Summary of the invention
The utility model comprises a kind of optical analysis reading device, comprise that at least one can incide the light source on the reagent strip, this reagent strip comprises first, second and the 3rd zone that separates on the space, this light source comprises three respectively to the light emitting diode in first, second and the 3rd zone on should reagent strip, and this device comprises that also can be accepted a trizonal catoptrical photodetector on this reagent strip.
Preferably, this light emitting diode and this photodetector are positioned at the homonymy of this reagent strip, and with the reagent strip lateral excursion.
More preferred, photodetector between first area and the 3rd zone and with this reagent strip lateral excursion.
Preferably, photodetector be right against this reagent strip second area and with this reagent strip lateral excursion.
Preferably, be provided with fence between three light emitting diodes.
More preferred, this reading device comprises that also the illumination of the 3rd light emitting diode in the 3rd zone that prevents to shine this reagent strip is mapped to first fence of this reagent strip first area, and the illumination of first light emitting diode that prevents to shine the first area of this reagent strip is mapped to second fence in this reagent strip the 3rd zone.
In another embodiment, be provided with dividing plate between this light emitting diode and this photodetector.
In another embodiment, this photodetector is accepted each regional light intensity difference on this reagent strip.
Preferably, this photodetector is accepted the whole light at least one zone on this reagent strip fully.
Above-mentioned preferred, photodetector comprises photodiode.
The utility model can also comprise a kind of reading device, comprises the shell that can hold reagent strip; And the light source that can shine reagent strip, this light source comprises three light emitting diodes, can shine the reference zone of this reagent strip respectively, surveyed area and control area; And a reference zone that is used to detect from this reagent strip, the photodetector of the light that reflects on surveyed area and the control area.
Preferably, this light emitting diode and this photodetector are positioned at the homonymy of this reagent strip, and with this reagent strip lateral excursion.
Preferably, the distance of this photodetector and this surveyed area is less than the distance in this photodetector and these other zones of reagent strip.
More preferred, this photodetector between this reference zone and this control area and with the reagent strip lateral excursion.
The utility model can also comprise a kind of reading device, comprises the reagent strip that can support that liquid crossflow is moving, and this reagent strip comprises white space, surveyed area and control area; The shell that can place and fix this reagent strip; A light source comprises the white space that shines this reagent strip respectively, three light emitting diodes of surveyed area and control area; The reference zone that can be used to detect this reagent strip, the catoptrical photodetector on surveyed area and the control area.
The utility model can further include a kind of reading device, comprising: counting circuit, and the current signal that photodetector is produced responds, and this signal represents whether there is liquid sample on the reagent strip; Calculating is along the speed of this reagent strip flowing liquid; The flow velocity that calculates and higher limit and lower limit are compared; And,, give up this analysis result if the flow velocity that calculates has exceeded higher limit and lower limit.
The utility model can further include a kind of reading device, comprising: counting circuit, input signal is responded, and this signal has been represented the amount of the analyte at least one zone on the reagent strip or the accumulation rate of analyte; This input signal and first threshold are compared; With this input signal with compare less than second threshold value of first threshold; If this input signal greater than first threshold or this input signal less than second threshold value, produce this output signal, if this output signal is greater than first threshold, first kind of result of this output signal indication, perhaps, if this input signal is less than second threshold value, this output signal is indicated second kind of result; And, if this input signal greater than first threshold or less than second threshold value, stops test.
The utility model comprises a kind of method of measuring the analysis result of reagent strip enforcement: sample is transferred on the reagent strip, and this reagent strip is located with respect to optical analysis reading device, and this reading device comprises the shell that holds a light source and a photodetector; And the light quantity of measuring this photodetector acceptance; Wherein, this light source comprises on three corresponding reagent strips of difference the light emitting diode in first, second and the 3rd zone, and this photodetector can be accepted trizonal reflected light on the reagent strip.
The utility model cost is low, is easy to produce, and simple to operate, intuitive display result has broken through two the conventional photodetectors and the combination of three light sources, has optimized the configuration of photodetector, reaches effect preferably.
Embodiment
Below the structure of optical analysis reading device and method or these employed technical terms are described further.
Detect
Detect the expression chemical examination or test a kind of material or whether material exists, such as, but be not limited to this, the metabolin of chemical substance, organic compound, mineral compound, metabolism product, medicine or drug metabolite, organic organization or organic organization, nucleic acid, protein or polymkeric substance.In addition, detect the quantity of expression test substances or material.Furtherly, immune detection, chemical detection, enzyme detection etc. are also represented in chemical examination.
