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CN-115777059-B - Optical module

CN115777059BCN 115777059 BCN115777059 BCN 115777059BCN-115777059-B

Abstract

An optical module (100) for reading a test area of an assay. The optical module comprises a first light source (101) for illuminating a test area of an assay, an optical detector (103) comprising a light input and an electrical output for receiving light emitted from the test area, a substrate (104) for mounting the first light source (101) and the optical detector (103), and a housing (105) comprising a first opening (106) for providing a first light path from the first light source (101) to the test area (103), wherein the housing (105) and the substrate (104) enclose the first light source (101) and the optical detector (103) and the position of the first light source (101) and the optical detector (103) is aligned with respect to the first opening (106). The housing (105) may include one or more legs (108), the legs (108) securing the housing (105) to the substrate (104) by snap-fit engagement and extending in a vertical direction from the first outer surface and/or the second outer surface of the housing (105).

Inventors

  • XIE WENZHONG
  • Frederic F
  • E. J. Ross

Assignees

  • 艾迈斯-欧司朗股份有限公司

Dates

Publication Date
20260505
Application Date
20210323
Priority Date
20200327

Claims (12)

  1. 1. An optical module (100) for reading a test area of an assay, the optical module comprising: -a first light source (101) for illuminating a test area of an assay; -an optical detector (103) comprising an optical input for receiving light emitted from a test area of an assay and an electrical output; -a substrate (104) for mounting the first light source (101) and the optical detector (103); -a housing (105), the housing (105) defining a first opening (106) for providing a first light path from the first light source (101) to the test area and from the test area to the optical detector (103); Wherein the housing (105) and the substrate (104) enclose the first light source (101) and the optical detector (103) and align the position of the first light source (101) and the optical detector (103) with respect to the first opening (106); A second light source (102) for illuminating a control zone of the assay; Wherein the second light source (102) is mounted on a substrate (104), Wherein the housing (105) comprises a second opening (107) for providing a second light path from the second light source (102) to the control zone and from the control zone to the optical detector (103), and Wherein the housing (105) and the substrate (104) also enclose the second light source (102) and align the position of the second light source (102) with respect to the first and second openings (106, 107) and the optical detector (103); -one or more first baffles (110), the first baffles (110) being located on the substrate (104) between the optical detector (103) and the first light source (101) to block light from directly propagating from the first light source (101) to the optical detector (103); -angled struts (2107) extending from the inner surface of the housing (105) between the first and second openings (106, 107) to the first baffle (110), said angles allowing said first baffle, said first opening and said second opening to be in an optimal position for highest signal to noise ratio.
  2. 2. The optical module of claim 1, wherein one or more walls of the housing (105) include a shaped surface (109), the shaped surface (109) configured to receive the substrate (104) in a predetermined position to provide alignment of the positions.
  3. 3. The optical module of claim 2, wherein the shaped surface (109) comprises one or more steps, slots and/or bevels on one or more surfaces of the wall of the housing (105).
  4. 4. An optical module according to any one of claims 1 to 3, wherein the housing (105) comprises one or more legs (108) extending in a vertical direction from the first outer surface and/or the second outer surface of the housing (105).
  5. 5. The optical module of claim 4, wherein one or more of the one or more legs (108) comprise a flexible hook.
  6. 6. The optical module of claim 5, wherein the flexible hooks are configured to secure the housing (105) to the substrate (104) by snap-fit engagement through one or more corresponding holes in the substrate (104), thereby preventing relative movement between the substrate (104) and the housing (105).
  7. 7. The optical module of claim 5, wherein the one or more legs (108) are configured to matingly engage one or more corresponding holes in a printed circuit board of an assay reader device to align a position of the optical module (100) relative to the printed circuit board of the assay reader device.
  8. 8. An optical module as claimed in any one of claims 1 to 3, comprising: One or more second baffles (111) on the inner surface of the housing (105) between the first and second openings (106, 107), the second baffles (111) for blocking light from propagating from the first light source (101) to the control zone and blocking light from propagating from the second light source (102) to the test zone.
  9. 9. The optical module according to claim 1 to 3, Wherein the first and second light sources (101, 102) and/or the optical detector (103) are encapsulated in a molded polymer compound (407 a), and Wherein the first optical path and the second optical path are provided through a molded polymer compound (407 a).
  10. 10. An optical module according to any one of claims 1 to 3, wherein a portion (901) of the housing (105) comprises a transparent material having an opaque material (902) on a surface thereof, and wherein the first opening and/or the second opening comprises a gap (903, 904) in the opaque material (902).
  11. 11. An optical module according to any one of claims 1 to 3, wherein the optical module comprises an electrical signal processor, wherein the first light source (101), the optical detector (103) and the second light source (102) and/or the electrical signal processor are arranged adjacent to each other in a first planar arrangement, wherein the first opening (106) and the second opening (107) are arranged in a second planar arrangement parallel to and facing the first planar arrangement.
  12. 12. An assay reader device (1000) comprising an optical module (100) according to any of claims 1-11.

