System for quantitative measurement of glycohemoglobin and method for measuring glycohemoglobin
Inventors
Choi, Eui Yul • Nahm, Kie Bong • Kim, Jae Hoon • Jeong, Dong Seok • Park, Sang Yeol • Moon, Joung Dae • Jung, Jin Ha • Kim, Young Min • Jung, So Young • Park, Ae Kyung • Kim, Byeong Chul • Kim, Sung Joong
Assignees
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Publication Number
US-8093057-B2
Publication Date
2012-01-10
Expiration Date
Abstract
The present disclosure provides a device for simultaneously detecting hemoglobin and glycohemoglobin in blood. The device includes a lateral flow assay strip, a laser-induced epifluorescence detection device, and an LED detection device. The present disclosure further provides a method for simultaneously quantifying hemoglobin and glycohemoglobin in blood by an immunological method using the same.
Core Innovation
The invention relates to an assay system for simultaneous quantification of glycohemoglobin (HbA1c) and non-glycohemoglobin/hemoglobin in a point-of-care quantitative system. The system uses an assay device that includes a pad configured to receive a sample comprising glycohemoglobin and non-glycohemoglobin, and a detector mixed with the sample. The detector has specificity in binding with glycohemoglobin while having little specificity in binding with non-glycohemoglobin, and the detector is included in a predetermined amount that is more than sufficient to bind with substantially all glycohemoglobin.
The assay device further includes a strip comprising a chromatographic medium configured to receive the mixture from the pad and let the mixture migrate in a direction. A first detection zone is provided at a first predetermined distance from the pad, and the first detection zone comprises a captor immobilized in that zone with specificity in binding with the detector. The captor is provided in an amount sufficient to capture substantially all the detector that are not bound with glycohemoglobin and reach the first detection zone, with access for detecting an amount of detector captured in the first detection zone.
A second detection zone is provided at a second predetermined distance from the pad, with access for detecting an amount of non-glycohemoglobin and glycohemoglobin that are staying or passing in the second detection zone at a detection time past an initial period of migration. The system includes a first detection device configured to irradiate first light beams to the first detection zone and detect fluorescence from a fluorescent moiety bound to the detector, and a second detection device configured to irradiate second light beams to the second detection zone and detect light emitted from non-glycohemoglobin and glycohemoglobin in response to the second light beams.
Claims Coverage
The independent claims are clm-00001 and clm-00012. They cover two inventive features: a glycohemoglobin-specific detector in predetermined excess, and a two-zone chromatographic assay with fluorescence detection in a first zone and light-emission-based detection in a second zone.
Glycohemoglobin-specific detector in predetermined excess
A pad configured to receive a sample comprising glycohemoglobin and non-glycohemoglobin and a detector for providing a mixture, wherein the detector has specificity in binding with glycohemoglobin while having little specificity in binding with non-glycohemoglobin, and wherein the detector is included in the mixture in a predetermined amount that is more than sufficient to bind with substantially all glycohemoglobin.
Two spatially separated detection zones with captor capture
A strip comprising chromatographic medium configured to receive the mixture from the pad and let the mixture migrate; a first detection zone distanced from the pad in which a captor having specificity in binding with the detector is immobilized and provided in an amount sufficient to capture substantially all detector not bound with glycohemoglobin and reaching the first detection zone, with access for detecting an amount of the detector captured; and a second detection zone distanced from the pad with access for detecting an amount of non-glycohemoglobin and glycohemoglobin staying or passing in the second detection zone at a detection time.
Fluorescence detection of captured detector in first detection zone
A first detection device configured to irradiate first light beams to the first detection zone and to detect fluorescence from a fluorescent moiety bound to the detector in response to the first light beams.
Second detection device for light emitted from non-glycohemoglobin and glycohemoglobin
A second detection device configured to irradiate second light beams to the second detection zone and to detect light emitted from non-glycohemoglobin and glycohemoglobin in response to the second light beams.
Method migration with capture at first detection zone
Providing an assay device with a pad and strip as defined, providing in the pad a mixture comprising glycohemoglobin in an unknown amount, non-glycohemoglobin in an unknown amount and a detector in a predetermined amount (with the detector specificity/excess as defined), permitting the mixture to migrate in the strip such that substantially all detector not bound with glycohemoglobin are captured in the first detection zone upon reaching the first detection zone, and measuring an amount of the detector captured in the first detection zone.
Timed measurement in second detection zone after migration
Measuring an amount of non-glycohemoglobin and glycohemoglobin that are staying or passing in the second detection zone at a detection time which is past a period after initial migration of the mixture in the strip.
Across clm-00001 and clm-00012, the core inventive coverage is the use of a glycohemoglobin-specific detector in predetermined excess with two distanced detection zones on a strip, where captured unbound detector is quantified via fluorescence in the first detection zone and non-glycohemoglobin/glycohemoglobin are quantified via light emission in the second detection zone, with the method measuring the second zone at a detection time past initial migration.
Stated Advantages
Documented Applications
Not explicitly described in patent.
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