CN105004855B - A kind of lateral flow detects test-strips - Google Patents
A kind of lateral flow detects test-strips Download PDFInfo
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- CN105004855B CN105004855B CN201410153847.3A CN201410153847A CN105004855B CN 105004855 B CN105004855 B CN 105004855B CN 201410153847 A CN201410153847 A CN 201410153847A CN 105004855 B CN105004855 B CN 105004855B
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- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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Abstract
The invention discloses a kind of lateral flow detection test-strips, the test-strips are provided with sample application zone, detection zone, positive control and imbibition area.Sample application zone is used to add sample to be tested；Whether detection zone is arranged to be used for indicating containing object in sample；Positive control area is provided as there is the positive control of object and/or as the active control of the detection reagent of the detection zone in sample；Imbibition area is used to drive the liquid from addition sample to flow to detection zone and positive control area from sample application zone；Detection zone is located at the near-end of the sample application zone, and described positive control area is located at the distal end of the sample application zone.The positive control with object, provides in a dried form in test-strips of the invention, can guarantee that its activity and stability.Positive control experiment is carried out with object test in sample every time, therefore, it is possible to the internal positive control detected as lateral flow type.
Description
Technical field
The present invention relates to biochemistry detection field, test-strips are detected more particularly to a kind of lateral flow.
Background technology
Lateral flow quick detection (lateral flow type detection) be designed to be detected from sample various antigens or
Antibody.
Lateral-flow immuno-chromatographic assay devices can be loaded into test-strips by by testing sample, be loaded with test-strips
There is one or more detection antibody of specific binding compatibility to object.Then testing sample lateral flow passes through migration
Film reaches p-wire, and be loaded with p-wire equally has one or more capture of specific binding compatibility anti-to object
Body.If there is object in testing sample, then detection antibody can be special with the object in the calmodulin binding domain CaM
Property combine, then can together with determination sample lateral flow to p-wire.Capture antibody at p-wire equally can be with institute
Object specific binding is stated, produces witness marking, the witness marking to constitute the positive test result of the diagnostic assay.Example
Such as, the mark such as colloid gold label detection antibody of colour developing can be used.When object carry q.s detection antibody to survey
During examination line, visible revealing label can be formed.For example when the detection antibody mark is collaurum, can be formed has
The mark of blush, pink or brown color.
As shown in figure 1, the key feature of lateral flow assay devices of the prior art is that have a detection line T, it is used for
Target substance presence or absence, and a nature controlling line C are indicated, the correctness for ensureing operation.In the prior art, in target substance
The nature controlling line can be formed presence or absence of in the case of.Reaction at nature controlling line can be that immunologic reaction can also be
The reaction of chemistry, therefore be only capable of indicating adding enough sample or the experimental implementation and carried out according to correct mode.This
Class Quality Control reaction is not appropriate for having carried out target substance in itself the information of correct immune response for providing antibody, nor
As real positive control, because its formation is unrelated with the presence or absence of target substance.Chinese patent application
200480027333.8, a kind of lateral flow assay devices and its application method are disclosed, the device includes absorbent material, filtering
The structures such as layer, reacting pad, but real positive control cannot be provided when detection.
Detected, it is necessary to the outside positive control for providing is added in sample in case of need, seen whether go out
Existing detection line.In existing lateral flow detection means, testing result includes detection line and nature controlling line, but nature controlling line is not
Real positive control, it is negative unrelated with the positive of sample.In the case where positive control is needed, it is necessary to carry out the positive of outside
Control experiment.
However, such a positive control, it is difficult to ensure that its stability within the shelf-life (is required under normal circumstances
Room temperature 2 years), can not be to obtain positive control while detection sample every time.Cannot judge that each is tried when therefore using
The validity of agent box.And external environment condition is complicated and changeable, testing equipment and control separately storage, it is difficult to ensure that testing equipment and right
According to quality synchronization.
Therefore, this area is in the urgent need to developing biochemistry detection technology that is new, can more accurately providing positive control result
And product.
The content of the invention
The purpose of the present invention is just to be to provide a kind of more accurate lateral flow quick detection for providing positive control result to produce
Product and method.
