CN1178325A - Test kits and devices - Google Patents
Test kits and devices Download PDFInfo
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- CN1178325A CN1178325A CN 97104530 CN97104530A CN1178325A CN 1178325 A CN1178325 A CN 1178325A CN 97104530 CN97104530 CN 97104530 CN 97104530 A CN97104530 A CN 97104530A CN 1178325 A CN1178325 A CN 1178325A
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Abstract
A test kit for determining qualitatively or quantitatively the presence of one or more analytes in a fluid sample, comprises an assay device together with a reading device which engages with the assay device and wherein precisely located engagement of the assay device with the reading device is essential for accurate reading of the assay result, wherein precisely located engagement of the assay device with the reading device causes a 'lock-and-key' interaction, ie. a unique 3-dimensional interaction, between the assay device and reading initiation means of the reading device. The invention also extends to any assay device possessing physical features that enable it to engage cooperatively with a reading device in a 'lock-and-key' manner as described herein.
Description
The present invention relates to be used for qualitative or determine the Test Equipment bag and the device of the existence of one or more analytes in the fluid sample quantitatively, more particularly, relate to the assay device of the major part of being convenient to constitute described Test Equipment bag and the correct interactional device between the readout device.
In our PCT patented claim WO 95/13531, we have described the readout device of the assay device that utilizes test strip.Usually, assay device has elongated shell, and this shell comprises test strip and one or more " window " arranged in this shell, can observe the result of laboratory test zone or the section of described test strip by these windows.Described readout device preferably includes the holding portion of fluting, described assay device can be inserted this holding portion, and, wherein, pass the light of test strip by electromagnetic means, especially emission and determine result of laboratory test.In order accurately to determine result of laboratory test, must make the surveyed area of test strip be arranged in described readout device, with respect to described light path or form the correct position of other device of synthetic read-out system.WO 95/13531 has described various being convenient to described assay device correctly has been contained in method in the readout device.
The fundamental purpose of these Test Equipment bags is: they for the personnel that do not live through training, especially should be useful at home user.A kind of need carry out any device of physical engagement to one of them unit and another unit the time when requiring domestic consumer to use, what make us feeling surprised is, its way is mistake normally.May have been misread by the careful and graphic explanation of word that manufacturer provides, perhaps, usually fully out in the cold.Requiring to read exactly under the present case of responsive result of laboratory test, realizing placing assay device readout device to be absolutely necessary exactly.Any misalignment of these two devices or incorrect cooperation all can cause inaccurate or misleading chemical examination reading.Do not comprise when being used for carefully checking assay device with any device of the suitable part determining to read at read-out system, this problem is especially serious.If control the exact position of surveyed area in the assay device during manufacture, and assay device is added on the readout device, makes surveyed area always be in the identical position with respect to described read-out system in constant mode, so, can reduce the cost and the complicacy of read-out system significantly.The purpose of this invention is to provide a kind of Test Equipment bag, wherein can reduce the possibility of makeing mistakes when the user is added on the readout device significantly to assay device.Relevant purpose provides a kind of Test Equipment bag, wherein, unless assay device is added on the readout device really otherwise does not begin to read described assay device, perhaps, wherein reminds the user that described assay device correctly is not added on the readout device.In WO 95/13531, we have described some and have been convenient to the frame mode of accurate set, and the present invention will provide further improvement.
Below with reference to useful when monitoring the body fluid analyte, especially monitor that in family useful Test Equipment bag describes the present invention to the urinalysis thing relevant with the state of definite human body onset of ovulation.This is as just example, and obviously, the present invention is useful comprising under many other situations of other sample liquids and analyte.In the needs occasion that is suitable for of result of laboratory test and Test Equipment bag of the present invention accurately, the example of the analysis of other type comprises: to the chemical examination of cancer sign, heart disease sign, blood sugar, forbidden drug, hormone, infectious disease sign; Mensuration to the medicine supervision; Make and raw material quality control; And to the mensuration of waste water and gas and pollution level.
The invention provides and be used for qualitative or determine the Test Equipment bag of the existence of one or more analytes in the fluid sample quantitatively, this Test Equipment bag comprises assay device and the readout device that engages with this assay device, wherein, the joint of accurately determining the position of assay device and readout device is absolutely necessary for reading result of laboratory test exactly, and, wherein, the correct joint of assay device and readout device causes " key " between the starting device of assay device and readout device to interact.
In this manual, our usefulness " key " interactional saying is represented the unique three-dimensional relationship between assay device and the readout device.Here in the most preferred embodiment of the present invention of set forth in detail, this produces three shaft alignements of passing through of described two devices.The single shaft that this three alignings are converted into the switchgear of reading that is used for starting assay device drives.
In one embodiment, assay device has the carrier slip of the porous that mainly is included in the hollow shell or the form of analog, and, wherein, result of laboratory test is by labelled reagent being shown with the surveyed area that special mull technique is bonded in the carrier slip, can distinguishing that by described readout device there is labelled reagent in surveyed area.
Readout device preferably includes: the storing apparatus that is used for holding assay device; And read starting device, in a single day it comprises transportable switch starting device or similar device when being contained in the described storing apparatus to assay device, wherein, the contact portion that correct the holding of described assay device causes described shell contacts with described movable switch starting part, described contact portion and described removable switch starting device can engage jointly by means of " key " engages, only make that when correctly holding assay device, described switch starting device can be moved and begin reading.
