JP2009503528A - Analytical reader with display - Google Patents

Abstract

  An analysis result reader for reading a result of an analysis performed by contacting a liquid sample with a liquid carrier or transporter on or in which the analysis is performed is disclosed. A receptacle for receiving a carrier or transporter, a reader for reading the results of the analysis, and a releasable attachment for releasably attaching a display capable of displaying the results of the analysis .

Description

  The present invention relates to an integrated analyzer and reader, the analyzer comprising means for releasably mounting the display.

  At present, simple analyzers for clinical use and for testing test substances at home are widely established and commercially available.

  EP-A-291194 includes an analyzer comprising a porous carrier containing a particle-labeled binding reagent that is free to move in solution and is specific for binding the analyte of interest. It is disclosed. The device also includes an unlabeled specific binding reagent for the same analyte and immobilizes the unlabeled binding reagent in a test zone located downstream of the specific binding reagent. A liquid sample that appears to contain the analyte of interest is applied to the porous carrier and reacts with the labeling reagent to form a binding co-complex with the labeled analyte. The complex interacts with the immobilized unlabeled specific binding reagent and travels along the porous carrier into the test zone that forms a complex with the reagent, and thus in the sample. The amount of the test substance present can be determined. However, this type of analysis requires interpretation of the results by the user, which may not be accurate.

  Electronic readers are known for use in combination with analytical test strips to determine the concentration and / or amount of analyte in a liquid sample. An example of this type of reader / test paper combination is disclosed in EP 0 653 625, where the reader uses optical methods to determine test results. An analytical test strip is inserted into the reader and light from a light source such as a light emitting diode (LED) is illuminated onto the test strip. In that case, the reflected or transmitted light is detected by the photodetector, thus allowing the determination of the amount of labeled analyte to be bound to the immobilized reagent and concentrated in the test zone.

  The visible signal generated within the detection zone (and control zone) is very narrow so that a small displacement of the detection or control zone relative to the corresponding photodetector will have a significant effect on the reading made by the photodetector. It is important that the analytical reader of this type of instrument and the test strip are carefully aligned due to the fact that A further consideration is the need for the photodetector to be as close as possible to the test strip in order to obtain optimal signal strength. Therefore, when using this type of device, it is important for the user to carefully align the test stick with the analysis result reader. This type of precise alignment can be difficult, especially for devices intended to be used at home.

  To overcome this problem, analyzers have been designed in which test strips and readers are integrated into a single integrated unit. An example of an analytical device suitable for the detection of the pregnancy hormone human chorionic gonadotropin (hCG) is marketed by Unipath Limited under the trade name Clearblue® Digital. The apparatus comprises an analytical test strip, a reader, and a display that displays the results of the analytical test.

  This type of integrated electronic analyzer has the advantage that they improve the accuracy of the analysis results, eliminating the need for the results to be interpreted by the user. Such devices are known in the art, for example European Patent Application Publication No. 1,484,601, European Patent Application Publication No. 1,484,611, and European Patent Application Publication No. No. 1,484,613. Typically, the integrated unit comprises means for reading the analysis results, means for signal conversion, means for display, circuit and electrical power source. Conventionally, the display comprises an LCD that requires a power source to change and maintain the information displayed.

  One drawback associated with this type of device is that the displayed information is lost if the power source is depleted or removed. Therefore, this type of analyzer requires a certain power supply in order to display the result of the analysis. As a result, the duration of the display result is determined by the power source used.

  In a first aspect, the present invention provides an analysis result reader for reading a result of an analysis performed by contacting a liquid sample with a liquid carrier or transporter on or in which the analysis is performed. Provided and releasable attachment for releasable mounting of a receptacle for receiving a liquid carrier or transporter, a reader for reading the results of the analysis, and a display capable of displaying the results of the analysis And an attachment portion.

  The apparatus preferably further comprises a releasable mounting display, which will preferably be a zero power display, the terms of which are described below.

  The releasable attachment can include any suitable mechanism for releasably attaching the display to the device. Preferably, the mechanism is operable without requiring any tools (eg, avoiding the need for a screwdriver or the like). In one embodiment, an elastically deformable portion is provided on the housing or display, which is housed and optionally accommodated in a corresponding opening, recess or groove on the display or housing. It can be held.

  The liquid carrier or transporter preferably comprises a lateral flow analyzer or test strip. This type of lateral flow analyzer or test strip is well known to those skilled in the art. Typically, they usually comprise a porous matrix such as nitrocellulose or a similar material together with a support layer or backing layer. The support layer or backing layer may comprise a relatively rigid material such as a synthetic plastic material. Mylar® is particularly suitable in this respect.

