CN210142078U

CN210142078U - Electronic reading device

Info

Publication number: CN210142078U
Application number: CN201920451422.9U
Authority: CN
Inventors: 徐方洲; 葛秀龙; 方剑秋
Original assignee: Zhejiang Orient Gene Biotech Co Ltd
Current assignee: Zhejiang Orient Gene Biotech Co Ltd
Priority date: 2019-04-04
Filing date: 2019-04-04
Publication date: 2020-03-13
Anticipated expiration: 2029-04-04

Abstract

The utility model belongs to biochemical detection area discloses an electronic reading device. The utility model discloses an electronic reading device includes: at least two light detectors, including a first light detector and a second light detector, for receiving reflected light from respective regions of the test element, wherein one of the at least two light detectors is separated in a separate space. The utility model discloses a device lets the light that comes from test element specific area as far as possible receive by the light detection, has reduced the interference of irrelevant regional light to the photodetector, has improved the accuracy and the sensitivity of detection.

Description

Electronic reading device

Technical Field

The present invention relates to the field of biochemical testing, and in particular, to an electronic reading device for reading test results used in conjunction with a test element using a biological immunoassay method.

Background

Currently, rapid test devices for detecting whether a sample contains an analyte are widely used in hospital or home diagnosis, and these rapid test devices include one or more test reagent strips, such as early pregnancy test, drug abuse test, and the like. The detection devices can obtain detection results within one minute or at most ten minutes, and have the advantage of convenient and quick operation. The combination of an electronic reader with a test carrier, such as an analytical test strip, for detecting the concentration and/or amount of analyte in a fluid sample allows for visual reading of the detection results.

US5580794 discloses a disposable integrated analytical reader and lateral flow analytical test strip that utilizes optics in the reader to obtain a test result by measuring reflected light. However, this device has a certain disadvantage that, when a plurality of light emitting elements are irradiated on corresponding regions of a narrow reagent strip, light reflected or transmitted from the corresponding regions may not be irradiated on only a specific one or more photodetectors, and light emitted from a light source may directly enter the photodetectors, thereby affecting the accuracy of the detection result.

US7315378 provides a solution to this problem by providing a baffle between the light-emitting element and the light detector to prevent light emitted by the light-emitting element from impinging directly on the light detector. However, there is still a need for improvements in these devices, particularly when multiple different tests are to be performed simultaneously on a single test strip, where the photodetector is required to accurately reflect the signal changes at the particular test area, while avoiding interference from light reflected from other non-test areas.

Chinese patent publication No. CN101650298 discloses an analytical reader for use with an analytical test strip, the reader comprising one or more light sources, light from the light sources being incident on at least two spatially separated regions of the test strip, one or more light detectors for detecting light emitted from each of the two regions of the test strip; to ensure that each light source can only illuminate its corresponding area in the test strip, each light source is optically isolated by a light-impermeable baffle and a ramp is provided between the light source and the light detector to prevent light from the light source from striking the light detector directly. The test strip is positioned above the light source of the reader without covering the light detector, making the reader relatively bulky, and the distance between the light source and the light detector needs to be precisely controlled, which may result in the light detector not receiving light reflected by the test strip.

Chinese patent publication No. CN104730229 discloses an electronic test device for performing analytical processing on test strips for assay detection, which includes a first and second intersecting separator, the first separator including a light source separator and an anti-scatter separator. The light source separator separates the plurality of light sources into two groups at the positions of the light sources and separates the detection area from the blank area of the test strip, the anti-scattering separator separates the detection area from the blank area of the test strip, and the second separator separates the light sources from the light detectors. This prevents interference of light between the blank area and the detection area, and between the light emitting area and the receiving area.

There are still many problems when it is desired to read the final test result very sensitively as the signal on the detection zone on the test strip changes.

Disclosure of Invention

The utility model provides a reading device for reading the detection result, which is used for reading the test result of the test on the test element, and the device can make the reflected light from the test element incident on the light detector as much as possible; in particular, it is possible to detect the effective reflected light from the test element, which reflects the detection result, by the photodetector, while avoiding the influence of other stray light.

The utility model discloses an in the first aspect, the utility model provides a read electronic reading device of chemical examination result, the device includes:

at least two light detectors, including a first light detector and a second light detector, for receiving reflected light from respective regions of the test element, wherein one of the at least two light detectors is separated in a separate space.

Preferably, the at least one light detector is partitioned in a separate space by a light blocking member enclosed around the light detector.

Preferably, the light blocking member has a notch for allowing light from the test element to pass through.

Preferably, the notch is disposed at a position corresponding to the test area or the control area of the test element.

Preferably, the indentations comprise first indentations and/or second indentations.

Preferably, the light blocking element includes a first light blocking member for separating the light detector and the light emitting element, and the first light blocking member has a first notch.

Preferably, the first notch is an inclined notch.

Preferably, the light blocking element further comprises a second light blocking member for separating the light detector from the test element, and the second light blocking member has a second notch thereon.

Preferably, the second notch is communicated with the first notch.

Preferably, the light blocking element further comprises a third light blocking member for separating the at least two photodetectors, and the third light blocking member has no notch.

Preferably, the device further comprises a light-emitting element, and the light-emitting element is arranged at a position corresponding to the test area or the control area of the test element.

Preferably, the number of the light emitting elements is at least two, and no light blocking element is arranged between the at least two light emitting elements.

Preferably, a third light detector is further included between the at least two light emitting elements.

Preferably, the at least two light-emitting elements and/or the third light detector are linearly arranged.

Preferably, the electronic reading device further comprises a lateral flow test element comprising a test zone and a control zone thereon.

As a second aspect of the present invention, the present invention provides an electronic reading device for reading a test result, the device includes:

first and second light emitting elements for emitting light to irradiate one or more regions corresponding to the test element;

first and second light detectors for receiving reflected light from respective one or more regions of said test element;

and a light blocking member for guiding a path of the light emitted from the light emitting member and/or the light from the test member, wherein the light blocking member separates the first photodetector and the second photodetector in mutually independent spaces.

Preferably, the first notch is an inclined notch.

Preferably, the second notch is communicated with the first notch.

Preferably, the light blocking element further includes a third light blocking member for separating the two photodetectors, and the third light blocking member has no notch.

Preferably, the two photodetectors are separated by a common third light blocking member, or the two photodetectors are separated by two third light blocking members separated from each other.

Preferably, the two third light blocking members separated from each other are in a longitudinally parallel structure.

Preferably, the first light detector and the second light detector are arranged linearly.

Preferably, the first light emitting element and the second light emitting element are respectively arranged at positions corresponding to the test area and the control area of the test element.

Preferably, the first light emitting element and the second light emitting element do not have a light blocking element therebetween.

Preferably, a third photodetector is further provided between the first light-emitting element and the second light-emitting element.

Preferably, the first light emitting element, the second light emitting element and/or the third photodetector are linearly arranged.

As a third aspect of the present invention, the present invention provides a method of reading a test result of a test element, providing an electronic reading device as described above, the device comprising: at least two light detectors, including a first light detector and a second light detector, for receiving reflected light from respective regions of the test element, wherein one of the at least two light detectors is separated in a separate space.

The utility model discloses a method is through letting light emitting component luminous, and light shines behind the corresponding region of test element, is received by the photo detector after reflecting, then forms the signal of telecommunication that can be detected and carries out the judgement of test result.

Preferably, at least one of the photodetectors is partitioned in a separate space by a light blocking member surrounding the photodetector to allow light from a specific region of the test element to enter the photodetector.

Preferably, the light blocking member has a notch for allowing light from the test element to pass therethrough, and light from a specific region of the test element enters the photodetector through the notch.

Preferably, the notch is disposed at a position corresponding to the test area or the control area of the test element, so that light from the test area or the control area of the test element enters the photodetector through the notch.

Preferably, the light blocking member includes a first light blocking member for separating the light detector and the light emitting element, the first light blocking member allows light from the light emitting element to be irradiated onto the test element without being directly irradiated onto the light detector, and the first light blocking member has a first notch.

Preferably, the first notch is an inclined notch.

Preferably, the light blocking element further includes a second light blocking member for separating the light detector and the test element, the second light blocking member allows light from the light emitting element to irradiate a corresponding region of the test element but not to irradiate other regions, or allows light from a specific region of the test element to enter the light detector, and the second light blocking member has a second notch thereon.

Preferably, the second notch is communicated with the first notch.

Preferably, the device further comprises a light-emitting element, wherein the light-emitting element is arranged at a position corresponding to the test area or the control area of the test element, and the light of the light-emitting element is irradiated to the test area or the control area of the test element.