Sample
The sample of the utility model indication refers to that those can be used for detecting, chemically examining or diagnose the material that whether has analyte of interest matter.Sample can be that for example, liquid sample, liquid sample can comprise blood, blood plasma, serum, urine, saliva and various juice, can also comprise that solid sample and semi-solid samples are through anticipating the liquid solution that the back forms.The sample of collecting can be used for methods such as immune detection, chemical detection, enzyme detection and detect whether there is analyte.
" upstream ", " downstream " refer to be divided along liquid flow direction, the upstream is to be positioned on the liquid flow direction, the downstream is positioned under the liquid flow direction, and upstream and downstream is a relative notion, and liquid can flow to downstream position from upstream position.
Analyte
Can analyze any analyte with apparatus and method of the present utility model.The example of the analyte of the enough apparatus and method stable detection of the present utility model of energy comprises (but not only comprising) human chorionic gonadotrophin (hCG), lutropin (LH), ovarian stimulation element (FSH), hepatitis C virus (HCV), hepatitis B (HBV), hepatitis B surface antigen, the medicine of AIDS virus and any abuse.Analyte can detect in any liquid or liquefied sample, urine for example, saliva, saliva, blood, blood plasma, perhaps serum.The example of other analyte also has the acid of flesh ammonia acid anhydride, cholerythrin, nitrite, protein (nonspecific), blood, leucocyte, blood sugar, heavy metal and toxin, the bacterium composition is (for example, special protein and the sugar of the bacterium of particular type, colon bacillus 0157: H7 for example, staphylococcus aureus, salmonella, C.perfringens, campylobacter, listeria monocytogenes, enteritis vibrios, perhaps cured shape bacillus).Analyte can also be some haptens materials, and these haptens comprise drugs (as drug abuse)." drug abuse " (DOA) is meant that the non-medical destination uses medicine (playing the paralysis nerve usually).Any other analyte of suitable lateral flow assay form can detect with this device.
Reagent strip
General reagent strip 5, reagent strip 5 can comprise the sample region of acceptance, marked region, surveyed area 52, control area 53 and suction zone.On the sample region of acceptance, comprise and finish reaction necessary material, for example some buffer reagents, pre-service sample reagent or the like; Comprise the fluorescence labeling material at marked region, the colloid gold label particle, or with painted gel marking particle, it can also be water-soluble mark substance, these mark substances can connect antibody, antigen, haptens or analyte similar substance or the like, on surveyed area 52, comprise fixed specific bond molecule, change color can on surveyed area 52, occur by the specific bond molecule and represent whether there is analyte in the sample.Downstream at surveyed area 52 can also comprise testing result control area 53.
Be used for including three zones on the reagent strip 5 of optical analysis reading, comprise first area 51, second area 52 and the 3rd zone 53.First area 51, second area 52 and the 3rd zone 53 are not defined especially, can be respectively reference zone 51, surveyed area 52 and control area 53.Reference zone 51 is meant does not generally have immunoreactive zone after sample flow is crossed on the reagent strip 5, generally do not contain raw material, such as the product of antigen, antibody, label and combination thereof, be used to compare on surveyed area 52 and the control area 53 owing to immune response having taken place produce Different Results light-struck differential responses.There is a common feature in these three zones, can produce reflected light when the incident light irradiation is arranged.Catoptrical generation, a part are because covering this trizonal film on the reagent strip 5 causes, as adopt smooth NC film, can produce surface reflection; Another part is by the liner plate on the reagent strip 5, and liner plate can be the liner plate as the MYLAR plastic layer of white reflection, drops on light on the liner plate from what light source 7 sent, can see through the light that reagent strip 5 reach any degree of depth in liner plate reflection horizon.Generally, the photodetector 6 preferential reflected light of measuring.Preferably, photodetector 6 can be measured the reference zone 51 from reagent strip 5 respectively, the light of reflection on surveyed area 52 and the control area 53.
Light source
Light source 7 is often referred to the luminophor that can send visible light here.Be used for the light source 7 of optical readings device, it is luminous normally to belong to atom, and the fluorescent material of smearing such as the fluorescent lamp tube inwall is excited by electromagnetic wave energy and produces light.Preferably, such as light emitting diode, abbreviate the LED lamp as.Diode by the compound of gallium and arsenic, phosphorus is made can give off visible light when electronics and hole-recombination, thereby can be used for making light emitting diode, as pilot lamp, perhaps forms literal or numeral shows in circuit and instrument.Light emitting diode is a kind of of semiconductor diode, can change into luminous energy to electric energy.Commonly used is glows, the diode of green glow or gold-tinted.Light source 7 can direct irradiation on reagent strip 5, preferred, optical analysis reading device can comprise a plurality of light sources 7.Same preferred, when optical analysis reading device comprises a plurality of light source 7, these light sources 7 are optimized be provided with, make and only open the specific zone of irradiation by one in a plurality of light sources 7.More preferred, light source 7 is selected three LED lamps for use, and the main region of shining reagent strip 5 respectively comprises reference zone 51, surveyed area 52 and control area 53.
