CN204214874U - A kind of device detecting sample - Google Patents

Abstract

The utility model relates to a kind of device detecting sample, comprises, test strips, and test strips comprises sample pad, label pad and detecting pad, and label pad is positioned at the downstream of sample pad, and detecting pad is positioned at the downstream of label pad; Wherein, the device of this detection sample also comprises catches pad, and this is caught pad and is positioned at the upstream of test strips and leads to test strips liquid phase flow; This is caught pad and is connected with test strips or does not connect.The device of detection sample of the present utility model is because catching pad and the antibody of catching on pad and be divided into two parts and separately, add the Time and place of the combination of analyte in antibody and sample, thus make combination more abundant, particularly for special sample, the false-positive possibility got rid of, improves the accuracy of detection.

Description

A kind of device detecting sample

Technical field

The utility model relates to the device detecting sample, especially for the test strips detecting sample.

Background technology

Immune association reaction principle is utilized to be widely used in every field to detect in sample this technology that whether there is analyte.The health status (early pregnancy, tumour, infectious disease, drugs etc.) of monitoring of diseases and the mankind can be carried out with the analyte that it detects various biological specimen (saliva, blood, urine, serum, sweat etc.).The cardinal principle of this detection technique is based upon the performance between immune molecule with specific bond, such as antibody and antigen, haptens/antibody, biotin and antibiotin etc.In addition, much such detection can complete on solid dielectric, such as conventional cross flow reagent strip, in glass or plastic microtiter plates, and device for immunochromatography etc.Usually, can again in conjunction with some solid particles or chemical substance on immune specific binding molecule, can come qualitative by naked eyes or other instrument and equipments like this, quantitative or semiquantitatively draw testing result.This solid particle can be colored colloidal solid (latex or gold grain), and this chemical substance can be the material with chromophoric group, and these materials can send specific wavelength to show testing result under other suitable conditions.

Utilize the detection reagent strip of these principles or device can find in the prior art, the reagent strip that such as the following patent describes or the device containing reagent strip: US 4857453; US 5073484; US5119831; US 5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US 5654162; US 5656503; US 5686315; US 5766961; US5770460; US 5916815; US 5976895; US 6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US 6306642; US 6352862; US6372515; US 6379620; With US 6403383.

Immune detection generally includes two kinds of principles, sandwich and competition law, and the haptens small-molecule substance wherein detected in sample with competing method is the most common.The method utilizing competition law to detect and reagent and pick-up unit are in US Patent No. 4235601; Be described later in detail in US4442204, US5208535, US5229073.These devices be all be described on surveyed area or result reading area does not have color change or do not have colored line to occur time, testing result is judged to the positive, represent that detecting sample may exist analyte, on the contrary, in time surveyed area or result reading area there is color change or have colored line to occur, testing result is judged to feminine gender, represents and detects in sample and may not there is analyte.

In some pick-up units, sample process region is separated with test strips, a kind of pick-up unit described in such as Chinese patent CN200610052628.1, comprises second reagent areas.This second reagent areas is separated with test strips, shifts to an earlier date and sample contact, the analyte in sample is combined fully with its antibody; Then, processed sample flows to test strips again and detects.

In the operation of reality, there is following problem in this pick-up unit: for thickness or the many saliva sample of the low foam of water cut cannot early stage, the antibody of catching in pad (the second reagent areas) elutes completely by, namely sample cannot be combined fully with catching the antibody on pad, cause not having the antigen in the antibody of q.s and label pad to combine, therefore cannot develop the color, thus cause false positive.

Utility model content

In order to address these problems, the utility model provides a pick-up unit improved and uses the method for device of this improvement, by improve pick-up unit and method the analyte in sample can be made to be combined more fully with the molecule (antibody) of catching the specific bond on pad, thus effectively overcome false-positive problem, improve the accuracy rate of Product checking.

On the one hand, a kind of device detecting sample provided by the utility model, comprise, test strips, test strips comprises sample pad, label pad and detecting pad, and label pad is positioned at the downstream of label pad, and detecting pad is positioned at the downstream of label pad; It is characterized in that, the device of this detection sample also comprises catches pad, described catch pay somebody's debt and expect repayment later comprise with analyte incoherent specific binding molecule to a kind of molecule and and the incoherent specific binding molecule of analyte to a kind of molecule, this is caught pad and is positioned at the upstream of test strips and leads to test strips liquid phase flow; This is caught pad and can be connected with test strips or not connect.

One preferred embodiment in, this is caught pad and comprises first and catch pad and second catch pad; Second catch the specific bond analyte on pad molecule and with the incoherent specific binding molecule of analyte to a kind of content of molecule be first and second catch the 15%-50% padding total amount.

In more preferred mode, first catches pad is positioned at second and catches pad upstream, and the two is not connected, but liquid communication.

In a concrete embodiment, second catches the upstream that pad is positioned at test strips, the two and liquid communication.Now, second catches pad can be connected with test strips, also can not be connected.

Catch pad and comprise two, and be not connected, the time that sample is flow through lengthens, and is namely catching the lengthening of the total residence time on pad.When catch pad includes the reagent reacted with analyte in sample time, analyte and reagent can be made to have Time and place more fully to combine.

