Kits and methods for determining physiologic level(s) and/or range(s) of hemoglobin and/or disease state
Inventors
Lam, Wilbur A. • Byrd, Morgan • Tyburski, Erika • McKinnon, Michael L. • O'Connor, Siobhan • Hotaling, Nathan A.
Assignees
Emory University • Georgia Tech Research Institute • Georgia Tech Research Corp • Childrens Healthcare of Atlanta Inc • US Department of Health and Human Services
Publication Number
US-10234466-B2
Publication Date
2019-03-19
Expiration Date
2033-03-15
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Abstract
Diagnostic kits and methods configured to rapidly and non-invasively determine physiologic levels of hemoglobin. A diagnostic kit may include a chamber pre-filled with an indicator, the indicator solution including a tetramethylbenzidine (TMB) solution, the indicator being configured to change color; a collection device configured to collect a test sample from a subject. The kit may also include a hemoglobin physiologic level identifier legend, the legend indicating 1) at least one color of the indicator and 2) a physiologic level and/or range of the hemoglobin and/or disease state associated with the color.
Core Innovation
The invention relates to diagnostic kits and methods configured to rapidly and non-invasively determine physiologic levels and/or ranges of hemoglobin and/or disease states from a test sample. The kit includes a chamber pre-filled with an indicator solution such as a tetramethylbenzidine (TMB) solution that changes color upon contact with the hemoglobin in the sample. The kit also includes a sample collection device configured to collect a test sample from a subject, and a hemoglobin physiologic level identifier legend indicating different colors of the indicator and the associated physiologic levels or ranges of hemoglobin and/or disease states linked to those colors.
The kits and methods facilitate home testing or self-monitoring of hemoglobin levels, enabling the user to determine whether they have anemia, polycythemia, or a healthy state. The indicator solution may include additional components such as buffer solutions and preservatives with concentrations tailored to detect different hemoglobin levels and disease states. The diagnostic device can include multiple chambers separated by seals and features such as observation regions for visual assessment of color change.
The problem being solved arises from the limitations of conventional anemia testing methods conducted in laboratory settings via blood drawing and complete blood count (CBC) analysis. These methods are invasive, require professional blood sampling, and are unsuitable for home testing or self-monitoring. The invention addresses the need for new diagnostic tools that enable rapid, user-friendly, and non-invasive hemoglobin level determination at home or outside clinical settings.
Claims Coverage
The patent contains two independent claims directed to methods involving placing a whole blood sample into a prefilled chamber with a TMB indicator solution, causing a colorimetric change, and interpreting the color using a legend to determine hemoglobin levels or diagnose hemoglobin conditions.
Method of determining physiologic hemoglobin levels using TMB indicator
The method comprises placing a whole blood sample into a testing device chamber prefilled with a tetramethylbenzidine (TMB) solution, shaking the device to mix and cause the indicator to change color based on hemoglobin level, visually comparing the color with a legend including blue, green, yellow, orange, and red colors associated with physiologic hemoglobin ranges, and determining the hemoglobin level based on the color, wherein the color order correlates to increasing hemoglobin levels from blue to red.
Method of diagnosing hemoglobin condition based on color indicator
The method comprises placing a whole blood sample into a testing device chamber prefilled with a TMB solution, shaking to cause color change of the indicator reflecting hemoglobin level, visually comparing the color with a legend having at least blue, green, yellow, orange, and red colors associated with physiologic hemoglobin ranges, and determining whether the subject has a hemoglobin condition (such as anemia or polycythemia) based on the color, with the color sequence corresponding to ascending hemoglobin levels.
The independent claims focus on methods for determining hemoglobin levels or diagnosing hemoglobin-related diseases via a colorimetric assay using a TMB indicator solution that changes color when mixed with whole blood, interpreted using a multicolor legend that correlates specific colors to hemoglobin physiologic levels and disease states.
Stated Advantages
Enables rapid, non-invasive, and user-friendly determination of physiologic hemoglobin levels.
Facilitates home-testing and self-monitoring without the need for laboratory equipment or professional blood drawing.
Provides a colorimetric, visual indicator that can distinguish among different ranges of hemoglobin and associated disease states, such as anemia and polycythemia.
Documented Applications
Use as diagnostic kits and methods for detecting and monitoring anemia and polycythemia in subjects via home-testing or self-monitoring.
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