonium chloride and alkaline buffer salt mixing generate gas.Or ammonium chloride and alkaline buffer salt are configured to solution, when detecting will Detection device is added in two kinds of solution, and mixing generates ammonia.

The gas of generation can also be combined with the steam in the test space, make indicator reaction that color change occur.

In some specific embodiments, ammonia is generated by the ammonium salt decomposition in alkaline environment to make on symbol display layer 2 Acid indicator 21 change colour.More specifically, some itself have the sample such as urine specimen of ammonium salt, then are added in sample To while being detected in detection device, ammonium salt generates ammonia with alkaline buffer salt mixed decomposition in sample, makes acid instruction Agent is altered to second of color by the first color, shows that indicator symbol or indicator meet and is superimposed with testing result line It forms result and shows symbol.In other embodiments, can in detection layers 1 advanced processing ammonium salt, while adding sample, Alkaline buffer salt is added, so that ammonium salt is decomposed release ammonia in alkaline environment, indicator 21 is made to change colour.Some preferred embodiments In, per se with ammonium salt in sample, when sample is added to detection layers 1, sample is made to be under alkaline environment, output ammonia, Indicator 21 is set to be altered to second of color by the first color.In some embodiments, the alkaline buffer salt is selected from borax, NaCO3, K3PO4 etc..

In a more specific embodiment, shown in Fig. 4, which can be in pattern detection layer 1 and symbol display layer 2 Between increase liquid barrier 5, the function of liquid barrier 5 is permeable watertight.And liquid barrier 5 is transparent.When After liquid sample is loaded onto detection layers, substance to be checked present in sample is reacted with pretreated substance generation in detection layers 1, shape At an apparent lines-detection line.Meanwhile while sample flows through detection layers 1, releases gas and penetrate liquid barrier Layer 5 makes indicator 21 discoloration of the processing on symbol display layer 2 form second of colored line.What substance reaction to be checked generated Lines form "+" or "-" with indicator lines.

The material of symbol display layer 2 can usually select transparent or semitransparent material, with facilitate observe it is capped Testing result region.2 material of symbol display layer can select waterproof material, 2 material of symbol display layer that can select ventilative Or airtight material；Such as PTFE film, permeable watertight film, PET, PE, PP etc..When 2 material of symbol display layer is airtight material When matter, indicator 21 is located at the one side of neighbouring pattern detection layer on symbol display layer 2.And when 2 material of symbol display layer is ventilative When material, indicator 21 can be located at the one side on symbol display layer 2 adjacent to pattern detection layer or one far from pattern detection layer Face, that is to say, that indicator 21 can be located at the front or the back side of symbol display layer.Certainly, it is examined in symbol display layer 2 and sample When surveying among layer 1 with liquid barrier 5,2 material of symbol display layer can select permeable material.

In some embodiments, pattern detection layer 1 includes detecting pad 17, has testing result viewing area 18 on detecting pad 17, Also, symbol display layer 2 is covered on detecting pad 17, keeps indicator region 23 corresponding with testing result viewing area 18, i.e., and two Person is spatially in the position of overlapping or superposition, shown in Fig. 5.In this way, indicator 21 can be made to be superimposed shape with testing result 171 At identifiable symbol, as shown in Figure 6 and Figure 7.

Also shown in FIG. 5, in some embodiments, pattern detection layer 1 further includes that pad 16 occurs for gas, which pads 16 are used for the generation of gas, and therefore, processing on pad 16, which occurs, for gas ammonium salt, after sample flows through gas, and pad 16 occur, ammonium salt Ammonia is decomposited in alkaline environment makes indicator 21 change colour.