Preferably, optical barrier 8 is set between each LED lamp or around it, with the zone of being shone by each light source 7 on the restriction reagent strip 5.For example, between first LED71 and second LED72, first fence 81 is set, prevents that the illumination of the 3rd LED71 is mapped on the first area; Between second LED72 and the 3rd LED73, second optical barrier is set, prevents that the illumination of first LED73 is mapped on the 3rd zone.
Photodetector
In optical assay device, after light signal arrives receiving end through Optical Fiber Transmission, at receiving end the conversion elements of a receiving optical signals is arranged, this element is transformed into electric signal with light signal, and then, restore into original signal at last by the process that electronic circuit amplifies.Photodetector 6 can be photodiode (PD).
Photodetector 6 can be accepted the reflected light on the reagent strip 5.The position of photodetector 6 and size have determined it to catoptrical reception and feedback on the reagent strip 5.In one embodiment, photodetector 6 can cover whole reagent strip 5, also can cover the several zones on the reagent strip 5, such as reference zone 51, surveyed area 52 and control area 53, like this, when receiving light, can accept all light substantially fully from the zone on the reagent strip 5.Photodetector 6 itself is relatively costly assembly, has occupied the overwhelming majority of complete cost.Cover or most of each regional photodetector 6 that covers on the reagent strip 5, cost relatively can be much higher.One preferred embodiment in, select the most of light that can accept on three zones for use, and don't be that the very big photodetector of area 6 is proper.Such photodetector 6, accepting on the reagent strip 5 each regional light intensity can be different, furtherly, such photodetector 6 can be accepted whole light in certain zone on the reagent strip 5 in theory, and the catoptrical acceptance on other zones does not then have such efficient.Preferably, photodetector 6 is accepted all reflected light of surveyed area 52 on the reagent strip 5.More preferred, optical analysis reading device is by being provided with the light intensity of different LED lamps, remedies on reference zone 51 except that surveyed area 52 and the control area 53 the catoptrical light intensity of accepting.
The seizure of 6 pairs of light signals of photodetector depends on light intensity and optical path direction.The signal of light receives strong and weak, and is then relevant with the emissive porwer of LED lamp.Photodetector 6 be positioned at certain zone over against the position on, can cover the light that reflects on this zone fully in theory; When there is angular deflection in photodetector 6 with zone on the reagent strip 5, can not accept the light of reflection on the reagent strip 5 fully, like this, be influential to the feedback of signal.Preferably, photodetector 6 is arranged on the position that reagent strip 5 can cover surveyed area 52, makes to detect most important result and can obtain completely effectively judging.More preferred, suitably increase the light intensity on reference zone 51 and the control area 53, make that the light signal on these two zones can be near the intensity of surveyed area 52.More preferred, the part on reference zone 51 and the control area 53 detects light and is stopped that by optical barrier 8 another part reflexes on the photodetector 6 along the angle of optical barrier 8.More preferred, above-mentioned angle is 30 degree.The position of photodetector 6, also can be in the both sides of reagent strip 5 with the LED lamp respectively, like this, by of the irradiation of LED lamp to reagent strip 5, the transmitted light that penetrates reagent strip 5 arrives photodetector 6, this mode is feasible, but compares reflected light, and can there be interference in various degree in transmission reagent strip 5.In the utility model, adopt a photodetector 6, measure trizonal reflected light on the reagent strip 5.This is considered to be difficult to realize in the prior art usually, but the technical scheme of this optical readings device that can provide support in the utility model reaches beyond thought technique effect.
Photodetector 6, the position relation between light source 7 and the reagent strip 5 is an emphasis of the present utility model.Photodetector 6 and light source 7 are positioned at the homonymy of reagent strip 5, and with reagent strip 5 lateral excursions.The direction of liquid flow is relevant on lateral excursion the notion here and the reagent strip 5, the direction of liquid flow is vertically, then be horizontal perpendicular to the direction of liquid flow, at reagent strip 5 transversely, with reagent strip 5 nonoverlapping positions, for the position of reagent strip 5 lateral excursions.Photodetector 6 and light source 7 (perhaps light emitting diode) are positioned at the homonymy of reagent strip 5, illustrate from light source 7 to shine light on the reagent strip 5, can be accepted by photodetector 6 through the reflection of reagent strip 5.These are different with some mode in the prior art, have disclosed the both sides that photodetector 6 and light source 7 are positioned at reagent strip 5 in the prior art, from the light of light source 7 irradiations, see through reagent strip 5, and wherein transmitted light is received by photodetector 6.In the utility model,, reduced the light intensity and the light quantity that see through reagent strip 5 losses, made photodetector 6 more responsive by the homonymy that photodetector 6 and light source 7 are positioned at reagent strip 5 is set.In addition, can not exist between photodetector 6 and the light source 7 to interfere with each other, thereby, in preferred scheme, be provided with dividing plate 9 between light source 7 and the photodetector 6, prevent that the light of light source 7 emissions from shining directly on the photodetector 6, cause result's error.