Preferably, the first light emitting element and the second light emitting element sequentially emit light, the light irradiates the test area and the control area of the test element, and the light enters the first light detector and the second light detector after being reflected to form an electric signal for determining the detection result, so as to determine the test result.

Advantageous effects：

The utility model discloses an electronic reading device leads or changes the light path route through the component that is in the light, provides the light path route of a preferred between light emitting component and photo detector, the utility model discloses an electronic reading device compact structure has guaranteed the abundant and effective utilization of light path signal, has increased the degree of accuracy and the sensitivity that detect. The light from the test area and the control area of the test element is received by the light detector as much as possible, and the interference of the light of an irrelevant area to the light detector is reduced, so that the detection accuracy and sensitivity are improved. And the utility model discloses an electronic reading device sets up the photo detector that is used for carrying out initial calibration between light emitting component, realizes that equipment adjusts luminance, calibration before using, has guaranteed the accuracy of testing result.

Drawings

Fig. 1 is a schematic perspective view of an electronic reading device according to an embodiment of the present invention.

Fig. 2 is a schematic cross-sectional structure diagram of an electronic reading device according to an embodiment of the present invention.

Fig. 3 is a partially enlarged schematic view of fig. 2, in which (a) is a top view and (B) is a front view.

Fig. 4 is a bottom schematic view of an electronic reading device in an embodiment of the invention.

Fig. 5 is a bottom schematic view of an electronic reading device in another embodiment of the invention.

Fig. 6 is a top schematic view of the electronic reading device of fig. 5.

Fig. 7 is an exploded view of an electronic reading device in accordance with an embodiment of the present invention.

Fig. 8 is a schematic diagram of a test element in an embodiment of the invention.

Reference numerals: 101 a first light emitting element, 102 a second light emitting element, 201 a first photodetector, 202 a second photodetector, 203 a third photodetector, 30 a light blocking element, 301 a first light blocking member, 302 a second light blocking member, 303 a third light blocking member, 304 a fourth light blocking member, 305 a fifth light blocking member, 306 a sixth light blocking member, 307 a seventh light blocking member, 308 an eighth light blocking member, 309 a ninth light blocking member, 310 a tenth light blocking member, 40 a test element, 401 a sample absorption zone, 402 a reagent zone, 403 a test zone, 404 a reference zone, 405 a control zone, 406 a water absorption zone, 407 and 408 a zone near the test zone, 409 and 410 a zone near the control zone, 50 a notch, 501 a first notch, 502 a second notch, 60 a substrate, 70, a pedestal detection window, 702 a notch, 703 a recess, 704 a bump, 80 an upper case, 90 a lower case, 100 a cover, 110 a sample stick, 120 a front end conduction electrode, 130 display, 140 power supply element, 150 buzzer.

Detailed Description

The structures referred to in the present invention or these terms of art used are further described below. These illustrations are merely exemplary of how the present invention may be implemented and are not intended to limit the present invention in any way.

Detection of

Detection refers to assaying or testing for the presence of a substance or material, such as, but not limited to, a chemical, organic compound, inorganic compound, metabolic product, drug or drug metabolite, organic tissue or a metabolite of organic tissue, nucleic acid, protein, or polymer. In addition, detection indicates the amount of the test substance or material. Further, the assay means immunodetection, chemical detection, enzyme detection, and the like.

Sample(s)

The sample that can be detected by the detection device of the present invention includes a biological fluid (e.g., a case fluid or a clinical sample). Liquid or fluid samples may be derived from solid or semi-solid samples, including fecal matter, biological tissue, and food samples. The solid or semi-solid sample may be converted to a liquid sample by any suitable method, such as mixing, triturating, macerating, incubating, dissolving, or enzymatically digesting a solid sample in a suitable solution (e.g., water, phosphate solution, or other buffered solution). "biological samples" include samples derived from animals, plants and food, including, for example, urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media derived from humans or animals. Preferably the biological sample is urine. Food samples include food processing materials, end products, meat, cheese, wine, milk and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell culture and medium. An "environmental sample" is derived from the environment (e.g., a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a waste liquid sample). The environmental sample may also include sewage or other wastewater.

With the device of the present invention and a suitable test element, any analyte can be detected. Preferably, the device of the present invention is used for early pregnancy detection. A preferred sample is a urine sample.

Analyte substance

Analytes detected with the device of the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone hormone, follicle stimulating hormone, etc.), blood, leukocytes, sugars, heavy metals or toxins, bacterial material (e.g., proteins or carbohydrates specific for a specific bacterium, such as E.coli 0157: H7, staphylococci, Salmonella, Clostridium, Campylobacter, L. monocytogenes, Vibrio or Cactus) and substances associated with physiological characteristics in urine samples, such as pH and specific gravity.

In addition, it can be used to detect drugs of abuse such as cocaine, amphetamine AMP, methamphetamine MET, barbiturate BAR, sedatives, lysergic acid (LSD), inhibitors (downs, goofballs, barbs, blue devils, yellow jamkes, hypnones), tricyclic antidepressants (TCAs), opiates, anxiolytics, and sedative hypnotics. The device of the utility model can also be used for detecting the medicine application, such as tricyclic antidepressants (imipramine or the like) and acetaminophen, which are easy to take medicine excessively. After being absorbed by human body, the medicines are decomposed into different small molecular substances, and the small molecular substances exist in body fluids such as blood, urine, saliva, sweat and the like or exist in partial body fluids.

Any other clinical urine chemical analysis can all utilize the cooperation of side direction crossing current detection form the utility model discloses the device detects.

In one embodiment, the analyte is any detectable substance. In one embodiment, the analyte comprises a labeled reagent, such as a labeled conjugate that exhibits binding affinity for the analyte of interest or an analog of the analyte of interest.

In one embodiment, the analyte comprises a direct label, such as a dye or gold particle. Accumulation of the substance labeled in this manner may have a detectable effect on the amount of light reflected or transmitted by the detection zone.

In a preferred embodiment, the analyte is HCG or LH, and is used to detect pregnancy or ovulation.

Test element

Multiple test elements may be used in combination with the present invention, with some embodiments of the present invention in which the test element is preferably a test strip. The test strip may take a variety of forms, such as a bio-immune or chemical test form, for detecting an analyte in a sample, such as a drug or a related metabolite indicative of a physical condition. In some forms, the test strip is a bibulous material having a sample application zone, a reagent zone, and a test zone. The sample is applied to the sample application zone and flows into the reagent zone by capillary action. In the reagent zone, the sample dissolves the reagent and mixes with it for detection of the analyte (if present in the sample). The sample with the reagent now continues to flow to the test zone. Other reagents, such as molecules that specifically bind to the analyte, are immobilized on the test zone. These reagents react with the analyte (if present) in the sample and bind the analyte to the zone, or to one of the reagents of the reagent zone.

In one embodiment, the test strip comprises a labeled specific binding reagent for an analyte, typically disposed in a reagent zone of the test strip, and a label-free specific binding reagent capable of specifically binding to the same analyte, immobilized in the test zone downstream of the labeled specific binding reagent, wherein when a liquid sample containing the analyte is applied to the test strip, the liquid sample flows over the test strip and the analyte binds to the labeled specific binding reagent to form a complex, wherein the label is colored. The complex is further moved to a test zone where it is combined with a specific binding reagent immobilized on the test zone without a label to form another complex, so that the analyte is detected at the test zone. In particular, the detection involves accumulation of a label in the test zone, the presence of analyte in the sample tending to cause accumulation of the label

The test strip may include a variety of materials for the transfer of the liquid sample. One of the materials may be coated on the other material, such as filter paper coated on a nitrocellulose membrane. One region of the test strip may be selected from one or more materials while another region is selected from a different one or more materials. The test strip may be adhered to some support or hard surface for increased strength of the pinch test strip.

During the detection process, the analyte is detected by the signal generating system, such as by one or more enzymes that specifically react with the analyte, and one or more combinations of signal generating systems are immobilized on the analyte test zone of the test strip by a method of immobilizing a specific binding substance on the test strip, such as described above. The signal-producing substance can be on the sample addition zone, the reagent zone, or the test zone, or the entire test strip, and the substance can fill one or more materials of the test strip. In particular, the detection preferably comprises accumulation of the label, typically in the test zone. The label may be a colored particle such as an enzyme, a radioisotope label, fluorescein, colloidal gold, colored latex, or the like.