  In one embodiment, the liquid carrier or transporter includes an integral component of the device so that the present invention analyzes to test for the presence and / or amount of the analyte of interest within the liquid sample. An integrated device is provided. In another embodiment, the liquid carrier or transporter does not form an integral component of the device of the present invention. For example, suitable lateral flow test papers can be manufactured and marketed separately. In one particular embodiment, the device of the present invention comprises means for forming a releasable engagement by a liquid carrier or transporter. Preferably, the liquid carrier or transporter can be inserted into the analysis result reader of the present invention in order to read the analysis result, and when the read data is captured, the liquid carrier or transporter is read by the reader. Can be removed or removed from and disposed of.

  According to the present invention, the display is separable from the device after the generation of the analysis results, and the information recorded on the display is kept in the absence of a power source for at least a limited period of time. . Preferably, in the absence of a power source, the display can be held for at least 24 hours, more preferably at least 72 hours, and more preferably at least 168 hours.

  A display capable of holding an information display under this type of condition can be referred to as a zero power display for this purpose. The preferred zero power display is electrical in the sense that it initially uses electrical power to generate or change the display of information, but power is then used to maintain the display of information. Not necessary. Preferably, the information display includes an alphanumeric display. A preferred zero power display is available via ZBD (see Zenithal Bistable displays, Malvern Research Park, Worcester, www.zbddisplays.com). Zenithal bistable displays are a type of LCD that does not require power to hold an image. The technology is based on a lattice structure developed by ZBD as described in EP 0856164. In ZBD displays, the molecule has two stable orientations, resulting in a black or white image. Zenithal bistable displays use a simple microstructured grating surface to control the alignment of liquid crystal molecules. The grid structure stores the image on its surface so that the image is retained after the power source is removed, despite the mechanical impact. The bistability of the display means that complex images can be written at once without the additional cost of using thin film transistors (TFTs) behind each pixel.

  Other zero power displays that can be used in accordance with the present invention are conductive polymer, electrochromic polymer, and electronic ink displays.

  An electronic ink display (available from E Ink Corporation, Cambridge MA, USA) is placed on a single plastic film sheet laminated to the circuit layer (multiple containing positively charged and negatively charged particles). Formed by printing electronic ink (including micro-microcapsules). The circuit forms a pattern of pixels that can be controlled by the display driver so that once it is formed, the image can be displayed without a power source.

  A BiNem® display (available from Nemoptic, 1 true Guinemer, Magny les Hameauux, France) uses LCD technology to form the display. The means of the display is bistable (i.e. stable in either of two different states), so that the contents of the display retains no power source due to the effect of the internal memory. In addition, the display uses nematic liquid crystals of the type used by most LCDs.

  The Olymt® display developed by Dupont (120 Cremona Driver, Santa Barbara, California, USA) uses organic materials to generate light. A thin layer of organic material is sandwiched between the appropriate anode and cathode layers, and a relatively small amount of voltage (typically between 2V and 10V) is applied across the organic material so that it is In a process known as electroluminescence, light will be emitted. The display can be held for a limited period of time when removed from the power source.

  Any of the above-described displays can be suitable for use with the present invention.

  According to the present invention, it is possible to display information related to analysis using a zero power display. A display is typically used to show the results of the analysis. Alternatively or in addition, the display can be used to display the date and time of analysis, patient information, batch code information, etc. The display can be separated from the integrated device using any suitable separation or release mechanism known to those skilled in the art. In one embodiment, the display can be attached to the device using a releasable latch mechanism. Conveniently, the zero power display can be removed from the integrated device, and the results can be retained and stored for future reference.

  Typically, the apparatus of the present invention additionally includes signal conversion mechanisms, circuits, and power sources.

  The device of the present invention preferably includes a lateral flow immunoassay device, in which a liquid sample that may contain the analyte of interest is applied to a test paper and moved along the paper. This type of analysis is well known to those skilled in the art and is disclosed, for example, in EP-A-0291194.

  In a preferred embodiment of the invention, the test strip is in fluid flow communication with a sample receiving zone to which the sample is applied. The test strip generally comprises a reaction zone containing a specific binding reagent capable of binding the analyte of interest to produce a complex of reagent and analyte, and the reagent and analyte. A test zone containing an immobilizing reagent capable of binding the complex of

  Typically, the reaction zone is located downstream from the sample receiving zone and the test zone is located downstream from the reaction zone.

  Preferably, the test strip is porous, thus allowing the sample to penetrate along the test strip. More preferably, nitrocellulose is selected as the test strip material. This has advantages over conventional test strip materials such as paper because it has the natural ability to bind proteins without the need to sensitize faster.

