Device for detecting analyzed object in specimen and method therefor

Inventors

YOO, SeungbumKim, EunkyungLee, Dong GyuOh, Sang HoonSohn, Mi Jin

Assignees

Sugentech Inc

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Publication Number

US-10254232-B2

Patent

Publication Date

2019-04-09

Expiration Date


Abstract

A device for detecting analytes in a sample includes (a) n light source units generating light; (b) a reaction strip including (i) a test area illuminated with light from the light source unit and including a material reacting to the analytes, (ii) a control area illuminated with the light from the light source unit and including a control material, and (iii) a background area illuminated with the light from the light source unit; and (c) at least n+1 light receiving units detecting light emitted from the test area, the control area, and the background area of the reaction strip, respectively.

Core Innovation

The invention provides a device for detecting an analyte in a sample using an optical analyte-detection configuration that includes n light source units and a reaction strip. The reaction strip includes a test area, a control area, and a background area arranged so that the test area and the control area are separately illuminated by light emitted from light source units, while the test area includes a material reacting to the analyte and the control area includes a control material.

The device includes n+1 light receiving units detecting light emitted from the test area, the control area, and the background area, respectively, and arranged to be in alignment with each of the test area, the control area, and the background area. The test area and the control area share the background area, and the light source unit positioning places the first light source unit at an equal distance from the test area and the background area and the second light source unit at an equal distance from the control area and the background area.

The disclosed approach emphasizes miniaturization with fixed light source units and an arrangement of aligned light receiving units to improve optical signal quality by treating and removing background noise using the shared illumination and alignment of the background area. The document describes calibration of a background-related detected value using comparison to values detected before a reaction and then computing final test/control measurement values, including forming final values from difference or ratio expressions based on calibration constants.

Claims Coverage

The claims coverage centers on one independent device claim that defines the core optical alignment and shared background illumination using n light source units and n+1 aligned light receiving units for test, control, and background areas.

Aligned test-control-background reaction strip with shared background illumination

A device for detecting an analyte in a sample includes a reaction strip with a test area, a control area, and a background area; the test area and background area are illuminated with a same one light from a first light source unit, and the control area and background area are illuminated with a same one light from a second light source unit.

n+1 light receiving units aligned to detect emitted light from respective areas

The device includes n+1 light receiving units that detect emitted light from the test area, the control area, and the background area of the reaction strip, respectively, and are arranged to be in alignment with the test area, control area, and background area, respectively, so that the emitted light detected is used for detection of the analyte.

Equal-distance positioning of first and second light source units relative to shared background

The first light source unit is positioned at an equal distance from the test area and the background area, and the second light source unit is positioned at an equal distance from the control area and the background area.

Across the independent claim, the inventive structure is the combination of a reaction strip having test, control, and background areas illuminated by first and second light source units with a shared background area, together with n+1 light receiving units aligned to those areas, supported by equal-distance positioning of the light sources relative to the shared background area.

Stated Advantages

Improved signal-to-noise by calibrating background noise using shared illumination and alignment.

Enables miniaturization by using fixed light source units and a compact aligned detection arrangement.

Allows both qualitative cutoff-based readout and quantitative analysis by mapping a final measurement value to a previously calculated quantification curve.

Documented Applications

Immunochromatography test-strip readout using a reaction strip with test, control, and background areas, including an LH immunochromatography strip example with cutoff-based and/or calibration-based readout.

Detection of an analyte in a sample for sample types including biological fluids and water-related samples, with biological fluids including blood, plasma, serum, urine, lymph, bone marrow, saliva, milk, ocular fluid, semen, brain extracts, spinal fluid, synovial fluid, thymic fluid, ascites, amniotic fluid, and cell tissue liquid.

Detection in water-related samples including buffer solution, tap water, polluted water, sewage, and ground water.

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