As used herein, term " switch starting device " is used for providing any device read that makes circuit electric or electronics connect or disconnect or alternately switch on and off so that realize directly or indirectly or influence assay device.Usually, this will be a kind of mechanical mechanism.Described starting device can be the part of actual switch or directly, for example be connected to actual switch or also can be the connection of indirect or remote control in the mode of physics.Important consideration is: the joint accurately of assay device and readout device influences the switch starting device uniquely, and, therefore realize needed electric and variation electronics.
Usually, the switch starting device comprises movably projection of projection that at least one is fixing and at least one, and the contact portion of described assay device shell comprises the recess that is processed into such shape, make this recess hold the fixing projection of switch starting device but do not hold its movably projection, described contact portion also comprises the interface section, when described fixing projection is accommodated in the described recess, the moveable part of this interface section contact and mobile described switch starting device.
Described storing apparatus preferably is equipped with the assay device that is held is pressed in bias gear on the described switch starting device.
In another most preferred embodiment, storing apparatus is equipped with cam gear, unless assay device is correctly held, otherwise described cam gear makes assay device depart from described switchgear.In theory, when assay device was correctly held, described cam gear provided " buckle (snap) " of assay device and storing apparatus to engage.
Feature as a supplement, assay device is preferably elongated, and storing apparatus comprises at least pack into wherein the line of rabbet joint of the part of elongated assay device, and the described line of rabbet joint has at least one flange portion that stretches in the outlet of this line of rabbet joint, when assay device correctly was contained in the line of rabbet joint, described flange portion play a part assay device is clamped in this line of rabbet joint.Best mode is, described flange portion is positioned at an end of the line of rabbet joint, and, when assay device inserts storing apparatus, can with the end engagement of elongated assay device.Be preferably in the other end of the line of rabbet joint or also be used in addition near it assay device is clamped in second flange portion in the line of rabbet joint.
The present invention also is generalized to any assay device with aforesaid physical features, and described physical features can mesh this assay device jointly with the mode and the readout device of " key ".
Fig. 1 to 10 below with reference to the accompanying drawings describes specific embodiment of the present invention in detail.These accompanying drawings only are used for reaching general illustrational purpose, rather than are used for calibrating.The reader of this instructions should also be noted that the technology contents of WO 95/13531.The present invention is and guarantees that the accurate aligning between assay device and the readout device is relevant.The mode that described assay device is used for producing readable chemical examination signal is not crucial, and described readout device is used for reading and explain sort signal and provides to the user that the mechanism of information neither be crucial.In WO95/13531, stated the example aspect all these.
Fig. 1 is the general view of readout device of the present invention, and the lid of opening has been showed this device and subscriber-related critical piece.
Fig. 2 is the plan view of the part of the device seen in Fig. 1, at length shows the line of rabbet joint that is used for holding assay device.
Fig. 3 is that it shows the rear wall of the described line of rabbet joint along the part sectioned view of the readout device of the longitudinal axis intercepting of the described line of rabbet joint.
Fig. 4 be also along the intercepting of the longitudinal axis of the described line of rabbet joint, but the part sectioned view of the readout device of observing from opposite direction, it shows the wall on the opposite of the described line of rabbet joint.
Fig. 5 is the partial elevation view of seeing into along the described line of rabbet joint from right hand end.
Fig. 6 is the user to be suitable for it is inserted the general view of the assay device that the orientation in the readout device holds.
Fig. 7 is the general view of a relative side of assay device.
Fig. 8 is from the readout device that observe previously, when inserting of readout device and the partial cross sectional views of assay device.
Fig. 9 is correctly inserted the partly cut-away of this line of rabbet joint under the situation in the line of rabbet joint and the plan view of partial cut-out at assay device.
Figure 10 is the planimetric map of amplification of partly cut-away of the switch starting mechanism of readout device.
With reference to figure 1, readout device comprises general flat elliptical shell 100 and is hinged on the top cover 101 at the rear portion of described housing.Lid each side 103 of 101 curves inwardly and sharp near described hinge, and the entire upper surface of housing 100 is 104 recessed, make when described lid closure, described readout device has concordant outside surface.In this respect, the shape of described lid and housing and ratio are aesthetic thing purely, do not have pipe with the present invention.Technical, described device there is no need any lid fully.The end face 104 of the described device that is represented by the lid of opening has towards its right side 106 groove 105.Groove 105 has the back that the certain operations parts are housed 107 of inclination inwards, and these parts are important to the user.These functional units and the present invention do not have direct relation, and still, as shown in fig. 1, these parts can comprise button 108, two pilot lamp 109 and 110 and be used for the small display panel 111 of the information of transmitting to the user.Groove 105 has flat underside 112.The left end 113 of groove 105 has the face 114 of inclination inwards, holds the left side 116 of the line of rabbet joint 115 described device of mind-set from dip plane 114 and flatly extends.The line of rabbet joint 115 almost extends to the left side of described device, and terminates in below the little dome shaped cover 117 of the upper surface that is molded to described device.Among Fig. 1, can see the rear wall 118 of the line of rabbet joint 115 and when assay device inserts the described line of rabbet joint, start the switch starting mechanism 119 of reading of assay device (not shown) and the square shell 120 of read-out system (being hidden in the readout device) so that obtain from the information of inserting assay device.Below with reference to Fig. 3,9 and 10 switch 119 is described in more detail.The flat underside 112 of described groove extends in the described line of rabbet joint.On the right side of groove 105, directly the flange 123 facing to the end 122 of the described line of rabbet joint, described device extends, forms the direct summit 124 consistent with the longitudinal axis of the described line of rabbet joint inwards with the form of middle convex bending.Inside surface at lid 101 has little groove 125, is used for being contained in when described lid is closed the vault 117 of the end of the described line of rabbet joint.Other characteristics of the described groove that can see among Fig. 1 are: on its most of length, its sidewall is parallel basically, still, when it when the described vault, its left field 126 is tapered inwards.At the other end of the described line of rabbet joint, promptly, openend 122, the flange 127 that extends is forward arranged on the coboundary 128 of rear wall 118.Because in zone 129 and 130, described antetheca and described rear wall outwards form stepped respectively, so the described line of rabbet joint has breadth extreme at its openend.