In some embodiments, second catches the upstream that pad is positioned at the sample pad of test strips, is connected with sample pad.

In a concrete embodiment, second catches the prolongation that pad is sample pad.

In other embodiments, catching mat material matter is dacron film or glass fibre membrane.

Preferred embodiment, first to catch mat material matter be dacron film; Second to catch mat material matter be glass fibre membrane.

The utility model also provides a kind of kit detecting sample, comprise: detect the device of sample and collect the device of sample, wherein, the device detecting sample comprises reagent strip, described test strips comprises sample pad, label pad and detecting pad, label pad is positioned at the downstream of sample pad, and detecting pad is positioned at the downstream of label pad; Wherein, collecting that the device of sample comprises can the collection head of absorbing fluid sample; It is characterized in that, also comprise in the device of described detection sample and catch pad, catch pad and be positioned at the upstream of test strips and lead to test strips liquid phase flow; This is caught pad and can be connected with test strips or not connect.

Preferably, catch pad to comprise first and catch pad and second catch pad; First catch pad be positioned at second catch pad upstream, the two be not connected but liquid phase flow lead to; Second catches the upstream that pad is positioned at the sample pad of test strips, and the two is connected and fluid-phase is communicated with; First catch pad and second catch the molecule that pad comprises specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule.

In some concrete embodiments, second catch the specific bond analyte on pad molecule and with the incoherent specific binding molecule of analyte to a kind of content of molecule be first and second catch the 15%-50% padding total amount.

First catch pad and second catch on pad for be combined with analyte reagent (molecule of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule) there is certain proportioning after, can react more fully with the analyte in sample.Some preferred embodiment in.Second catch the specific bond analyte on pad molecule and with the incoherent specific binding molecule of analyte to a kind of content of molecule be first and second catch the 20%-35% padding total amount.

In some embodiments, detecting pad comprises a kind of fixed, with catch pad the incoherent specific binding molecule of analyte to another kind of molecule.

In other embodiments, first catches pad above comprises the first antibody of analyte with the molecule of the second specific bond analyte of catching on pad; Label pad comprises the second antibody of analyte.

Preferably, described with the incoherent specific binding molecule of analyte to be selected from following molecule to one of: biotin/affinity element (biotin/avidin); Biotin/Streptavidin (biotin/streptavidin); The antibody (rhodamine/anti-rhodamine) of rhodamine/rhodamine; The antibody (Mouse IgG/anti-mouse IgG) of mouse IgG/ mouse IgG.

Be included in catch reagent on pad (molecule of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule) be processed and be fixed on to catch on pad, when liquid sample be added to catch pad go up and flow through catch pad time, be fixed process catching after the reagent on pad combines with analyte and can flow with liquid.Wherein, reagent be processed at catch pad upper type various.In some concrete embodiments, the molecule of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule be processed at whole first and catch and pad and second to catch on pad.In this mode, analyte and reagent can be made to react fully.

Other preferred embodiment in, the molecule of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule be processed at whole first and catch on pad; The molecule of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule be processed at second in linearly aligned mode and catch on a line of pad.The second linearly aligned reagent arrangement of catching on pad is more concentrated, make all samples can both flow through linear place and carry out sufficient liquid comes into contact, make combination more abundant, thus the also more effective mode false positive of product.

On the other hand, the utility model also provides a kind of method that whether there is analyte in tracer liquid sample, comprise: a kind of device detecting sample is provided, this pick-up unit comprises reagent strip and catches pad, described reagent strip test strips comprises sample pad, label pad and detecting pad, label pad is positioned at the downstream of sample pad, and detecting pad is positioned at the downstream of label pad; Catch pad to comprise first and catch pad and second catch pad; First catch pad be positioned at second catch pad upstream, the two be not connected but liquid phase flow lead to; Second catches the upstream that pad is positioned at the sample pad of test strips, and the two is connected and fluid-phase is communicated with; It is characterized in that: catch the upper adding liquid sample of pad to first, allow this liquid sample first catch reagent reacting on pad with first after 30 seconds-60 minutes; Then allow liquid sample flow to second successively and catch sample pad, label pad, detecting pad the reagent reacting padded with each completes detection in pad and test strips; Read testing result.

In some embodiments, the reagent of catching on pad comprise specific bond analyte molecule and with the incoherent specific binding molecule of analyte to a kind of molecule; This molecule is connected with the molecule of described specific bond analyte or combines and can flow with liquid.

Some preferred embodiment in, second catch the specific bond analyte on pad molecule and with the incoherent specific binding molecule of analyte to a kind of content of molecule be first and second catch the 15%-50% padding total amount.

Other preferred embodiment in, after catching pad adding liquid sample to first, allow liquid sample and first catch-30 minutes seconds of reagent reacting 30 on pad.

Beneficial effect

The device of detection sample of the present utility model is because catching pad and the antibody of catching on pad and be divided into two parts and separately, add the Time and place of the combination of analyte in antibody and sample, thus make combination more abundant, particularly for special sample, the false-positive possibility got rid of, improves the accuracy of detection.