  In a preferred embodiment, coupling the reagent-to-analyte complex to the immobilized reagent within the test zone results in the generation of a signal that is measured using an analytical reader. . In principle, the integrated device of the present invention can be used for the detection of any amount of analyte or its presence. The sample may be of biological, industrial or environmental origin.

  The signal that accumulates during the performance of the analysis may be any that is appropriate for the purpose of the analysis. Typically, signal accumulation includes the production or accumulation of readily detectable substances, such as color reaction products. Preferably, the analysis involves the accumulation of labeled reagent within the test zone of the test strip. Some examples of labels that can be used in accordance with the present invention are enzymes, radio labels, fluorescent dyes, color particles, or the like. Preferably, the label comprises label particles, which may be gold particles or a color polymer such as latex.

  In general, the presence of the test substance in the sample tends to cause signal accumulation. However, in other analytical forms (such as competitive or displacement morphological analysis), the absence of the analyte of interest will result in the accumulation of relevant signals.

  In a preferred embodiment of the invention, the analysis result reader comprises an optical detector system for monitoring the accumulation of labels. The reader typically includes means for generating a signal (preferably a digital signal) that is proportional to the level of the accumulated label. Conveniently, an optical detector system can be used to measure any optical property, eg, the amount of light reflected and / or transmitted from the test zone where the label is accumulated.

  Preferably, the optical detection system will comprise at least one light source and at least one photodetector. More preferably, the light source includes a light emitting diode (LED). The reflected or transmitted light is measured by a photodetector. For this purpose, reflected light is taken to mean light from a light source that is reflected from a porous carrier or another liquid transport means onto the photodetector. Typically, in this example, the detector is provided on the same carrier as the light source. Transmitted light is taken to mean light passing through the carrier. In order to detect the transmitted light, a detector is typically provided on the carrier opposite the light source.

  Preferably, the device comprises a housing formed from an opaque material. Conveniently, the housing is formed from a synthetic plastic material such as polycarbonate, ABS, polystyrene, or polypropylene. Desirably, an opening is provided at one end of the housing so that a test strip or similar porous carrier can be inserted through the opening or is already contained within the housing. It can protrude from the part. In order to perform analytical measurements using the integrated device according to the present invention, a test strip contained in the device is brought into contact with the liquid sample. In an alternative embodiment, the liquid sample can be first applied to the sample receiving zone of the test paper and then the test paper can be inserted into the apparatus. The sample moves along the test strip and any analyte present in the sample undergoes an associated reaction.

  Once the result is determined, the display can be separated from the device and saved for future reference. Preferably, the display is first attached to the device and then removable following the performance of the analysis.

  Advantageously, the device of the present invention can be used at home or in clinical trials.

  In one embodiment, the apparatus of the present invention can be used to detect pregnancy hormone hCG. Thus, for example, a display showing a positive result (ie, pregnancy) can be removed from the device of the present invention and retained as a souvenir or a memory, and the displayed information will not be lost.

  According to another embodiment, the device of the invention can be used for the detection of infectious pathogens such as Streptococcus A or for the diagnosis of infectious or other diseases. Advantageously, the device can be tested at home for the presence of Streptococcus A. The display can then be separated from the device, and the results can then be submitted to a doctor or another medical professional.

  In a further embodiment, the device of the invention can be used for the detection of drugs of abuse.

  Prior to the present invention, it was not possible to separate and store the results from the analyzer. Thus, conventional lateral flow analyzers often have a display that is contaminated with a sample from the analyzer. The device of the present invention has the advantage that the display is separable from the device, thus minimizing the risk of sprinkling or spreading contaminated material, thereby improving hygiene.

  In a second aspect, the present invention provides a method for determining the presence and / or amount of an analyte of interest in a sample, the method comprising: a sample with a liquid carrier of a device according to the first aspect as defined above. Contacting.

  In a third aspect, the present invention provides a method of forming an integrated device according to the first aspect of upper air definition.

  In a further aspect, the present invention provides an integrated apparatus for performing an analysis to test for the presence and / or amount of an analyte of interest in a liquid sample according to the first aspect of the invention as defined above, And means for attaching to a zero power display.

  To avoid misunderstanding, any feature of the invention described as "preferred", "desirable", "convenient", "advantageous", or the like is not Or in combination with any other feature or features described as such.

  The invention will now be further described by way of example and with reference to the following drawings in which:

Example 1
An embodiment of an integrated device according to the present invention is shown in FIG.

  The device is about 12 cm long and about 2 cm wide and is generally shaped like a finger or cigar. However, any convenient shape can be used. The integrated device comprises a housing (2) formed from an opaque synthetic plastic material. At one end of the housing is provided a narrow opening through which the liquid transporter or carrier (4) can project beyond and beyond the housing to contact the liquid sample.