More specifically in embodiment, pattern detection layer 1 further includes label pad 13, sample pad 12, sample pad 12 and label Pad 13 is sequentially connected with occurs 16 upstreams of pad in gas, and gas occurs pad 16 and is connected to 17 upstream of detecting pad, i.e. sample sequentially flows through Pad 16 and detecting pad 17 occur for sample pad 12, label pad 13, gas.In another embodiment, detection layers 1 further include being connected to Pad 16 and detecting pad 17, water absorption pad 8 occur for the water absorption pad 8 and fixed sample pad 12 in 17 downstream of detecting pad, label pad 13, gas Bottom card 11.At this point it is possible to by alkaline buffer salt treatment in sample pad 12, after sample is added in sample pad 12, alkali is driven Property buffer salt flowing, reach gas occur pad 16, make gas occur pad 16 on ammonium salt ammonia is decomposited in alkaline environment.

In further embodiments, as long as the gas that the triggering of pad 16 generates, which occurs, through gas can touch symbol display layer 2 On indicator 21, gas occurs deposit position of the pad 16 in detection device 10 and can arbitrarily select.

In some embodiments, 2 one end of symbol display layer is connected in sample pad 12, and the other end is connected on water absorption pad 8, is made Symbol display layer 2 and label pad 13, gas occur to form a space between pad 16 and detecting pad 17, and the space is logical for gas Road is more advantageous to the diffusion of gas.This space can be open, can also be closed.

It in some embodiments, can be fixedly connected between symbol display layer 2 and pattern detection layer 1, can also be movable Connection or detachable connection.For example, symbol display layer 2 is directly adhesively fixed with pattern detection layer 1；Or by pattern detection layer 1 is fixed on a bottom plate, and symbol display layer 2 is fixed on a lid, when lid is closed with bottom cover, symbol display layer 2 It covers on pattern detection layer 1, shown in Figure 20.Again alternatively, the end of symbol display layer 2 is fixed on sample by peelable stick In this detection layers 1, shown in Figure 11 etc..In some preferred embodiments, symbol display layer 2 forms one with pattern detection layer 1 Fixed space 22 makes have a certain distance between the indicator region 23 of symbol display layer and detection layers 1, as shown in Figure 5.

In some specific embodiments, as shown in figure 11, the end bosses 3 of the pattern detection layer of detection device, symbol is shown Show that the end of layer is connected in protrusion 3, to make symbol display layer 2 and pattern detection layer 1 mutually lid close connection, and the two it Between formed a space 22.Wherein, indicator region is corresponding with the superposition of results display area domain position, as seen in figures 11 and 16.

The detection device of the present invention is described in some specific embodiments below.

Embodiment 1：Detection device described in Fig. 5, Fig. 6, Fig. 7 and Fig. 8

The detection device 10 of lateral flow as shown in Figure 5, for detecting hCG in urine, including detection layers 1 and symbol it is aobvious Show that layer 2, symbol display layer 2 are covered in the top of detection layers 1, and retain certain space between the two, as gaseous volatilization Channel 22.Specifically, detection layers 1 include bottom card 11, and sample pad 12, mark are sequentially mutually pasted to overlap joint on bottom card 11 Remember that pad 16, detecting pad 17 and water absorption pad 8 occur for pad 13, gas, as shown in Figure 5.2 one end of symbol display layer is overlapped on sample pad 12 On, the other end is overlapped on water absorption pad 8, and symbol display layer 2 and label pad, gas is made to occur to form one between pad and detecting pad Space 22.Sample pad 12 is transferred to functional cushion (such as label pad, detection downstream for receiving detection sample, and by sample Pad etc.) on.The Anti-hCG antisera (labelled antibody) of colloid gold label is coated in label pad 13 in the present embodiment, the label is anti- Body forms the first conjugate with the hCG antigen bindings in sample.At least provided with detection line 171 on detecting pad 17, in the present embodiment In, it is coated with hCG antibody at detection line 171, flows to the first conjugate on detecting pad and the Anti-hCG antisera knot in detection line Conjunction forms macroscopic lines.If the hCG contents in urine are less than the minimum threshold values of detection, meat will not be formed in detection line The visible lines of eye.Can also include nature controlling line 172 on detecting pad 17, the nature controlling line 172, which is used to indicate this detection, is It is no to smoothly complete.