Accompanying drawing explanation

Fig. 1 is the decomposition texture schematic diagram of common test strips;

Fig. 2 is the vertical view of common test strips;

Fig. 3 is the structural representation of the device of detection sample before improvement of the present utility model;

Fig. 4 is the structural representation of the device of detection sample after improvement of the present utility model;

Fig. 5 is before the pick-up unit of the utility model concrete scheme detects and detects rear result schematic diagram;

Fig. 6 is before the pick-up unit of another concrete scheme of the utility model detects and detects rear result schematic diagram;

Fig. 7 is before the pick-up unit of another concrete scheme of the utility model detects and detects rear result schematic diagram;

Fig. 8 is the decomposing schematic representation that the utility model comprises the detection box of the device improving rear detection sample;

Fig. 9 is the diagrammatic cross-section that Fig. 8 detects parts of box.

Description of reference numerals:

100,300 reagent strips; 101 sample pad; 102 label pad; 103, detecting pad; 132 testing result lines; 133 testing result control lines; 104 adsorptive pads; 105 support chips; 210 catch pad; 310 first catch pad; 320 second catch pad; 400 pick-up units; 500 gathering-devices; 501 collect handle; 502 collect head; 4011 first collecting chambers; 4012 second collecting chambers; 401 collecting chambers; 4011-1,4011-2 first through hole of collecting chamber; 403,403-1,403-2 O-ring seal; 406 sample ingress areas; 406-1 sample imports through hole; 3101 paste-sides; 3102 reagent ends; 404 bodies; 4041 read window; Confirm chamber 407; 4071 bases; 4073 derive through hole; 4072 stoppers; 4043 upper plates; 4045 lower plates.

Embodiment

The structure related to the utility model below or these technical terms used are described further.

test strips 100

General reagent strip, as depicted in figs. 1 and 2, reagent strip 100 comprises sample application zone and marked region and surveyed area, and surveyed area comprises a kind of specific binding molecule.The reagent strip more optimized also comprises the suction zone being positioned at surveyed area downstream, and sample can flow on reagent strip along the direction of arrow indication.Sample application zone has comprised reaction necessary material, such as some buffer reagents, pre-service sample reagent etc.; Fluorescence labeling material is comprised at marked region, colloid gold label particle, or with painted gel marking particle, it can also be water-soluble marker's material, these mark substances can connect antibody, antigen, haptens or analyte similar substance etc., surveyed area comprises fixed specific binding molecule, can occur on surveyed area that color change represents in sample whether there is analyte by specific binding molecule.Testing result control area 133 can also be comprised in the downstream of surveyed area.Reagent strip can be made up of following parts, sample pad 101 and label pad 102, detecting pad 103, adsorptive pads 104, and these materials are assembled on support chip 105 and form whole reagent strip 100 (as Fig. 1); Wherein on detecting pad 103, comprise surveyed area 132, preferential scheme also comprises testing result control area 133 in the downstream of surveyed area.Liquid sample finally can arrive adsorptive pads 104 along the direction of arrow indication from sample pad 101 sequentially through label pad 102, detecting pad 103.The all parts of composition reagent strip can be made up of absorbent material, and usually, detecting pad 103 can be nitrocellulose filter, one of cellulose acetate membrane or nylon membrane are formed.These form the parts of reagent strips and material and process some conventional chemical reagent on these parts and disposal route is all disclosed in prior art.

catch pad 210

Catch that pad 210 comprises can with the molecule of the specific bond analyte of liquid flow, this is caught pad 210 and is positioned at the upstream of reagent strip 100 and is separated with reagent strip 100.A scheme as shown in Figure 3, catches the upstream that pad 210 is positioned at the sample pad 101 of reagent strip 100, and liquid sample first flows through to catch in sample pad that then pad 210 arrive on reagent strip 100 101 and complete whole detection.