The first aspect of the present invention provides a kind of lateral flow and detects test-strips, and the test-strips are provided with：
Sample application zone, the sample application zone is used to add sample to be tested；
Whether detection zone, the detection zone is arranged to be used for indicating containing object in sample；
Positive control area, the positive control area is provided as in sample the positive control and/or work that there is object
It is the active control of the detection reagent of the detection zone；With
Imbibition area, the imbibition area is used to drive the liquid from addition sample to flow to detection zone and the positive from sample application zone
Check plot；
Also, described detection zone is located at the near-end of the sample application zone, and described positive control area is located at the sample-adding
The distal end in area.
No matter whether contain object in sample, after the completion of detection, positive control can occur in the positive control area
Band, and only in the case where the detection reagent of test-strips is not inactivated, just manifest positive control band.
In another preference, baffle area optionally is provided between detection zone and positive control area, the baffle area is used for
Intercept interfering material and enter positive control area.The interfering material may be interfered to the normal reaction of positive control area.
In another preference, the interfering material includes：Determinand, the capturing agent for capturing the determinand and
The compound that the determinand is formed with the capturing agent.
Preferably, can capture antigen or the Ag-Ab in sample that the baffle area has immobilization check the anti-of thing
Body.
Preferably, can capture antibody or the Ag-Ab in sample that the baffle area has immobilization check the anti-of thing
It is former.
In another preference, described positive control area includes：
First positive load region, the described first positive load region is loaded with moveable positive loaded article, and
Second positive load region, the described second positive load region is loaded with the positive loaded article of immobilization,
Wherein, the positive loaded article of the immobilization can react and be formed and can examine with the moveable positive loaded article
The compound of survey, the compound is used as positive control.
Preferably, the moveable positive loaded article contains marking particle.The marking particle is preferably gold mark
Grain.
In another preference, the moveable positive loaded article includes antigen, and the positive loaded article bag of immobilization
Containing the antibody for resisting the antigen.
In another preference, the moveable positive loaded article includes antibody, and the positive loaded article bag of immobilization
Containing the antigen that can be combined with the antibody.
In another preference, the moveable positive loaded article is comprising antigen and resists the antibody of the antigen, and fixes
The positive loaded article of change is the different antibodies for the antigen, or for the antiantibody of the antibody.Preferably, the antigen and anti-
The antibody of the antigen is provided separately.
In another preference, the positive control area is arranged on the downstream of detection zone, and test is loaded into detection process
Fluid sample on bar, to flow through and reach positive control area after detection zone.Defined in the present invention, on the test strip, liquid first flows
Through position for the position flowed through after liquid, region where the position that liquid is first flowed through is located at after liquid what is flowed through
The upstream in the region where position.Alternatively, the positive control area can also be arranged in parallel with the detection zone.
In another preference, positive control and the first detection reagent are contained in the positive control area, and the positive is right
Specific reaction can occur with first detection reagent according to thing, and show macroscopic or machine readable result.
In another preference, one in the positive control and first detection reagent is fixed, and another
One can flow with liquid.
In another preference, the set-up mode of the positive control and first detection reagent includes：
I () described positive control is movably disposed in the test-strips, the first detection reagent immobilization
It is arranged in the test-strips, and the positive control is arranged on the upstream of first detection reagent；Or
(ii) first detection reagent is movably disposed in the test-strips, the positive control immobilization
It is arranged in the test-strips, and first detection reagent is arranged on the upstream of the positive control.
" movably " refer to, when liquid flow is out-of-date can be with liquid flow forward.
Preferably, the positive control can show macroscopic after being reacted with first detection reagent
Or the result (mark manifested after such as being irradiated through ultraviolet) of machine readable.The positive control is preferably and the object
With identical component.
In another preference, the positive control and first detection reagent on the positive control area are with hirudo leech
Form set on the carrier.
In another preference, the positive control area is loaded with positive control, the first detection reagent and the second detection
Reagent, positive control described in detection process reacts to form complex with first detection reagent, and the complex can
Macroscopic or machine readable result is reacted and showed with second detection reagent.
Preferably, marking particle, the mark are connected with first detection reagent or on the positive control
Grain is preferably gold grain.