Description

Optical module Technical Field The present invention relates to assay readers and in particular, but not exclusively, to optical modules for assay readers. Background One of three methods is commonly used to identify disease. The first method is a central laboratory analysis in which samples are collected and sent to a central laboratory for thorough analysis using expensive large-scale high-throughput equipment. The second approach is point-of-care testing using one of many different technology platforms, such as microfluidic-based testing, in which appropriate expert diagnostic equipment is deployed on site, such as in a hospital. The third method is point-of-care testing using lateral flow testing techniques. Lateral flow techniques are based on a series of capillary beds, such as porous papers, microstructured polymers or sintered polymers. Each of these elements has the ability to spontaneously transport fluids (e.g., urine). The first element (sample pad) acts as a sponge to hold excess sample liquid. When the first element is wetted, the fluid migrates to the second element (conjugate pad) where the manufacturer stores the so-called conjugate, i.e. in the form of dried bioactive particles in a salt-sugar matrix containing everything that ensures an optimal chemical reaction between the target molecule (e.g. antigen) and the chemical partner (e.g. antibody) that has been immobilized on the surface of the particle. As the sample fluid dissolves the salt-sugar matrix, it also moves the particles and, in a combined transport action, the sample and conjugate mix as they flow through the porous structure. In this way, the analyte binds to the particles while migrating further through the third capillary bed. Such materials have one or more regions (often referred to as strips or lines) in which the third molecule is immobilized by the manufacturer. By the time the sample-conjugate mixture reaches the strips, the analyte has bound to the particles, and a third "capture" molecule binds to the complex. Over time, as more and more liquid passes through the strip, particles accumulate and the strip area changes color. Typically, there are at least two regions: 1. One area (control) captures any particles to indicate that the reaction conditions and technique are working well, and a test line usually appears on the strip before the control line. 2. The second zone (test) contains specific capture molecules and only captures particles on which the analyte molecules have been immobilized. This makes the diagnostic result of the test visible. After passing through these reaction zones, the fluid enters the final porous material, i.e., the wick, which acts only as a waste reservoir and also helps control the flow rate. The plurality of test lines may also be arranged adjacent to each other, with the last line on the test strip acting as a control line. There are typically three lateral flow tests. 1. Lateral flow test without any electronic device. The user "reads" the color change by the naked eye, thereby giving the user a "yes/no" answer. These types of lateral flow tests are not suitable for diagnostic tests that require quantification. For the identification of many diseases, quantitative measurements are important, and these qualitative types of "yes/no" tests are often unsuitable for quantitative diagnostic tests. 2. Lateral flow test using external optical readings. This test supports higher quantification levels and sensitivity. In particular, quantitative measurements typically use imaging techniques (e.g., fluorescence, luminescence, absorbance, and/or reflectance imaging) to image a test area of a lateral flow strip, with quantitative values being determined based on the intensity of color changes in the test area in the simplest case. But for such lateral flow tests an external reading device, such as a desktop level reading device, is required. Furthermore, the external device means that the distance between the quantized color change and the detector is typically large, e.g. about more than 5-10 cm. An increase in the distance between the quantized color change and the detector results in a decrease in signal strength. 3. Lateral flow test with light source and detector assembled on a printed circuit board, for example. One advantage of such a reading system is that it can be quantified and that it can increase sensitivity without the need for external detector hardware. But this approach utilizes discrete components such as LEDs, photodiodes, and various structural components assembled by the pick-and-place machine. Typically, the components are held in place by glue and/or solder. An example of such an assembly is illustrated in WO/2020/049066 and shown in figure 1 f. One problem with such assemblies is that the components may be displaced in an uncontrolled manner due to solder or glue reflow at the high temperatures applied in one or more manufacturing steps. This problem may be particularly prono