pick-up unit 400

As Fig. 8, shown in 9, pick-up unit 400 comprises body 404 and collection well 401, wherein reagent strip 100, and 300 are arranged in body 404, catches pad and is arranged in collection well 401; Catch pad and reagent strip be in liquid communication state." liquid communication state " mentioned here refers to that liquid can flow to reagent strip from collecting chamber 401, this flowing can be flowed due to the Action of Gravity Field of liquid itself, also can between collecting chamber 401 and reagent strip 300, have through hole and flow, some flow guiding structures can also be installed simultaneously between collecting chamber and reagent strip, liquid can be allowed like this to flow to reagent strip from collecting chamber more smoothly.More specifically, body 404 comprises and reads window 4041 and sample ingress area 406, sample ingress area 406 comprises sample and imports through hole 406-1 etc., reading window 4041 in surveyed area on reagent strip and body 404 is corresponding, and the sample application zone (sample pad) of reagent strip and sample import through hole correspondence.Then the sample sample application zone that can flow on reagent strip flowed into by sample importing through hole 406-1 is arrived surveyed area and completes whole detection reaction.Collecting chamber 401 comprises the first collecting chamber 4011 and the second collecting chamber 4012, first collecting chamber 4011 one end open is for receiving the sample of needs detection or receiving the gathering-device with sample, have several the liquid through-hole 4011-1 that liquid can be allowed to pass through, 4011-2 etc. (Fig. 9) on an opposite end; The correspondence position of liquid through-hole 4011-1 has a vertical bar beam, and this beam one end can be fixed on the sidewall of the first collecting chamber 4011, and the other end also through liquid through-hole 4011-1 to downward-extension, is caught pad and is positioned on vertical bar beam.Catch pad one end can be fixed on the surface of vertical beam, the other end can arrive the bottom of the second collecting chamber 4012 through liquid through-hole, the one end of catching pad comprises can with the molecule (Y1) of the specific bond analyte of liquid flow and with the incoherent specific binding molecule of analyte to a kind of molecule (M1) in (M1/M2); This material of catching pad can be some water-absorbing materials composition, and can process some protein substances above, such as glass fibre, filter paper, acetate fiber etc., the one end of catching pad can be bonded at the surface of vertical beam by organic nothing or machine glue.This is caught pad and also can be adhesive in liquid through-hole 4011-2.Catch pad also can be present in other forms in collecting chamber 401, such as catch the bottom that pad can be placed directly in the first collecting chamber 4011, also can be placed on bottom the first collecting chamber and bottom the second collecting chamber between in the insulating space that formed, as long as catching pad is placed in collecting chamber 401, sample can be allowed fully to contact with it just passable, in collecting chamber 401, catch pad and can be fully immersed in sample, also can partly be immersed in sample.Catch on pad and can also comprise some other auxiliary reagents, the buffer reagent of such as buffer action, some protein moleculars etc.Other forms that one of ordinary skill in the art is all easily expected in conjunction with the utility model or mode can as examples of implementation of the present utility model.First collecting chamber 4011 and the second collecting chamber 4012 are assembled into collecting chamber 401 (Fig. 8).Second collecting chamber 4012 comprises one end open, and the other end has several liquid through-hole, is separately installed with corresponding O-ring seal 403,403-1,403-2 etc. at these liquid through-holes.Similar being described in U.S. Patent application 2005/0180882A1 with other concrete structures of this device has concrete description.

In specific embodiment, catch pad can also comprise with analyte incoherent specific binding molecule to a kind of molecule M1, this molecule is connected with the molecule Y1 of specific bond analyte or combines.Catch the upstream that pad can be positioned at sample pad on reagent strip.More specifically, catch the upstream that pad is positioned at sample pad 201 exactly, sample pad is positioned at the upstream of label pad 202, and label pad is positioned at the upstream of detecting pad; Surveyed area on detecting pad is fixed with the another kind of molecule Y2 of specific bond analyte, label pad comprises mark substance L and with the incoherent specific binding molecule of analyte to another kind of molecule M2 (Fig. 5 A).In time reacting, if containing analyte A in sample, then analyte A and the specific binding molecule Y1 caught on pad carries out combination and forms compound substance A-Y1-M1; When this compound substance is arrived in label pad by sample pad, just form new compound substance A-Y1-M1-M2-L; When new compound substance flows through on detecting pad time, be fixed on the compound substance that specific binding molecule Y2 specific bond on surveyed area is new, thus on surveyed area, occur that color represents positive findings (Fig. 5 B).

In another specific embodiment, catch pad can also comprise with analyte incoherent specific binding molecule to a kind of molecule M1, this molecule is connected with the molecule Y1 of specific bond analyte or combines, the surveyed area of detecting pad is fixed with analyte incoherent specific binding molecule to another kind of molecule M2, label pad comprises mark substance L and the another kind of molecule Y1 (Fig. 6 A) with specific bond analyte.In time reacting, if containing analyte A in sample, then analyte A and the specific binding molecule Y1 caught on pad carries out specific bond and forms compound substance A-Y1-M1; When this compound substance is arrived in label pad by sample pad, just form new compound substance M1-Y1-A-Y2-L; When new compound substance flows through on detecting pad time, be fixed on surveyed area with the incoherent specific binding molecule of analyte to the new compound substance of another kind of molecule M2 specific bond, form M2-M1-Y1-A-Y2-L, thus on surveyed area, occur that color represents positive findings (Fig. 6 B).

In another specific embodiment, based on competition law, catch pad comprises with analyte incoherent specific binding molecule to a kind of molecule M1, this molecule is connected with the molecule Y1 of specific bond analyte or combines, the surveyed area of detecting pad is fixed with analyte incoherent specific binding molecule to another kind of molecule M2, label pad comprises the similar substance A* (Fig. 7 A) of mark substance L and analyte.Catch pad and the reagent concentration in test strips can be different and regulate arbitrarily along with the requirement of detection; Such as in illicit drugs inspection, need to allow when the concentration of certain drugs is greater than the concentration C pre-set in sample, allow and do not occur that colored line represents positive findings on surveyed area, when being less than concentration C, surveyed area occurs colored line represents negative findings.