In another preference, the positive control and first detection reagent are movably disposed at the test
On bar, the downstream for being arranged on the positive control and first detection reagent of the second detection reagent immobilization.
In another preference, when the positive control be antigen when, first detection reagent for can with it is described
The antibody that positive control specifically binds.In detection process, the positive control and first detection reagent
After reaction forms complex, the complex reacts with second detection reagent and shows macroscopic or machine readable
Result.Second detection reagent can be can with the complex specifically bind antigen, or can with it is described
The antibody of complex specific binding.Preferably, it is connected with mark in the positive control or first detection reagent
Grain, the marking particle is preferably gold grain.
In another preference, when the positive control be antibody when, first detection reagent for can with it is described
The antigen that positive control specifically binds.In detection process, the positive control and first detection reagent
After reaction forms complex, the complex reacts with second detection reagent and shows macroscopic or machine readable
Result.Second detection reagent can be can with the complex specifically bind antigen, or can with it is described
The antibody of complex specific binding.Preferably, it is connected with mark in the positive control or first detection reagent
Grain, the marking particle is preferably gold grain.
It should be understood that within the scope of the present invention, above-mentioned each technical characteristic of the invention and have in below (eg embodiment)
Can be combined with each other between each technical characteristic of body description, so as to constitute new or preferred technical scheme.As space is limited, exist
This no longer tires out one by one states.
Brief description of the drawings
Fig. 1 is a lateral flow assay devices of the prior art, and A is absorption pad in figure, and N is NC films, and C is nature controlling line, T
It is detection line.
Fig. 2 is test-strips (sandwich method) schematic diagram of a preferred embodiment of the invention.
Fig. 3 is test-strips (competition law) schematic diagram of a preferred embodiment of the invention.
Specific embodiment
The present inventor's in-depth study by extensive, is improved to existing lateral flow Fast Detection Technique, first
It is secondary to be prepared for a kind of structure novelty, the lateral flow detection test-strips containing built-in positive control.Test result shows, in detection
During sample, positive control can be synchronous with sample detection or be carried out simultaneously, and (or even elimination) false positive can not only be greatly decreased
Or the testing result of false negative, and positive control result can be extremely accurate provided.It is long when detection product standing time
Or store improper when causing product failure, the information of product failure can be also provided.The present invention is completed on this basis.
As used herein, term " lateral flow type detection technique " includes existing various lateral flow Fast Detection Techniques, especially
It is competitive type lateral flow type detection technique and sandwich type lateral flow type detection technique.
The lateral flow detection test-strips of built-in positive control of the invention, positive control and detection are carried out simultaneously, and with
The form of drying solid sets positive control on the test strip, stablizes at room temperature, with the shelf-life more long.
Term " object " used herein typically refers to test substance.For example, object can include antigenic substance,
Haptens, antibody and its combination.Object includes but is not limited to toxin, organic compound, protein, peptide, microorganism, amino
Acid, nucleic acid, hormone, steroidal, vitamin, medicine (including given for treatment mesh and violated mesh and give), in medicine
The metabolite or antibody of mesosome or byproduct, bacterium, virion and any of the above-described material.The specific example of some objects
Including ferritin；Creatine kinase MIB (CK-MB)；Digoxin；Phenytoinum naticum；Phenobarbital；Carbamazepine；Vancomycin；Celebrating is big mould
Element；Theophylline；Valproic acid；Quinindium；Lutropin (LH)；Follicle-stimulating hormone (FSH) (FSH)；Estradiol, progesterone；C reactive protein；
IgE antibody；Vitamin B2 microglobulin；Glycosylated hemoglobin (Gly.Hb)；Cortisol；Digitophyllin；Bilirubin；Urobilin
It is former；N-Acetylprocainamide (NAPA)；Procainamide；Rubella antibody, such as rubella-IgG and rubella IgM；Toxoplasmosis
Antibody, such as toxoplasmosis IgG (Toxo-IgG) and toxoplasmosis IgM (Toxo-IgM)；Testosterone；Salicylate；Acetparaminosalol
Phenol；Hepatitis b virus s antigen (HBsAg)；Antibody to hepatitis B core antigen, such as resistance of hepatitis B cAg IgG and
IgM (anti-HBC)；Human immunodeficiency virus I and 2 (HIV1 and 2)；Human T-leukemia virus 1 and 2 (HTLV)；It is B-mode
Hepatitis e antigen (HBeAg)；Hepatitis B e antigen antibody (anti-HBe)；Influenza virus；Thyrotropic hormone (TSH)；Thyroid gland
Plain (T4), TT3 (total T3), free triiodothyronine (free T3)；Carcinomebryonic antigen (CEA) and
Alpha-fetoprotein (AFP).Drug abuse and controlled substance include but are not intended to be limited to, amphetamine；Crystal methamphetamine；Barbiturates, such as
Amytal, quinalbarbitone, amobarbital, phenobarbital and barbital；Benzodiazepine, such as librium and stable；As printed
Degree hemp and hemp；Cocaine；Fentanyl；LSD；Methaqualone；Opiates, such as heroin, morphine, codeine, Hydromorphone, hydrogen
Can ketone, methadone, Oxycodone, Oxymorphone and opium；Hog and propoxyhene (propoxyhene).Other are potential
Object is described in United States Patent (USP) No.6436651 and No.4366411.