With reference to figure 2, can be clear that these identical characteristics of the line of rabbet joint 115 more.Other characteristics that can see among Fig. 2 are: the rectangular cover 120 that is used for described read-out system is outwards protruded and is had a sharp edge 200 of splaying from the rear wall 118 of the line of rabbet joint 115.At the antetheca 126 of the described line of rabbet joint, the spring load button 201 and 202 of two protrusions is arranged, one of them (201) directly in the face of starting switch 119 and another (202) the outlet 122 of the described line of rabbet joint near, facing to flange 127 from rear wall 118 extensions.Second button 202 has the bevel 203 of the outlet of the contiguous described line of rabbet joint.
Fig. 3 shows the rear wall 118 of the line of rabbet joint 115.Switch-starter 119 is divided into three parts.Its global shape is round, and still, it comprises the diagonal angle core 300 of the whole width of crossing over this trigger, and two arch sections 301 and 302, lays respectively at each side of described diagonal angle core.Described arch section fixes, and diagonal angle, described center part is can press inwards so that start the read operation of described device.Fig. 3 also illustrates the zone 303 of the flat underside 131 of the described line of rabbet joint, and its is close to vault 117 and is inclined upwardly sharp and end wall 304 junctions of the described line of rabbet joint below described vault.
What Fig. 4 showed the line of rabbet joint 115 comprises two spring-loaded buttons 201 and 202 relative wall 126.The button 202 of the outlet 122 of the contiguous described line of rabbet joint has asymmetric shape, and splayed downwards in its top, and its left surface 203 (as seeing in Fig. 4) is also splayed.Between described two buttons is the groove 401 of rectangle, is system's (cannot see) of the part of the described chemical examination sense station of illustrative formation in the back of this groove.Groove 401 is arranged in the relative wall of the described line of rabbet joint, directly in the face of the position of the cover 120 of the protrusion of read-out system.Below vault 117, can see once more the described line of rabbet joint flat underside 131 acclivitous regional 303.
As shown in Figure 5, can see that along the line of rabbet joint 115 observations the downside 500 of flange has protruding curved surface.Other parts of seeing among Fig. 5 have: the button of being splayed 202; The read-out system cover 120 that protrudes; Vault 117 at the far-end of the described line of rabbet joint; And below described vault acclivitous base plate 303.
Fig. 6 shows the assay device that comprises elongated housing 600 and dismountable cover 601.Compare with main part 603, the left part 602 (as seen in Figure 6) of housing 600 has narrow xsect, and attenuates sharp in its left distal end 604.This attenuating results from:
A) splayed towards the left part in the front 605 of described device; And
B) lower surface 606 is inclined upwardly sharp at the place, left part.
In the front 605 of the narrow part 602 of described housing rectangular window 607 is arranged, the side 608 of the inclination of this window puts in described housing rolled-up stock.This window shows the test strip 609 in the described device, and as shown in FIG., this comprises two result of laboratory test districts 610 and 611.
With reference to figure 7, this figure shows an opposite side of described assay device, and the opposing face 700 of the narrow part 602 of described housing also comprises the rectangle window 701 of recessed housing.With see by another window the same, this window also shows test strip 609 and identical detection zone 610 and 611.At the groove 703 and 704 that a pair of arc that is separated by diagonal angle part 705 is arranged on this same of described device, between window 701 and terminal 702, described diagonal angle part 705 flushes with described device remainder herein.
Fig. 8 shows the assay device 600 that is inserted in the readout device.The end 702 of assay device housing be placed in vault 117 below, and greatly about the mid point of the narrow part 602 of this housing, this housing contact and rest on the upper part of button 201 is not though see button 201 in the figure.This is a stable position, need be by light downwards housing 603 and/or the cover 601 of pressing described device of user, overcome owing to this action the resistance that can mobile button 201 be produced and enter the state of horizontal alignment more in the described line of rabbet joint so that this device pushed.This figure also shows when correctly being inserted in the readout device for reading accurately with dot-and-dash line, the position that described assay device must occupy.The described assay device of this correct status requirement is in complete horizontal state (with respect to the base plate of described readout device), and terminal 702 far-ends 800 that are included into the following and described cover of vault 117 fully abut against the turning-in part 124 on the right side of readout device.Can also see, the end 702 of assay device be inclined upwardly part 606 below described vault, the acclivity 303 of the base plate of the described line of rabbet joint is consistent.When assay device was correctly inserted the line of rabbet joint, the wide part 603 of described housing was clamped in below the flange 127 of rear wall 118 of the line of rabbet joint closely.