The various regions of the test strip may be arranged in the following manner: a sample adding area, a reagent area, a testing area, a control area, a sample adulteration area and a liquid sample absorption area. The control zone is located after the test zone. All zones may be arranged on a strip of test paper using only one material. The zones may be in direct contact with the liquid sample, or different zones may be arranged according to the direction of flow of the liquid sample, with the ends of each zone being contiguous with and overlapping the ends of the other zone. The used material can be a material with good water absorption such as filter paper, glass fiber or nitrocellulose membrane, and the like, and can also adopt other forms.

The test element applied to the present invention may be a so-called lateral flow test strip (Lateralflowtest strip), the specific structure and detection principle of these test strips being well known in the art by a person skilled in the art, e.g. in the form disclosed in US6156271, US5504013, EP728309, etc. The test element may comprise a plurality of zones, such as a sample collection zone comprising a sample receiving pad, a labeling zone comprising a labeling pad, a test zone comprising a bibulous pad, and a detection zone comprising a desired chemical, such as an immunological or enzymatic reagent, capable of detecting the presence of the analyte. Of course, a control zone may also be included downstream of the test zone, typically the control and test zones are in the form of transverse lines, either detection lines or control lines. Typically, the test strip carries a dry chemical reagent component, such as an immobilized antibody or other reagent, which when exposed to the liquid sample flows along the test strip by capillary action, allowing the dry reagent component to dissolve in the liquid as it flows, and then to the next zone where it reacts with the dry reagent in that zone to perform the necessary test. The liquid flow is mainly by capillary action.

In one embodiment of the present invention, see fig. 7, test element 40 has a sample uptake region 401, a reagent region 402, a test region 403, a reference region 404, a control region 405, and an uptake region 406. Test zone 403 is the area of the test element where the optical signal is formed, and is a stacking or reservoir area for labels, such as particulate colored binding reagents, that indicate the presence of the substance to be analyzed, although some assays, such as displacement assays, may form a signal in the absence of the analyte to be detected. Control zone 405 is another area of the test element capable of forming a light signal for indicating whether the detection is performed correctly and/or whether the binding is actually functional, regardless of the presence of the substance to be analyzed. Reference zone 404 is the region between the test zone and the control zone that is only responsible for the formation of a "background" signal, which can be used, for example, to calibrate an analytical reader and/or to provide a referenceable background signal for the test signal. There may also be no reference zone disposed between the test zone and the control zone.

In one embodiment of the present invention, the test area 403 and/or the control area 405 of the test element correspond to the light-emitting element of the electronic reading device, the light emitted by the light-emitting element is incident on the test area 403 or the control area 405 of the test element, and the light reflected from the area is incident on the corresponding light detector, so as to generate an electrical signal that can be detected, which represents the amount of the analyte in the area.

In other aspects, the device includes a light blocking member 30, such as that shown in FIG. 3, where the light blocking member 30 separates the light detector from the light emitting element, thereby preventing light emitted by the light emitting element from directly entering the light detector, while directing light from the test element into the light detector, or substantially being received by the light detector. Further, the light blocking member 30 blocks light from a corresponding one or more regions of the test element 40 and directs light from the light emitting element to impinge on a corresponding other one or more regions of the test element to direct light from the corresponding other one or more regions of the test element to the light detector, preferably the light blocking member directs light from the test element test area and the control area to impinge on, or substantially be received by, the light detector, as will be described in more detail below.

Light-emitting element and photodetector

The light emitting element and the light detector constitute an optical detection system for detecting the accumulation of the analyte on the test element. The light-emitting element is used for emitting light and irradiating one or more corresponding areas of the test element, and various light sources capable of emitting light are suitable for being used as the light-emitting element. In one embodiment, the light emitting element is a light emitting diode, such as an LED lamp. The photodetector is used to detect the reflected light that has been irradiated thereon and convert it into a detectable electrical signal that is proportional to the amount of label accumulated on the test element, wherein the reflected light is formed by the light emitted by the light-emitting element after reflection by the test element and can also be considered as light from the test element, although the light is substantially from the light-emitting element. In one embodiment, the light detector is a photodiode (PD detector). Suitable light emitting elements and light detectors are well known to those skilled in the art.

In a specific embodiment, the electronic reading device of the present invention comprises at least two light detectors, including a first light detector 201 and a second light detector 202, wherein the first light detector 201 and the second light detector 202 respectively receive reflected light from corresponding regions of the test element. In a preferred mode, the first light detector 201 and the second light detector 202 are disposed at positions corresponding to the test area and the control area of the test element, and respectively receive the reflected light from the test area and the control area of the test element. In a preferred mode, the first light detector 201 and the second light detector 202 are arranged linearly.

In a particular embodiment, the electronic reading device of the present invention comprises at least one light emitting element and at least two light detectors. The at least one light-emitting element includes a first light-emitting element 101, light emitted by the first light-emitting element 101 is irradiated onto one or more corresponding regions of the test element 40, and the light is reflected by corresponding regions of the test element 40 and then received by a first light detector 201 and a second light detector 202. In a preferred embodiment, the first photodetector 201 and the second photodetector 202 are arranged linearly, and the first light emitting element 101 is located opposite to the first photodetector 201 and the second photodetector 202 and is arranged in parallel with the first photodetector 201 and the second photodetector 202, that is, the first photodetector 201 and the second photodetector 202 share one light emitting element. In a preferred embodiment, the first light emitting element 101, the first photodetector 201, and the second photodetector 202 are arranged in a zigzag pattern.

In another specific embodiment, the electronic reading device of the present invention comprises at least two light emitting elements and at least two photodetectors, wherein the at least two light emitting elements comprise a first light emitting element 101 and a second light emitting element 102, the light emitted from the first light emitting element 101 and the second light emitting element 102 respectively irradiates one or more corresponding regions of the testing element 40, and the light is reflected and received by the photodetector 201 and the photodetector 202 respectively (fig. 4). In a preferred embodiment, the light detector 201 is disposed corresponding to the first light emitting element 101, the light detector 202 is disposed corresponding to the second light emitting element 102, and the

light detectors

201 and 202 can respectively receive light emitted from at least two spatially separated regions of the test element. In a preferred embodiment, the first light emitting element 101 is located opposite to the first photodetector 201 and is linearly arranged with the first photodetector 201, and the second light emitting element 102 is located opposite to the second photodetector 202 and is linearly arranged with the second photodetector 202. In a preferred form, the first light-emitting element 101 emits light to the test region of the test element 40 and to regions 407 and 408 (FIG. 8) adjacent the test region, such as to the test region 403 and/or a portion of the reference region 404 and/or a portion of the reagent region 402, the second light-emitting element 102 emits light to the control region 405 of the test element and to regions 409 and 410 (FIG. 8) adjacent the control region, such as to the control region 405 and/or a portion of the reference region 404 and/or a portion of the bibulous region 406, the light detector 201 receives light from the test region 403 of the test element and from regions adjacent the test region, and the light detector 202 receives light from the control region 405 of the test element and from regions adjacent the control region. In a preferred embodiment, light from the first light-emitting element 101 is directed to the test area 403 of the test element 40, light from the second light-emitting element 102 is directed to the control area 405 of the test element, and the light detector 201 and the light detector 202 receive light from the test area 403 and the control area 405 of the test element, respectively. The light-emitting elements correspond to the photodetectors one by one, so that the optical information of each area of the test element can be more accurately reflected, and the accuracy and the sensitivity of detection are ensured. In a preferred embodiment, the first light emitting element 101 and the second light emitting element 102 are linearly arranged, and the first light detector 201 and the second light detector 202 are linearly arranged. Preferably, the two light emitting elements emit light sequentially, that is, the emitted light has a time difference between before and after emission, thereby forming a light emission time difference. Preferably, the light emitted by the two light-emitting elements has the same energy.

In another specific embodiment, the electronic reading device of the present invention comprises at least two light emitting elements and at least three photodetectors, wherein the at least two light emitting elements comprise a first light emitting element 101 and a second light emitting element 102, the light emitted from the first light emitting element 101 and the second light emitting element 102 respectively illuminates one or more corresponding regions of the testing element 40, the light is reflected and then received by the photodetector 201 and the photodetector 202, respectively, and the third photodetector 203 is used for initial calibration or dimming before using the electronic reading device of the present invention (fig. 5 and 6).

In a preferred embodiment, the photodetector 201 is provided corresponding to the first light emitting element 101, the photodetector 202 is provided corresponding to the second light emitting element 102, the first light emitting element 101 and the second light emitting element 102 are linearly arranged, the first photodetector 201 and the second photodetector 202 are linearly arranged, and the third photodetector 203 is provided between the first light emitting element 101 and the second light emitting element 102. In a preferred embodiment, the third light detector 203 is located between the first light emitting element 101 and the second light emitting element 102. In a preferred embodiment, the third photodetector 203 is located between the first light emitting element 101 and the second light emitting element 102 and is linearly aligned with the first light emitting element 101 and the second light emitting element 102.