In time reacting, if containing analyte A in sample, and when being greater than the concentration C pre-set, then catch specific binding molecule Y1 on pad almost completely and analyte A carry out specific bond and form compound substance A-Y1-M1, now also may exist and remain excessive analyte A; When this compound substance is arrived in label pad by sample pad, owing to catching reagent Y1-M1 on pad by complete reaction, the reagent A *-L in label pad just not can be incorporated on Y1-M1; When this compound substance A-Y1-M1 flows through on detecting pad time, be fixed on surveyed area with the incoherent specific binding molecule of analyte to another kind of this compound substance of molecule M2 specific bond, form M2-M1-Y1-A, thus on surveyed area, do not occur that color represents positive findings (Fig. 7 B).

On the contrary, if containing analyte A in sample, and when being less than the concentration C pre-set, then catching specific binding molecule Y1 on pad just the carrying out specific bond with analyte A and form compound substance A-Y1-M1 of part, now also may there is the Y1-M1 that residue is excessive; When this compound substance is arrived in label pad by sample pad, the reagent A *-L in label pad just and Y1-M1 combine formation M1-Y1-A*-L; When these compound substances A-Y1-M1, M1-Y1-A*-L flow through on detecting pad time, be fixed on surveyed area with the incoherent specific binding molecule of analyte to another kind of this compound substance of molecule M2 specific bond, form M2-M1-Y1-A and M2-Y1-A*-L, thus on surveyed area, occur that color represents negative findings (Fig. 7 B).

The incoherent specific binding molecule of analyte comprises (M1/M2), but be not limited only to this, biotin/affinity element (biotin/avidin), biotin/Streptavidin (biotin/streptavidin), antibody/antigen (antibody/antigen) (not comprising antibody and the analyte itself of anti-analyte), the antibody (rhodamine/anti-rhodamine) of rhodamine/rhodamine, antibody (Mouse IgG/anti-mouse IgG) of mouse IgG/ mouse IgG etc.Analyte A can be antibody or antigen, Y1 and Y2 can be the specific antigen or antibody molecule or antibody fragment that on analyte, different loci is corresponding.Mark substance L includes but are not limited to this, colloid gold particle, latex particle, water-soluble marker's material etc., and mark substance is connected with some special antigens, antibody or other specific binding molecule or the technology that combines is existing known technology.Certainly, can also comprise other chemical reagent that some regulate reaction system conditions in sample application zone, such as phosphoric acid buffer reagent, borate buffer reagent, carbonic acid buffer reagent or other albumen, large molecule etc. carry out optimizing reaction system.These Optimized Measures are all that persons skilled in the art are easily expected in conjunction with the utility model and prior art and implement.

In utilization, the mask body device executed in example can detect low concentration or small-molecule substance in sample, because the molecular weight of some important analytes concentration in the sample very end or analyte is very little, the requirement utilizing traditional pick-up unit often can not to detect or arrive because the analyte concentration in sample is very low on clinical meaning.Device of the present utility model is utilized in advance the agent treated needed and sample reacts to be caught on pad, one be can allow sample and reagent reacting abundant, can not affect the degree of having reacted because liquid will flow in time, another is exactly the reagent that operator does not need to add in addition other again.

But in the detection of reality, the above-mentioned pick-up unit of catching pad of comprising is for some special thickness or the many sample of the low foam of water cut, the saliva sample of such as thickness, still there will be following problem: because the viscosity of sample is higher, water cut is few, or show bubble state, cause sample can not to react fully with the reagent of catching on pad when catching on pad, cause the reagent (molecule of antibody or specific bond) of catching on pad to be combined completely and along with sample flow into downstream test strips on, subsequently in the testing process of test strips, can cause not having the antigen in the antibody of q.s and label pad to combine, cannot develop the color, thus cause false positive (especially for the product that competition law detects).

Address this problem, then need to enable the analyte in sample fully with the reagent of catching on pad (the molecule Y1 of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule M1) combine, one preferred embodiment in, increase by one and catch pad, make to catch pad and comprise 2, and catch pad for 2 not separately to be connected, reagent (Y1 pad processing respectively and has analyte in sample to be combined is caught at two that separate, M1), the total amount of this reagent is identical with the total amount that original is caught pad.Like this, make sample first flow through first and catch pad, after reacting fully with the reagent of catching on pad, then flow through second and catch pad, react again with the reagent on it.Like this, when reagent total amount is identical, the Time and place that analyte and reagent carry out combining all increases, thus make the combination of the two more abundant, therefore, in the testing process of follow-up test strips, avoid the deficiency of the antibody carried because of analyte and the false positive caused that cannot develop the color in detection zone.

In some specific embodiments, first to catch pad 310 identical with original pad 210 shape of catching, and difference is that reagent (Y1, the M1 etc.) amount processed thereon reduces; And first catches pad 310 is still positioned on the first collecting chamber 401 of pick-up unit.Second catches pad 320 is positioned in test strips, more specifically, is positioned in the sample pad 101 of test strips, overlaps, as shown in Figure 4 with sample pad 101 part; Second catches process on pad 320 the reagent (Y1 of another part, M1), sample first flows through second and catches pad 320 and combine with the reagent on it, then flows through sample pad, label pad, detecting pad and adsorptive pads in test strips more successively, completes detection.