With reference to figure 9, correctly the assay device of Cha Ruing is locked in the appropriate position by the combination of parts.Assay device is pushed with strength to the rear wall 118 of the line of rabbet joint from the pressure of two buttons 201 and 202.The cover 120 of the protrusion of read-out system is allocated in the window groove 701 of assay device housing exactly.The fixing arch section 301 and 302 of switch-starter is allocated in the arc groove 703 and 704 of assay device housing exactly, and, diagonal angle, the center part 300 of the described switch of diagonal angle housing parts 705 extruding between described two grooves.The part 300 of described switch-starter push the reading that causes assay device by the mechanism of describing below with reference to Figure 10.The three-dimensional state that the purpose of this invention is to provide a kind of uniqueness, the assay device that is received is the starting switch trigger in this state.The position of representing vault 117 and flange 127 with dot-and-dash line.The wide part 603 of the housing of assay device is accommodated in the outlet of outside enlarging of the described line of rabbet joint.
Other parts that show among Fig. 9 are: the illuminator 900 that is in light diffuser 901 back in the antetheca 126 of the described line of rabbet joint; And the one group of optical sensor 902 that on the rear wall 118 of the described line of rabbet joint, is in cover 120 back.Because these parts are not crucial for the present invention, therefore, only they are carried out simple explanation with graphic method.The suitable example of these parts has been described in WO 95/13531.
The parts of seeing in the part sectioned view of described assay device are: the test strip 609 of being clamped in each side by transparent plastic tab 903 and 904; Two detection zones 610 in the described test strip and 611; And the pin in the assay device stampings 905, it passes described test strip and topped thin slice, so that during the manufacturing of this device, for two detection zones provide the accurate in locating device.
Figure 10 shows the switch starting mechanism of readout device in greater detail.The switch 1000 that is connected to the reality of electronic processors in the readout device itself is in the inside of device, and the housing 100 among the previous figure only can be seen in by local Fig. 9 that cuts away.The unit 119 of the reality that can see at the back side of the line of rabbet joint is a kind of independently physical construction, it contacts and operate this switch with switch 1000 when using.As depicted in figure 10, switch 1000 is positioned on the printed circuit board (PCB) 1001.Two switch contacts 1002 and 1003 are arranged at the back side of this printed circuit board (PCB).
Be arranged in the rear wall of the line of rabbet joint with the described physical construction of the proving installation interaction of correctly inserting.Just as has been described, described mechanism comprises: two external fixation parts 301 and 302; And center section 300 movably, this part moves when described proving installation is correctly inserted inwards.As depicted in figure 10, the moveable part 300 of described starter mechanism comprises tubular shaft 1004, and this tubular shaft is placed between two fixed parts of described mechanism, and constitutes the bearing that is free to slide between 301 and 302.Tapped through hole 1005 is along axially passing whole tubular shaft and meshing with the screw rod 1006 that is fixed in this.Described tubular shaft extends to outside the inside surface 1007 of line of rabbet joint wall, and stops with the form of flange 1008.The width of the flange section of described tubular shaft surpasses the width of channel between two fixed parts of described mechanism, and described two fixed parts comprise the main body of described bump.Have slit 1009 between the wall of the described flange and the described line of rabbet joint, and in this slit coil spring 1010 is arranged, each end of this spring nestles up the surface of described flange and described inwall.The position that spring 1010 plays to setover slightly described axle makes the end 1011 of when described mechanism is in as shown in Figure 10 equilibrium position described screw rod against described switch.The power of spring 1010 is less than the needed power of the described switch of starting.Screw rod 1006 extends to outside the flange 1008.
When making readout device, regulating spring 1006 like this, make when generation contacts in the described switch, the outer surface of central shaft 300 is the position of A in the distance of the end that leaves fixed part 301 and 302.Can control this adjusting in the manufacture process by the contact of measuring described switch.
When as Fig. 8 illustrated, inserting assay device in the readout device according to the mode of suggestion, " toe " of assay device place vault 117 below, and the light downwards assay device of pressing, the fulcrum rotation that assay device is centered on set up by the flange of described vault and " quickly " enter the described line of rabbet joint by the various parts from two walls protrusion inner chamber.The cover 120 that protrudes, also have the described fixed part of starting switch and the flange 127 of protrusion on lesser extent, they play action of cam, force the housing of described device to leave described rear wall and against described two buttons.When assay device is rotated down, and, when the cover of described protrusion and the fixed part of starting switch begin with their suitable engagement in the assay device housing, by the pressure that described button produces assay device is pressed to the rear wall of the described line of rabbet joint, and make it " once " enter position below the described flange.The curvature of described flange downside is convenient to this last motion that assay device enters its suitable read-out position.If as at present general in mass-produced diagnostic device, use such as the described assay device of the plastic mould pressing of polystyrene, so, it can have the enough flexibilities that can be out of shape and be convenient to described motion.Really, can utilize the natural elasticity of assay device rolled-up stock therefrom to acquire benefit, because, when correctly inserting in the readout device assay device, described distortion and subsequently loosen " " the engagement once that can strengthen between these two Test Equipment bag parts.Thereby the edge that can make contact point on the edge of assay device rolled-up stock and the readout device becomes the edge to help slip between these two parts, and avoids occurring this two situations that parts are crowded together.