In the linear arrangement, it is preferable that the first light emitting element 101 and the second light emitting element 102 are located on the same straight line, and the first photodetector 201 and the second photodetector 202 are located on the same straight line, or the first light emitting element 101 and the first photodetector 201 are located on the same straight line, or the second light emitting element 102 and the second photodetector 202 are located on the same straight line, or the first light emitting element 101, the second light emitting element 102 and the third photodetector 203 are located on the same straight line, but it is not limited to be located only on the same straight line, between two light emitting elements, and/or between two photodetectors, and/or between the first light emitting element 101 and the first photodetector 201, and/or between the second light emitting element 201 and the second photodetector 202, and/or between the first light emitting element 101, the second light emitting element 102 and the third photodetector 203 may be staggered with each other, for example, the first light emitting element 101, the second light emitting element 102 and the third light detector 203 may be arranged in a "pin" shape, because the test element generally has a certain width, the light receiving the light emitting element has a certain area, and the light reflected or emitted from the test element also has a certain area, and actually has a certain three-dimensional shape of the light beam or the area of the light, as long as the light detector is within the three-dimensional shape of the light beam or the area of the light. Therefore, a slight positional shift between the light emitting elements and/or between the photodetectors also belongs to an aspect of the present invention.

Light-blocking element

In some preferred forms, the light emitted from the light-emitting element is incident on a specific area of the test element and reflected by the test element to enter the light detector, in which case the light-emitting element and the light detector are generally disposed on the same side of the test element, and therefore, in some forms, it is desirable to provide a light blocking member 30 that allows light from the test element to be received by the light detector. The light blocking member 30 is used to prevent light from the light emitting element from directly entering the photodetector, and to allow light from a specific area of the test element to be received by the photodetector, while blocking light from other areas to be substantially received by the photodetector. Thus, by arranging the light blocking element to alter the path of light emitted by the light emitting element and/or from the test element, light from the light emitting element is incident on the corresponding zone or zones of the test element, while light from the corresponding zone or zones of the test element is received by or substantially received by the light detector. The light path is related to the distance between the light emitting element and the test element, the distance between the light blocking element and the light emitting element, and the height or width of the light blocking element. In general, the light-emitting element emits light, and it is desirable to irradiate the corresponding region on the test element as much as possible, and it is undesirable that the light-emitting element emits light to irradiate other regions unrelated to the detection result, or that the light of the light-emitting element is directly received by the photodetector, and in this case, the light-blocking element is generally disposed to prevent the light emitted by the light-emitting element from being directly received by the photodetector. Although this reduces the interference, if the light from the test element, especially the light not in the target area, is not received by the light detector, the interference of the ineffective light to the light detector is further reduced, and the detection result is more sensitive and reliable.

When light from the light emitting element is directed onto the test strip 40, it is generally of course desirable to direct light onto a test area on the test strip, such as a previously tested area, where a substance, such as an antibody, has been treated, which has an accumulation of colored particulate matter, thereby causing changes in the light emitted by the area, which changes are desirably received by the light detector as much as possible, thereby more sensitively reflecting the optical changes and making the test result more accurate. However, at this time, the light emitted from the light emitting element may be irradiated not only to a specific region, such as the test region 403, but also to other regions outside the test region, such as the reference region 404 between the test region 403 and the control region 405, and the

regions

407 and 408 near the test region, and the light of other regions outside the test region may be irradiated to the photodetector, and the light may not reflect the change of the light of the test region but may be of a type of interference light, which, if received by the photodetector, may cause interference with normal light, thereby failing to sensitively recognize the change of the test region, resulting in inaccuracy of the test result. And the light blocking element is adopted to block the interference light from the test area from being received by the light detector, so that the light from the specific area is received by the light detector as much as possible, and the detection sensitivity is improved.

In some embodiments, the light blocking member 30 can be used to direct the path of light emitted by the light emitting element and/or light from the test element, so that the light emitting element illuminates a specific area of the test element, or so that light from the test element (e.g., a specific area) is received by the light detector as much as possible.

The light blocking member 30 is made of a material that is required to satisfy the function of blocking light, and preferably, the light blocking member 30 is an optical barrier (e.g., opaque and incapable of transmitting the visible light portion of the bopp), and suitable materials include a synthetic plastic resin having a dark or dark black color or black color, such as PPO (polyphenylene oxide).

In a preferred embodiment, the device comprises at least two light detectors, including a first light detector 201 and a second light detector 202, wherein one of the at least two light detectors is separated in a separate space. Referring to fig. 1 to 3, at least one of the two photodetectors is partitioned in an independent space by disposing a light blocking member 30 around the photodetector. By separate space is meant that the partitioned light detector is enclosed in a relatively closed space with respect to the light emitting element, the test element and the further light detector, such that some light outside this space cannot enter the space, in particular that the light detector is not in contact with the light emitting element, such that light emitted by the light emitting element cannot directly enter the light detector, the light detector is not in contact with the test element or a part of the area of the test element, such that light from the test element or a part of the area of the test element cannot enter the light detector, and the light detector is not in contact with the further light detector, such that light entering the relatively closed space cannot be received by the further light detector. In a preferred embodiment, the light-blocking element 30 has a cutout 50 for transmitting light from the test element, which cutout is arranged such that light from a corresponding region of the test element can enter the light detector through the cutout, while light from another region of the test element cannot enter the light detector. The recess 50 serves, on the one hand, to guide the light of the corresponding region of the test element into the light detector and, on the other hand, to guide the path of the light emitted by the light-emitting element, so that as much light as possible of the light-emitting element can impinge on the region of the test element that is intended to be impinged upon. In a preferred form, the notch 50 is located at a position corresponding to the test or control zone of the test element for directing light from the test or control zone of the test element to be received by the light detector. In a preferred manner, the notch 50 comprises a first notch 501 and/or a second notch 502.

In a preferred embodiment, the light blocking element 30 includes a first light blocking member 301 for separating the light detector and the light emitting element, and the first light blocking member 301 is located between the light emitting element and the light detector and is used for guiding the path of the light emitted by the light emitting element to irradiate one or more regions of the test element but not directly irradiate the light detector. In a preferred mode, the first light-blocking member has a first notch 501, specifically, a recess is formed at a position of the first light-blocking member 301 close to the test element 40, when the test element 40 is fixed to the electronic reading device, the first light-blocking member 301 forms the first notch 501 between the recess and the test element 40, and the presence of the first notch 501 reduces the blocking of the light emitted by the light-emitting element and the reflected light from the test element by the first light-blocking member 301, so that the light from the corresponding region of the test element can enter the photodetector through the first notch 501 on one hand, and the light emitted by the light-emitting element can be irradiated onto the corresponding region of the test element to a greater extent on the other hand. In a preferred mode, the first opening 501 is an inclined opening, and specifically, the recess on the first light blocking member 301 is a slope on the side surface adjacent to the light detector and/or the light emitting element, so as to form an inclined first notch 501, and the slope is configured to further reduce the blocking of the reflected light of the test element and/or the light emitted by the light emitting element by the first light blocking member 301, on one hand, to facilitate the light from the corresponding area of the test element 40 to enter the light detector, so as to ensure that the light detector receives the reflected light from the corresponding area of the test element with the largest area, on the other hand, to make the light emitted by the light emitting element irradiate the corresponding area of the test element as much as possible, so that the detection effect is better. In a preferred embodiment, the first notch 501 is disposed corresponding to the test area 403 or the control area 405 of the test element. In a preferred mode, the first notch 501 is arranged corresponding to the position of the test line or the control line of the test element. In a preferred manner, the width of the first indentation 501, i.e. the length of the groove in the first light-blocking member 301, is equal to or less than the width of the test zone 403 or the control zone 405 of the test element.

