Distinguishing between a bacterial and non-bacterial infection at the point of care
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
G01N-031/22
C12Q-001/04
C12Q-001/32
C12Q-001/48
출원번호
US-0319305
(2014-06-30)
등록번호
US-9562253
(2017-02-07)
발명자
/ 주소
Turner, Ronald
출원인 / 주소
POINT OF CARE DIAGNOSTICS, LLC
대리인 / 주소
Brisbin, Esq., Richard A.
인용정보
피인용 횟수 :
1인용 특허 :
15
초록▼
A method includes obtaining a sample from a patient; applying, to the sample, a reagent to cause bacterial cells to release adenosine triphosphate (ATP) when the sample includes the bacterial cells; applying another reagent that reacts with the ATP to form a colorimetric agent; detecting whether the
A method includes obtaining a sample from a patient; applying, to the sample, a reagent to cause bacterial cells to release adenosine triphosphate (ATP) when the sample includes the bacterial cells; applying another reagent that reacts with the ATP to form a colorimetric agent; detecting whether the sample changes in appearance as observed by an unaided eye of a practitioner when a concentration of the agent is greater than a threshold; identifying a time period from when the other reagent is applied to when the change in appearance is detected; and determines a severity, of a bacterial infection, based on the time period. The severity corresponds to a severity level when the time period is less than a duration of a point of care visit by a first amount, or a higher severity level when the time period is less than the duration by more than the first amount.
대표청구항▼
1. A method for determining whether a sample, obtained from a patient, includes a bacterial infection, the method comprising: obtaining, from the patient, the sample that includes a plurality of cells of the patient;applying, to the sample, one or more first reagents to cause adenosine triphosphate
1. A method for determining whether a sample, obtained from a patient, includes a bacterial infection, the method comprising: obtaining, from the patient, the sample that includes a plurality of cells of the patient;applying, to the sample, one or more first reagents to cause adenosine triphosphate (ATP) to be released from bacterial cells, when the plurality of cells include the bacterial cells;applying, to the sample, a second reagent, in liquid form, to react with the ATP that is released from the bacterial cells, when the plurality of cells include the bacterial cells, the reaction with the ATP forming a colorimetric agent that can be detected by an unaided eye of a medical practitioner;determining whether the colorimetric agent is detected by the unaided eye of the medical practitioner;identifying a time period from when the second reagent is applied to when the colorimetric agent is detected by the unaided eye of the medical practitioner; anddetermining that the patient: has the bacterial infection when the time period, from when the second reagent is applied to when the colorimetric agent is detected by the unaided eye of the medical practitioner, is less than a threshold, the threshold corresponding to a duration of a point of care office visit between the patient and the medical practitioner, ordoes not have the bacterial infection when the time period, from when the second reagent is applied to when the colorimetric agent is detected by the unaided eye of the medical practitioner, is not less than the threshold. 2. The method of claim 1, where the duration of the point of care office visit is less than or approximately equal to 30 minutes. 3. The method of claim 1 further comprising: determining that the patient does not have the bacterial infection when the colorimetric agent is not detected by the unaided eye of the medical practitioner. 4. The method of claim 1, where the change in appearance can be detected by the medical practitioner without using a sensing device or an amplifying device. 5. The method of claim 1, where the colorimetric indicator corresponds to a reduction of formazane dye that occurs when the second reagent reacts with the ATP. 6. The method of claim 1, where determining the level of severity of the bacterial infection further includes: determining whether the time period is greater than a first threshold,determining that the level of severity of the bacterial infection corresponds to: a first level of severity when the time period is not greater than the first threshold, anda second level of severity when the time period is greater than the first threshold, the second level of severity being less than the first level of severity. 7. The method of claim 1, further comprising: detecting the colorimetric agent, after applying the second reagent to the sample, when the sample has changed from at least one of: a first color to a second color, the first color being different than the second color;a first pattern to a second pattern, the first pattern being different than the second pattern; ora first texture to a second texture, the first texture being different than the second texture. 