For the user, following way also is possible: by the end of assay device being placed the openend of the described line of rabbet joint, flatly advance described device then, enter fully in the described line of rabbet joint, thereby assay device is inserted in the line of rabbet joint, reaches its correct read-out position until it.When this alternative step finishes, will make this maintenance exactly of described chemical examination in position by above-mentioned various interactions again.
If in normal use,, so, can not realize the accurate in locating of described various parts owing to the described assay device of any reason is inserted in the line of rabbet joint improperly.Starting switch will not be depressed.If necessary, auxiliary mensuration mechanism can be installed,, thereby can send the caution signal that the described assay device of expression is not in its tram to the user so that find to occur the assay device of insertion improperly.
Can come the wall described readout device of mold pressing, that comprise the described line of rabbet joint and the housing of base plate with durable plastics such as polystyrene.The most handy more durable material is made each projection of described button and switch starting mechanism, because between the operating period of whole continuity, these parts must be stood the contacting repeatedly with various disposable proving installations.What is called " hard engineering plastics " such as propylene green grass or young crops-butadiene-styrene terpolymer (ABS) is desirable.This material has good dimensional stability, and harder than polystyrene.Described material should have natural bearing performance.The desirable ABS that can buy on the market is " Delrin ".
The shape accurately and the relation that are used to provide above-mentioned each parts of reliable three-dimensional interlocking when assay device is correctly inserted only are for example purposes.Experienced reader will readily appreciate that: can realize the reliable interlocking effect that can compare on the performance with various shapes that substitute and structure.
As a setting and example, the present invention be convenient to simple, provide the result of laboratory test readout device and relevant Sample testing device that can provide quantitative accurately chemical examination information with the cost reasonable manner fast.This device can be used for the far-ranging place such as hospital, clinic, doctor's office and family.According to circumstances, the analyte of being studied also can change in the scope widely.Sample has: infectious disease biology or mark, the metabolite in the body fluid of the variation of expression patient's health or state is perhaps such as the may command or the ingestible material of medicine or forbidden drug.Needed chemical examination standard can be by say that unbred personnel carry out, and especially can carry out at home on meaning relatively.Home-use chemical examination mainly is the physiological change that will check human body, its objective is the health that promotes human body, general kilter or the life style that keeps human body.Become day by day unsoundness consciousness of consumer, and the consumer monitors that he or she bodily fuctions's ability improves just day by day.In some cases, this can the person of boosting consumption the cooperatively interacting of individual and medical circle.
The chemical examination that has many expression Human Physiologies to change can only utilize complicated laboratory technique to carry out at present.For the Useful Information of the human body that relates to test is provided, this chemical examination need produce the result who represents with the Exact Number clause usually, for example the concentration of specific analyte in the body fluid.Therefore, exist a kind of for improved assay system, be particularly useful for testing the demand of the assay system of humoral sample at home, this system combines traditional sample test with digital assay method simple, the rational result of laboratory test of cost.
Described many assay devices in technical literature, wherein suggestion can be read result of laboratory test with optical instrument.Usually suggestion utilizes fluorescent emission or light reflection.Though in the blood sugar test of commercialization, used the light reflection,, these technology major parts are applicable to the laboratory of advanced technology.In WO 95/13531, we have described the read-out system that utilizes by the light transmission of test strip or similar film.
Can provide as single Test Equipment bag described assay device/readout device combination to the user.But, in general, readout device will be user's relatively permanent device that can use repeatedly (and, it can have electronics storage/data processing equipment, it makes might carry out data preparation to the result of many continuous chemical examinations), and described assay device will design for disposable use, will be thrown away after using.Therefore, can with readout device dividually, for example provide assay device for the user with many form.
By guaranteeing the interlocking accurately between assay device and the readout device; and the accurate aligning of guaranteeing the position of surveyed area in assay device inside; to make when assay device being inserted readout device at every turn, described detection zone will be added in the readout device with constant preposition.Therefore, can make the structure of optical system in the readout device (light source and sensor) remain on simple as far as possible state, because, described sensor needn't comprise any scanister, otherwise,, then will need this scanister if for example do not know the accurate position of detection zone.Owing to avoided demand, so can reduce the cost of readout device/monitor for the optical pickup system of complexity.The simplification of optical pickup system also may make readout device/monitor have little size, and this will help to use easily and unobtrusively in the family this device.Certainly, if necessary, also can in described readout device, comprise scanister.
It is automated production and the quality control that helps described assay device that the other benefit of the internal alignment system that is used for guaranteeing the accurate location of described detection zone in proving installation is provided.Since it is contemplated that for example, under the situation of the monitor onset of ovulation, the consumer will need to use several assay devices in every month, therefore, may be with a large amount of production experiment devices of low cost.The internal alignment method can promote automated production and high yield.
