CN210090318U - Reading device and reading device for reading detection result - Google Patents

Abstract

The utility model relates to a biochemical detection field, concretely relates to reading device and reading device of reading testing result, the device includes first light emitting component, photo-detector and light blocking component, wherein, the light blocking component includes first and second light blocking component, first light blocking component is located between light emitting component and the photo-detector, and it guides the light that light emitting component sent to shine on the test element; the second light blocking element is positioned above the light detector and directs light from the test element to be received by the light detector. 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 to improve sensitivity, reduced the interference of irrelevant regional light to the photodetector in addition, improved the accuracy and the sensitivity that detect.

Description

Reading device and reading device for reading detection result

Technical Field

The present invention relates to the field of biochemical testing, and in particular, to a 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 device of chemical examination result, include: the first light-emitting element emits light and irradiates one or more corresponding areas of the test element; a light detector receiving reflected light from a corresponding one or more regions of the test element.

In some preferred forms, the device further comprises a light blocking member which allows light from the test element to be received by the light detector. In some forms, the element prevents light from the light emitting element from impinging directly on the light detector. In some preferred forms, the element allows illumination from a particular area of the test element to be received by the light detector, while blocking light from other areas to be substantially received by the light detector. In some preferred forms, the specific area may be one or more of the test area or the control area, and the other area may be an area preceding the test area or the control area, for example, an area between the control area and the test area, or a marking area, a water absorption area.

In some approaches, when a test element is present, the light blocking element is positioned between the light detector and the test element. Thus, a part of the area of the test element is blocked from receiving the light emitted from the light emitting element, or a part of the area of the test element is blocked from emitting the light onto the photodetector. In some embodiments, the light blocking member is longitudinally parallel to the test member. In some approaches, the light blocking member is in contact with certain areas of the test member.

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

In some preferred forms, the light blocking element includes a first light blocking element and a second light blocking element, wherein the first light blocking element is configured to guide light emitted from the light emitting element to irradiate one or more regions of the test element. In some preferred forms, the second light blocking element allows light from the test element or a particular area of the test element to be received by the light detector. In some preferred forms, the first light blocking element and the second light blocking element cooperate to direct light emitted by the light emitting element to impinge on one or more regions of the test element, such that light from the test element or a particular region of the test element is received by the light detector.

Preferably, the second light blocking element is located above the photodetector.

Preferably, the second light blocking element is arranged between the light detector and the test element.

Preferably, the extension of the first light blocking element intersects with the test element, and the second light blocking element is longitudinally parallel to the test element.

Preferably, the second light blocking element and the first light blocking element are arranged perpendicular to each other.

Preferably, the device further comprises a third light-blocking element, wherein the light detector is located between the first and third light-blocking elements.

Preferably, the second light blocking element is located between the first and third light blocking elements and covers the photodetector.

Preferably, a second light emitting element is provided outside the third light blocking element.

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

Preferably, the first light blocking element and the second light blocking element have a gap through which light from the test element passes.

Preferably, the gap is an inclined gap.

Preferably, the second light blocking element is arranged in a region between the test zone and the control zone of the test element.

Preferably, the first light blocking element guides light from the light emitting element to the test element, and the second light blocking element guides light from the test element to the photodetector.

Preferably, the first light blocking member guides light emitted from the light emitting member to the test member without irradiating the light to the photodetector.

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

In a preferred embodiment, the present invention provides a reading device for reading test results from an assay on a test element, the device comprising:

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

a light detector for receiving reflected light from a corresponding one or more regions of the test element;

and the light blocking element is used for guiding the path of light emitted by the light emitting element and/or light from the testing element, wherein the light blocking element comprises a first light blocking element, a second light blocking element and a third light blocking element, the light detector is positioned between the first light blocking element and the third light blocking element, and the second light blocking element is positioned above the light detector and is positioned between the first light blocking element and the third light blocking element.

Preferably, the first light emitting element is located outside the first light blocking element, and the second light emitting element is located outside the third light blocking element.

Preferably, the first and second light emitting elements and the photodetector are linearly arranged.

Preferably, the second light-blocking element is arranged parallel to the test element, and the extensions of the first and third light-blocking elements intersect the test element.

Preferably, the first and third light-blocking elements are not in contact with the test element, and the third light-blocking element is in contact with the test element.

Preferably, the second light blocking element is arranged between the light detector and the test element.

In a second aspect of the present invention, the present invention provides a method of reading a test result of a test element, providing a reading device as described above, the device comprising: the first light-emitting element emits light and irradiates one or more corresponding areas of the test element; a light detector for receiving reflected light from a corresponding one or more regions of the 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 so that the light from the test member is received by the photodetector or substantially received by the photodetector.

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

In some embodiments, the light blocking element includes a first light blocking element and a second light blocking element, wherein the first light blocking element is located between the light emitting element and the light detector, so that light emitted from the light emitting element is irradiated onto the test element but not onto the light detector.

In some embodiments, the second light blocking element is located above the light detector, so that the second light blocking element guides the light from the test element to the light detector.

In some embodiments, the second light blocking element is positioned between the light detector and the test element to separate the corresponding area or areas of the test element from the light detector, or to separate the corresponding area or areas of the test element from the light detector, such that light from the corresponding area of the test element is received by the light detector and light from another corresponding area of the test element is not received by the light detector.

In some embodiments, the second light blocking element is disposed in a region of the test element between the test zone and the control zone such that light from the test element test zone and/or the control zone is received by the light detector and light from the region of the test element between the test zone and the control zone is not received by the light detector.

In some embodiments, the second light blocking element is disposed in a reference region of the test element, and separates the test region from the control region of the test element, such that light from the test region and/or the control region of the test element is received by the light detector and light from the reference region of the test element is not received by the light detector.

In some specific embodiments, the first light blocking element extends across the test element, and the second light blocking element is longitudinally parallel to the test element.

In some specific embodiments, the second light blocking element and the first light blocking element are arranged in a mutually perpendicular manner.

In some embodiments, the device further comprises a third light blocking element, such that the light detector is positioned between the first and third light blocking elements.

In some embodiments, the second light blocking element is located between the first and third light blocking elements, and the second light blocking element is disposed over the light detector.

In some specific embodiments, a second light emitting element is disposed outside the third light blocking element.

In some embodiments, the first light-emitting element and the photodetector are linearly arranged, or the first light-emitting element and/or the second light-emitting element and the photodetector are linearly arranged.