Term " sample " used herein typically refers to the doubtful material containing object.Test sample can be from raw material
Obtaining and being used after directly use or pre-process the property for changing sample.Test sample can come from any biological raw material, such as physiology
Body fluid, including blood, tissue fluid, saliva, ocular lens fluid, cerebrospinal fluid, sweat, urine, milk, ascites, synovia, peritoneal fluid,
Vaginal secretion, amniotic fluid etc..Test sample can use preceding pretreatment, such as prepare blood plasma from blood, dilute sticky liquid etc..Treatment
Method can include filtering, precipitation, dilution, distillation, mixing, concentration, inactivation interference component and add reagent.Except physiology body
Liquid, can also use other fluid samples, such as water, food and the analog for carrying out environment aspect or food-production assays.This
Outward, the doubtful solid matter containing object can serve as test sample.In some cases, solid sample is transformed into liquid
Medium or to discharge object be beneficial.
As used herein in the present, term " label " or " marking particle " can refer to luminescent substance (for example different luminol and
Acridinium ester), fluorescent material (such as fluorescein and rhodamine), biotin, coloring matter (such as latex particle, colloid gold particle
(gold mark)).
Lateral flow detects test-strips or effluent piece
As shown in Fig. 2 the lateral flow detection test-strips in present embodiment are provided with：Sample application zone 1, detection zone 2, obstruct
Area 3, positive control area 4 and imbibition area 5.Sample application zone 1 is used to add sample to be tested.Detection zone 2 is arranged to be used for indicating
Whether contain object in sample.Baffle area 3 enters positive control area for intercepting interfering material.The interfering material refers to possibility
The material that the normal reaction of positive control area can be interfered.Positive control area 4 is provided as there is object in sample
Positive control and/or as the active control of the detection reagent of detection zone 2.Imbibition area 5 is used to drive from addition sample
The liquid of product flows to detection zone 2 and positive control area 4 from sample application zone 1.Detection zone 2 is located at the near-end of sample application zone 1, and positive right
The distal end of sample application zone 1 is located at according to area 4.
No matter whether contain object in sample, after the completion of detection, positive control band can occur in positive control area,
And only in the case where the detection reagent of test-strips is not inactivated, just manifest positive control band.
Positive control area 4 includes the first positive positive load region 42 in load region 41 and second.First positive load region 41 is negative
Moveable positive loaded article is loaded with, the second positive load region 42 is loaded with the positive loaded article of immobilization.The positive of immobilization
Loaded article can react with moveable positive loaded article and form detectable（Such as, it is macroscopic）Compound is used as the positive
Control.
In sandwich method detection, the first positive load region 41 can separate loading positive control and the first detection reagent
(e.g., loading region 411 and region 412 in figure 3 respectively) loads as " moveable positive loaded article " in second positive
Area 42 loads the second detection reagent as " the positive loaded article of immobilization ".
