US2019212345A1PendingUtilityA1

Kits and methods for determining physiologic level(s) and/or range(s) of hemoglobin and/or disease state

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Assignee: UNIV EMORYPriority: Aug 9, 2012Filed: Mar 14, 2019Published: Jul 11, 2019
Est. expiryAug 9, 2032(~6 yrs left)· nominal 20-yr term from priority
Inventors:Wilbur LamMorgan ByrdErika TyburskiMichael L. MckinnonSiobhan O'ConnorNathan A. Hotaling
A61B 5/150305A61B 5/150412A61B 5/15105A61B 5/150343A61B 5/150022G01N 33/721A61B 5/150358G01N 2800/22A61B 5/150755A61B 5/150351A61B 5/157A61B 5/150503
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Claims

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.

Claims

exact text as granted — not AI-modified
1 . A kit comprising:
 a chamber pre-filled with an indicator solution, the indicator solution including a tetramethylbenzidine (TMB) solution, the indicator solution changing color upon directly contacting a whole blood sample, the color change based on a hemoglobin level in the whole blood sample; and   a collection device that collects the whole blood sample obtained from a subject, wherein the whole blood sample is placed into the chamber via the collection device; and   a hemoglobin physiologic level identifier legend including blue, green, yellow, orange, and red colors and a physiologic level and/or range of the hemoglobin associated with each color,   wherein a relationship of the colors with respect to the associated physiologic level or range of hemoglobin is blue<green<yellow<orange<red.   
     
     
         2 . (canceled) 
     
     
         3 . The kit according to  claim 1 , wherein the indicator solution further includes a buffer solution. 
     
     
         4 . The kit according to  claim 3 , wherein the indicator solution further includes a preservative solution. 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . The kit according to  claim 1 , wherein a blue color indicates an anemic disease state and/or less than about 9 g/dL of hemoglobin. 
     
     
         10 . The kit according to  claim 1 , wherein a green color and/or yellow color indicates about 10-11 g/dL of hemoglobin. 
     
     
         11 . The kit according to  claim 1 , wherein a green color and/or yellow color indicates an anemic disease state. 
     
     
         12 . The kit according to  claim 1 , wherein an orange color indicates about 12-14 g/dL of hemoglobin. 
     
     
         13 . The kit according to  claim 1 , wherein an orange color indicates a healthy state. 
     
     
         14 . The kit according to  claim 1 , wherein a red color indicates greater than about 14 g/dL of hemoglobin. 
     
     
         15 . The kit according to  claim 1 , wherein a red color indicates a healthy state. 
     
     
         16 . The kit according to  claim 1 , wherein at least one color indicates an anemic disease state. 
     
     
         17 . The kit according to  claim 1 , the kit further comprising:
 a puncture device.   
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . (canceled)

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