In the embodiment that some are concrete, first catches the reagent content that pad 310 and second catches on pad 320 has certain proportioning, in some specific embodiments, second catch reagent on pad (the molecule Y1 of specific bond analyte and and the incoherent specific binding molecule of analyte to a kind of molecule M1) between the 15-50% of reagent total amount.Under this proportioning, the analyte in sample and the combination of reagent more abundant.Another is more in preferred embodiment, second catch reagent on pad (the molecule Y1 of specific bond analyte and and the incoherent specific binding molecule of analyte to a kind of molecule M1) between the 20-35% of reagent total amount.

In a specific embodiment, the conveniently production of test strips, second catches pad can be directly identical with sample pad, is the prolongation of sample pad.After the part process extended has Y1 and M1, be namely equivalent to the function that second catches pad, play the effect that second catches pad.

The material of catching pad can be selected from and catch mat material matter is dacron film, glass fibre membrane and can the filter paper etc. of stream material.First catches pad can be identical with the second material of catching pad, also can be different.One preferred embodiment in, first to catch mat material matter be dacron film; Second to catch mat material matter be glass fibre membrane.

Below with collection saliva detect in saliva whether exist drugs for example describe in detail how to use pick-up unit of the present utility model and detect box.As shown in Figure 8, it is the collection phase before detecting, it is inner that first collecting chamber 4011 is positioned at the second collecting chamber 4012, and second liquid through-hole on collecting chamber be not import through hole 406-1 with the sample on sample ingress area 406 to communicate, but sealed by the baseplane of sample ingress area 406, in order to increase the sealing of the baseplane of collecting chamber 401 and sample ingress area 306, the liquid through-hole correspondence position in the bottom of the second collecting chamber 4012 can be installed by O-ring seal.First the saliva that will detect is collected, first collect the saliva sample needing to detect with sample collection device 500, collection 502 is put in the mouth of detected person, and 502 are made up of absorbent material, such as sponge material, so this collection head can absorb the saliva sample needing to detect.Then the collection of saliva sample 502 there is is to put in the first collecting chamber 4011 in collecting chamber 401 suction, extrude collect 502 by rotating the handle 501 of gathering-device, at this time the saliva sample collected on head is just extruded in the first collecting chamber 4011, and is flow in two collecting chambers 4012 by liquid through-hole.In this process, because first in the first collecting chamber 4011 catches pad 310 to extend to the second collecting chamber 4012 bottom by liquid through-hole, while extruding sample, saliva sample just fully reacts with the first reagent of catching on pad 310, after by the time reacting suitable time, as 10,20 or 30 seconds, 1, after 2,3,4,5,6,7,8,9,10,15,20,30,45,60 minutes, rotate collecting chamber 401, allow the liquid on the liquid through-hole of the second collecting chamber and liquid ingress area import through hole communicate, liquid through-hole and liquid import through hole and communicate.This time, saliva sample just imports through hole by liquid and flows on reagent strip, first liquid arrive second of test strips upstream extremity and catch pad place, liquid sample continues to be combined fully with the second reagent of catching on pad, then, liquid flow in sample pad again, flow further downstream successively, arrive label pad and detecting pad, finally arrive adsorptive pads, carry out detection reaction, if there are a certain amount of drugs in saliva, the surveyed area of reagent strip not occurring, colored line represents positive findings, just occur that colored line represents negative findings on the contrary, this testing result on surveyed area can by reading window 4041 observations on body, reading on window 4041 can be that transparent material covering surveyed area also can directly allow surveyed area outside exposed.Saliva sample can also import through hole by liquid and enter and confirm chamber 407, detects saliva sample in order to further confirm.Confirm that chamber 407 is surrounded by the sidewall of base 4071 and surrounding, entering the liquid confirming chamber can take out by deriving through hole 4073, derives through hole 4073 and is sealed by a stopper 4072 before sampling.When thinking that testing result needs further by other means, such as, time, gas chromatography with liquid phase look general or other more accurate instruments confirm testing result, remove stopper 4073, take out part saliva sample to detect (as Fig. 8 and 9) from confirmation chamber 407.Here being only describe how to use pick-up unit of the present utility model with saliva sample in detail as an example, except saliva, can also be other liquid samples, such as blood, urine, sweat, ight soil etc.

Embodiment

In order to how clearer elaboration the utility model realizes, be described with limited experiment now, these explanations only do limited citing under the marrow of claim of the present utility model, do not form the restriction to the utility model claim.

Experiment: the pick-up unit before and after improving with the utility model detects in saliva whether there is certain density anxiolytic and hypnotic sedative agent (BZO).

Part I: the assembling of reagent strip of the present utility model and pick-up unit and parts make (have first and second and catch pad)

Reagent strip 100 is as shown in Figure 3 used for illustrating parts and the method for making of this experiment reagent strip of the present utility model used.