In a preferred mode, the light blocking element 30 further includes a second light blocking member 302 for separating the light detector and the testing element, and the second light blocking member 302 is disposed between the light detector and the testing element and covers or partially covers the testing element and/or the light detector. When the test element is fixed to the reading device, the second light blocking member 302 contacts the test element 40, covering a partial area of the test element 40. In a preferred form, there is a second notch 502 in the second light blocking member 302, and the area of the test element that contacts the second notch 502 is not covered when the test element 40 is secured to the reading apparatus. The existence of the second notch 502 reduces the blocking of the second light-blocking component 302 to the light of the light-emitting device and the reflected light from the test device, so that on one hand, the light from the area of the test device in contact with the second notch, which is not covered by the second light-blocking component, can enter the photodetector through the second notch 502, and on the other hand, the light of the light-emitting device can be irradiated to the corresponding area of the test device in a wider range, that is, the light of the light-emitting device can be irradiated to the area of the test device in contact with the second notch, which is not covered by the second light-blocking component 302. In this way, the second notch 502 is arranged in correspondence with the test zone 403 or the control zone 405 of the test element, i.e. when the test element is fixed on the reading device, a part of the test zone or the control zone of the test element is not covered by the second light blocking member 302. In a preferred mode, the second notch 502 is disposed corresponding to a position of a test line or a control line of the test element. In a preferred manner, the width of the second notch 502 is equal to or less than the width of the test zone 403 or the control zone 405 of the test element. The second light blocking member 302 can be considered as a plate-like structure disposed between the test element and the photodetector, and the plate-like structure has a hollowed-out area at a position corresponding to the test area or the control area of the test element, thereby forming a second notch 502. The second light blocking member 302 may also be considered to be separated into the fourth light blocking member 304 and the fifth light blocking member 305 separated from each other at the second notch 502, and the second light blocking member 302 may also be considered to be composed of the fourth light blocking member 304 and the fifth light blocking member 305 separated from each other, and the distance between the fourth light blocking member 304 and the fifth light blocking member 305 is equal to the width of the second notch 502.

In a preferred mode, the first notch 501 is communicated with the second notch 502. Specifically, the first notch 501 and the second notch 502 are disposed at the same position with respect to the test area 403 or the control area 405, and there is no connection between the first notch 501 and the second notch 502, that is, the first notch 501 and the second notch 502 are combined together so that the light blocking member 30 has an L-shaped notch 50. In a preferred mode, the width of the first notch 501 is equal to the width of the second notch 502. In a preferred mode, the width of the first notch 501 is not equal to the width of the second notch 502. In a preferred embodiment, a connecting member is provided at the joint of the first notch 501 and the second notch 502, so that the first notch 501 and the second notch 502 are not communicated, and the connecting member is not limited in shape and size, and may have a strip-shaped structure or a sheet-shaped structure, as long as the first notch 501 and the second notch 502 are not completely covered. In a preferred embodiment, the first notch 501 and the second notch 502 may be located at a certain offset, because the width of the test area 403 or the control area 405 has a certain range, and the offset between the first notch 501 and the second notch 502 also ensures that the notch 50 is located at the position of the test area 403 or the control area 405. In a preferred mode, when the second notch 502 is formed in the second light blocking member 302, the first notch 501 may not be formed in the first light blocking member 301.

In a preferred manner, the light-blocking element 30 further comprises a third light-blocking member 303 for separating at least two light detectors. The third light-blocking member 303 is located between the two photodetectors to separate the two photodetectors. In a preferred mode, there is no gap on the third light-blocking member 303, so that light entering the partitioned space cannot enter the other light detector. In a preferred mode, the two photodetectors share one third light-blocking member 303, that is, two adjacent photodetectors are separated by one third light-blocking member 303 disposed therebetween. In a preferred embodiment, the two photodetectors are separated by two third light-blocking members 303, which are independent of each other. In a preferred mode, the two third light blocking members 303, which are independent of each other and are used for separating two adjacent photodetectors, are separated by a distance. In a preferred mode, the two independent third light-blocking members 303 for separating two adjacent light detectors are longitudinally parallel. In a preferred mode, the region between the two independent third light-blocking members 303 for separating the two adjacent light detectors corresponds to the reference region 404 of the test element.

In some preferred forms, the test element 40 may be a separate device that is introduced into an electronic reading device for analyte detection, such as a lateral flow test strip, with which the test element 40 is removably assembled, the light emitting element, light detector, and test element 40 forming a detection space for analyte detection when the test element 40 and electronic reading device are secured together. In some embodiments, the test element 40 is a lateral flow test strip having a sample absorbing zone 401, a reagent zone 402, a test zone 403, a reference zone 404, a control zone 405 and a water absorbing zone 406, the light detector is positioned relative to the test zone or the control zone when the test element 40 is secured to the reading apparatus, the first light blocking member 301 directs light emitted by the light emitting element onto a corresponding area or areas of the test element, the light reflects off of the corresponding area of the test element and into the light detector, and the range of illumination of the light emitting element on the test element and the range of light reflected from the test element and into the light detector is related to the distance between the light emitting element and the test element 40, the height of the first light blocking member 301 and the coverage of the second light blocking member 302.

In a preferred embodiment, the first light blocking member 301 is connected to the third light blocking member 303. In a preferred mode, the angle between the first light blocking member 301 and the third light blocking member 303 at the connection is 90 °, that is, the first light blocking member 303 and the third light blocking member 303 are perpendicular to each other. In a preferred mode, the second light blocking member 302 is located above the first light blocking member 301 and the third light blocking member 303, that is, the second light blocking member 302 is overlaid on the first light blocking member 301 and the third light blocking member 303. In a preferred mode, the second light blocking member 302 is vertically configured with the first light blocking member 301 and the third light blocking member 303. In a preferred mode, the first light-blocking members 301 respectively have longitudinal extensions which intersect the test element 40 and are perpendicular to the short axis of the test element 40, the second light-blocking members 302 are in contact with the test element 40 and have a longitudinally parallel structure, and the third light-blocking members 303 respectively have longitudinal extensions which intersect the test element 40 and are perpendicular to the long axis of the test element 40. In a preferred mode, the light blocking element composed of the first light blocking member 301, the second light blocking member 302, and the third light blocking member 303 partitions the at least one photodetector in a separate space, or may be regarded as a light blocking element composed of the first light blocking member 301, the third light blocking member 303, the fourth light blocking member 304, and the fifth light blocking member 305 partitions the at least one photodetector in a separate space.

In a preferred embodiment, the device further comprises a light-emitting element, and the light-emitting element is disposed at a position corresponding to the test region 403 or the control region 405 of the test element. In a preferred embodiment, at least two light emitting elements are provided, and are respectively disposed opposite to the first photodetector 201 and the second photodetector 202, and the light blocking element 30 is provided between the light emitting elements and the photodetectors. In a preferred mode, the light blocking member 30 is not provided between the two light emitting elements. In a preferred approach, a third light detector 203 is provided between the two light emitting elements for initial calibration or dimming of the device.

Electronic reading device

The electronic reading device is a device for reading the test result on the test element, and the electronic reading device of the present invention may not include the test element 40, and may also include the test element 40. As noted above, test element 40 may be a separate device that is introduced into the electronic reader for analyte detection, or test element 40 may be an integral part of the electronic reader. If the test element 40 is an integral part of the electronic reading device, the electronic reading device may include a test element 40 capable of performing microfluidic or lateral flow assays. The electronic reading device may contain space for receiving the test element 40, but need not necessarily contain the test element 40, and the test element 40 may be combined with the electronic reading device at any suitable time later. When the electronic reading device comprises the test element 40, the electronic reading device can be considered as a detection device for detecting whether the sample contains the analyte, i.e. the electronic reading device of the present invention is essentially a detection device for detecting the analyte in the sample, and any analyte can be detected by using the device of the present invention and a suitable test element. Preferably, the device of the present invention is used for early pregnancy detection.

In one embodiment, the electronic reading device of the present invention comprises a first light emitting element 101 and a second light emitting element 102, which emit light and irradiate one or more corresponding regions of the test element 40; a first light detector 201 and a second light detector 202 that receive reflected light from a corresponding one or more regions of the test element 40; and a light blocking member for guiding a path of the light emitted from the light emitting member and/or the light from the test member to separate the first photodetector 201 and the second photodetector 202 in separate spaces. In a preferred embodiment, the first light emitting element 101 and the first photodetector 201 are disposed at a position corresponding to the test element test area 403, and the second light emitting element 102 and the second photodetector 202 are disposed at a position corresponding to the test element control area 405. Among them, the light blocking member including the first light blocking member 301, the second light blocking member 302, and the third light blocking member 303 partitions the first photodetector 201 in a separate space, and the light blocking member including the sixth light blocking member 306, the seventh light blocking member 307, and the eighth light blocking member 308 partitions the second photodetector 202 in a separate space. In a preferred mode, the light blocking element separating the first photodetector 201 has a notch 50, the notch 50 corresponds to the test area 403 of the test element, the notch 50 includes a first notch 501 located on the first light blocking member 301 and a second notch 502 located on the second light blocking member 302, and the first notch 501 and the second notch 502 are connected. The second light blocking member 302 is separated into the fourth light blocking member 304 and the fifth light blocking member 305 separated from each other at the second notch 502, and thus it can be also considered that the light blocking member 30 including the first light blocking member 301, the third light blocking member 303, the fourth light blocking member 304, and the fifth light blocking member 305 encloses the first photodetector 201 in an independent space. In a preferred mode, the light-blocking element 30 separating the second light detector 202 has a notch 50, the notch 50 corresponds to the control region 405 of the test element, the notch 50 includes a first notch 501 located on the sixth light-blocking component 306 and a second notch 502 located on the seventh light-blocking component 307, and the first notch 501 and the second notch 502 are in communication. The seventh light-blocking member 307 is separated into a ninth light-blocking member 309 and a tenth light-blocking member 310 separated from each other at the second notch 502, and thus it can also be considered that the light-blocking element 30 including the sixth light-blocking member 306, the eighth light-blocking member 308, the ninth light-blocking member 309 and the tenth light-blocking member 310 encloses the second photodetector 202 in a separate space (fig. 3).