In some embodiments, the first light blocking element and the second light blocking element have a gap for transmitting light from the test element.

In some embodiments, the gap is a slanted gap through which light from the test element is received by the light detector.

In some specific embodiments, the first light-emitting element corresponds to a test area of the test element, the second light-emitting element corresponds to a control area of the test element, the first light-emitting element and the second light-emitting element sequentially emit light, and the light is reflected and received by the photodetector after being irradiated on the test area and the control area of the test element, so as to form an electrical signal for determining a detection result.

In some specific embodiments, the reading device further comprises a fourth light blocking element and a fifth light blocking element, and the fourth light blocking element and the fifth light blocking element are respectively located on the first light emitting element and the second light emitting element, and cover or partially cover the first light emitting element and the second light emitting element.

In some specific embodiments, the fourth light-blocking element and the fifth light-blocking element are respectively located on two sides of the second light-blocking element, and are in a longitudinal parallel structure with the test element, so that when the test element is fixed to the reading device, the fourth light-blocking element and the fifth light-blocking element are in contact with the test element, and cover corresponding areas of the test element.

In some embodiments, the fourth light blocking element covers a region before the test area of the test element, and blocks the light emitted by the first light emitting element from being irradiated onto the region before the test area of the test element.

In some specific embodiments, the fifth light-blocking element covers an area behind the control area of the test element, and blocks light emitted by the second light-emitting element from being irradiated onto the area behind the control area of the test element.

In some specific embodiments, gaps for allowing light emitted by the first light emitting element and the second light emitting element to irradiate the test element are respectively arranged between the fourth light blocking element and the first light blocking element, and between the fifth light blocking element and the third light blocking element.

Advantageous effects：

The utility model discloses a 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 a reading device compact structure has guaranteed abundant and the effective utilization of light path signal, has increased the degree of accuracy and the sensitivity that detect. The light from the specific area of the test element is received by the light detector as much as possible, so that the sensitivity is improved, the interference of the light of an irrelevant area to the light detector is reduced, and the accuracy and the sensitivity of the detection are improved.

Drawings

Fig. 1 is a schematic diagram of the principle structure of the present invention.

Fig. 2 is a schematic longitudinal sectional view of a reading device according to an embodiment of the present invention.

Fig. 3 is a schematic diagram of a partially enlarged structure of a reading device according to an embodiment of the present invention.

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

Fig. 5 is an exploded view of a reading device in accordance with an embodiment of the present invention.

Fig. 6 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 photodetector, 301 a first light blocking element, 302 a second light blocking element, 303 a third light blocking element, 304 a fourth light blocking element, 305 a fifth light blocking element, 40 a test element, 401 a sample absorbing region, 402 a reagent region, 403 a test region, 404 a reference region, 405 a control region, 406 a water absorbing region, regions near the test regions of 408 and 409, 501 a first gap, 502 a second gap, 503 a third gap, 504 a fourth gap, 60 a substrate, 70 a pedestal, 701 a detection window, 702 a clamping groove, 703 a clamping holder, 704 a bump, 80 an upper shell, 90 a lower shell, 100 a cover, 110 a sample absorbing rod, 120 a front end conducting electrode, 130 a display, 140 a power supply element, 150 a 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. 5, 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 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 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 ways, the device includes a light blocking member 302, such as that of FIG. 1, positioned between the light detector PD and the test element 40, such that light from the test element is partially blocked by the light blocking member 302, thereby preventing reception by the light detector PD. In one approach, the reference region, e.g., in fig. 1, between the test region and the control region is blocked by light blocking element 302, which does not allow light from the reference region to be received by photodetector PD, thereby reducing interference. The following is a specific explanation.

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 the corresponding one or more regions of the test element, and various light sources capable of emitting light are suitable as the light emitting element. The photodetector is used for detecting the reflected light irradiated thereon and converting the reflected light into a detectable electric signal which is proportional to the amount of the marker accumulated on the test element, wherein the reflected light is formed by the light emitted from the light emitting element after being reflected by the test element and can also be regarded as light from the test 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 particular embodiment, the reading device of the present invention comprises at least one light emitting element and at least one light detector. 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 the corresponding regions of the test element 40 and then received by a light detector 201. In a preferred embodiment, the first light emitting element 101 and the photodetector 201 are linearly arranged.

In another specific embodiment, the reading device of the present invention comprises at least two light emitting elements and at least one light detector, 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, the light is reflected and then received by the light detector 201, and the first light emitting element 101 and the second light emitting element 102 share one light detector 201. In a preferred embodiment, the photodetector 201 is located between the first light-emitting element 101 and the second light-emitting element 102, and is capable of receiving light emitted by at least two spatially separated regions of the test element in sequence (fig. 1 and 4). In a preferred embodiment, the light emitted from the first light emitting element 101 and the light emitted from the second light emitting element 102 are irradiated to the test area 403 and the control area 405 of the test element, respectively, and the photodetector 201 is located between the first light emitting element and the second light emitting element, and receives the light from the test area 403 and the control area 405 of the test element in this order. In a preferred embodiment, the first light emitting element 101 and/or the second light emitting element 102 are linearly arranged with the photodetector 201. 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 wavelengths of the light emitted by the two light-emitting elements are identical.

In the linear arrangement, it is preferable that the light emitting element and the light detector are located on the same straight line, but it does not mean that they are located only on the same straight line, and the light emitting element and the light detector may be staggered from each other because the test strip 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 strip 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 element and the photodetector 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 element that allows light from the test element to be received by the light detector. The light blocking element is used on one hand to prevent light from the light emitting element from directly entering the light detector, and on the other hand to allow light from a certain area of the test element to be received by the light detector, while blocking light from other areas to be substantially received by the light detector. 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 one or more regions of the test element, while light from 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. Generally, the light emitted from the light emitting element is desired to be irradiated into the corresponding region on the test element as much as possible, but the light emitted from the light emitting element is not desired to be directly received by the photodetector at this time, and the light blocking element is generally disposed to prevent the light emitted from the light emitting element from being directly received by the photodetector at this time. Although this mitigates interference, it is even more so if the light from the test element, and particularly the light not in the target area, is not received by the light detector. When light from the light emitting element LED1 is directed onto the test strip 40, such as shown in fig. 1, it is generally desirable, of course, that the test area on the test strip, e.g., the previously tested area, has been treated with a substance, such as an antibody, that has an accumulation of colored particulate matter, causing a change in the light emitted by that area, and that such changes be received by the photodetector as much as possible, so that these optical changes can be more sensitively reflected and more accurate results can be measured. 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 between the test region and the control region, and the regions 407 and 408 near the test region, and the light of the reference region may be irradiated onto the photodetector, or the slow reflection of the light of the reference region formed in the region between the light blocking members 301 and 303 may be received by the photodetector, and the light may not reflect the change of the light of the test region but may be of the type of disturbing light, which, if received by the photodetector, causes disturbance to normal light, thereby failing to sensitively recognize the change of the test region, thereby causing 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 approaches, when a test element is present, the light blocking element is positioned between the light detector and the test element. Thus, a part of the area of the test element is blocked from receiving the light emitted from the light emitting element, or a part of the area of the test element is blocked from emitting the light onto the photodetector. In some embodiments, the light blocking member is longitudinally parallel to the test member. In some approaches, the light blocking member is in contact with certain areas of the test member.