The variety classes indicator shown in table 1 is configured to solution according to certain concentration.The indicator that will be prepared again Solution is handled respectively to be formed index line 21 in different transparent plastic on piece (transparent plastic sheet in the example is exactly institute of the present invention The symbol display layer 2 stated).One side with indicator on slide is assembled adjacent to pattern detection layer and pattern detection layer one It rises, index line is located at right over detection line, forms cross.

In a specific embodiment, the width of pattern detection layer is 7.2 millimeters, is covered in pattern detection layer accordingly The width of slide (symbol display layer) be 7.2 millimeters, the width of indicator is 1 millimeter, and length is 8 millimeters.

In the present embodiment, ammonium salt, such as ammonium chloride or ammonium carbonate etc. are configured to 1% aqueous solution, with immersion etc. Mode, which is handled, to be generated in gas on pad 16, and the processing of sample pad 12 has alkaline buffer salt.For example, the alkaline buffer salt is 100mM Tris buffer solutions, pH8.0, after sample pad is immersed in the buffer solution, obtain with alkaline buffer sample pad.After immersion Gas generate pad and sample pad detection device is assembled into drying regime.When test, sample is mixed with sample pad alkaline buffer salt After conjunction, the pH of sample is increased.After ammonium salt is with alkaline sample contact in gas is generated and padded, ammonium salt decomposition generates ammonia and simultaneously discharges Out.Sample brings gaseous ammonia in chromatography process, is contacted with the indicator of transparent plastic sheet, and color change occurs for indicator.

When the hCG contents in sample are higher than minimum detected value, a naked eyes can be formed in the detection line 171 of detecting pad The color line that can be seen.The color line spatially forms meeting for "+" with the index line on symbol display layer 2.Tester's energy It is the positive according to the "+" judgement sample of appearance, as shown in Figure 6.If hCG contents are less than minimum detected value in urine, detecting A colored line will not be formed in the detection line of pad, only occur macroscopic instruction in the detection line of symbol display layer Line, to form the symbol of "-", as shown in Figure 7.Tester is feminine gender according to "-" judgement sample.

It is detected with the urine standard items of the hCG containing 100mIU/ml.21 color of index line and detection line color are recorded, It the results are shown in Table 1.

Table 1：

Apparent color change can be generated after each indicator reaction.Display color power is also proper.Certainly, exist , can also be by ammonium salt processing in sample pad in the present embodiment, and alkaline buffer salt treatment is occurred in gas on pad.Work as urine After sample is added in sample pad, ammonium salt flow to gas with sample and occurs to pad upper and alkaline buffer reactant salt, generates ammonia.

Embodiment 2：Detection device described in Fig. 5, Fig. 6, Fig. 7 and Fig. 8

10 structure of detection device in the embodiment 2 is identical with embodiment 1, unique the difference is that not having in sample pad 12 There is processing alkaline buffer salt.During examinations, after adding sample, the sample of the alkaline buffer salt of adding liquid immediately On this pad 12.Alkaline buffer salt sequentially flows through sample pad 12, label pad 13, and reaching sample generation pad 16 makes ammonium salt decomposition ammonia. The ammonia released is combined with the indicator on 2 index line 21 of symbol display layer, and indicator 21 is caused to change colour, and is formed apparent Index line "-"；Meanwhile sample continues to flow through gas and pad 16 occurs, and reaches detecting pad and is detected, to obtain testing result, Have detection line " ∣ " or there is no detection line, to which the symbol of "+" or "-" be presented.