In principle, any electromagnetic radiation can be used for realizing transmission measurement.Preferably can become scattering to electromagnetic radiation.Described electromagnetic radiation is the light in visible light or near visible scope preferably.This comprises far red light and ultraviolet light.Generally it is contemplated that, as the detectable material of record in the chemical examination be a kind of will be by for example absorption and visible light or the interior interactional material of light of near visible scope.The wavelength of selected electromagnetic radiation is preferably such, makes under this wavelength or near the wavelength it, described light is subjected to the strong influence of record, for example be recorded single strong absorption.For example, if record be a kind of strong painted material, promptly, visible when this material naked eyes of people when concentrated, so, desirable electromagnetic radiation is the light with complementary predominant wavelength.Particulate guiding label, for example, metal (for example gold) colloidal sol, nonmetalloid (for example selenium, carbon) colloidal sol, dye sols and painted emulsion fluid (polystyrene) particulate are desirable examples.For example, under the situation of the emulsion fluid particulate of dying blue look, desirable electromagnetic radiation is with by the visible ruddiness of described blue particulate strong absorption.
Use the major advantage of scattered light or other radiation to be in this emulsion fluid: surface imperfection on the assay device or polluter reduce most likely greatly to the deleterious effect of reading of result of laboratory test.For example, if use the light of focusing rather than the light of scattering, so, the dust in the zone that the above radiation of assay device must be passed or cut will seriously influence the precision of measurement result.Owing to use scattering light source, so, such result of laboratory test readout device might be provided, the result of laboratory test that can accurately read even produce by the assay device of substantial transparent, described result of laboratory test is not subjected to the influence of pollution slight on the assay device or damage (for example surface scratch).
From the electromagnetic radiation of light source pulsed preferably.By make described light source and detecting device (sensor) synchronously, make detecting device only work with phase time at radiation source with pulse, just might eliminate any background interference that may cause by external radiation, for example ambient light.Home-use chemical examination is to carry out under the environment of natural daylight with great majority, even more carries out under the environment of the artificial light line of being everlasting.Artificial light has the pulse characteristic (being the 50-100 hertz generally speaking) by the AC characteristic generation of power supply usually.By the pulse radiation source being used for the illumination of readout device assay device, can ignore the interference of natural daylight.By the described pulsed frequency of such selection, make it be different from the frequency of general artificial light significantly, any interference that also can avoid artificial light to cause.The pulsed frequency of light source preferably should be to be not less than about 1000 hertz.Desirable pulsed frequency is about 16000 hertz.The professional and technical personnel is for being familiar with for the synchronous necessary electronic circuit of pulse measurement of realization.The use of pulse light is very useful, because it makes described monitor need not to be " lighttight ".This has not only simplified the structure of monitor, and carries out reading of result of laboratory test when making it possible to be in " disconnection " state at monitor.
Light source or other electromagnetic radiation source can be made of traditional parts fully.Desirable example is the light emitting diode that can buy on the market, but preferably selects the light emitting diode of the optical wavelength that produces test material strong absorption suitable, that be concentrated in the test section for use.Light from light emitting diode should pass through strong light diffuser before arriving assay device.If necessary, can adopt the light emitting diode matrix of being switched on successively.
For example, suitable light diffuser can be made of plastics, and can buy on market.If necessary, can be by mixing the astigmatic characteristic that strengthens photodiffusion material such as the microparticle material of titania and barium sulphate.Desirable photodiffusion material comprises polyester or the polycarbonate that contains titania.The content of suitable microparticle material is about at least 1% (by weight), preferably about 2%.Owing to use light diffuser, the difference of different time from the light of light source output eliminated in all relevant zones of experiment with measuring slip simultaneously.
The sensor that is used for detecting the light of ejaculation can be the legacy device such as photodiode, for example silicon photodiode.
The front that is preferably in described sensor is provided with second light diffuser, and second light diffuser can be with making with the identical materials of first light diffuser.This guarantees that the image of being seen by sensor is not subjected to exist or do not exist in the described reading head influence of test strip.As a result, can under the situation that does not have test strip, proofread and correct described monitor, then, measure result of laboratory test existing under the situation of test strip.
Owing to use uniform light source, therefore might provide such test strip read-out system, the variation of their positions of test section when not having relatively to allow under the situation of scanning sensor from a test strip to another test strip.But,, so, will obtain the very important benefit of chemical examination precision aspect if as described, control the position of test section herein.
In order to improve the possibility of gestation, sold such assay device, it makes the user can monitor the concentration (LH) of the metakentrin in the urine, and the latter arrives peaking greatly sharp about the previous day of ovulation.For example, the measurement day by day of the LH concentration during " water level indication " (" the dipstick ") technology of using is urinated provides result of laboratory test by painted result, and the degree of depth of color is proportional to LH concentration.Because provide result and the standard colour code relatively that makes it possible to day by day to the user, so, can be simply with eyes observations " LH fluctuation ".Regrettably, the supervision of LH concentration is the very rare chemical examination examples this simple level technology, that rely on the sxemiquantitative data that are suitable for, only since the LH fluctuation to be that example outstanding in the relative concentration project just makes this supervision become possible.For other chemical examination that comes in handy of great majority, the variation of analyte concentration wants much intricate in the body fluid, thereby has only by instrument and could detect.
Therefore, be necessary the measuring technology of the family expenses qualitatively that can access is at present expanded to accurate quantitative test zone.Promote in the pregnancy test of family expenses and the logic of the interest aspect the ovulation expected test as present user, one easily example be to be generalized to monitor ovulatory cycle exactly, not only in order to improve the possibility of gestation, and for the reliable information of the purpose that is provided for practising contraception.For this purpose has been advised analysing body fluid.Common theme is the cyclic fluctuation that will monitor the various hormone metabolite content in the urine.