In some embodiments, the light blocking element can be used to direct the path of light emitted by the light emitting element and/or light from the test element, such that the light emitting element illuminates a particular specific area of the test element, or such 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 is made of a material that satisfies the function of blocking light, and preferably the light blocking member is an optical barrier (e.g., opaque and incapable of transmitting the visible light portion of the bopp), and suitable materials include dark or dull black or black synthetic plastic resins such as PPO (polyphenylene oxide) and the like.

In a preferred embodiment, the light blocking element includes a first light blocking element 301 and a second light blocking element 302. The first light blocking element 301 is used to guide the light emitted from the light emitting element to irradiate one or more regions of the test element, and the second light blocking element 302 is used to receive the light from the test element or the light from a specific region of the test element by the light detector 201. In some preferred forms, the first light barrier 301 and the second light barrier 302 cooperate to direct light emitted by the light emitting device to one or more areas of the test device, and to allow light from the test device or a particular area of the test device to be received by the light detector 201 (FIG. 1).

In a preferred mode, the first light blocking member 301 is disposed corresponding to the position of the first light emitting element 101 and the photodetector 201, is located between the first light emitting element 101 and the photodetector 201, separates the first light emitting element 101 from the photodetector 201, and guides the light emitted from the first light emitting element 101 to the test element 40 without being irradiated to the photodetector 201. In a preferred mode, the first light-blocking member 301 guides the light emitted from the first light-emitting member 101 to irradiate one or more corresponding regions of the test member, and the irradiation range of the light on the test member is related to the distance between the first light-emitting member 101 and the test member 40 and the height of the first light-blocking member 301.

In a preferred manner, the second light blocking element 302 is located above the photo detector 201, i.e. the second light blocking element 302 is spatially located above the photo detector 201, covering the photo detector 201 and being spaced apart from the photo detector 201.

In some embodiments, the test element 40 can be a separate device that is introduced into the reader for analyte detection, such as a lateral flow test strip, and the test element 40 is removably assembled with the reader, such that the first light emitting element 101, the light detector 201, and the test element 40 form a detection space for analyte detection when the test element 40 and the reader are secured together. In some embodiments, test element 40 is a lateral flow test strip having a sample uptake zone 401, a reagent zone 402, a test zone 403, a control zone 405, and an uptake zone 406, etc., or a reference zone 404 between test zone 403 and control zone 405, where test zone 403 is a zone in the test element where a light signal is formed (e.g., a stacking or storage zone for a label of a particulate colored binding reagent) indicating the presence or absence of an analyte, control zone 405 is used to indicate whether the test is being performed properly, regardless of the presence or absence of an analyte, and reference zone 404 is a zone where a background signal is formed that can be used to calibrate the reading device or provide a referenceable background signal for the test signal.

In a preferred form, the second light blocking member 302 is positioned between the light detector 201 and the test element 40 when the test element 40 is secured to the reading apparatus. In a preferred mode, when the test element 40 is fixed to the reading device, the second light blocking element 302 is in contact with the corresponding zone or zones of the test element 40, covers the corresponding zone or zones of the test element 40, separates one or more zones of the test element 40, or separates one or more zones of the test element 40 from the light detector 201, so as to block light emitted by the first light emitting element 101 from reaching the zone of the test element 40 covered by the second light blocking element 302, and/or block light from the zone of the test element 40 covered by the second light blocking element 302 from entering the light detector 201, i.e. to guide light from the zone of the test element 40 capable of reflecting the accumulation of the markers to the light detector 201. In a preferred form, the second light blocking member 302 is spaced from and covers the corresponding area or areas of the test element 40 when the test element 40 is secured to the reading apparatus, such that light from the first light emitting element 101 does not impinge on the covered area of the test element 40, or such that light from the covered area of the test element 40 does not impinge on the light detector 201.

In a preferred manner, the second light-blocking element 302 is arranged in correspondence with the area between the test zone 403 and the control zone 405 of the test element 40, separating the test zone 403 and the control zone 405 of the test element 40, so as to block the light emitted by the first light-emitting element 101 from impinging on the area between the test zone 403 and the control zone 405 of the test element 40 and/or from entering the light detector 201 from the area between the test zone 403 and the control zone 405 of the test element 40. In a preferred manner, the second light blocking element 302 is positioned in an area corresponding to the reference area 404 of the test element 40, so as to block light emitted by the first light emitting element 101 from impinging on the reference area 404 of the test element 40 and/or to block light from the reference area 404 of the test element from entering the light detector 201. The light from the area between the test zone 403 and the control zone 405 of the test element or the light from the reference zone 404 of the test element is independent of the presence or absence of the analyte, and blocking the light emitted by the first light-emitting element 101 from impinging on the area or blocking the light from the area from entering the light detector 201 can effectively avoid the influence of ineffective light on the detection result, and contributes to the improvement of the sensitivity and accuracy of the detection.

In a preferred manner, the longitudinal extension of the first light barrier 301 intersects the test element 40, while the second light barrier 302 is longitudinally parallel to the test element 40, the second light barrier 302 and the first light barrier 301 being arranged in a mutually perpendicular manner, i.e. the longitudinal extension of the first light barrier 301 intersects the transverse extension of the second light barrier 302 and the angle is 90 °.