Detection method
Detection method in detection zone of the present invention can be configured according to the usual manner of this area, e.g., using immune
The mode of reaction, can also use competition law using sandwich method.
The detection process of sandwich method is as follows, so that object is as antigen as an example, testing sample is loaded into the test-strips
Sample-adding end, testing sample will preset moveable color mark along the test-strips lateral flow in the detection zone of test-strips
First antibody, first antibody can occur specific compatible reaction with target antigen, and testing sample flows through detection zone, works as target
In the presence of antigen, target antigen will react to form compound with the first antibody, and compound continues to flow with sample, in test
Immobilization is provided with SA at the detection line of bar, and SA also can occur specific compatible reaction with object,
When sample flows through p-wire, compound reacts with SA, forms sandwich type " first antibody-antigen-SA "
Compound, and form macroscopic band.If not having object in sample, detection zone is not in band.
The detection process of competition law is as follows, so that object is as antigen as an example, testing sample is loaded into the test-strips
Sample-adding end, testing sample will preset moveable color mark along the test-strips lateral flow in the detection zone of test-strips
With target identical antigen, immobilization sets the antibody that can be combined with antigentic specificity at the detection line of test-strips, in sample
Antigen and the antigen of color mark when flowing to p-wire together, combined emulative with antibody.If shown at detection line
Color, does not have target antigen in this explanation sample, if not having band to manifest at detection line, illustrates that there is target in sample resists
It is former.
Main advantages of the present invention are：
In (a) test-strips with object positive control, provide in a dried form, be effectively guaranteed its activity and
Stability；
B () carries out positive control experiment with object test in each sample, therefore, it is possible to be detected as lateral flow type
Internal positive control；
C () default positive control can keep stabilization within the whole shelf-life of kit, as long as locating within the shelf-life
In drying regime；
D () is able to ensure that detection symbol relevant regulations in test every time by built-in positive control, functioned not only as
Journey is compareed, and also serves as proving the positive findings control of detection reaction, and is able to ensure that the sensitivity of each test.
With reference to specific embodiment, the present invention is expanded on further.It should be understood that these embodiments are merely to illustrate the present invention
Rather than limitation the scope of the present invention.
Embodiment 1A group streptococcus (Strep A) quick detection (sandwich method)
The test-strips used in the present embodiment are as shown in Figure 3.The present embodiment test-strips include
First board 21：The first antibody of moveable gold mark, the anti-Strep Staphylococal Protein As of the first antibody are set；
Detection line 22 (T lines)：The SA of the anti-Strep A containing immobilization, has Strep Staphylococal Protein As to deposit in the sample
First antibody-Strep Staphylococal Protein As-SA compound can be formed in case, and shows band, the first board
21 and detection line 22 (T lines) constitute detection zone 2；
Captured line 31 (F lines)：Sheep anti-mouse antibody containing immobilization, it is all anti-on the first board 21 to capture
Body, captured line 31 (F lines) constitutes baffle area 3；
In the region 411 of the first positive load region 41, be generally but not it is required with the identical of the first board 21
Antibody, the antibody is movably set；
The region 412 of the first positive load region 41, is located at the downstream in region 411：Comprising moveable dry Strep A
Antigen；
Second positive load region 42 is used as positive control line (C lines)：Comprising with the identical antibody of detection line 22.
Region 411, the positive load region 42 in region 412 and second have collectively constituted positive control area 4.
Negative findings：There is no detection line (T lines) to manifest.But captured line (F) and positive control line (C) manifest, it was demonstrated that anti-
The anti-Strep A of body have correct immunoreactivity, also demonstrate that the test is correctly implemented (for example, adding enough liquid
Body and reagent be stored in it is suitable under the conditions of without inactivation), positive control line can be used as real process control and the positive
Control.
Positive findings：Except captured line and control line, detection line can also manifest.From the StrepA antigens in sample solution
Detection line region is positioned in, the detection line of sandwich type is formed, with the antigen on the antibody on time domain 411 and region 412
Positive control line is positioned in, sandwich is formed, and form macroscopic positive control line.