In a specific manner, as shown in fig. 3, the light emitted from the first light-emitting element 101 can be irradiated to the test zone 403 of the test element, and the

regions

407 and 408 near the test zone, so that the reflected light from the region before the test zone and the region after the test zone is blocked by the fourth light-blocking member 304 and the fifth light-blocking member 305 and cannot enter the first photodetector 201 due to the presence of the fourth light-blocking member 304 and the fifth light-blocking member 305; since the second gap 502 is formed between the fourth light-blocking component 304 and the fifth light-blocking component 305, the second gap 502 is disposed at a position corresponding to the test area 403 of the test element, and the presence of the second gap 502 enables the test area 403 above the first light detector 201 to be not covered by the light-blocking component, so that light emitted by the light-emitting component can more irradiate the test area 403 of the test element, and light from the test area 403 of the test element can also be received by the first light detector 201. In a specific manner, the light emitted by the second light emitting element 102 can be irradiated to the control region 405 of the test element, and the

regions

409 and 410 near the control region, so that the reflected light from the region before the control region and the region after the control region is blocked by the ninth light blocking member 309 and the tenth light blocking member 310 from entering the second photodetector 202 due to the presence of the ninth light blocking member 309 and the tenth light blocking member 310; since the second gap 502 is formed between the ninth light blocking member 309 and the tenth light blocking member 310, the second gap 502 is disposed at a position corresponding to the position of the test element control region 405, and the control region 405 above the second light detector 202 is not covered by the light blocking member due to the presence of the second gap 502, so that light emitted by the light emitting element can be more irradiated onto the control region 405 of the test element, and light from the test element control region 405 can be received by the second light detector 202.

In the present invention, each light-blocking component constituting the light-blocking element 30 further defines a light path and a light irradiation area by cooperating with each other, specifically, the light emitted from the first light-emitting element 101 irradiates the test area 403 of the test element 40, and then the light from the test area 403 of the test element is received by the light detector 201 through the notch 50, the light emitted from the second light-emitting element 102 irradiates the control area 405 of the test element 40, and then the light from the control area 405 of the test element is received by the light detector 202 through the notch 50, and the light from the test area 403 and the control area 405 of the test element is only received by the light detector through the above light path optimization, so that the effective light from the test element, which can reflect the detection result, is received by the light detector, and other ineffective light is prevented from entering the light detector, thereby completely improving the detection sensitivity and accuracy. Moreover, the arrangement of the notches on the light blocking element enables light emitted by the first light emitting element 101 and the second light emitting element 102 to respectively irradiate the test area 403 and the control area 405 of the test element as much as possible, and then the light is reflected by the test element and received by the first light detector 201 and the second light detector 202, so that the blocking of the light blocking element on the light emitting element is reduced, and the path of the light from the target area of the test element is also limited.

In a specific embodiment, the reading device of the present invention further comprises a substrate 60 and a base frame 70, wherein the light emitting element and the photodetector are located on the substrate 60, and the substrate 60 is a PCB; the base frame 70 has a detection window 701, and the light blocking member is located in the detection window 701 of the base frame 70. When the substrate 60 is combined with the base frame 70 and the test element 40 is fixed on the base frame 70, the detection window 701 encloses the light emitting element, the light detector 201 and one or more regions of the test element 40 in a closed space.

In a specific embodiment, the reading device of the present invention further comprises a housing for supporting the components of the reading device and/or protecting them from the external environment, the housing being composed of an upper shell 80, a lower shell 90 and a cover 100.

In a preferred embodiment, the reading device includes a processor for receiving the electrical signals and performing analysis and result determination. The processor controls the two light-emitting elements to emit light to irradiate the detection area 403 and the control area 405 of the test element 40, the light detector receives the reflected light from the detection area 403 and the control area 405 in turn and converts the reflected light into electric signals, and the processor receives the electric signals from the light detector to perform reading and analysis processing.

In a preferred embodiment, the reading device further comprises a display 130 and a power supply element 140. The processor displays the results of the processing on display 130 to facilitate viewing of the test results. The power supply element 140 is used for supplying power to the entire photoelectric detection system, and may adopt a power supply element such as a button cell.

In a preferred embodiment, the reading device further comprises a buzzer 150 for prompting the progress or result of the test.

It should be understood that the terms "first light-blocking component, second light-blocking component … …, first light-emitting element, second light-emitting element, first light detector, second light detector, first gap, second gap, etc" in the present invention are merely names used for the structure of the electronic reading device of the present invention, and are not intended to limit the present invention.

Detachable combination

Detachable combination means that the two parts are connected in several different states or positions, for example in the case of two physical parts, initially separated, in the case of a suitable first condition connected or combined together, and in the case of a suitable second condition separated by a physical space without touching. Alternatively, the two components may initially be combined, and where appropriate, may be physically separated. Alternatively, the two objects may be initially separate and combined to perform a function when desired, and then separated, or later combined again for a purpose. In general, the combination of the two components or the separation of the two components can be easily performed, and the combination or the separation can be repeated for a plurality of cycles, and of course, the combination and the separation can be performed in a disposable manner. In addition, the two components can be detachably combined, and also three or more components can be detachably combined in pairs.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1 and 7, in some preferred embodiments, the light blocking member is located in the detection window 701 of the base frame 70, the light emitting member and the light detector are disposed on the substrate 60, and the substrate 60 and the base frame 70 are detachably connected, combined, or combined. In a preferred embodiment, the test element 40 is a separate device that incorporates a reading device to which the test element 40 is removably attached, combined or integrated, and the base frame 70 is provided with a card slot 702 that receives the test element 40, the test element 40 being combined with the base frame as appropriate. When the substrate 60 is combined with the base frame 70 and the test element 40 is fixed on the base frame 70, the detection window 701 encloses the light emitting element, the light detector and one or more regions of the test element 40 in a closed space for performing the reading or detection.

Detection method

The utility model provides a method for reading test element's test result provides the electron reading device as before, and the device includes: at least two photodetectors, including a first photodetector 201 and a second photodetector 202, for receiving reflected light from respective areas of the test element, wherein one of said at least two photodetectors is separated in a separate space.

The utility model discloses a method is through letting light emitting component luminous, and light shines behind the corresponding region of test element, is received by the photo detector after reflecting, then forms the signal of telecommunication that can be detected and carries out the judgement of test result. The electrical signal is caused by the accumulated amount of label and is dependent on the amount of analyte in the sample, thereby detecting the amount of analyte in the sample.

In a preferred form, at least one of the photodetectors is separated in a separate space by a light blocking member 30 that surrounds the photodetector to allow light from a particular area of the test element to enter the photodetector.

In a preferred mode, the light blocking member 30 has a notch 50 for allowing light from the test element to pass through, and light from a specific region of the test element enters the light detector through the notch 50.

In a preferred embodiment, the notch is located at a position corresponding to the test area 403 or the control area 405 of the test element, so that light from the test area 403 or the control area 405 of the test element enters the photodetector through the notch 50.

In a preferred manner, the indentations comprise a first indentation 501 and/or a second indentation 502.

In a preferred embodiment, the light blocking member 30 includes a first light blocking member 301 for separating the light detector and the light emitting element, the first light blocking member 301 allows light from the light emitting element to irradiate the test element but not directly irradiate the light detector, and the first light blocking member 301 has a first notch 501.

In a preferred embodiment, the first notch 501 is an inclined notch.

In a preferred mode, the light blocking element 30 further includes a second light blocking member 302 for separating the light detector from the testing element 40, the second light blocking member 302 allows light from the light emitting element to irradiate a corresponding region of the testing element but not irradiate other regions, or allows light from a specific region of the testing element to enter the light detector, and the second light blocking member 302 has a second notch 502.