In a preferred mode, the first light emitting element 101 and the photodetector 201 are linearly arranged, the first light blocking element 301 is located between the first light emitting element 101 and the photodetector 201, and the second light blocking element 302 is located above the photodetector 201.

In a preferred mode, when the test element 40 is fixed to the reading device, the second light blocking member 302 is in contact with the test element 40, while the first light blocking member 301 is not in contact with the test element 40, and a first gap 501 for transmitting light from the test element 40 is formed between the first light blocking member 301 and the second light blocking member 302. Specifically, the height of the first light blocking member 301 is smaller than the vertical distance between the test element 40 and the first light emitting element 101, and the second light blocking member 302 is not in contact with the first light blocking member 301, so that a first gap 501 capable of allowing the reflected light from the test element to pass through is formed between the first light blocking member 301 and the second light blocking member 302. In a preferred manner, the first gap 501 is an inclined gap, and specifically, the side surface of the first light blocking element 301 and/or the second light blocking element 302 adjacent to the light detector 201 is a slope surface, so as to form the inclined first gap 501, and the slope surface is configured to further reduce the blocking of the reflected light by the first light blocking element 301 and/or the second light blocking element 302, so as to facilitate the light from the test element 40 to enter the light detector 201, so as to ensure that the light detector 201 receives the reflected light from the corresponding area of the test element with the largest area, so that the detection effect is better.

In another preferred embodiment, the device further comprises a third light blocking element 303, wherein the light detector 201 is located between the first light blocking element 301 and the third light blocking element 303. In a preferred mode, the second light blocking element 302 is located between the first light blocking element 301 and the third light blocking element 302 and covers the light detector 201.

In a preferred embodiment, the second light-emitting element 102 is disposed outside the third light-blocking element 303, and the first light-blocking element 301 and the third light-blocking element 303 respectively separate the first light-emitting element 101 and the second light-emitting element 102 from the photodetector 201, so as to ensure that the light emitted by each light-emitting element only irradiates the corresponding region of the test element and not irradiates the photodetector.

In a preferred form, when the test element 40 is secured to the reading apparatus, the second light blocking element 302 is in contact with the test element 40, the third light blocking element 303 is not in contact with the test element 40, and a second gap 502 is provided between the third light blocking element 303 and the second light blocking element 302 to allow light from the test element 40 to pass therethrough. Specifically, the height of the third light blocking element 303 is smaller than the vertical distance between the test element 40 and the second light emitting element 102, and the second light blocking element 302 is not in contact with the third light blocking element 303, so that a second gap 502 capable of transmitting the reflected light from the test element 40 is formed between the second light blocking element 302 and the third light blocking element 303. In a preferred embodiment, the second gap 502 is an inclined gap, and in particular, the side of the third light blocking element 303 and/or the second light blocking element 302 adjacent to the light detector 201 is a slope, so as to form the inclined second gap 502, and the slope is configured to further reduce the blocking of the reflected light by the third light blocking element 303 and/or the second light blocking element 302, so as to facilitate the light from the test element 40 to enter the light detector 201.

In other words, in the above embodiment, the second light blocking member 302 is spatially located between the first light blocking member 301 and the third light blocking member 303, the width of the second light blocking member 302 is equal to or smaller than the horizontal distance between the first light blocking member 301 and the third light blocking member 303, and the height of the first light blocking member 301 and the third light blocking member 303 is smaller than the vertical distance between the test member 40 and the light emitting member, thereby forming the first gap 501 and the second gap 502 described above.

In a preferred mode, the first, second and third light blocking elements are rectangular parallelepiped plate-shaped structures, and when the side surface of the first light blocking element 301 and/or the second light blocking element 302 and/or the third light blocking element 303 adjacent to the light detector is a slope surface, the width of the second light blocking element 302 is equal to or less than the horizontal distance between the first light blocking element 301 and the third light blocking element 303.

In a preferred embodiment, the first light emitting element 101 and/or the second light emitting element 102 are linearly arranged with the photodetector 201. The first light emitting element 101 or the second light emitting element 102 corresponds to the test area 403 or the control area 405 of the test element, respectively, and the emitted light irradiates the test area 403 or the control area 405, respectively.

In a preferred embodiment, the first light emitting element 101 and the second light emitting element 102 are linearly arranged with the photodetector 201, and the photodetector 201 is disposed in the middle of the two light emitting elements, that is, the two light emitting elements share one photodetector. The first light emitting element 101 corresponds to the test area 403 of the test element 40, and the second light emitting element 102 corresponds to the control area 405 of the test element; wherein the first light blocking element 301 is located between the first light emitting element 101 and the light detector 201 and blocks light emitted from the first light emitting element 101 from entering the light detector 201, the third light blocking element 303 is located between the second light emitting element 102 and the light detector 201 and blocks light emitted from the second light emitting element 102 from entering the light detector 201, the second light blocking element 302 is located between the first light blocking element 301 and the third light blocking element 303 and covers the light detector 201, and the test area 403 and the control area 405 of the test element 40 are separated from each other corresponding to an area between the test area 403 and the control area 405 of the test element 40 or corresponding to the reference area 404 of the test element 40. The arrangement is such that, in use, light emitted by the two light-emitting elements impinges on the test zone 403 and the control zone 405 of the test element 40, respectively, and does not impinge on the region of the test element 40 between the test zone 403 and the control zone 405, or does not impinge on the reference zone 404, and the light detector 201 also receives reflected light from the test zone 403 and the control zone 405 in turn, and does not receive light from the region of the test element 403 and the control zone 405 or from the reference zone 404, thereby further improving the sensitivity and accuracy of the detection.

In another preferred embodiment, the reading device further comprises a fourth light-blocking member 304 and a fifth light-blocking member 305, wherein the fourth light-blocking member 304 and the fifth light-blocking member 305 are respectively located above the first light-emitting element 101 and the second light-emitting element 102, and cover or partially cover the first light-emitting element 101 and the second light-emitting element 102. In a preferred manner, the fourth light-blocking element 304 is spatially located outside the first light-blocking element 301, and the fifth light-blocking element 305 is spatially located outside the third light-blocking element 303, so as to further define the irradiation range of the light emitted by the first light-emitting element 101 and the second light-emitting element 102 on the test element 40. In a preferred mode, the fourth light-blocking element 304 and the fifth light-blocking element 305 are respectively located at two sides of the second light-blocking element 302, and are in a longitudinally parallel structure with the test element 40, and when the test element 40 is fixed to the reading device, the fourth light-blocking element 304 and the fifth light-blocking element 305 are in contact with the test element 40, and cover corresponding areas of the test element 40. In a preferred mode, when the test element 40 is fixed to the reading device, the fourth light-blocking member 304 covers the area of the test element before the test area, and blocks the light emitted from the first light-emitting member 101 from being irradiated onto the area of the test element before the test area. In a preferred mode, when the test element 40 is fixed to the reading device, the fifth light-blocking member 305 covers the area behind the control area of the test element, and blocks the light emitted by the second light-emitting element 102 from irradiating the area behind the control area of the test element.