Improved Test Equipment bag of the present invention can be measured any body fluid analysis thing, especially can be used for monitoring the human body ovulatory cycle by measuring such as for example LH of the body fluid of urinating and/or one or more hormones or the metabolite of oestrone-3-glucosiduronic acid (E3G).See the big quantity research that ins all sorts of ways enhancement " nature " family planning and carry out decades recently, wherein, monitored the physiological parameter of expression ovulatory cycle state.In EP-706346, we have described a kind of like this method, and it utilizes the estradiol in the urine or the measurement of metabolite, and especially the measurement to oestrone-3-glucosiduronic acid (E3G) provides the warning that begins for the ovum fertilization phase.At EP-A-656118, among EP-A-656119 and the EP-A-656120 relevant method has been described.In these instructionss, relevant proving installation and Test Equipment bag described in WO-96/09553 also.
In this case, it is contemplated that, the fluid sample proving installation of family expenses generally will comprise for example porous carrier materials of slip, added fluid sample is for example urinated and can be infiltrated this carrier, and, wherein, by means of in the zone (surveyed area) of the accurate regulation of carrier but in special bonding test material, for example comprise the narrow lines or the point of fixing special bonding reagent, obtain result of laboratory test.Therefore, but the present invention relates to and can be positioned at method in the above-mentioned surveyed area to test material exactly with simple and cost reasonable manner.The apparatus for household use of the analysis that is used for urinating for example, is used for the device of conceived test and ovulation expected test, comes into the market widely at present.Many such devices are based on the principle of immunology chromatograph (immunochromatography), and, generally include the hollow casing that contains the test strip of carrying predose reagent that constitutes by plastics.Reagent in the described device can comprise that one or several are marked with the reagent of guiding label, for example, dye sols, metal (for example gold) colloidal sol, perhaps painted emulsion fluid (for example polystyrene) particulate can visually see when they are concentrated in the smaller pilot region of test strip.The user only need be added to urine samples just can begin chemical examination in the parts of described shell.In a few minutes, the user does not need further to operate just can visually see result of laboratory test.The example of this device has been described among EP-A-291194 and the EP-A-383619.Realize the collection of sample easily by means of the suction member, described suction member constitutes the part of this device, and can for example obtain fluid sample from urine stream easily.A kind of random way is described suction member is stretched out, so that apply sample from the shell of device.But except the object lesson of test material already mentioned above, also can utilize to stop or other material of reflecting electromagnetic radiation rather than absorption of electromagnetic radiation, for example, such as the white particles of the emulsion fluid particulate that is in its natural state that is unstained.Another kind method is, described label can be reactant or catalyzer, and they participate in generating the material of absorbed radiation or the material of block radiation, for example, generate a kind of alcohol, thereby but this alcohol and substrate react the test material at detection zone generation such as coloured material.
Generally speaking, it is contemplated that the material of described shell will be opaque, for example white or painted plastics, still, if necessary, shell also can be translucent or transparent.
Described luminaire can comprise the one group of light emitting diode that is embedded in the dispersive medium or is placed in the dispersive medium back, and this luminaire is for covering the illumination that all even diffusions are provided with reference to the test strip of district and signaling zone.
The purpose that fan diffuser helps proofreading and correct is installed between described device and test strip.In order there not to be under the test strip institute situation each optical channel of correction, below this point very necessary, that is, each detecting device is collected light from the identical zone when having assay device of luminaire.Described light diffuser is elected to be main diffusion device in the light path, makes the insertion of test strip can not cause the variation of the illumination profile of seeing by described detecting device significantly.In addition, described light diffuser element can make described optical assembly contain the surface of " cleaning ", and this is that the long term repeatability of described optical assembly can be required.Modulate by illumination luminaire, can be under situation not by means of dismountable parts, before inserting assay device and proofread and correct optical channel under the invisible situation of user.
Test strip can comprise the optical diffusion layer of nitrocellulose or similar material, and this diffusion layer preferably is clipped in two clean thin layers of optics, for example between two polyester layers such as " mylar ".The described nitrocellulose optical diffusion layer of chemical examination reaction takes place in described clean film protection therein.Because by the problem that direct reflection causes, it is very difficult carrying out reflection measurement by transparent membrane.Transmission measurement allows to constitute the optical mirror slip perpendicular to surface measurements, and can reduce to minimum to the deleterious effect of reflection.
The present invention is particularly useful for by nitrocellulose and similar reading of the test strip made of diffusion film, and the thickness of described test strip preferably is no more than 1 millimeter.
The component parts of described shell can by impact-resistant material or similarly plastics, for example polystyrene and polycarbonate mold pressing form, and be fixed together by " sucking fit " clip or screw rod or other suitable mechanism.
Be appreciated that and do to be different from sizable change of foregoing and not depart from the scope of the present invention the general layout and the general shape of described monitor.The needs of effectively cooperating with assay device are depended in the general shape of described reading head and general layout, and still, its shape also can be done sizable change.Equally, also can do sizable change, and this depends on aesthetic consideration to a great extent to the layout and the kind of operable control of user and information display device.