8. The method of claim 1, where applying the one or more first reagents further comprises: applying, to the sample, a first reagent, of the one or more first reagents, to cause background ATP to be released from somatic cells, of the plurality of cells, associated with the patient; andapplying, to the sample, a different first reagent, of the one or more first reagents, to cause the background ATP to be removed from the sample. 9. A method for performing an assay on a sample from a patient to detect a bacterial infection or a severity level of the bacterial infection, the method comprising: obtaining, from the patient, the sample that includes a plurality of cells of the patient;applying, to the sample, one or more first reagents to cause adenosine triphosphate (ATP) to be released from bacterial cells when the sample includes the bacterial cells;applying, to the sample, a second reagent in liquid form to cause the second reagent to react with the released ATP when the sample includes the bacterial cells, the reaction forming a colorimetric agent having a concentration that is based on a quantity of the released ATP;detecting whether the sample has changed in appearance, the change in appearance being detected by an unaided eye of a medical practitioner when the concentration of the colorimetric agent is greater than a threshold;identifying a time period from when the second reagent is applied to the sample to when the change in appearance is detected; anddetermining a level of severity, of the bacterial infection, based on the time period, from when the second reagent is applied to the sample to when the change in appearance is detected, the level of severity corresponding to at least one of: a first level of severity when the time period is less than a duration of a point of care visit by a first amount,a second level of severity, that is more severe than the first level of severity, when the time period is less than the duration of the point of care visit by a second amount, the second amount being greater than the first amount, ora third level of severity, that corresponds to an absence of the bacterial infection, when the time period is not less than the duration of the point of care visit. 10. The method of claim 9 where the duration of the point of care visit is less than or approximately equal to thirty minutes. 11. The method of claim 9, where the first level of severity corresponds to a first quantity of the bacterial cells and the second level of severity corresponds to a second quantity of the bacterial cells, the first quantity of bacterial cells being less than the second quantity of bacterial cells. 12. The method of claim 9, where the colorimetric agent corresponds to a reduction of formazane dye that occurs when the second reagent reacts with the ATP. 13. The method of claim 9, where a quantity of the ATP is approximately equal to zero when the sample does not include the bacterial cells, or where the concentration of the colorimetric agent is approximately equal to zero when the quantity of the ATP is approximately equal to zero. 14. The method of claim 9 where when applying the one or more first reagents further comprises: applying, to the sample, a first reagent, of the one or more first reagents, to: cause background ATP to be release from somatic cells, of the plurality of cells, within the sample, andhydrolyze the released background ATP to cause the background ATP to be removed from or become inert within the sample; andapplying, to the sample and after applying the particular reagent, a different first reagent, of the one or more first reagents, to cause the ATP to be released from the bacterial cells when the sample includes the bacterial cells. 15. A method for determining a level of severity of a bacterial infection within a sample obtained from a patient, the method comprising: receiving the sample;applying, to the sample, a first reagent to release and remove background adenosine triphosphate (ATP) from the sample when the sample includes somatic cells of the patient;applying, to the sample, a second reagent to release ATP from bacterial cells of the patient when the sample includes the bacterial cells;applying, to the sample, a third reagent to react with the released ATP to form a colorimetric agent when the sample includes the bacterial cellsmonitoring, the sample, to detect whether the colorimetric agent causes the reagent to change in appearance;detecting that the reagent has changed in appearance, the change in appearance being detected by an unaided eye of an observer or without using a luminometer or optical amplification device;identifying a time period from a first time when the third reagent is applied to the sample to