In a preferred mode, a third gap 503 and a fourth gap 504 are respectively arranged between the fourth light-blocking member 304 and the first light-blocking member 301, and between the fifth light-blocking member 305 and the third light-blocking member 303, for enabling the light emitted by the first light-emitting element 101 and the second light-emitting element 102 to irradiate the test element 40. The fourth light blocking member 304 and the fifth light blocking member 305 guide the light emitted from the light emitting element to irradiate only a specific region of the test element, preferably only the test region 403 and the control region 405 of the test element, or only the region where the test line and the control line of the test element are located.

In a preferred mode, the first to fifth light blocking elements cooperate with each other to further define a light path and a light irradiation area, specifically, the light emitted from the first light emitting element 101 is irradiated only to the test region 403 of the test element 40 through the third gap 503, and light from the test element test area 403 is received by the light detector 201 through the first gap 501, light emitted by the second light emitting element 102 is irradiated only to the control area 405 of the test element 40 through the fourth gap 504, light from the test element control area 405 is then received by the light detector 201 through the second gap 502, the light emitted by the light-emitting elements illuminates only the test zones 403 and the control zones 405 of the test elements by means of the above-described optical path optimization, the effective light from the test element capable of reflecting the detection result is received by the light detector, and other ineffective light is prevented from entering the light detector, so that the detection sensitivity and accuracy are comprehensively improved.

Reading device

The reading device is a device for reading the test result on the test element, and the reading device of the present invention may not include the test element 40, and may also include the test element 40. As described above, test element 40 may be a separate device that is introduced into the reader for analyte detection, or test element 40 may be an integral part of the reader. If the test element 40 is an integral part of the reader, the reader may include a test element 40 capable of microfluidic detection or lateral flow detection. The reading device may contain a space for receiving the test element 40, but does not necessarily have to contain the test element 40, and the test element 40 may be combined with the reading device at any suitable time later. When the reading device comprises a test element 40, the reading device can also be considered as a detection device for detecting whether the sample contains the analyte, i.e. the 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 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 reading device of the present invention comprises a first light emitting element 101, which emits light to one or more corresponding regions of the test element 40; a light detector 201 for receiving reflected light from a corresponding one or more regions of the test element 40; and a light blocking element for guiding a path of light emitted by the light emitting element and/or light from the test element, wherein the light blocking element includes a first light blocking element 301 and a second light blocking element 302, the first light blocking element 301 is located between the first light emitting element 101 and the photodetector 201 and blocks light from the first light emitting element 101 from entering the photodetector 201, and the second light blocking element 302 is located above the photodetector 201 and guides light from the test element 40 to enter the photodetector 201.

In a specific embodiment, the reading device of the present invention further comprises a second light emitting element 102 and a third light blocking element 303, wherein the first light emitting element 101 is located outside the first light blocking element 301, the second light emitting element 102 is located outside the third light blocking element 303, the light detector 201 is located between the first light blocking element 301 and the third light blocking element 303, and the first light emitting element 101, the second light emitting element 102 and the light detector 201 are arranged linearly. The first light blocking element 301 blocks light from the first light emitting element 101 from entering the light detector 201, the third light blocking element 303 blocks light from the second light emitting element 102 from entering the light detector 201, and the second light blocking element 302 is located above the light detector 201 and between the first light blocking element 301 and the third light blocking element 302, and guides light from a corresponding area of the test element 40 to be received by the light detector 201.

In a specific embodiment, the reading apparatus of the present invention further comprises a fourth light-blocking element 304 and a fifth light-blocking element 305, wherein the fourth light-blocking element 304 and the fifth light-blocking element 305 are respectively located on the first light-emitting element 101 and the second light-emitting element 102, and respectively correspond to an area before the test area of the test element and an area after the control area of the test element, and block light emitted from the first light-emitting element 101 from being irradiated onto the area before the test area of the test element and block light emitted from the second light-emitting element 102 from being irradiated onto the area after the control area of the test element.

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 101/102 and the light detector 201 are located on the substrate 60, 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 one or more regions of the first light emitting element 101, the second light emitting element 102, the photodetector 201, and 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.

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. 5, in some preferred embodiments, the light blocking element 301-305 is located in the detection window 701 of the base frame 70, the light emitting element 101-102 and the light detector 201 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 one or more regions of the first light emitting element 101, the second light emitting element 102, the photodetector 201 and the test element 40 in a closed space for performing the reading or detection.

Detection method

The utility model discloses still provide a method of reading test element's test result, provide the reading device as before, the device includes: a first light emitting element 101 emitting light to irradiate one or more regions corresponding to the test element; a light detector 201 for receiving 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 allow the light from the test member 40 to be received by the light detector 201 or substantially received by the light detector 201.

The utility model discloses a method lets light emitting component luminous, and light shines behind the corresponding region of test element, is received by the photo detector through the reflection, then forms the signal of telecommunication that can be detected and carries out the judgement of test result. In a preferred form, the photodetector will produce a voltage that is approximately linearly related to the intensity of the light impinging thereon. This voltage is caused by the accumulated amount of label and depends on the amount of analyte in the sample, thereby detecting the amount of analyte in the sample.

In some specific embodiments, the light blocking element includes a first light blocking element 301 and a second light blocking element 302, wherein the first light blocking element 301 is located between the first light emitting element 101 and the light detector 201, so that light emitted from the first light emitting element 101 is irradiated onto the test element 40 and not irradiated onto the light detector 201.

In some embodiments, the second light blocking element 302 is located above the photo-detector 201, such that the second light blocking element 302 guides the light from the testing element 40 to the photo-detector 201.