The process of nitrocellulose filter.Detecting pad 103 is nitrocellulose filter (NC), and nitrocellulose filter has two lines, and one is detection line 132, is positioned at the testing result control line 133 in detection line downstream.Detection line is fixedly connected with the Streptavidin (streptavidin-IgG) of IgG; Fixing foster anti-rabbit IgG on testing result control line.Fixing method can process automatically with spray film handling machine automatically, and the concentration wherein detecting lines in process is 1.0 mg/ml, and dilution buffer liquid is phosphate buffer (PBS); Testing result control line fixes goat anti-rabbit igg antibody; Concentration is 1.0 mg/ml, and dilution buffer liquid is phosphate buffer (PBS).The nitrocellulose filter handled well is placed in 37 DEG C of baking ovens and dries.

The process of label pad 102.Marker slip is polymer PET, and what marked by colloid gold particle divides the BZO haptens of BSA to be processed on polymer PET with coupled protein.The OD value of Treatment Solution is 57, and dilute solution is 1 times of PBS buffer solution, wherein also contains the BSA of 1%.On marker slip, also process has the rabbit igg antibody of colloid gold label.The marker slip handled well is placed in 37 DEG C of baking ovens and dries.

The process of sample pad 101.Sample blank film is glass fibre element film, and the solution that this film processes is: Borax (0.07M/L); Tween20 (1%); Cholic Acid (1%); Tris (0.1M).The sample blank film handled well is placed in 37 DEG C of baking ovens and dries.

First process of catching pad 310.Catch pad and comprise the paste-side 3101 of unwetted and absorptive reagent end 3102.The material of reagent end is polyester film, and the chemical solution of reagent end process comprises: the anti-BZO antibody materials connecting upper biotin (Biotin) is dissolved in 1 times of PBS buffer solution, makes ultimate density be 1.0 mg/ml; Wherein also contain the BSA of 1%, make the first anti-BZO antibody materials content of catching on pad handled well be 0.0025 milligram.The pad of catching handled well is placed in 37 DEG C of baking ovens and is dried.Then the polymer PET small pieces (3102) containing reagent to be pasted onto on the small pieces of unwetted on (3101).

Second process of catching pad 320.A part second is caught pad and is processed chemical solution whole catching on pad: the anti-BZO antibody materials connecting upper biotin (Biotin) is dissolved in 1 times of PBS buffer solution, makes ultimate density be 0.2 mg/ml; Wherein also contain the BSA of 1%; The the second anti-BZO antibody materials content of catching on pad handled well is made to be 0.0005 milligram.Another part second catches pad, and be sprayed on by the anti-BZO antibody materials of 0.2 mg/ml in a mode of spray second catches pad apart from the position of the linear series at a port 2mm place.Catch pad to be placed in 37 DEG C of baking ovens to dry all second.

The content ratio finally making the anti-BZO antibody materials content and second in the first sample pad catch on pad is about 5:1.

The assembling of reagent strip 300.The all parts handled well according to the appearance assembling shown in Fig. 4, allow second to catch upstream that pad (two kinds) is positioned at sample pad, allow sample pad be positioned at the upstream of label pad, label pad, between detecting pad and sample pad, places the filter paper 104 of water suction in the downstream of detecting pad.These parts are all placed on the support chip 105 of a unwetted.

The assembling of pick-up unit.Pick-up unit as Fig. 8, shown in 9.The paste-side 3101 that first catches pad is pasted onto on the surface of the vertical bar beam on the first collecting chamber 4011, the other end 3102 passes liquid through-hole and arrives the bottom of the second collecting chamber 4012.Then whole collecting chamber 401 is arranged in the snap ring of sample Lead-In Area 406 of body 404, and allows the bottom of the second collecting chamber 4012 be in be imported into the position of basal surface sealing (Fig. 8) in region.Be placed between upper plate 4043 and lower plate 4045 with the reagent strip 300 of catching pad, make the surveyed area of reagent strip 100 corresponding with reading window 4041, it is corresponding that sample application zone and liquid import through hole 306-1.It is an entirety that upper plate and lower plate fasten.So just be assembled into this and test pick-up unit used.

Part II: the assembling of control stripes bar 100 and pick-up unit 400 and making (have and catch pad).

Compare with pick-up unit with reagent strip recited above, contrast agents bar and pick-up unit are identical substantially with it.With it unlike, install on detection means for catching pad, simultaneously in test strips, do not have second and catch pad.Wherein, the process of pad 210 is caught.The chemical solution of catching the reagent end process of pad comprises: the anti-BZO antibody materials connecting upper biotin (Biotin) is dissolved in 1 times of PBS buffer solution, makes ultimate density be 1.0 mg/ml; Wherein also contain the BSA of 1%, make the anti-BZO antibody materials content of catching on pad handled well be about 0.003 milligram.

Testing result record all reads after 10 minutes adding saliva sample.Usually, in setting saliva sample, the concentration of BZO is 10ng/ml (nanograms/milliliter) is detection threshold.The meaning of detection threshold just refers to if the concentration of the analyte BZO in sample is greater than detection threshold, and in theory, testing result should be positive, otherwise if the concentration of analyte BZO is less than detection threshold, testing result is negative.

