Point of care sepsis assay device and method

a sepsis and test device technology, applied in the field of disposable assay test devices, can solve the problems of organ dysfunction and death, and patients with systemic infection are often difficult to distinguish from patients with similar clinical signs and laboratory findings

Inactive Publication Date: 2018-06-28
SEPSIS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

Enables rapid and accurate detection of sepsis with a simple, portable device that uses whole blood samples, reducing the need for extensive laboratory procedures and providing immediate results, improving patient outcomes by facilitating early diagnosis and treatment.

Problems solved by technology

In response to microbes or viruses in the blood, urine, lungs, skin, or other tissues, the body may develop a systemic inflammatory response, eventually resulting in organ dysfunction and death.
Patients with systemic infection are often difficult to distinguish from patients with similar clinical signs and laboratory findings without infection.
Further, it requires time to grow a culture of organism from a blood sample to confirm the presence of infective bacteria and the results may be incorrect due to contamination, etc.
There is a continuing need to find early indicators or markers of infection, SIRS and hemostatic dysfunction due to lack of specificity of current methods of diagnosis.

Method used

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  • Point of care sepsis assay device and method
  • Point of care sepsis assay device and method
  • Point of care sepsis assay device and method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0051]1. Assay Performed on a Phillips PU8730 Spectrophotometer:[0052]A spectrophotometer cell that had a pathlength of 1.5 mm was used to test the assay. The absorbance was set to 480 nm. For the blank reading, 2 μl of PBS was added to a biphasic plasma sample (18 μl). This mixture was mixed well and added to the cell (20 μl). The door was then closed and readings were taken every 10 seconds up to 4 minutes. The cell was then washed with PBS and allowed to dry. This process was repeated with the PBS being substituted for 100 mM CaCl2 (2 μl).[0053]This entire procedure was repeated for each of the tested plasma samples.

[0054]2. Assay Performed on the Prototype Device Platform with Reaction Channel:[0055]A clear reaction chamber was constructed to effectively monitor the sepsis turbidity assay. In order to achieve a prototype card two pieces of topaz plastic were used with the inclusion of clear films provided by Cadillac Plastic Limited (8010MC.175). One piece was cut in half and a ...

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Abstract

Disclosed is a point of care sepsis assay comprising a disposable assay cartridge with a sample inlet for a blood sample, a filter to isolate blood plasma, a source of multivalent cations to cause a turbidity change in the plasma sample and a transparent window to measure the change in turbidity and the use of said assay in the diagnosis of sepsis.

Description

FIELD OF THE INVENTION[0001]The present invention relates generally to the field of disposable assay test devices, particularly for use in point-of-care assays. The invention further relates to the use of such devices, including kits comprising such devices, to facilitate the accurate measurement of the levels of sepsis in the blood.BACKGROUND[0002]Sepsis, or blood poisoning, is a potentially deadly medical condition characterized by a whole-body inflammatory state triggered by an infection. Sepsis is a vast clinical entity that takes many forms. The pathophysiology of a host response to infection is complex and the signs and symptoms of systemic inflammation may have an infectious or non-infectious etiology and are not specific. In response to microbes or viruses in the blood, urine, lungs, skin, or other tissues, the body may develop a systemic inflammatory response, eventually resulting in organ dysfunction and death. Patients with systemic infection are often difficult to distin...

Claims

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Application Information

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Patent Type & AuthorityApplications(United States)
IPC IPC(8): G01N33/49G01N15/06G01N21/59
CPCG01N2015/0687G01N21/59G01N33/49G01N33/491G01N15/06
InventorNICHOLLS, ANTHONY
OwnerSEPSIS