In a preferred mode, the second notch 502 is in communication with the first notch 501.

In a preferred mode, the light blocking member 30 further includes a third light blocking member 303 for separating the at least two light detectors, and the third light blocking member 303 has no notch.

In a preferred embodiment, the device further includes a light emitting element, and the light emitting element is disposed at a position corresponding to the test area 403 or the control area 405 of the test element, so that light of the light emitting element is irradiated to the test area 403 or the control area 405 of the test element.

In a preferred embodiment, the number of the light emitting elements is at least two, and the light emitting elements include a first light emitting element 101 and a second light emitting element 102, and the light blocking element 30 is not disposed between the at least two light emitting elements.

In a preferred embodiment, a third light detector 203 is further included between the at least two light-emitting elements.

In a preferred embodiment, the at least two light emitting elements and/or the third light detector 203 are arranged linearly.

In a preferred mode, the first light emitting element 101 and the second light emitting element 102 are sequentially made to emit light, light is irradiated on the test area 403 and the control area 405 of the test element, and the light is reflected to enter the first photo detector 201 and the second photo detector 202 to form an electrical signal for determining a detection result, so as to determine the test result.

Use the utility model discloses an electronic reading device reads test element's test result or carries out the step when assay of analyte quality testing and does: (1) the first light-emitting element 101 and the second light-emitting element 102 are programmed to emit light, and the third light detector 203 performs initial calibration or dimming on the device; (2) applying a liquid sample to the test element 40, the liquid flowing over the test element 40, the label accumulating in the test zone 403 of the test element; (3) the first light-emitting element 101 and the second light-emitting element 102 are controlled by a program to sequentially emit light, wherein the light from the first light-emitting element 101 is irradiated onto the test area 403 of the test element, and is received by the first light detector 201 through the notch 50 after being reflected; the light from the second light emitting element 102 is irradiated onto the control area 405 of the test element, reflected and received by the second photodetector 201 through the notch 50; (4) the first photodetector 201 and the second photodetector 202 form electrical signals that can be detected for determination and analysis of the test results.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings, and the described embodiments are only some embodiments, not all embodiments, of the present invention. Based on the embodiment of the present invention, all other technical solutions obtained by a person of ordinary skill in the art without creative work belong to the protection scope of the present invention.

It is to be understood that the terms "above," "before," "after," "out of the way," and the like, are used in the orientations and positional relationships illustrated in the drawings, and are used for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be operated in a particular orientation, and thus should not be construed as limiting the present invention.

Example 1

In this embodiment, the present invention provides a reading device for reading test results of an assay on a test element, the device comprising: the first light-emitting element 101 and the second light-emitting element 102 are respectively arranged at positions corresponding to the test area 403 and the control area 405 of the test element, emit light and irradiate the corresponding area of the test element 40; a first photodetector 201 and a second photodetector 202, respectively disposed opposite to the first light emitting element 101 and the second light emitting element 102, for receiving reflected light from corresponding regions of the test element 40; the light blocking member 30 is used for guiding the path of the light emitted by the light emitting element and/or the light from the testing element, and separates the two photodetectors in a separate space (fig. 1).

In the present embodiment, the first and second

light emitting elements

101 and 102 are light emitting diodes, specifically, LED lamps, and the first and

second photodetectors

201 and 202 are Photodiodes (PDs) for detecting light irradiated thereto and converting into electrical signals that can be detected.

In the present embodiment, the first light emitting element 101 and the second light emitting element 102 are linearly arranged, the first photodetector 201 and the second photodetector 202 are linearly arranged, and the first light emitting element 101 and the first photodetector 201, and the second light emitting element 102 and the second photodetector 202 are linearly arranged, respectively.

In this embodiment, the light blocking element separating the first light detection 201 is provided with a notch 50 for transmitting light from the test area 403 of the test element, the notch 50 is disposed at a position corresponding to the test area 403 of the test element, and includes a first notch 501 and a second notch 502, and the first notch 501 and the second notch 502 are communicated; the light blocking element separating the second light detector 202 is provided with a notch 50 for transmitting light from the control area 405 of the test element, the notch 50 is arranged at a position corresponding to the control area 405 of the test element, and comprises a first notch 501 and a second notch 502, and the first notch 501 is communicated with the second notch 502.

Wherein the light blocking elements comprising the first light blocking member 301, the third light blocking member 303, the fourth light blocking member 304 and the fifth light blocking member 305 enclose the first light detector 201 in an independent space, a first notch 501 is formed on the first light-blocking member 301, the surface of the first notch 501 adjacent to the first light-emitting element 101 and the first light detector 102 is a slope, a second gap 502 is provided between the fourth light blocking member 304 and the fifth light blocking member 305, the first gap 501 and the second gap 502 have the same width, so that an L-shaped notch 50 is formed in the light blocking member enclosing the first photodetector 201, so that the light emitted from the first light-emitting element 101 can be irradiated to the test area 403 as much as possible, and the light from the test area 403 can enter the first photo-detector 201, thereby effectively avoiding the invalid light in the area near the test area from entering the first photo-detector 201. Wherein the light blocking elements comprising the sixth light blocking member 306, the eighth light blocking member 308, the ninth light blocking member 309 and the tenth light blocking member 310 enclose the second light detector 202 in a separate space, a first notch 501 is formed in the sixth light-blocking member 306, the surface of the first notch 501 adjacent to the second light-emitting element 102 and the second light detector 202 is a slope, between the ninth light blocking member 309 and the tenth light blocking member 310, there is a second gap 502, the first gap 501 and the second gap 502 have the same width, thereby forming an L-shaped notch 50 in the light blocking member surrounding the second photodetector 202, so that the light emitted from the second light-emitting element 102 can be irradiated on the control region 405 as much as possible, and the light from the control region 405 can enter the second photodetector 202, thereby effectively avoiding the invalid light in the area near the control region from entering the second photodetector 202. The light path and the light irradiation area are further effectively limited through the light path optimization, so that the sensitivity and the accuracy of the detection result are improved.

In this embodiment, when the test element 40 is fixed on the electronic reading device, the fourth light-blocking member 304, the fifth light-blocking member 305, the ninth light-blocking member 309 and the tenth light-blocking member 310 are in contact with the test element 40 and are longitudinally parallel to the test element 40, and the longitudinal extensions of the first light-blocking member 301, the third light-blocking member 303, the sixth light-blocking member 306 and the eighth light-blocking member 308 intersect with the test element 40.

In this embodiment, the electronic reading device further comprises a third light detector 203, and the third light detector 203 is located between the first light emitting element 101 and the second light emitting element 102, and is linearly arranged with the first light emitting element 101 and the second light emitting element 102, and is used for performing initial calibration or dimming on the electronic reading device.

In this embodiment, the device includes a lateral flow test element 40, and as noted above, the test element 40 may be a separate device introduced into the reader for analyte detection, or the test element 40 may be an integral part of the reader. If the test element is an integral part of the reader, the reader may include a test element 40 that enables microfluidic detection or lateral flow detection.

In this embodiment, the electronic reading device includes a slot or other opening to accommodate insertion of the test element 40 into the reading device, the slot or opening being shaped and dimensioned to allow successful insertion of a test element 40 only in the proper orientation.

In this embodiment, the electronic reading device includes a processor for receiving the electrical signals and performing analysis and result determination. The processor controls the two light-emitting elements to emit light to irradiate the detection area 403 and the control area 405 of the test element 40, the first light detector and the second light detector receive the reflected light from the detection area 403 and the control area 405 in turn and convert the reflected light into electric signals, and the processor receives the electric signals of the light detectors to perform reading and analysis processing.

In this embodiment, the electronic reading device further comprises a display 130 and a power supply element 140. The processor displays the results of the processing on display 130 to facilitate viewing of the test results. The power supply element 140 is used for supplying power to the entire photoelectric detection system, and a power supply element such as a button cell (fig. 7) can be adopted.

In this embodiment, the reading device further comprises a buzzer 150 for prompting the detection process or the detection result.

In the present embodiment, the reading device includes a substrate 60 and a base frame 70, wherein the light emitting elements and the light detectors are located on the substrate 60, and the substrate 60 is an elongated circuit board structure, such as a PCB board. The base frame 70 has a detection window 701, and the light blocking member is located in the detection window 701. In one embodiment, the light blocking member 30 is located in the detection window 701, wherein the fifth light blocking member 305 and the tenth light blocking member 310 may be separate members connected to the detection window 701 or may be formed by extending a distance inward from the detection window 701. Further, the light blocking member 30 and the base frame 70 may be integrally formed (fig. 2 and 5).