Method of operating:

The bottom first allowing each pick-up unit be in the second collecting chamber 4012 of collecting chamber 401 is imported into the state that region 406 is closed.

Then add the sample that will detect, allow and to catch reagent reacting on pad (first catches pad) in sample and collecting chamber 401 1 minute;

Rotating collection chamber 401, allows saliva fluid from collecting chamber, flow to the sample application zone of reagent strip and complete reaction;

The actual result of detection is recorded after 10 minutes.

Illustrate:

Control is the pick-up unit before improving; Lot1, for improving rear device, wherein second catches pad bulk treatment reagent; Lot2, for improving rear device, wherein second catches pad linear process reagent

1. utilize standard solution to compare the detection sensitivity of pick-up unit before and after improving.The concentration arranging BZO in master sample is respectively 0ng/ml (negative sample); 30ng/ml, utilizes each device to detect.

Analyze:

Pick-up unit after improvement ratio in detection sensitivity is higher before improving.

2. the detection of pair negative sample: the saliva sample gathering our company employee detects

Analyze:

False positive sample before improvement, after utilizing the pick-up unit after improving to detect, eliminates completely.Therefore, the pick-up unit after this improvement can avoid the false-positive existence detected, and improves the accuracy rate detected.

3. the detection of pair positive sample:

Gather multiple negative saliva sample, in these salivas, add the BZO (seeing attached list) of various concentration respectively, detect respectively

Analyze:

From upper table, the pick-up unit after improvement with improvement before compared with, detect positive sample time, without any change.Therefore, the pick-up unit after improvement detect positive sample time without any impact.

Comprehensive above interpretation:

1. the pick-up unit after improving increases compared with before-improvement in detection sensitivity;

2. the pick-up unit after improving effectively can avoid the false positive issue of negative sample, improves the accuracy rate detected;

3. improve after pick-up unit detect positive sample time with improve before identical, do not affect positive sample detection accuracy.

Claims (13)

1. detect a device for sample, comprise, test strips, test strips comprises sample pad, label pad and detecting pad, and label pad is positioned at the downstream of sample pad, and detecting pad is positioned at the downstream of label pad; It is characterized in that, the device of this detection sample also comprises catches pad, described catch pay somebody's debt and expect repayment later comprise with analyte incoherent specific binding molecule to a kind of molecule and and the incoherent specific binding molecule of analyte to a kind of molecule, this is caught pad and is positioned at the upstream of test strips and leads to test strips liquid phase flow; This is caught pad and is connected with test strips or does not connect.

2. the device of detection sample according to claim 1, is characterized in that, this is caught pad and comprises first and catch pad and second catch pad; Second catch the specific bond analyte on pad molecule and with the incoherent specific binding molecule of analyte to a kind of content of molecule be first and second catch the 15%-50% padding total amount.

3. the device of detection sample according to claim 2, is characterized in that, first catches pad is positioned at second and catches pad upstream, and the two is not connected, but liquid communication.

4. the device of detection sample according to claim 3, is characterized in that, second catches the upstream that pad is positioned at test strips, the two liquid communication.

5. the device of detection sample according to claim 4, is characterized in that, second catches the upstream that pad is positioned at the sample pad of test strips, and is connected with sample pad.

6. the device of detection sample according to claim 5, is characterized in that, second catches the prolongation of pad for sample pad.

7. the device of detection sample according to claim 6, is characterized in that, catching mat material matter is dacron film or glass fibre membrane.

8. the device of detection sample according to claim 7, is characterized in that, first to catch mat material matter be dacron film; Second to catch mat material matter be glass fibre membrane.

9. the device of detection sample according to claim 8, is characterized in that, the molecule of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule be processed at whole first and catch and pad and second to catch on pad.

10. the device of detection sample according to claim 8, is characterized in that, the molecule of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule be processed at whole first and catch on pad; The molecule of specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule be processed at second in linearly aligned mode and catch on a line of pad.

11. 1 kinds of kits detecting sample, comprising: detect the device of sample and collect the device of sample, wherein, the device detecting sample comprises reagent strip, described test strips comprises sample pad, label pad and detecting pad, and label pad is positioned at the downstream of sample pad, and detecting pad is positioned at the downstream of label pad; Wherein, collecting that the device of sample comprises can the collection head of absorbing fluid sample; It is characterized in that, also comprise in the device of described detection sample and catch pad, catch pad and be positioned at the upstream of test strips and lead to test strips liquid phase flow; This is caught pad and can be connected with test strips or not connect.

12. kits as claimed in claim 11, is characterized in that, catch pad and comprise first and catch pad and second catch pad; First catch pad be positioned at second catch pad upstream, the two be not connected but liquid phase flow lead to; Second catches the upstream that pad is positioned at the sample pad of test strips, and the two is connected and fluid-phase is communicated with; First catch pad and second catch the molecule that pad comprises specific bond analyte and with the incoherent specific binding molecule of analyte to a kind of molecule.

13. kits as claimed in claim 12, it is characterized in that, second catch the specific bond analyte on pad molecule and with the incoherent specific binding molecule of analyte to a kind of content of molecule be first and second catch the 15%-50% padding total amount.