In human body stool in hemoglobin test, Sample dilution is obtained with alkaline buffer dilution stool sampl, it will Sample dilution is added dropwise in the sample pad of the detection device described in this example, while triggering the alkaline buffer salt for generating gas It is added dropwise in sample pad.Alkaline buffer salt sequentially flows through sample pad 12, label pad 13, and reaching sample generation pad 16 makes ammonium salt decomposition Generate ammonia.The ammonia released is combined with the indicator on 2 index line 21 of symbol display layer, and indicator 21 is caused to change colour, Form apparent index line "-".Include the antihuman hemoglobin antibody of latex label in label pad 13, it is fixed on detecting pad The antibody of specific bond human hemoglobin.Pad 16 occurs for the labeled pad of diluent stream, gas, reaches detecting pad and is detected, To obtain testing result, that is, have detection line " ∣ " or there is no detection line, to which the symbol of "+" or "-" be presented.

Certainly, in the present embodiment, can also occur to add on pad 16 in gas after sample is added in sample pad 12 Alkaline buffer salt, alkaline buffer salt occur the ammonium salt on pad 16 with gas and react, and generate ammonia, the ammonia and indicator 21 Contact makes indicator 21 change colour.

Also, in the present embodiment, it can also be added in sample pad 12 in sample by ammonium salt processing in sample pad 12 It adds on alkaline buffer salt to sample pad 12 immediately afterwards, so that ammonium salt is reacted with alkaline buffer salt and generate ammonia.

Alternatively, in the present embodiment, it can also be by ammonium salt processing in sample pad 12, after sample is added in sample pad When ammonium salt is flow to sample at gas generation pad 16, addition alkaline buffer salt to gas occurs on pad 16, makes ammonium salt and alkalinity Buffer salt, which reacts, generates ammonia.

Embodiment 3：Detection device described in Fig. 9 and Figure 10

The detection device 10 of detection urine specimen as shown in FIG. 6, including detection layers 1 and symbol display layer 2, symbol is shown Layer 2 is covered in the top of detection layers 1.The detection layers 1 include bottom card 11, sequentially mutually paste sample to overlap joint on bottom card 11 This pad 12, label pad 13, detecting pad 17 and water absorption pad 8.2 one end of symbol display layer is overlapped in sample pad 12, other end overlap joint On water absorption pad 8, make to form a space 22 between symbol display layer 2 and label pad and detecting pad.It include inspection on detecting pad 17 Survey line 171, symbol display layer 2 are provided with index line 21, index line 21 and detection with respect to 171 region of detection line on detecting pad 17 Mutual alignment relation between line 171 is in cruciform shape.Include the indicator for meeting ammonia discoloration in the position of index line, such as Bromophenol blue, bromocresol green.

In the embodiment, the detection device being compared in embodiment 1 is padded provided with gas less, is commonly used in liquid Carry the detection of ammonium salt in body sample, or additional ammonium salt in the sample or applied to the ammonium salt in detection device when detection.

In the present embodiment, include alkaline buffer salt in sample pad 12.When test, due to containing in itself in urine specimen Ammonium salt.When urine passes through sample pad 12, under the action of 12 alkaline buffer salt of sample pad, the pH of urine specimen is increased.Urine In ammonium salt decomposed under alkaline environment, generate ammonia simultaneously released from urine.The ammonia released diffuses to symbol It at display layer 2, is combined with the indicator on symbol display layer index line 21, indicator 21 is caused to change colour, form apparent instruction Line "-", in conjunction with testing result, to which the symbol of "+" or "-" be presented, as shown in Figures 6 and 7.

Embodiment 4：Detection device described in Fig. 9 and Figure 10

The present embodiment 4 is identical as the structure of the detecting device of embodiment 3, only in sample pad 12 and not comprising alkaline buffer Liquid.When test, urine specimen be added sample pad 12 after, toward sample pad 12 on alkaline buffer is added dropwise, the ammonium salt in urine is in alkali Property buffer salt under the action of decompose and generate ammonia, the ammonia released combined with the indicator on symbol display layer index line, Cause indicator discoloration, forms apparent index line, "-", in conjunction with testing result, to which the symbol of "+" or "-" be presented.