In case understand the information that factor that monitoring arrangement must consider and this device must provide to the user, the electronics technical professional can easily provide a kind of so detailed electronic circuit of monitoring arrangement, described monitoring arrangement can receive, storage and Treatment Analysis substrate concentration data, and the optimized electronic characteristic that described device is provided, and, suitably expect in the future incident according to this data, for example the onset of ovulation causes the state of educating.Some independent parts are traditional parts fully, and the electronics technical professional will understand, and can utilize other combination of these parts and layout to realize purpose of the present invention.For example, can replace traditional microprocessor with so-called " hardwire " system and " neural network " based on " chip " technology.
Can transmit information to the user by for example liquid crystal or light emitting diode indicator.If desired, can transmit about causing the information of the state of educating by the combination of simple vision indication, for example colored demonstration, for example, green expression can not be given birth to, and red expression can be given birth to.Especially, if this device is mainly used to help contraception, so, it should be by showing that " can give birth to " signal carries out " fail-safe ".
Claims (10)
1. one kind is used for qualitative or determines the Test Equipment bag of the existence of one or more analytes in the fluid sample quantitatively, this Test Equipment bag comprises assay device and the readout device that engages with this assay device, wherein, the joint of accurately determining the position of assay device and readout device is absolutely necessary for reading result of laboratory test exactly, it is characterized in that:
The correct joint of assay device and readout device causes " key " between the starting device of assay device and readout device to interact.
2. according to the Test Equipment bag of claim 1, it is characterized in that:
Described assay device has the carrier slip of the porous that mainly is included in the hollow shell or the form of analog, and
Result of laboratory test is by labelled reagent being shown with the surveyed area that special mull technique is bonded in the carrier slip, can debating other surveyed area by described readout device and have labelled reagent.
3. according to the Test Equipment bag of claim 1 or claim 2, it is characterized in that:
Described readout device comprises: the storing apparatus that is used for holding assay device; And read starting device, in a single day it comprises transportable switch starting device or similar device when being contained in the described storing apparatus to assay device,
The contact portion that correct the holding of described assay device causes described shell contacts with described movable switch starting part, described contact portion and described removable switch starting device can engage jointly by means of " key " engages, only make that when correctly holding assay device, described switch starting device can be moved and begin reading.
4. according to the Test Equipment bag of claim 3, it is characterized in that:
Described switch starting device comprises movably projection of projection that at least one is fixing and at least one, and
The contact portion of described assay device shell comprises the recess that is processed into such shape, make this recess hold the fixing projection of switch starting device but do not hold its movably projection, described contact portion also comprises the interface section, when described fixing projection is accommodated in the described recess, the moveable part of this interface section contact and mobile described switch starting device.
5. according to the Test Equipment bag of claim 3 or claim 4, it is characterized in that:
Described storing apparatus is equipped with the assay device that is held is pressed in bias gear on the described switch starting device.
6. according to any one the Test Equipment bag in the claim 3 to 5, it is characterized in that:
Described storing apparatus is equipped with cam gear, unless assay device is correctly held, otherwise described cam gear makes assay device depart from described switch starting device.
7. according to the Test Equipment bag of claim 6, it is characterized in that:
When described assay device was correctly held, described cam gear provided " buckle (snap) " of described assay device and described storing apparatus to engage.
8. the Test Equipment bag of any one in requiring according to aforesaid right is characterized in that:
Described assay device is elongated, and described storing apparatus comprises at least pack into wherein the line of rabbet joint of the part of elongated assay device, and
The described line of rabbet joint has at least one flange portion that stretches in the outlet of this line of rabbet joint, when described assay device correctly was contained in the line of rabbet joint, described protruding lip portion play a part described assay device is clamped in this line of rabbet joint.
9. Test Equipment bag according to Claim 8 is characterized in that:
Described flange portion is positioned at an end of the described line of rabbet joint, and, when described assay device inserts described storing apparatus, can with the end engagement of described elongated assay device.
10. according to the Test Equipment bag of claim 9, it is characterized in that:
At the other end of the described line of rabbet joint or have near it and be used for described assay device is clamped in second flange portion in the described line of rabbet joint.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 97104530 CN1178325A (en) | 1996-09-27 | 1997-03-14 | Test kits and devices |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP96307089.1 | 1996-09-27 | ||
| CN 97104530 CN1178325A (en) | 1996-09-27 | 1997-03-14 | Test kits and devices |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1178325A true CN1178325A (en) | 1998-04-08 |
Family
ID=5167413
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 97104530 Pending CN1178325A (en) | 1996-09-27 | 1997-03-14 | Test kits and devices |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1178325A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105552275A (en) * | 2016-02-26 | 2016-05-04 | 重庆市紫建电子有限公司 | Button type rechargeable lithium ion battery |
| WO2022198968A1 (en) * | 2021-03-25 | 2022-09-29 | 江苏硕世生物科技股份有限公司 | Test result reading device |
-
1997
- 1997-03-14 CN CN 97104530 patent/CN1178325A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105552275A (en) * | 2016-02-26 | 2016-05-04 | 重庆市紫建电子有限公司 | Button type rechargeable lithium ion battery |
| WO2022198968A1 (en) * | 2021-03-25 | 2022-09-29 | 江苏硕世生物科技股份有限公司 | Test result reading device |
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