In some embodiments, the second light blocking element 302 is disposed between the light detector 201 and the test element 40 to separate one or more corresponding regions of the test element 40 from the light detector 201, or to separate one or more corresponding regions of the test element 40 from the light detector 201, such that light from the corresponding regions of the test element 40 can be received by the light detector 201, while light from other corresponding regions of the test element 40 cannot be received by the light detector 201.

In some embodiments, the second light blocking element 302 is disposed in a region between the test zone 403 and the control zone 405 of the test element 40, such that light from the test element test zone 403 and/or the control zone 405 can be received by the light detector 201, while light from the region between the test zone and the control zone of the test element cannot be received by the light detector.

In some embodiments, second light blocking element 302 is disposed in reference zone 404 of test element 40, separating test zone 403 and control zone 405 of test element 40, allowing light from test element test zone 403 and/or control zone 405 to be received by light detector 201, and allowing light from reference zone 404 of the test element to be not received by light detector 201.

In some embodiments, the first light blocking element 301 extends to intersect the test element 40, and the second light blocking element 302 is longitudinally parallel to the test element 40.

In some specific embodiments, the second light blocking element 302 and the first light blocking element 301 are disposed perpendicular to each other.

In some embodiments, the apparatus further comprises a third light blocking element 303, such that the light detector 201 is located between the first light blocking element 301 and the third light blocking element 303.

In some embodiments, the second light blocking element 302 is located between the first light blocking element 301 and the third light blocking element 303, and the second light blocking element 302 is covered above the photodetector 201.

In some specific embodiments, the second light emitting element 102 is disposed outside the third light blocking element 303.

In some embodiments, the first light emitting element 101 and the photodetector 201 are linearly arranged, or the first light emitting element 101 and/or the second light emitting element 102 and the photodetector 201 are linearly arranged.

In some embodiments, the first light blocking member 301 and the second light blocking member 302 have a gap for transmitting light from the test element 40.

In some embodiments, the gap is a slanted gap through which light from the test element 40 is received by the light detector 201.

In some specific embodiments, the first light emitting element 101 corresponds to the test area 403 of the test element, the second light emitting element 102 corresponds to the control area 405 of the test element, the first light emitting element 101 and the second light emitting element 102 sequentially emit light, and the light is reflected and received by the photodetector 201 after being irradiated on the test area 403 and the control area 405 of the test element, so as to form an electrical signal for determining the detection result.

In some specific embodiments, the reading device further comprises a fourth light-blocking member 304 and a fifth light-blocking member 305, such that the fourth light-blocking member 304 and the fifth light-blocking member 305 are respectively located above the first light-emitting element 101 and the second light-emitting element 102, and cover or partially cover the first light-emitting element 101 and the second light-emitting element 102.

In some embodiments, the fourth light-blocking element 304 and the fifth light-blocking element 305 are respectively disposed on two sides of the second light-blocking element 302 and are not in contact with the second light-blocking element 302, and are in a longitudinally parallel structure with the test element 40, so that the fourth light-blocking element 304 and the fifth light-blocking element 305 are in contact with the test element 40 to cover corresponding regions of the test element 40 when the test element 40 is fixed to the reading device.

In some embodiments, the fourth light blocking member 304 covers the area before the testing area of the testing member, and blocks the light emitted from the first light emitting element 101 from being irradiated onto the area before the testing area of the testing member.

In some embodiments, the fifth light-blocking element 305 covers the area behind the control region of the test element, and blocks the light emitted from the second light-emitting element 102 from being irradiated onto the area behind the control region of the test element.

In some specific embodiments, gaps for allowing the light emitted from the first light emitting element 101 and the second light emitting element 102 to irradiate the test element 40 are respectively arranged between the fourth light blocking element 304 and the first light blocking element 301, and between the fifth light blocking element 305 and the third light blocking element 303.

Use the utility model discloses a reading device reads test element's test result or carries out the step when assay of analyte quality testing and does: (1) 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; (2) 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 through the third gap 503, and is received by the photodetector 201 through the first gap 501 after being reflected; light from the second light emitting element 102 is illuminated 504 through the fourth gap onto the control region 405 of the test element and reflected through the second gap 502 to be received by the light detector 201; (3) the photodetector 201 forms an electrical signal that can be detected to determine and analyze the test results.

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: a first light emitting element 101 and a second light emitting element 102 which emit light and irradiate one or more regions corresponding to the test element 40; a light detector 201 for receiving reflected light from a corresponding one or more regions of the test element 40; and a light blocking member for directing the path of light emitted by the light emitting member and/or light from the test member such that the light from the test member is received by the light detector or substantially received by the light detector (fig. 1).

In particular, the light emitting element is used for emitting light, such as various light sources, and in one embodiment, the light emitting element is a light emitting diode, e.g., an LED lamp. The photodetector 201 is used to detect the light irradiated thereon and convert the light into an electrical signal that can be detected, and in one embodiment, the photodetector 201 is a photodiode (PD detector).

The light blocking element includes a first, a second and a third light blocking element, wherein the light detector 201 is located between the first light blocking element 301 and the third light blocking element 303, wherein the second light blocking element 302 is located above the light detector 201 and is located between the first light blocking element 301 and the third light blocking element 303.

In a specific embodiment, the first light emitting element 101 is located outside the first light blocking element 301, the second light emitting element 102 is located outside the third light blocking element 303, and the light detector 201 is located between the first light blocking element 301 and the third light blocking element 303, so as to separate the first light emitting element 101 and the second light emitting element 102 from the light detector 201.

In a specific embodiment, the second light blocking element 302 is longitudinally parallel to the test element 40, and the longitudinal extensions of the first light blocking element 301 and the third light blocking element 303 intersect the test element 40.

In a particular embodiment, when the test element 40 is fixed to the reading device, the first light-blocking element 301 and the third light-blocking element 303 are not in contact with the test element 40, while the second light-blocking element 302 is in contact with the test element 40 and is located between the light detector 201 and the test element 40, separating one or more zones of the test element 40, or separating one or more zones of the test element 40 from the light detector 201.

In one embodiment, second light blocking element 302 is positioned to correspond to an area between test zone 403 and control zone 405 of the test element, or to reference zone 404 of the test element, and when test element 40 is secured to the reading apparatus, second light blocking element 302 is in contact with an area between test zone 403 and control zone 405 of the test element, or second light blocking element 302 is in contact with reference zone 404 of the test element, thereby separating test zone 403 and control zone 405 of the test element, or separating an area between test zone 403 and control zone 405 of the test element from light detector 201, or separating reference zone 404 of the test element from light detector 201, to prevent light emitted by the light emitting element from impinging on the area, and/or to prevent light from the area from entering light detector 201, thereby interfering with the detection results.