Detection process is：
By taking positive as an example, Strep Staphylococal Protein As are contained in sample, after sample is loaded into test-strips, lateral flow, stream
There is specific reaction with the first antibody of the anti-Strep Staphylococal Protein As of gold mark to the first board 21, form compound, be combined
Thing continues flow forward, and the antibody of the anti-Strep A of the immobilization into detection line 22 (T lines), with detection line 22 is combined to form
Sandwich structure simultaneously develops the color, and when liquid continuation flow forward flow to captured line 31, the anti-of sandwich structure is not formed in liquid
Body is combined with the sheep anti-mouse antibody in captured line 31, so as to remove unnecessary antibody.Liquid flows through the first positive load region 41
During region 411, the antibody of the anti-Strep Staphylococal Protein As of the gold mark in region 411 is with liquid flow forward to the first positive load
Strep Staphylococal Protein As in the region 412 in area 41, with region 412 combine to form compound, compound with liquid flow forward, extremely
Combine to form sandwich structure and develop the color with the antibody in the second positive load region 42 during the second positive load region 42.
If antibody (the first antibody and/or SA) inactivation in test-strips, positive control line will not manifest, because
This can exclude the result of false negative.If positive control line does not manifest, need to detect sample again.
Embodiment 2 morphine (Morphine, MOR) quick detection (competition law)
As shown in Fig. 2 the present embodiment test-strips include：
First board 21：Anti- MOR antibody comprising flowable gold mark；
Detection line 22 (T lines)：MOR-BSA comprising immobilization, the first board 21 and detection line 22 (T lines) constitute inspection
Survey area 2；
Captured line 31 (F lines)：Anti- MOR antibody comprising immobilization, captured line 31 (F lines) constitutes baffle area 3；
First positive load region 41：MOR-BSA comprising flowable gold mark；
Second positive load region 42：Anti- MOR antibody containing immobilization；
The first positive positive load region 42 in load region 41 and second has collectively constituted positive control area 4.
Detection process is：
Negative sample, does not contain MOR (object), after sample is loaded into test-strips, lateral flow, through first in sample
After board 21, the anti-MOR antibody flow detection line 22 of the gold mark in the first board 21, when reaching detection line 22, Jin Biao
The anti-MOR antibody of note is combined and developed the color with the MOR-BSA in detection line 22, and liquid continues flowing, is flowed through captured line 31 and is entered the
During one positive load region 41, the MOR-BSA of the gold mark in the first positive load region 41 flows to second positive with liquid
Load region 42, the MOR-BSA of gold mark is combined and developed the color with the anti-MOR antibody of the immobilization in the second positive load region 42.
Positive, contains MOR (object), after sample is loaded into test-strips, lateral flow, with the first knot in sample
The anti-MOR antibody of gold mark is combined in plywood 21, then flow detection line 22 together, when reaching detection line 22, in sample
The anti-MOR antibody of the emulative gold marks with the first board 21 of MOR-BSA in MOR and detection line 22 is combined, because
This, causes not developed the color at detection line 22 or color weakens.Liquid continues to flow, when flowing through captured line 31, unnecessary MOR in sample
Combined with the anti-MOR antibody of the immobilization in captured line 31, unnecessary MOR is fixed on captured line 31 can not be continued to flow forward
Dynamic, when liquid continues to the first positive load region 41, the MOR-BSA of the gold mark in the first positive load region 41 is with liquid
The second positive load region 42 is flow to, is combined and developed the color with the anti-MOR antibody in the second positive load region 42.
If after sensing, positive control line does not develop the color, illustrate antibody in test-strips and/or antigen failure, it is necessary to
Again detect.
The all documents referred in the present invention are all incorporated as reference in this application, independent just as each document
It is incorporated as with reference to such.In addition, it is to be understood that after above-mentioned instruction content of the invention has been read, those skilled in the art can
Made various changes or modifications with to the present invention, these equivalent form of values equally fall within the model that the application appended claims are limited
Enclose.