The utility model also relates to the process of using optical analysis reading device to carry out the sample analysis detection.
Optical analysis reading device can also comprise a counting circuit, can the current signal that photodetector 6 produces be responded, and this signal represents whether there is sample on the reagent strip 5.In testing process, the reagent strip 5 that contacts with sample is positioned in the reading device, and liquid each zone on the reagent strip 5 of flowing through is successively calculated along the speed of this reagent strip 5 flowing liquids by counting circuit then.The flow velocity that calculates and the higher limit and the lower limit that configure are compared,, abandon this analysis result if the flow velocity that calculates has exceeded higher limit and lower limit.In testing process, may cause correctly to show testing result owing to the not enough race plate that detection sample deficiency causes, perhaps because excessive " Flooding " phenomenon that causes of sample causes the invalid of testing result.Which kind of signal no matter above-mentioned two kinds of situations show on the results display area territory of reagent strip 5, all be the result who is considered to invalid.Increase above-mentioned counting circuit, can avoid because above-mentioned two kinds of resultant errors that situation causes.Higher limit and lower limit are meant the flow velocity of liquid sample in the general prior art.
Optical analysis reading device also can comprise another kind of counting circuit, can respond input signal, and this signal has been represented the amount of the analyte at least one zone on the reagent strip 5 or the accumulation rate of analyte.Input signal is produced by photodetector 6.In reagent strip 5, each zone is shone by light source 7 on the reagent strip 5 in sample flow, and its reflected light is reflected to photodetector 6 successively and receives, thereby produces an input signal.In counting circuit, design a first threshold and second threshold value in advance, so that compare less than first threshold.If this input signal less than second threshold value, produces this output signal greater than first threshold or this input signal.If this output signal is greater than first threshold, first kind of result of this output signal indication, perhaps, if this input signal less than second threshold value, second kind of result of this output signal indication; And, if this input signal greater than first threshold or less than second threshold value, stops test.Preferably, if input signal is between the first threshold and second threshold value, counting circuit will be waited for certain hour, the time of setting, the input signal of accumulative total still is between the first threshold and second threshold value, then stops test.In a specific embodiment, if whether pregnancy is an example to measure, then first result is " conceived ", and second result is " not conceived ".In another embodiment, to measure in the sample whether contain drug materials class power, first result can be " not containing drug materials ", and second result is " containing drug materials ".
The utility model also designs a kind of method of measuring the analysis result of reagent strip 5 enforcements: sample is transferred on the reagent strip 5, this reagent strip 5 is with respect to the optical analysis reading device location, and this reading device comprises the shell that holds a light source 7 and a photodetector 6; And the light quantity of measuring these photodetector 6 acceptance; Wherein, this light source 7 comprises on three corresponding reagent strips 5 of difference the light emitting diode in first, second and the 3rd zone, and this photodetector 6 can be accepted trizonal reflected light on the reagent strip 5.In specific embodiment, reagent strip 5 can be inserted in the optical analysis reading device after liquid sample adds.Preferably, the pre-aligned and reading device inside of reagent strip.Reading device inside is provided with counting circuit, this counting circuit can the measuring light detecting device 6 light quantities of accepting, and carry out result's output, direct demonstration testing result on the LCDs 3 of reading device outside.
Below in conjunction with concrete accompanying drawing examples of implementation of the present utility model are described in detail.These specific embodiment only are limited the enumerating under the utility model spirit, do not get rid of one of ordinary skill in the art prior art and the utility model in conjunction with and other specific embodiments of producing.
Embodiment 1
As shown in Figure 1, this optical analysis reading device profile is the form of a stroke or a combination of strokes.This device comprises the housing 1 that lighttight synthetic plastic is made from the appearance, lid 2, and LCDs 3 and battery 4 are formed.LCDs 3 can be with qualitative or quantitative mode display analysis object information.When beginning to detect, lid 2 is taken off, liquid sample contacts with the suction rod of reading device front end, starts reading device simultaneously.When the liquid of suction in the rod is transferred on the reagent strip 5 of housing 1 inside, on reagent strip 5, can carry out the detection reaction whether sample exists.After detection finished, testing result can show net result on LCDs 3, simultaneously, can strip out battery 4 from reading device, in order to avoid cause situations such as electric leakage.