Embodiment 5

The apparatus structure of the present embodiment 5 is identical as embodiment 1 or embodiment 3, and the ammonium salt for being only intended to generate gas may be used also To add respectively on the fluid path that sample pad, label pad, gas occur before pad or detecting pad etc. generate detection line.

Embodiment 6

The apparatus structure of the present embodiment 6 is identical as embodiment 1 or embodiment 3, can distinguish ammonium salt and alkaline buffer salt Processing has therebetween a certain distance in sample pad.It adds in sample and goes forward ammonium salt and alkaline buffer in sample pad Salt does not contact, and after sample flows in sample pad, drive one in ammonium salt and alkaline buffer salt (to handle and flowed in sample One of upstream) it is driven at another, so that the two is reacted, generating gas makes indicator discoloration.

Embodiment 7

The apparatus structure of the present embodiment 7 is same as Example 1, can handle ammonium salt and alkaline buffer salt in gas respectively Occur on pad, there is therebetween a certain distance.Ammonium salt and alkaline buffer before pad occurs for gas above are flow in sample Salt does not contact, and after sample flow to gas generation pad above, drive one in ammonium salt and alkaline buffer salt (to handle in sample One of flowing upstream) it is driven at another, so that the two is reacted, generating gas makes indicator discoloration.

Embodiment 8：The detection device of the vertical current of Figure 11 and Figure 12 descriptions

As Figure 11 to 12 design scheme in, detection device 10 is a kind of detection structure of liquid vertical current, including symbol Display layer 2 and pattern detection layer 1, symbol display layer 2 are covered on pattern detection layer 1；Wherein, pattern detection layer 1 includes bottom plate 11 and detecting pad 17, detecting pad 17 be located on bottom plate 11.The detecting pad 17 includes the reagent reacted with analyte；It is needing When, also processing has the reagent that can generate gas, such as ammonium salt on detecting pad 17.Both ends side has sticking block 3, symbol on bottom plate Display layer 2 is sticked on grume and is covered in 17 top of detecting pad, which can be that symbol display layer one end is made to be fixedly connected on On bottom plate 11, the other end can tear the flexible connection being adhered by repeatedly, can also be both ends be that can tear to glue again repeatedly The flexible connection of conjunction.Processing has acid-base indicator on symbol display layer 2, is formed between 21 region of indicator and detecting pad 17 empty Between 22, symbol display layer 2 can be torn with grume and detach.When detection, the symbol display layer 2 being movably connected on grume 2 is torn One end, expose detecting pad 17, by sample and/or alkaline buffer salt addition on detecting pad 17 after, then will be avulsed Symbol display layer 2 is sticked to again on grume 3.When there is analyzed substance in sample, there is detection line on detecting pad 17 171.Simultaneously under alkaline environment, ammonium salt decomposition that is in sample or handling on detecting pad goes out ammonia and releases, and generates Ammonia gas contacted with the indicator on symbol display layer, index line 21 shows color, and "+" or "-" are formed with detection line 171 Symbol, form "+" for index line 21 and detection line 171 shown in Figure 15.

In a more specific embodiment, the detection device 10 of vertical current includes substrate pad, and gas pads, reacting pad, every From pad 5 and indicator pad 2.The characteristics of according to different product, pad and reacting pad, which occur, for gas can be unified into one layer as detection Layer 1.The function of isolating pad 5 is permeable watertight.After liquid sample is loaded onto in detection device, sample penetrates substrate pad, Pad and reacting pad occur for gas.Substance to be checked present in sample react with pretreated substance generation on reacting pad, formation one The apparent lines of item.Meanwhile when sample flows through substrate pad and gas pads, also ammonia is released simultaneously.Ammonia penetrate every From pad 5, indicator discoloration is made to form apparent lines.The lines that substance reaction to be checked generates form "+" with indicator lines.