Claims (8)
1. a kind of lateral flow detects test-strips, it is characterised in that the test-strips are provided with：
Sample application zone, the sample application zone is used to add sample to be tested；
Whether detection zone, the detection zone is arranged to be used for indicating containing object in sample；
Positive control area, the positive control area is provided as the active control of detection reagent of the detection zone；With
Imbibition area, the imbibition area is used to drive the liquid from addition sample to flow to detection zone and positive control from sample application zone
Area；
Also, described detection zone is located at the near-end of the sample application zone, and described positive control area is located at the sample application zone
Distal end；
Baffle area is provided between detection zone and positive control area, the baffle area enters positive control for intercepting interfering material
Area；
Described positive control area includes：
First positive load region, the described first positive load region is loaded with moveable positive loaded article, and
Second positive load region, the described second positive load region is loaded with the positive loaded article of immobilization,
Wherein, the positive loaded article of the immobilization can react and form detectable with the moveable positive loaded article
Compound, the compound is used as positive control；
The moveable positive loaded article includes antigen, and the positive loaded article of immobilization includes the antibody for resisting the antigen；Or
Person
The moveable positive loaded article includes antibody, and the positive loaded article of immobilization includes what can be combined with the antibody
Antigen；Or
The moveable positive loaded article comprising antigen and resist the antigen antibody, and the positive loaded article of immobilization be for
The different antibodies of the antigen, or for the antiantibody of the antibody.
2. test-strips as claimed in claim 1, it is characterised in that what the baffle area had an immobilization can capture sample
The antibody of antigen or antigen-antibody complex.
3. test-strips as claimed in claim 1, it is characterised in that what the baffle area had an immobilization can capture sample
The antigen of antibody or antigen-antibody complex.
4. test-strips as claimed in claim 1, it is characterised in that the moveable positive loaded article contains marking particle.
5. a kind of lateral flow detects test-strips, it is characterised in that the test-strips are provided with：
Sample application zone, the sample application zone is used to add sample to be tested；
Whether detection zone, the detection zone is arranged to be used for indicating containing object in sample；
Positive control area, the positive control area is provided as the active control of detection reagent of the detection zone；With
Imbibition area, the imbibition area is used to drive the liquid from addition sample to flow to detection zone and positive control from sample application zone
Area；
Also, described detection zone is located at the near-end of the sample application zone, and described positive control area is located at the sample application zone
Distal end；
Baffle area is provided between detection zone and positive control area, the baffle area enters positive control for intercepting interfering material
Area；
Wherein, positive control and the first detection reagent are contained in the positive control area, the positive control can with it is described
There is specific reaction in the first detection reagent, and show macroscopic or machine readable result；
When the positive control is antigen, first detection reagent is specific for that can occur with the positive control
With reference to antibody；
When the positive control is antibody, first detection reagent is specific for that can occur with the positive control
With reference to antigen.
6. test-strips as claimed in claim 5, it is characterised in that in the positive control and first detection reagent
One is fixed, and another can flow with liquid.
7. test-strips as claimed in claim 6, it is characterised in that the positive control and first detection reagent set
The mode of putting includes：
I () described positive control is movably disposed in the test-strips, the setting of the first detection reagent immobilization
In the test-strips, and the positive control is arranged on the upstream of first detection reagent；Or (ii) described first inspection
Test agent is movably disposed in the test-strips, and the positive control immobilization is arranged in the test-strips, and
First detection reagent is arranged on the upstream of the positive control.
8. test-strips as claimed in claim 5, it is characterised in that the positive control area is loaded with positive control, first
Detection reagent and the second detection reagent, positive control described in detection process react to form compound with first detection reagent
Body, the complex can react with second detection reagent and show macroscopic or machine readable result.
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| EP3304069A4 (en) * | 2015-05-29 | 2018-10-17 | Polymer Technology Systems, Inc. | Systems and methods for combined vertical/lateral flow blood separation technologies with cotinine detection |
| CN106706917A (en) * | 2016-11-09 | 2017-05-24 | 百奥森（江苏）食品安全科技有限公司 | Test paper plate for detecting solanine in potatoes |
| CN108918896A (en) * | 2018-05-29 | 2018-11-30 | 郑州左安检测科技有限公司 | A kind of FITC test strips and its preparation method and application method detecting Benzodiazepine |
| CN108957017A (en) * | 2018-05-29 | 2018-12-07 | 郑州左安检测科技有限公司 | A kind of test strips and its preparation method and application method detecting Benzodiazepine |
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