In a specific embodiment, a first gap 501 and a second gap 502 for allowing light from the test element 40 to pass through are respectively formed between the first light blocking element 301 and the second light blocking element 302, and between the third light blocking element 303 and the second light blocking element 302, and the gaps are preferably inclined gaps. Specifically, the heights of the first light blocking member 301 and the third light blocking member 303 are smaller than the vertical distance between the test element 40 and the light emitting element, and the second light blocking member 302 is not in contact with the first light blocking member 301 and the third light blocking member 303, so that a first gap 501 and a second gap 502, through which the reflected light from the test element 40 can pass, are formed between the first light blocking member 301 and the second light blocking member 302, and between the second light blocking member 302 and the third light blocking member 303, respectively. Further, the sides of the first light blocking element 301 and/or the second light blocking element 302 and/or the third light blocking element 303 adjacent to the light detector 201 are sloped, thereby forming an inclined gap for light transmission.

In a preferred embodiment, the reading device further comprises a fourth light-blocking member 304 and a fifth light-blocking member 305, wherein the fourth light-blocking member 304 and the fifth light-blocking member 305 are respectively positioned above the first light-emitting element 101 and the second light-emitting element 102, and cover or partially cover the first light-emitting element 101 and the second light-emitting element 102. In a preferred manner, the fourth light-blocking element 304 is spatially located outside the first light-blocking element 301, and the fifth light-blocking element 305 is spatially located outside the third light-blocking element 303, so as to further define the irradiation range of the light emitted by the first light-emitting element 101 and the second light-emitting element 102 on the test element 40. In a preferred mode, the fourth light-blocking element 304 and the fifth light-blocking element 305 are respectively located on two sides of the second light-blocking element 302 and are not in contact with the second light-blocking element 302, and are in a longitudinally parallel structure with the test element 40, and when the test element 40 is fixed to the reading device, the second light-blocking element 302, the fourth light-blocking element 304 and the fifth light-blocking element 305 are in contact with the test element and cover corresponding areas of the test element 40. In a preferred mode, when the test element 40 is fixed to the reading device, the fourth light-blocking member 304 covers the area of the test element before the test area, and blocks the light emitted from the first light-emitting member 101 from being irradiated onto the area of the test element before the test area. In a preferred mode, when the test element 40 is fixed to the reading device, the fifth light-blocking member 305 covers the area behind the control area of the test element, and blocks the light emitted by the second light-emitting element 102 from irradiating the area behind the control area of the test element.

In a preferred mode, a third gap 503 and a fourth gap 504 are respectively arranged between the fourth light-blocking member 304 and the first light-blocking member 301, and between the fifth light-blocking member 305 and the third light-blocking member 303, for enabling the light emitted by the first light-emitting element 101 and the second light-emitting element 102 to irradiate the test element 40.

In a preferred mode, the first to fifth light blocking elements cooperate with each other to further define a light path and a light irradiation area, specifically, light emitted by the first light emitting element 101 only irradiates the test region 403 of the test element through the third gap 503, light from the test region 403 of the test element is received by the light detector 201 through the first gap 501, light emitted by the second light emitting element 102 only irradiates the control region 405 of the test element through the fourth gap 504, and light from the control region 405 of the test element is received by the light detector 201 through the second gap 502.

In one particular embodiment, the device includes a lateral flow test element 40, as described 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 one particular embodiment, the reader may include a slot or other opening shaped and dimensioned to accommodate insertion of a test element 40 into the reader to allow successful insertion of a test element 40 only in the proper orientation.

In a specific embodiment, the first and second light emitting elements 101 and 102 and the photodetector 201 are arranged linearly, and the photodetector 201 is located between the first and second light emitting elements 101 and 102, wherein the first light emitting element 101 corresponds to the test region 403 of the test element, the second light emitting element 102 corresponds to the control region 405 of the test element, and the photodetector 201 corresponds to the region between the test region 403 and the control region 405 of the test element, or the reference region 404.

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 a power supply element such as a button cell (fig. 5) may be adopted.

In a preferred embodiment, the reading device further comprises a buzzer 150 for prompting the progress or result of the test (fig. 5).

In a preferred embodiment, the reading device comprises 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 first light blocking element 301, the second light blocking element 302, the third light blocking element 303, the fourth light blocking element 304 and the fifth light blocking element 305 are located in the detection window 701. In one embodiment, the light blocking element is connected to an inner wall of the detection window 701, wherein the first light blocking element 301 and the third light blocking element 303 form a structure parallel to each other in the detection window 701, the second light blocking element 302 is perpendicular to the first light blocking element 301 and the third light blocking element 303, respectively, and the fourth light blocking element 304 is perpendicular to the first light blocking element 301, the fifth light blocking element 305 and the third light blocking element 303. In a preferred mode, the fourth light blocking member 304 and the fifth light blocking member 305 may be separate members connected to the detection window 701, or may be formed of a portion from which the detection window 701 extends. Further, the light blocking member and the base frame 70 may be integrally formed (fig. 2 and 5).

In a preferred 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.

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 can 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 photodetector 201 and the test element 40 in a closed space. At this time, the first light blocking element 301 and the third light blocking element 303 are in seamless contact with the mounting planes of the light emitting element 101/102 and the photodetector 201, and separate the first light emitting element 101 and the second light emitting element 102 from the photodetector 201, respectively; second light blocking element 302 abuts seamlessly with test element 40, separating one or more zones of test element 40, preferably test zone 403 and control zone 405 of the test element, blocking light from the area of test element 40 covered by second light blocking element 302 from entering the light detector; the fourth light blocking element 304 is in seamless abutment with the test element 40, and blocks light from the first light emitting element 101 from irradiating on the area before the test element test area; the fifth light blocking member 305 is in seamless abutment with the test element 40, and blocks light from the second light emitting element 102 from impinging on the area behind the test element control area. In a specific embodiment, light emitted by the first light emitting element 101 and the second light emitting element 102 is irradiated onto the test area 403 and the control area 405 of the test element through the third gap 503 and the fourth gap 504, respectively, and reflected light from the test area 403 and the control area 405 of the test element is received by the photodetector 201 through the first gap 501 and the second gap 502, respectively, and is converted into an electrical signal capable of being detected by the processor. Here, the light barrier element may perform additional functions, such as supporting the test element 40 appropriately, keeping the test element 40 and the light emitting element and/or the light detector at an appropriate distance (fig. 3).