Such as the detection product of saliva alcohol, alcohol present in sample on reacting pad enzyme and substrate react, Form a blue lines.Meanwhile when sample flows through substrate layer and layer occurs for gas, also ammonia is released simultaneously.Ammonia is saturating Isolating pad is crossed, indicator discoloration is made to form apparent lines.The lines that alcohol reaction generates form "+" with indicator lines.

Embodiment 9：The detection device of Figure 13, Figure 14 and Figure 15 description

In the design scheme as shown in Figure 13 to 15, detection device 10 is similarly perpendicular flow detection structure, with embodiment 8 It compares, detection layers 1 further include that pad 16 occurs for gas, and is pasted successively on bottom plate 11 in addition to including bottom plate 11 and detecting pad 17 There is gas that pad 16 and detecting pad 17 occurs.Processing on pad 16, which occurs, for gas the substance, such as ammonium salt etc. for generating gas.Grume 3 The both ends of detecting pad 17 are located at, symbol display layer 2 is covered on grume 3, to which the symbol comprising indicator 21 is shown Layer 2 is covered in above detecting pad.It include the reagent reacted with analyte on detecting pad 17.When detection, tears and connect on grume 3 One end of the symbol display layer 2 connect exposes detecting pad 17, after sample and/or alkaline buffer salt are added on detecting pad 17, Avulsed symbol display layer 2 is sticked to again on grume 3.When there is analyzed substance in sample, occur on detecting pad 17 Detection line 171.Sample continues vertical downflow, and after being contacted with gas generation pad, the ammonium on pad 16 occurs in gas with processing Salt contacts, and is that ammonium salt decomposition generates gas, and the gas of generation is contacted with the indicator 21 on symbol display layer, and index line shows, The symbol of "+" or "-" is formed with detection line.

In the present embodiment, can occur to handle simultaneously on pad 16 in gas has ammonium salt and alkaline buffer salt, the two not to handle Together.After sample flow to gas, and pad occurs above, with the flowing of liquid, alkaline buffer salt is mixed with ammonium salt, generates gas Body.

Implement 10：The detection device of Figure 17 descriptions

In design scheme as shown in figure 17, detection device 10 is with 10 position of detection device in Figure 13 on the contrary, i.e. from upper It is that 16 and of pad occurs for sample pad 12, gas generation pad 16, detecting pad 17 and symbol display layer 2, sample pad 12, gas successively under and Detecting pad 17 constitutes detection layers 1.In sample-adding to sample pad 12, pad 16, detecting pad 17 occur sample for inflow gas successively.It generates After gas is contacted with symbol display layer 2, indicator discoloration is shown as the symbol of "+" or "-" with detection line Overlapping display testing result Number.Wherein, ammonium salt, which can be handled, occurs in sample pad 12, gas on pad 16 or detecting pad 17, likewise, alkaline buffer salt is same It can handle and occur on pad 16 or detecting pad 17 in sample pad 12, gas.Only, when alkaline buffer salt and ammonium salt processing are same When on pad, the two is not handled in same position, in order to avoid reacting in advance, generates gas.

Implement 11：The detection plate of Figure 18, Figure 19 and Figure 20

The detection plate 40 as shown in Figure 18 to 20 includes upper plate 41, lower plate 42 and detection device 10.The detection device 10 can Can also be the Test paper of vertical current to be the Test paper of lateral flow.The processed material of detection device 10 structure and component Matter and method are also identical with embodiment 1-10.

Shown in Figure 19, detection device 10 is placed in bottom plate 41, and is fixed in it；In 41 upper cover closing lid plate of bottom plate 42, so that detection device 10 is closed between the cover board 42 and bottom plate 41 of detection plate by lid.There is well 45, sample-adding on cover board 42 45 position of hole is corresponding with 12 position of sample pad, to keep the position of sample pad 12 exposed at the well 45 of detection plate 40, energy Sample is set to be directly appended to up in sample pad 12 by well 45.Also there is window 43 on cover board 42, it is final for observing Testing result.