The inner structure of reading device, as shown in Figure 2, comprise reagent strip 5, light source 7, a photodetector 6, light source 7 comprise three LED lamps, the reference zone 51 on first LED71 irradiation reagent strip 5, control area 53 on 52, the three LED73 irradiations of surveyed area reagent strip 5 on second LED72 irradiation reagent strip 5.Photodetector 6 and light source 7 are positioned at the homonymy of reagent strip 5, and with reagent strip 5 lateral excursions.The light that photodetector 6 detects from each regional reflex, and produce electric current, this electric current is proportional to the light quantity that incides on the photodetector 6.Current conversion city voltage is through buffering and feed back to converter 13, is finally read the digital signal of gained by microcontroller 12.
When using, Closing Switch 11 also starts reading device, carries out initial calibration, and it is basic identical to make photodetector 6 accept from trizonal each the measuring-signal of reagent strip 5.Then, liquid sample is contacted with reagent strip 5.Behind the certain hour, begin measuring from trizonal intensity of reflected light successively.The interval of measuring can be set in 1-10 in second, and repeats to measure between each district, and is repeatedly most according to the order of sequence at short notice, thereby will see minimum owing to light quantity changes the influence that produces on the reagent strip 5.
Embodiment 2
Present embodiment is described preferably configuration among the embodiment 1 more in detail.Photodetector 6 is photodiode (PD), and light source 7 is light emitting diode (LED).As shown in Figure 3 and Figure 4, reading device comprises a PD and three LED lamps.Reference zone 51 on the rayed reagent strip 5 that sends from first LED71, the surveyed area 52 of the rayed reagent strip 5 that sends from second LED72, the control area 53 of the rayed reagent strip 5 that sends from the 3rd LED73.Lighttight fence 8 optically separates each LED lamp, guarantees that each LED lamp can only shine corresponding zone.Fig. 5 has shown the spatial relationship of LED lamp and PD, has dividing plate 9 between LED lamp and the PD, prevents that the light on the light source 7 from shining directly on the PD.Any light of injecting reagent strip 5 with angle β will be reflected on the PD with same angle.
Embodiment 3
In embodiment 3, the useful area of photodetector 6 makes 1.5mm * 1.5mm.Light source 7 provides light, to the small part light wavelength be 635nm.The material that is used for baffle assembly 10 makes black nylon.
Embodiment 4
Fig. 6-11 has illustrated embodiment 4 contained each parts, comprise: be used for fixing printed circuit board (PCB), the baffle assembly 10 of LCDs 3 and reagent strip 5, baffle assembly 10 comprises that three limit window 101, reagent strip 5 can be fixed on the baffle assembly 10, and three zones on the reagent strip 5 limit window 101 corresponding to three.Comprise a PD and three LED lamps on the printed circuit board (PCB).PD and LED lamp be installed on the same plane and be positioned at limit window 101 below, like this, the light that sends from one or more LED lamp can arrive reagent strips 5 and be reflexed to downwards on the PD by limiting window 101.As shown in Figure 8, optical analysis reading device also comprises the groove 103 of immobile liquid crystal display screen 3, and the plastic column 102 that baffle assembly 10 is connected with housing 1.In addition, as shown in Figure 9, also comprise by fence 8 between three LED lamps, only shine corresponding three zones on the reagent strip 5, reference zone 51, surveyed area 52 and control area 53 (Figure 10) to guarantee each LED lamp.
Embodiment 5
Optical analysis reading device among this embodiment, except comprising the assembly identical with embodiment 2, also comprise a counting circuit, if the analysis measurement signal surpasses higher limit or is lower than lower limit, reading device can be announced analysis result finishing between the analysis.
Embodiment 6
Optical analysis reading device among this embodiment, except comprising the assembly identical with embodiment 2, the system that also comprises the tracer liquid sample flow, the flow velocity that calculates and the higher limit and the lower limit that configure are compared, if the flow velocity that calculates has exceeded higher limit and lower limit, abandon this analysis result.
Embodiment 7
Optical analysis reading device among this embodiment except comprising the assembly identical with embodiment 2, also comprises a kind of flow rate detection system.This detection system can respond input signal, and this signal has been represented the amount of the analyte at least one zone on the reagent strip 5 or the accumulation rate of analyte.