  A zero power display (6) is releasably attached to the device and displays information to the user. The zero power display (6) can be removed from the device after generating the analysis results. The downward pressure on the elastically deformable clip (8) allows the zero power display to be removed from the housing after the analysis is complete and the results displayed. The zero power display continuously displays the analysis results and any other displayed information, isolated from the power source, so that the results can be retained by the user for future reference. Information recorded on the display can be retained after removal from the device, or alternatively after the power source is depleted.

  As best seen in FIGS. 3 and 4, the housing (2) houses an analytical assembly generally indicated by reference numeral (10).

  The analysis assembly (10) comprises two LEDs aligned with the test zone of the nitrocellulose lateral flow paper (16) in fluid communication with the liquid transporter or carrier sampling portion (4), 2 One photodiode (14) includes a printed circuit board (12) mounted thereon. The test zone is a zone in which the labeled reagent accumulates when the target analyte is present (or absent if necessary). This accumulation affects the optical properties of the test strip (16), such as its reflectivity or transmittance, which can be measured by the use of an LED / photodiode array. Thus, the photodiode produces an output current magnitude that is related to the amount of label stored in the test zone.

  The analysis assembly (10) also includes an electrical power source (button cell 18) to supply power to the display (6) when attached to the housing (2). The display (6) is releasably attached to the housing by holding a clip (8) in an appropriately shaped and dimensioned opening provided in the housing (2). In addition, the groove (20) is provided in the upper part of the housing, and a slightly flange-like portion of the display (6) is introduced into the groove by sliding movement from the open end of the housing (2). Is possible. When correctly positioned, the electrical connector on the display will come into contact with the electrical connector (22) provided on the housing, so that there is a gap between the display (6) and the analysis assembly (10). The electrical contact is ensured.

  The analysis assembly (10) comprises a data storage buffer, an analog to digital converter (ADC), and a signal conversion component (24) including a microprocessor or microcontroller. The display (6) is responsive to output from the microprocessor or microcontroller.

1 is a schematic diagram of one embodiment of an integrated analyzer and reader and attached display according to the present invention. FIG. FIG. 2 is a schematic view of the apparatus shown in FIG. 1 with an attached display. FIG. 3 is a plan view of the embodiment of the apparatus shown in FIG. 2. 2 is a partial cross-sectional side view of the embodiment of the apparatus shown in FIG. 1 (with attached display). FIG.

Claims (17)

  An analysis result reader for reading a result of an analysis performed by contacting a liquid sample with a liquid carrier or transporter on or in which the analysis is performed, the liquid sample receiving the liquid carrier or transporter An analysis result reader comprising: a receptacle; a reader for reading the analysis result; and a releasable attachment for releasably attaching a display capable of displaying the analysis result.   The analysis result reader according to claim 1, further comprising a display releasably attached.   The analysis result reader according to claim 2, wherein the releasably attached display is a zero power display.   The analysis result reading device according to any one of claims 1 to 3, further comprising a power source.   The analysis result reading device according to claim 4, wherein the power source is an electrical power source.   6. The analysis result reading device according to any one of claims 1 to 5, wherein when removed from the device, the display continues to display the analysis result or other display information for at least 24 hours.   The analysis result reading device according to claim 6, wherein the display continuously displays the analysis result or other display information for at least 72 hours when removed from the device.   7. The analysis result reader of claim 6, wherein the display continuously displays the analysis result or other display information for at least 168 hours when removed from the device.   The analysis result reader according to any one of claims 1 to 8, wherein the display comprises a bistable liquid crystal display, a conductive polymer display, an electrochromic polymer display, or an e-ink display.   The analysis result reader according to claim 1, further comprising a liquid carrier or transporter.   The analysis result reader according to claim 10, wherein the liquid carrier or transporter is porous.   The analysis result reader according to claim 10, wherein the liquid carrier or transporter comprises a lateral flow test paper.   The analysis result reading device according to any one of claims 1 to 12, further comprising at least one light source and / or at least one photodiode.   14. The analysis according to any one of the preceding claims, further comprising one or more components selected from the group consisting of a microprocessor or microcontroller, an analog to digital converter, and a data storage buffer. Result reader.   15. A liquid carrier or transporter is releasably engageable with a result reading device and is removable or removable from the device when an analysis result is read. Analysis result reader.   16. A method of forming an analysis result reader according to any one of claims 1 to 15, comprising assembling necessary components in a housing, wherein the housing is releasably attached to a display. A method having attachment means.   A method of reading an analysis using an analysis result reader according to any one of the preceding claims.

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