In other embodiments, window 43 does not cover transparent covering layer in advance, but symbol display layer 2 is directly covered At window 43, indicator 21 is coated at the symbol display layer of the window's position, and on detection line 171.

Detection plate 40 as shown in figure 20 includes upper plate 41, lower plate 42 and detection device 10.Window 43 covers in advance Bright coating, and symbol display layer is adhered directly at window 43, indicator 21 be located at window and positioned at detection line 171 it On.

Detection plate 40 as shown in figure 17 includes upper plate 41, lower plate 42 and detection device 10.Detection device 10 includes sample Detection layers 1 and 2 symbol display layer of symbol display layer are adhered on pattern detection layer, and have certain sky with pattern detection layer Gap.Detection device 10 is placed in bottom plate 41, in 41 upper cover closing lid plate 42 of bottom plate, detection device 10 is made to be closed in detection plate by lid Cover board 42 and bottom plate 41 between.

Detection plate 40 as shown in figure 18 includes upper plate 41, lower plate 42 and detection device 10.Detection device 10 is vertical current Test paper, be more specifically the detection device shown in the embodiment 6 to 8.

Embodiment 12：Screen the substrate vectors that gas occurs

Experimentation:

A. the processing of 1%NH4Cl substrate solutions is dried on glass, filter paper and polyester film respectively for use.

B. processed glass, filter paper and water suction rod are respectively assembled at Test paper (the detection examination in such as embodiment 1 Paper) sample pad.It is compared with the product of unassembled substrate layer.

C. it is detected with 100mIU/ml hCG urine standard items.Record index line time of occurrence and color grade and Detect line color.

Experimental result:

Conclusion：When substrate processing on the carrier of unlike material, the rate of release of substrate can be influenced, to influence index line Time of occurrence and intensity.In contrast experiment, although without addition 1%NH4Cl substrates on Test paper.But due to this in urine Body releases ammonia and is contacted with indicator, be indicator with ammonium salt after the alkaline buffer of urine and Test paper contacts Discoloration.Again since the ammonium salt concentration in urine is relatively low, thereby indicate that the color of line is partially shallow.When being added to ammonium on Test paper The gas of salt substrate pads, and sample itself can be overcome to be differed comprising ammonium salt concentration, and index line develops the color inhomogenous disadvantage. It ensure that the index line lines of different pattern detection results are uniform, shade is consistent.

Embodiment 13：Influence of the presence of index line to detection line

Experimentation:

A. the slide that index line will be handled well, is assembled together with the detection device that gas pads, and forms hCG Test strip (target cross hCG test strips).Common hCG Test papers (being padded without gas) are carried out at the same time as a comparison Detection.

B. it is detected with 25mIU/ml and 100mIU/ml hCG urine standard items.Record detection line color grade.

Experimental result:

Detection reagent	25mIU/ml	100mIU/ml
			Common hCG reagent strips	There is indistinct detection line	There is apparent detection line
Target cross hCG reagent strips	There is indistinct detection line	There is apparent detection line

Conclusion：Indicate that the presence of cable architecture will not impact detection line power.

Detection device of the present invention, the sample type that can be applicable in include：Urine, blood, the liquid samples such as saliva, Or it can be processed into the sample that liquid is detected again, such as stool etc..

Color indicator of the present invention can also be redox class indicator, such indicator encounter it is mating anti- Color change can be generated when the oxidizing substance or reducing substances answered.Such as potassium bichromate sheet is as faint yellow, Blue is become after encountering alcohol gas.

Claims

1. a kind of detection device, including pattern detection layer, pattern detection layer be equipped with the detection reagent reacted with analyte and Results display area domain, which is characterized in that the device further includes symbol display layer, and being handled on symbol display layer has indicator；It is described Indicator with can make its change colour gas contact after, the indicator becomes second of color from the first color.