In this embodiment, the processor is a circuit system, and the processor, the display 130, the power supply element 140, and the buzzer 150 are disposed on the substrate 60.

In the present embodiment, the substrate 60 is located on one side of the detection window 701, the test element 40 is located on the other side of the detection window 701, the substrate 60 and the base frame 70 may be detachably combined, and when the substrate 60 and the base frame 70 are combined and the test element 40 is fixed on the base frame 70, the detection window 701 encloses one or more regions of the first light emitting element 101, the second light emitting element 102, the first light detector 201, the second light detector 202, the third light detector 203, and the test element 40 in a closed space. At this time, the first light blocking member 301, the third light blocking member 303, the sixth light blocking member 306, and the eighth light blocking member 308 are in seamless contact with the mounting plane of the light emitting element 101/102 and the photodetectors 201 to 203, and separate the first light emitting element 101 and the second light emitting element 102 from the first photodetector 201 and the second photodetector 202, respectively, and separate the first photodetector 201 from the second photodetector 202; the fourth light-blocking member 304, the fifth light-blocking member 305, the ninth light-blocking member 309, and the tenth light-blocking member 310 are in seamless contact with the test element 40, and cover one or more regions of the test element 40, preferably partial regions located before and after the test region, and partial regions located before and after the control region, thereby blocking light emitted from the light-emitting element from reaching the covered regions on the one hand, and blocking light from the covered regions from entering the photodetector on the other hand. The reflected light from the test element test zone and the control zone is received by the two photodetectors through the notches, respectively, and converted into electrical signals that can be detected by the processor. Here, the light blocking element may perform additional functions, such as supporting the test element 40 appropriately, keeping the test element 40 at an appropriate distance from the light emitting element and/or the light detector.

In this embodiment, the test element 40 may be a separate component that is introduced into the reader, with the test element 40 being secured in the card slot 702 on the pedestal 70. In this embodiment, a sample stick 110 is provided at one end of the test element 40 near the detection zone 403. The dipstick 110 is a conventional lateral flow dipstick having one end attached to the sample absorbing zone 401 of the test element 40, i.e. the sample absorbing zone 401 of the test element 40 overlaps the dipstick 110 and the other end is adapted to contact the sample (fig. 7). The sample suction rod 110 is fixed in a groove 703 arranged at one end of the base frame 70, the groove 703 is not in the same horizontal plane with the card slot 702 connected with the test element 40, the position of the groove 703 is lower than the card slot 702, and when the sample suction rod 110 is fixed in the groove 703, the sample suction rod 110 is substantially flush with the test element 40 or the card slot 702 for placing the test element. The groove 703 has a protrusion 704 on the surface for contacting the stick 110, and the protrusion 704 can be inserted into the stick 110 to fix the stick 110 (fig. 1). In use, a sample is drawn by the wand 110 and is fluidically conveyed through the test element 40.

In this embodiment, the electronic reading device has a conducting means for activating or waking up the reading device. The conducting device is a front conducting electrode 120, one end of the front conducting electrode 120 is connected with the sample absorbing rod 110, and the other end of the front conducting electrode is connected with a front electrode contact of a conducting circuit of the reading device. In this embodiment, there are two front-end conductive electrodes 120. In this embodiment, the front end conductive electrode 120 is disposed in the recess 703 for fixing the sample stick 110, and is in contact with the sample stick 110. Specifically, the front-end conducting electrode 120 is located between the groove 703 and the sample suction rod 110, and after the sample is sucked by the sample suction rod 110, when the liquid flows through the front-end conducting electrode 120, the detection system is conducted, and the device starts to perform self-detection. Set up front end conducting electrode 120 between recess 703 and inhale kind stick 110 and can guarantee that the front end conducts electrode 120 and inhales kind stick 110's good contact, because in the use, inhale kind stick 110 and probably take place certain aversion because of collision or misoperation for front end conducting electrode 120 and inhale kind stick 110 can not effective contact, the utility model discloses a device can effectively prevent to switch on or unable activation device because of the front end conducting electrode 120 and inhale that kind stick 110 contact failure arouses.

In this embodiment, the electronic reading device may further include a housing. The function of the housing is to simultaneously support the components of the reading device and/or to protect them from the external environment. The housing may be formed into an optimal shape from a carbonized plastic such as polystyrene or ABS (acrylonitrile butadiene styrene). The housing includes an upper case 80, a lower case 90, and a cover 100. The upper case 80, the lower case 90, and the cover 100 cooperate to form a hollow housing. In this embodiment, the upper housing 80, the lower housing 90, and the cover 100 are detachably combined by a snap, which facilitates assembly. The upper case 80 has a window for observing the result of the test. The structure of the housing is not limited to this, and the detachable combination of the upper housing 80, the lower housing 90 and the cover 100 is not limited to a buckle, for example, screws are suitable for the present invention. The sample suction rod 110 is exposed through an opening at one end of the housing, so that a sample can be conveniently sucked.

The reading device is in a low energy consumption dormant state when not in use, the sample is sucked by the sample sucking rod 110, the liquid sample flows through the front electrode 120 to be conducted, and the reading device is activated. The device will wake up to activate within about 5-15 seconds and immediately begin self-testing to check the calibration parameters.

In one embodiment, after the sample is added to the test element 40 for a period of time (the period of time refers to a reaction time between the analyte in the sample and a detection substance preset on the test element and capable of reacting with the analyte in the sample, and is typically 5-10 minutes), the processor controls the two light-emitting elements to alternately emit light according to a timing design, and the light-emitting elements respectively irradiate the test area 403 and the control area 405 of the test element, the light-receiving area reflects the light, and the reflected light irradiates the light detector 201 and the light detector 202 respectively through the notch 50. The photodetector 201 and the photodetector 202 detect corresponding electrical signals or voltages, respectively, and feed back detection information to the processor, which performs analysis and determination based on the received detection information.

The utility model discloses an electronic reading device provides the light path route of preferred between light emitting component and photo detector, reachs the light intensity signal, changes the judgement value that supplies to judge the comparison through the treater. The reading device with optimized light path can be used on other similar broad spectrum detection equipment.

The invention shown and described herein may be practiced in the absence of any element or elements, limitation or limitations, which is specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, and it is recognized that various modifications are possible within the scope of the invention. It should therefore be understood that although the present invention has been specifically disclosed by various embodiments and optional features, modification and variation of the concepts herein described may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

The contents of the articles, patents, patent applications, and all other documents and electronically available information described or cited herein are hereby incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. Applicants reserve the right to incorporate into this application any and all materials and information from any such articles, patents, patent applications, or other documents.

Claims

1. An electronic reading device for reading the results of an assay test on a test element, the device comprising:

2. An electronic reading device according to claim 1 wherein at least one of the light detectors is separated in a separate space by light blocking elements which surround the light detector.

3. An electronic reading device according to claim 2 wherein the light barrier member has a notch therein to allow light from the test element to pass therethrough.

4. An electronic reading device according to claim 3 wherein the indentation is located at a position corresponding to the test zone or the control zone of the test element.

5. An electronic reading device according to claim 3 wherein the indentation comprises a first indentation and/or a second indentation.

6. An electronic reading device according to claim 3 wherein the light blocking member comprises a first light blocking member for separating the light detector from the light emitting element, the first light blocking member having a first aperture therein.

7. An electronic reading device in accordance with claim 6 wherein the first notch is a slanted notch.

8. An electronic reading device according to claim 3 wherein the light barrier further comprises a second light barrier for separating the light detector from the test element, the second light barrier having a second aperture therein.

9. An electronic reading device in accordance with claim 8 wherein the second aperture is in communication with the first aperture.

10. An electronic reading device according to claim 3, wherein the light barrier member further comprises a third light barrier member separating the at least two light detectors, the third light barrier member being free of apertures.

11. An electronic reading device according to claim 1 further comprising a light emitting element, the light emitting element being positioned at a location corresponding to the test zone or the control zone of the test element.

12. An electronic reading device in accordance with claim 11 wherein there are at least two of the light emitting elements, and no light blocking element is located between the at least two light emitting elements.

13. An electronic reading device in accordance with claim 12 further comprising a third light detector between the at least two light emitting elements.

14. An electronic reading device according to claim 13 wherein the at least two light emitting elements and/or the third light detector are arranged linearly.

15. An electronic reading device in accordance with claim 1 further comprising a lateral flow test element comprising a test zone and a control zone thereon.