a second time when the reagent changing in appearance is detected; anddetermining a level of severity, of the bacterial infection, based on the time period, from a first time when the third reagent is applied to the sample to a second time when the reagent changing in appearance is detected, the level of severity corresponding to at least one of: a first level of severity when the time period is less than a threshold by a first amount, the threshold being associated with a typical duration of a point of care visit between the patient and a medical practitioner,a second level of severity when the time period is less than the threshold by an amount that is less than the first amount, the second level of severity being less severe than the first level of severity, ora third level of severity, when the time period is not less than the threshold, the third level of severity indicating that the sample does not include the bacterial infection. 16. The method of claim 15, where the typical duration of the point of care visit is less than or approximately equal to thirty minutes. 17. The method of claim 15, where the first reagent includes at least one of: a first constituent agent that causes somatic cell membranes to become permeable to the background ATP, which enables the background ATP to be released from the somatic cells; ora second constituent agent that hydrolyzes or binds the released background ATP to render the background ATP inert, inactive, and/or effectively removed from the sample. 18. The method of claim 15, where the second reagent includes at least one of: a first constituent agent to cause bacterial cell membranes, associated with the bacterial cells, to become permeable to ATP to enable the ATP to be released from the bacterial cells when the sample includes the bacterial cells. 19. The method of claim 15, where the third reagent includes at least one of: hexokinase,glucose,magnesium sulfate heptahydrate,glucose 6 phosphate dehydrogenase,nicotinamide adenine dinucleotide (NAD),diaphorase,formazane dye, ora buffer. 20. The method of claim 15, where the third reagent includes at least one of: hexokinase within a range of 0.5 percent to 2.0 percent of the third reagent by volume at approximately 125 enzyme units per milligram,glucose within a range of 2.0 percent to 10.0 percent of the third reagent by volume,magnesium sulfate heptahydrate within a range of 2.0 percent to 6.0 percent of the third reagent by volume at approximately 2.0 moles per liter (M),glucose 6 phosphate dehydrogenase within a range of 0.1 percent to 0.6 percent of the third reagent by volume at approximately 450 enzyme units per milligram,nicotinamide adenine dinucleotide (NAD) within a range of 5.0 percent to 10.0 percent of the third reagent by volume,diaphorase within a range of 0.5 percent to 3.0 percent of the third reagent by volume at approximately 100 enzyme units per milligram,formazane dye within a range of approximately 6.0 percent to approximately 15.0 percent of the reagent by volume, ora buffer within a range of approximately 30.0 percent to approximately 50.0 percent of the third reagent by volume at approximately 2.0 moles per liter. 21. The method of claim 20, where the reagent includes at least one of: phosphofructokinase or glucose dehydrogenase as a substitute for the hexokinase,lactose as a substitute for the glucose,magnesium hexahydrate as a substitute for the magnesium sulfate heptahydrate,lactate dehydrogenase as a substitute for the glucose 6 phosphate dehydrogenase,flavin adenine dinucleotide as a substitute for the nicotinamide adenine dinucleotide (NAD),glutathione reductase or lipoyl dehydrogenase as a substitute for the diaphorase, orresazurin as a substitute for the formazane dye. 22. The method of claim 15, where the colorimetric agent corresponds to a reduced formazane dye.
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이 특허에 인용된 특허 (15)
Bruce J. Bryan ; Stephen Gaalema ; Randall B. Murphy, Apparatus and method for detecting and identifying infectious agents.
Fletcher James C. Administrator of the National Aeronautics and Space Administration ; with respect to an invention of ( Baltimore MD) Chappelle Emmett W. (Baltimore MD) Picciolo Grace L. (Tantallon , Application of luciferase assay for ATP to antimicrobial drug susceptibility.
Fletcher James C. Administrator of the National Aeronautics and Space Administration ; with respect to an invention of ( Tantallon MD) Picciolo Grace L. (Tantallon MD) Chappelle Emmett W. (Baltimore , Determination of antimicrobial susceptibilities on infected urines without isolation.
Kolehmainen Seppo E. (Rte. 2 ; Riveredge Dr. ; Box 66 X Titusville FL 32780) Tarkkanen Veikko (Postbus 31101 6370 AC Schaesberg NLX), Selective determination of nucleotides in viable somatic and microbial cells.
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