2. detection device according to claim 1, which is characterized in that the detection device further includes gas-forming agent, institute It states gas-forming agent and generates the gas for making indicator that color change occur.

3. detection device according to claim 1, which is characterized in that the result of the indicator and pattern detection layer is shown Region does not contact.

4. detection device according to claim 3, which is characterized in that the results display area domain on pattern detection layer and symbol Gas passage is equipped between indicator region on display layer.

5. detection device according to claim 1 or 4, which is characterized in that results display area domain on pattern detection layer with Indicator regional location on symbol display layer is corresponding.

6. detection device according to claim 5, which is characterized in that symbol display layer is located on pattern detection layer, and And symbol display layer is the transparent or translucent material that pattern detection layer testing result can be observed, the finger on symbol display layer When showing that agent chance gas becomes second of color, identifiable symbol is formed with the detection line on pattern detection layer.

7. detection device according to claim 1 or 6, which is characterized in that between pattern detection layer and symbol display layer It is provided with liquid barrier, the liquid barrier layer material is selected from transparent permeable watertight material.

8. detection device according to claim 2, which is characterized in that the combinations of pairs of the indicator and gas-forming agent Mode is selected from：Reagent occurs for acid-base indicator and acid-base reaction.

9. detection device according to any one of claims 8, which is characterized in that the acid-base indicator is selected from bromthymol blue, bromine cresols It is green, phenolphthalein；The acid-base reaction occurs reagent and is selected from alkaline buffer salt or ammonium salt and alkaline buffer salt combination.

10. detection device according to claim 9, which is characterized in that the acid-base reaction occurs reagent and is processed at sample In this detection layers；The ammonium salt and alkaline buffer salt are separately handled on pattern detection layer, and pattern detection is added in sample Layer goes forward ammonium salt and alkaline buffer salt does not contact.

11. according to the detection device described in one of claim 1-10, which is characterized in that the pattern detection layer includes detection Pad, results display area domain is located on detecting pad.

12. detection device according to claim 11, which is characterized in that pattern detection layer further includes sample pad and label Pad；The sample pad and label pad are sequentially connected in detecting pad upstream.

13. detection device according to claim 12, which is characterized in that the pattern detection layer further includes gas Pad, gas occur pad and are connected between label pad and detecting pad.

14. detection device according to claim 12 or 13, which is characterized in that alkaline buffer salt and/or ammonium salt are separately located Reason occurs in sample pad, label pad, gas on pad or one or two pads of detecting pad；Ammonium salt and alkaline buffer salt treatment are same When on one pad, there is therebetween certain spacing.

15. the detection device described in claim 13, which is characterized in that pattern detection layer further includes water absorption pad, water absorption pad connection In detecting pad downstream；Symbol display layer one end is covered in sample pad, and the other end is covered on water absorption pad；Symbol display layer and mark Note pad, detecting pad and gas do not contact between padding, and form gas passage.

16. detection device according to claim 11, which is characterized in that the detection device further includes that gas pads；Institute It states gas and pad and detecting pad vertical current connection relation occurs, pad occurs for the gas and symbol display layer is respectively in detecting pad two Face.

17. detection device according to claim 16, which is characterized in that further include sample pad, sample pad is connected to gas The one side that pad is not connect with detecting pad occurs.

18. detection device according to claim 16 or 17, which is characterized in that the both ends of the detecting pad one side have The grume of viscosity；Symbol display layer is connect by grume with detecting pad；There is gas passage between symbol display layer and detecting pad.

19. detection device according to claim 17, which is characterized in that alkaline buffer salt and/or ammonium salt are separately handled Sample pad, gas occur on pad or one or two pads of detecting pad；Ammonium salt and alkaline buffer salt treatment when on same pad, Therebetween there is certain spacing.