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 a card slot 702 (FIG. 4) on the pedestal 70. In one embodiment, a pipette tip 110 is provided at an end of the test element 40 adjacent to 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. 5). The sample suction rod 110 is fixed on a card holder 703 arranged at one end of the base frame 70, the card holder 703 is not on the same horizontal plane with the card slot 702 connected with the test element 40, the position of the card holder 703 is lower than that of the card slot 702, and when the sample suction rod 110 is fixed on the card holder 703, the sample suction rod 110 is basically on the same horizontal plane with the test element 40 or the card slot 702 for placing the test element. The card holder 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. 4). In use, a sample is drawn by the wand 110 and is fluidically conveyed through the test element 40.

In one embodiment, the reading device has a conducting means for activating or waking up the reading device. In a specific embodiment, the conducting device is a front conducting electrode 120, one end of the front conducting electrode 120 is connected to the sample absorbing rod 110, and the other end is connected to a front electrode contact of the conducting circuit of the reading device. In one specific embodiment, the front-end conductive electrode 120 is disposed in a holder 703 that holds the pipette tip 110, and is connected to the pipette tip 110. Specifically, the front-end conducting electrode 120 is located between the card holder 703 and the sample suction rod 110, and after the sample suction rod 110 sucks a sample, when liquid flows through the front-end conducting electrode 120, the detection system is conducted, and the device starts self-testing. Set up front end conduction electrode 120 and can guarantee the good contact of front end conduction electrode 120 with inhale appearance stick 110 between card support 703 and inhale appearance stick 110, because in the use, inhale appearance stick 110 and probably take place certain aversion because of collision or misoperation for front end conduction electrode 120 can not effective contact with inhale appearance stick 110, the utility model discloses a device can effectively prevent to switch on or can't the activation device because of the front end conduction electrode 120 with inhale that appearance stick 110 contact failure arouses (figure 5).

In a preferred embodiment, the reading device may further comprise 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 pipette tip 110 is exposed through an opening in one end of the housing to facilitate aspiration of the sample (FIG. 5).

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 through the first gap 501 and the second gap 502. The photodetector 201 detects the corresponding electrical signal or voltage, respectively, and feeds back the detected information to the processor, which performs analysis and determination based on the received detected information.

The reading device provides a better light path between the light-emitting element and the light detector to obtain a light intensity signal, and the light intensity signal is converted into a judgment value for judgment and comparison through the processor. 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 (26)

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

the first light-emitting element is used for emitting light and irradiating the light to one or more corresponding areas of the test element;

a light detector for receiving reflected light from a corresponding one or more regions of the 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.

2. A reading apparatus according to claim 1, wherein the light blocking member comprises first and second light blocking members, wherein the first light blocking member is located between the light emitting member and the photodetector, and directs light emitted from the light emitting member to the test element.

3. A reading apparatus according to claim 2 wherein the second light blocking element is located above the light detector.

4. A reading apparatus according to claim 2, wherein the second light blocking element is disposed between the light detector and the test element.

5. A reading apparatus according to claim 2, wherein the first light blocking element extends across the test element and the second light blocking element is longitudinally parallel to the test element.

6. A reading device according to claim 5 or 2, wherein the second light blocking element and the first light blocking element are arranged in a mutually perpendicular manner.

7. A reading device according to claim 2, wherein the device further comprises a third light blocking element, wherein the light detector is located between the first and third light blocking elements.

8. A reading apparatus according to claim 7 wherein the second light blocking member is located between the first and third light blocking members and overlies the light detector.

9. A reading device according to claim 8, wherein a second light emitting element is provided on the outside of the third light blocking element.

10. A reading device according to claim 9, wherein the first and/or second light-emitting elements are in linear arrangement with the light detector.

11. The reading device of claim 2, wherein the first and second light blocking elements have a gap that allows light from the test element to pass through.

12. The reading device of claim 11, wherein the gap is a slanted gap.

13. A reading device according to claim 2, wherein the second light blocking element is arranged in a region between the test zone and the control zone of the test element.

14. The reading device of claim 2, wherein the first light blocking element directs light from the light emitting element onto the test element and the second light blocking element directs light from the test element onto the light detector.

15. The reading device according to claim 14, wherein the first light blocking member directs light emitted by the light emitting member to impinge on the test member and not on the light detector.

16. A reading device according to claim 2, wherein the device further comprises a lateral flow test element comprising a test zone and a control zone.

17. A reading apparatus according to claim 1, wherein the light blocking member is located between the light detector and the test element.

18. A reading apparatus according to claim 1, wherein the light blocking member allows light from the test element to be received by, or substantially received by, the light detector.

19. A reading device for reading the result of a test, for reading the result of an assay test on a test element, the device comprising:

the first light-emitting element and the second light-emitting element emit light and irradiate the corresponding one or more areas of the test element;

a light detector for receiving reflected light from a corresponding one or more regions of the test element;

and the light blocking element is used for guiding the path of light emitted by the light emitting element and/or light from the testing element, wherein the light blocking element comprises a first light blocking element, a second light blocking element and a third light blocking element, the light detector is positioned between the first light blocking element and the third light blocking element, and the second light blocking element is positioned above the light detector and positioned between the first light blocking element and the third light blocking element.

20. The reading device of claim 19, wherein the first light emitting element is located outside the first light blocking element and the second light emitting element is located outside the third light blocking element.

21. A reading device according to claim 19 or claim 20, wherein the first and second light emitting elements and the light detector are in a linear arrangement.

22. A reading device according to claim 19, wherein the second light blocking element is arranged parallel to the test element, the first and third light blocking elements extending across the test element.

23. The reading device of claim 19, wherein the first and third light blocking elements are not in contact with the test element and the second light blocking element is in contact with the test element.

24. A reading apparatus according to claim 19 wherein the second light blocking element is disposed between the light detector and the test element.

25. A reading apparatus according to claim 19, wherein the light blocking member is located between the light detector and the test element.

26. A reading apparatus according to claim 19, wherein the light blocking member allows light from the test element to be received by, or substantially received by, the light detector.

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